For Patients and Caregivers
Important Safety Information
What is DARZALEX® (daratumumab)?
DARZALEX® is a prescription medicine used to treat adults with multiple myeloma:
- In combination with the medicines lenalidomide and dexamethasone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant) and in people who have received at least one prior medicine to treat multiple myeloma
- In combination with the medicines bortezomib, melphalan, and prednisone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant)
- In combination with the medicines bortezomib, thalidomide, and dexamethasone in newly diagnosed people who are eligible to receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant)
- In combination with the medicines bortezomib and dexamethasone in people who have received at least one prior medicine to treat multiple myeloma
- In combination with the medicines carfilzomib and dexamethasone in people who have received one to three prior medicines to treat multiple myeloma
- In combination with the medicines pomalidomide and dexamethasone in people who have received at least two prior medicines to treat multiple myeloma, including lenalidomide and a proteasome inhibitor
- Alone in people who have received at least three prior medicines, including a proteasome inhibitor and an immunomodulatory agent, or did not respond to a proteasome inhibitor and an immunomodulatory agent
It is not known if DARZALEX® is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Do not receive DARZALEX® if you have a history of a severe allergic reaction to daratumumab or any of the ingredients in DARZALEX®. See below for a complete list of ingredients.
Before you receive DARZALEX®, tell your healthcare provider about all of your medical conditions, including if you:
- have a history of breathing problems
- have had shingles (herpes zoster)
- have ever had or might now have a hepatitis B infection as DARZALEX® could cause hepatitis B virus to become active again. Your healthcare provider will check you for signs of this infection before, during, and for some time after treatment with DARZALEX®. Tell your healthcare provider right away if you get worsening tiredness or yellowing of your skin or white part of your eyes
-
are pregnant or plan to become pregnant. DARZALEX® may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with DARZALEX®
- Females who are able to become pregnant should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of DARZALEX®. Talk to your healthcare provider about birth control methods that you can use during this time
-
Before starting DARZALEX® in combination with lenalidomide, pomalidomide, or thalidomide, females and males must agree to the instructions in the lenalidomide, pomalidomide, or thalidomide REMS program
- The lenalidomide, pomalidomide, and thalidomide REMS has more information about effective methods of birth control, pregnancy testing, and blood donation for females who can become pregnant
- For males who have female partners who can become pregnant, there is information in the lenalidomide, pomalidomide, and thalidomide REMS about sperm donation and how lenalidomide, pomalidomide, and thalidomide can pass into human semen
- are breastfeeding or plan to breastfeed. It is not known if DARZALEX® passes into your breast milk
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive DARZALEX®?
- DARZALEX® may be given alone or together with other medicines used to treat multiple myeloma
- DARZALEX® will be given to you by your healthcare provider by intravenous (IV) infusion into your vein
- Your healthcare provider will decide the time between doses as well as how many treatments you will receive
- Your healthcare provider will give you medicines before each dose of DARZALEX® and after each dose of DARZALEX® to help reduce the risk of infusion-related reactions
- If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment
DARZALEX® may cause serious reactions, including:
- Infusion-related reactions. Infusion-related reactions are common with DARZALEX® and can be severe or serious. Your healthcare provider may temporarily stop your infusion or completely stop treatment with DARZALEX® if you have infusion-related reactions. Get medical help right away if you get any of the following symptoms: shortness of breath or trouble breathing, dizziness or lightheadedness (hypotension), cough, wheezing, throat tightness, runny or stuffy nose, headache, itching, nausea, vomiting, chills, fever
- Changes in blood tests. DARZALEX® can affect the results of blood tests to match your blood type. These changes can last for up to 6 months after your final dose of DARZALEX®. Your healthcare provider will do blood tests to match your blood type before you start treatment with DARZALEX®. Tell all of your healthcare providers that you are being treated with DARZALEX® before receiving blood transfusions
- Decreases in blood cell counts. DARZALEX® can decrease white blood cell counts, which help fight infections, and blood cells called platelets, which help to clot blood. Your healthcare provider will check your blood cell counts during treatment with DARZALEX®. Tell your healthcare provider if you develop fever or have signs of bruising or bleeding
The most common side effects of DARZALEX® include: tiredness; nausea; diarrhea; shortness of breath; feeling weak; fever; cough; cold-like symptoms (upper respiratory infection); nerve damage causing tingling, numbness, or pain; swollen hands, ankles, or feet; constipation.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of DARZALEX®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of DARZALEX®
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider or pharmacist for information about DARZALEX® that is written for health professionals.
Active ingredient: daratumumab.
Inactive ingredients: glacial acetic acid, mannitol, polysorbate 20, sodium acetate trihydrate, sodium chloride, and water for injection.
Please click here to see the Important Product Information.
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What is DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)?
DARZALEX FASPRO® is a prescription medicine used to treat adult patients with multiple myeloma:
- in combination with the medicines bortezomib, melphalan, and prednisone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant)
- in combination with the medicines lenalidomide and dexamethasone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant) and in people whose multiple myeloma has come back or did not respond to treatment, who have received at least one prior medicine to treat multiple myeloma
- in combination with the medicines bortezomib, thalidomide, and dexamethasone in newly diagnosed people who are eligible to receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant)
- in combination with the medicines bortezomib and dexamethasone in people who have received at least one prior medicine to treat multiple myeloma
- alone in people who have received at least three prior medicines, including a proteasome inhibitor and an immunomodulatory agent, or did not respond to a proteasome inhibitor and an immunomodulatory agent
DARZALEX FASPRO® is a prescription medicine also used in combination with the medicines bortezomib, cyclophosphamide and dexamethasone in patients with newly diagnosed light chain (AL) amyloidosis. For light chain (AL) amyloidosis, DARZALEX FASPRO® is approved based on medical studies that measured how many patients responded to treatment. Continued approval may depend on the benefit demonstrated by additional data from medical studies.
It is not known if DARZALEX FASPRO® is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Do not receive DARZALEX FASPRO® if you have a history of a severe allergic reaction to daratumumab or any of the ingredients in DARZALEX FASPRO®.
Before you receive DARZALEX FASPRO®, tell your healthcare provider about all of your medical conditions, including if you:
- have a history of breathing problems
- have had shingles (herpes zoster)
- have ever had or might now have a hepatitis B infection as DARZALEX FASPRO® could cause hepatitis B virus to become active again. Your healthcare provider will check you for signs of this infection before, during, and for some time after treatment with DARZALEX FASPRO®. Tell your healthcare provider right away if you get worsening tiredness or yellowing of your skin or white part of your eyes.
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are pregnant or plan to become pregnant. DARZALEX FASPRO® may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with DARZALEX FASPRO®.
- Females who are able to become pregnant should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of DARZALEX FASPRO®. Talk to your healthcare provider about birth control methods that you can use during this time.
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Before starting DARZALEX FASPRO® in combination with lenalidomide or thalidomide, females and males must agree to the instructions in the lenalidomide or thalidomide REMS program.
- The lenalidomide and thalidomide REMS have more information about effective methods of birth control, pregnancy testing, and blood donation for females who can become pregnant.
- For males who have female partners who can become pregnant, there is information in the lenalidomide and thalidomide REMS about sperm donation and how lenalidomide and thalidomide can pass into human semen.
- are breastfeeding or plan to breastfeed. It is not known if DARZALEX FASPRO® passes into your breast milk.
Before you receive DARZALEX FASPRO® for light chain (AL) amyloidosis, tell your healthcare provider if you have a history of heart problems. DARZALEX FASPRO® should not be used in light chain (AL) amyloidosis patients with highly advanced heart disease outside of clinical trials.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
DARZALEX FASPRO® may cause serious reactions, including:
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Serious allergic reactions and other severe injection-related reactions. Serious allergic reactions and reactions due to release of certain substances by your body (systemic) that can lead to death, can happen with DARZALEX FASPRO®. Tell your healthcare provider or get medical help right away if you get any of these symptoms during or after an injection of DARZALEX FASPRO®.
- shortness of breath or trouble breathing
- dizziness or lightheadedness (hypotension)
- cough
- wheezing
- heart beating faster than usual
- low oxygen in the blood (hypoxia)
- throat tightness
- runny or stuffy nose
- headache
- itching
- high blood pressure
- nausea
- vomiting
- chills
- fever
- chest pain
- Injection site reactions. Skin reactions at or near the injection site (local), including injection site reactions, can happen with DARZALEX FASPRO®. Symptoms may include itching, swelling, bruising, or redness of the skin. These reactions sometimes happen more than 24 hours after an injection of DARZALEX FASPRO®.
- Decreases in blood cell counts. DARZALEX FASPRO® can decrease white blood cell counts, which help fight infections, and blood cells called platelets, which help to clot blood. Your healthcare provider will check your blood cell counts during treatment with DARZALEX FASPRO®. Tell your healthcare provider if you develop fever or have signs of bruising or bleeding.
- Changes in blood tests. DARZALEX FASPRO® can affect the results of blood tests to match your blood type. These changes can last for up to 6 months after your final dose of DARZALEX FASPRO®. Your healthcare provider will do blood tests to match your blood type before you start treatment with DARZALEX FASPRO®. Tell all of your healthcare providers that you are being treated with DARZALEX FASPRO® before receiving blood transfusions.
- Heart problems in patients with light chain (AL) amyloidosis. Heart problems, in some cases fatal, have occurred. Your healthcare provider will monitor you closely during treatment with DARZALEX FASPRO®. Call your healthcare provider right away if any of the following symptoms occur: chest pain, feeling faint, swollen legs, shortness of breath, or abnormal heart rhythm.
The most common side effects of DARZALEX FASPRO® when used alone include cold-like symptoms (upper respiratory infection).
The most common side effects of DARZALEX FASPRO® used in combination therapy include:
- tiredness
- nausea
- diarrhea
- shortness of breath
- trouble sleeping
- fever
- cough
- muscle spasms
- back pain
- vomiting
- cold-like symptoms (upper-respiratory infection)
- nerve damage causing tingling, numbness, or pain
- constipation
- lung infection (pneumonia)
- swollen hands, ankles, or feet
These are not all the possible side effects of DARZALEX FASPRO®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of DARZALEX FASPRO®
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider or pharmacist for information about DARZALEX FASPRO® that is written for health professionals.
Active ingredient: daratumumab and hyaluronidase-fihj
Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 20, sorbitol, water for injection
Please click here to see the Product Information.
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What is EDURANT® (rilpivirine)?
EDURANT® is a prescription medicine that is used with:
-
other antiretroviral medicines to treat Human Immunodeficiency Virus (HIV-1) in people 12 years of age and older and who weigh at least 77 lbs (35 kg) who:
- have never taken HIV medicines before, and
- have an amount of HIV-1 in their blood (this is called ‘viral load’) that is no more than 100,000 copies/mL.
- oral VOCABRIA (cabotegravir) for short term treatment of HIV-1 infection in adults when their healthcare professional determines that they meet certain requirements.
HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
If you take EDURANT® in combination with oral VOCABRIA (cabotegravir), you should also read the Patient Information that comes with oral VOCABRIA (cabotegravir).
It is not known if EDURANT® is safe and effective in children less than 12 years of age or who weigh less than 77 lbs (35 kg).
IMPORTANT SAFETY INFORMATION
Who should not take EDURANT®?
Do not take EDURANT® if you also take:
-
anti-seizure medicines:
- carbamazepine
- oxcarbazepine
- phenobarbital
- phenytoin
-
anti-tuberculosis (anti-TB) medicines:
- rifampin
- rifapentine
-
proton pump inhibitor (PPI) medicine for certain stomach or intestinal problems:
- esomeprazole
- lansoprazole
- omeprazole
- pantoprazole sodium
- rabeprazole
- more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate
- St. John’s wort (Hypericum perforatum)
What should I tell my healthcare professional before taking EDURANT®?
Before taking EDURANT®, tell your healthcare professional about all your medical conditions, including if you:
- have or had liver problems, including hepatitis B or C virus infection
- have kidney problems
- have ever had a mental health problem
- are pregnant or plan to become pregnant. It is not known if EDURANT® will harm your unborn baby. Tell your healthcare professional if you become pregnant during treatment with EDURANT®
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are breastfeeding or plan to breastfeed. Do not breastfeed if you take EDURANT®
- You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
- It is not known if EDURANT® passes into your breast milk. Talk with your healthcare professional about the best way to feed your baby during EDURANT® treatment.
Tell your healthcare professional about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Some medicines interact with EDURANT®. Keep a list of your medicines to show your healthcare professional and pharmacist when you get a new medicine. You can ask your healthcare professional or pharmacist for a list of medicines that interact with EDURANT®.
Do not start taking a new medicine without telling your healthcare professional. Your healthcare professional can tell you if it is safe to take EDURANT® with other medicines.
How should I take EDURANT®?
- Take EDURANT® every day exactly as your healthcare professional tells you to.
- Take EDURANT® 1 time each day with a meal. A protein drink alone does not replace a meal.
- Do not change your dose or stop taking EDURANT® without first talking with your healthcare professional. Stay under the care of your healthcare professional during treatment with EDURANT®.
- Do not miss a dose of EDURANT®.
- If you take an H2-receptor antagonist (famotidine, cimetidine, nizatidine, or ranitidine), you should take these medicines at least 12 hours before or at least 4 hours after you take EDURANT®.
- If you take antacids, or other products that contain aluminum, calcium carbonate, or magnesium hydroxide, you should take these medicines at least 2 hours before or at least 4 hours after you take EDURANT®.
- If you miss a dose of EDURANT® within 12 hours of the time you usually take it, take your dose of EDURANT® with a meal as soon as possible. Then, take your next dose of EDURANT® at the regularly scheduled time. If you miss a dose of EDURANT® by more than 12 hours of the time you usually take it, wait and then take the next dose of EDURANT® at the regularly scheduled time.
- Do not take more than your prescribed dose to make up for a missed dose.
- If you take too much EDURANT®, call your healthcare professional or go to the nearest hospital emergency room right away.
- When your supply of EDURANT® starts to run low, get more from your healthcare professional or pharmacy. It is important not to run out of EDURANT®. The amount of HIV in your blood may increase if the medicine is stopped even for a short time.
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When your healthcare professional prescribes use of EDURANT® with oral VOCABRIA (cabotegravir):
- Take EDURANT® and oral VOCABRIA (cabotegravir) once a day at approximately the same time with a meal.
- You will receive treatment with EDURANT® tablets in combination with oral VOCABRIA (cabotegravir) tablets for one month (at least 28 days) before you receive the long-acting medicine called CABENUVA (cabotegravir; rilpivirine extended-release injectable suspensions) for the first time. This will allow your healthcare professional to assess how well you tolerate these medicines.
- Your final dose of EDURANT® and oral VOCABRIA should be taken on the same day you receive your first CABENUVA injections.
What are the possible side effects of EDURANT®?
EDURANT® can cause serious side effects including:
-
Severe skin rash and allergic reactions. Skin rash is a common side effect of EDURANT®. Skin rash can be serious. Call your healthcare professional right away if you get a rash. In some cases, rash and allergic reaction may need to be treated in a hospital.
If you get a rash with any of the following symptoms, stop taking EDURANT® and get medical help right away:
- fever
- skin blisters
- mouth sores
- redness or swelling of the eyes (conjunctivitis)
- swelling of the face, lips, mouth, tongue, or throat
- trouble breathing or swallowing
- pain on the right side of the stomach (abdominal) area
- dark-colored urine “tea colored”
- Change in liver enzymes. People with a history of hepatitis B or C virus infection or who have certain liver function test changes may have an increased risk of developing new or worsening liver problems during treatment with EDURANT®. Liver problems have also happened during treatment with EDURANT® in people without a history of liver disease. Your healthcare professional may need to do tests to check your liver enzymes before and during treatment with EDURANT®.
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Depression or mood changes. Tell your healthcare professional right away if you have any of the following symptoms:
- feeling sad or hopeless
- feeling anxious or restless
- have thoughts of hurting yourself (suicide) or have tried to hurt yourself
- Changes in body fat can happen in people who take HIV medicine. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these problems are not known.
- Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare professional right away if you start having any new symptoms after starting your HIV-1 medicine.
The most common side effects of EDURANT® include depression, headache, trouble sleeping (insomnia), and rash.
This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare professional right away.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also report side effects to Janssen Products, LP, at 1-800-JANSSEN (1-800-526-7736).
Please read accompanying full Product Information for more details.
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What is ERLEADA®?
ERLEADA® (apalutamide) is a prescription medicine used for the treatment of prostate cancer:
- that has spread to other parts of the body and still responds to a medical or surgical treatment that lowers testosterone,
OR
- that has not spread to other parts of the body and no longer responds to a medical or surgical treatment that lowers testosterone.
It is not known if ERLEADA® is safe and effective in females.
It is not known if ERLEADA® is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Before taking ERLEADA®, tell your healthcare provider about all your medical conditions, including if you:
- have a history of heart disease
- have high blood pressure
- have diabetes
- have abnormal amounts of fat or cholesterol in your blood (dyslipidemia)
- have a history of seizures, brain injury, stroke, or brain tumors
- are pregnant or plan to become pregnant. ERLEADA® can cause harm to your unborn baby and loss of pregnancy (miscarriage).
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have a partner who is pregnant or may become pregnant.
- Males who have female partners who are able to become pregnant should use effective birth control (contraception) during treatment and for 3 months after the last dose of ERLEADA®.
- Males should use a condom during sex with a pregnant female.
Talk with your healthcare provider if you have questions about birth control.
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are breastfeeding or plan to breastfeed. It is not known if ERLEADA® passes into breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ERLEADA® can interact with many other medicines.
You should not start or stop any medicine before you talk with the healthcare provider that prescribed ERLEADA®.
Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist when you get a new medicine.
How should I take ERLEADA®?
- Take ERLEADA® exactly as your healthcare provider tells you.
- Your healthcare provider may change your dose if needed.
- Do not stop taking your prescribed dose of ERLEADA® without talking with your healthcare provider first.
- Take your prescribed dose of ERLEADA® 1 time a day, at the same time each day.
- Take ERLEADA® with or without food.
- Swallow ERLEADA® tablets whole.
- If you miss a dose of ERLEADA®, take your normal dose as soon as possible on the same day. Return to your normal schedule on the following day. You should not take extra tablets to make up the missed dose.
- You should start or continue a gonadotropin-releasing hormone (GnRH) analog therapy during your treatment with ERLEADA® unless you have had a surgery to lower the amount of testosterone in your body (surgical castration).
- If you take too much ERLEADA®, call your healthcare provider or go to the nearest hospital emergency room.
What are the possible side effects of ERLEADA®?
ERLEADA® may cause serious side effects including:
-
Heart Disease, Stroke, or Mini-Stroke. Bleeding in the brain or blockage of the arteries in the heart or in part of the brain have happened in some people during treatment with ERLEADA® and can lead to death. Your healthcare provider will monitor you for signs and symptoms of heart or brain problems during your treatment with ERLEADA®. Call your healthcare provider or get medical help right away if you get:
- chest pain or discomfort at rest or with activity
- shortness of breath
- numbness or weakness of the face, arm, or leg, especially on one side of the body
- trouble talking or understanding
- trouble seeing in one or both eyes
- dizziness, loss of balance or coordination, or trouble walking
- Fractures and Falls. ERLEADA® treatment can cause bones and muscles to weaken and may increase your risk for falls and fractures. Falls and fractures have happened in people during treatment with ERLEADA®. Your healthcare provider will monitor your risks for falls and fractures during treatment with ERLEADA®.
- Seizure. Treatment with ERLEADA® may increase your risk of having a seizure. You should avoid activities where a sudden loss of consciousness could cause serious harm to yourself or others. Tell your healthcare provider right away if you have a loss of consciousness or seizure. Your healthcare provider will stop ERLEADA® if you have a seizure during treatment.
The most common side effects of ERLEADA® include:
- feeling very tired
- joint pain
- rash. Tell your healthcare provider if you get a rash.
- decreased appetite
- fall
- weight loss
- hypertension
- hot flash
- diarrhea
- fracture
ERLEADA® may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility. Do not donate sperm during treatment with ERLEADA® and for 3 months after the last dose of ERLEADA®.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of ERLEADA®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see the full Prescribing Information for ERLEADA®.
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What is INTELENCE® (etravirine)?
- INTELENCE® is a prescription medicine that is used in combination with other antiretroviral medicines to treat human immunodeficiency virus-1 (HIV-1) infection in adults and children 2 years of age and older, who have taken HIV-1 medicines in the past. HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
- INTELENCE® is not recommended for use in children less than 2 years of age.
INTELENCE® does not cure HIV infection or AIDS. You must stay on continuous HIV therapy to control your HIV infection and decrease HIV-related illnesses.
Ask your healthcare provider if INTELENCE® is right for you.
IMPORTANT SAFETY INFORMATION
What are the possible side effects of INTELENCE®?
INTELENCE® can cause serious side effects including:
- Severe skin rash and allergic reactions. Skin rash is a common side effect of INTELENCE®. The risk of getting a skin rash is higher in females. Rarely, rash can be severe and may lead to death. Severe skin rash with blisters or peeling skin, including the area around the mouth or eyes, may happen more frequently in children less than 18 years of age who take INTELENCE® in combination with other HIV-1 medicines than in adults. Call your healthcare provider right away if a rash develops; severe cases may need to be treated in a hospital
-
If you get a rash with any of the following symptoms, stop taking INTELENCE® and call your healthcare provider right away:
- fever
- generally ill feeling
- extreme tiredness
- muscle or joint aches
- blisters or sores in mouth
- blisters or peeling of the skin
- redness or swelling of the eyes
- swelling of the mouth, lips, or face
- problems breathing
-
Sometimes allergic reactions can affect body organs, such as your liver. Call your healthcare provider right away if you have any of the following signs or symptoms of liver problems:
- yellowing of your skin or whites of your eyes
- dark or tea-colored urine
- pale-colored stools (bowel movements)
- nausea or vomiting
- loss of appetite
- pain, aching, or tenderness on the right side of your stomach area
- Changes in your immune system can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden
- Changes in body fat can happen in people taking HIV-1 medicines. The cause and long-term health effects of this condition is not known
- The most common side effects of INTELENCE® in adults include rash as well as numbness, tingling or pain in the hands or feet
- The most common side effects of INTELENCE® in children include rash and diarrhea
This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare provider right away.
What should I tell my healthcare provider before taking INTELENCE®?
-
Before taking INTELENCE®, tell your healthcare provider if you:
- have liver problems, including hepatitis B or C
- are pregnant or plan to become pregnant. Tell your healthcare provider if you become pregnant during treatment with INTELENCE®
- are breastfeeding or plan to breastfeed. Do not breastfeed if you take INTELENCE®. INTELENCE® can pass to your baby in your breast milk. You should not breastfeed if you have HIV because of the risk of passing HIV to your baby
- Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements
- Do not start a new medicine without telling your healthcare provider
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see the full Product Information in PDF format for more details.
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What is INVEGA SUSTENNA®?
INVEGA SUSTENNA® (In-VEY-guh Suss-TEN-uh) (paliperidone palmitate) Extended-Release Injectable Suspension is a prescription medicine given by injection by a healthcare professional. INVEGA SUSTENNA® is used for schizoaffective disorder in adults, either alone or in combination with other medicines such as mood stabilizers or antidepressants, and is used to treat schizophrenia in adults.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about INVEGA SUSTENNA®?
INVEGA SUSTENNA® can cause serious side effects, including an increased risk of death in elderly people who are confused, have memory loss, and have lost touch with reality (dementia-related psychosis). INVEGA SUSTENNA® is not for treating dementia-related psychosis.
Do not receive INVEGA SUSTENNA® if you are allergic to paliperidone, paliperidone palmitate, risperidone, or any of the ingredients in INVEGA SUSTENNA®. See the end of the Patient Information leaflet in the full Prescribing Information for a complete list of INVEGA SUSTENNA® ingredients.
Before you receive INVEGA SUSTENNA®, tell your healthcare professional about all your medical conditions, including if you:
- have had Neuroleptic Malignant Syndrome (NMS)
- have or have had heart problems, including a heart attack, heart failure, abnormal heart rhythm, or long QT syndrome
- have or have had low levels of potassium or magnesium in your blood
- have or have had uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia)
- have or have had kidney or liver problems
- have diabetes or have a family history of diabetes
- have had a low white blood cell count
- have had problems with dizziness or fainting or are being treated for high blood pressure
- have or have had seizures or epilepsy
- have any other medical conditions
-
are pregnant or plan to become pregnant. It is not known if INVEGA SUSTENNA® will harm your unborn baby
- If you become pregnant while taking INVEGA SUSTENNA®, talk to your healthcare professional about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
- Infants born to women who are treated with INVEGA SUSTENNA® may experience symptoms such as tremors, irritability, excessive sleepiness, eye twitching, muscle spasms, decreased appetite, difficulty breathing, or abnormal movement of arms and legs. Let your healthcare professional know if these symptoms occur.
- are breastfeeding or plan to breastfeed. INVEGA SUSTENNA® can pass into your breast milk. Talk to your healthcare professional about the best way to feed your baby if you receive INVEGA SUSTENNA®.
Tell your healthcare professional about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show to your healthcare professional or pharmacist when you get a new medicine.
Patients (particularly the elderly) taking antipsychotics with certain health conditions or those on long-term therapy should be evaluated by their healthcare professional for the potential risk of falls.
What should I avoid while receiving INVEGA SUSTENNA®?
- INVEGA SUSTENNA® may affect your ability to make decisions, think clearly, or react quickly. Do not drive, operate heavy machinery, or do other dangerous activities until you know how INVEGA SUSTENNA® affects you
- avoid getting overheated or dehydrated
INVEGA SUSTENNA® may cause serious side effects, including:
- See “What is the most important information I should know about INVEGA SUSTENNA®?”
- stroke in elderly people (cerebrovascular problems) that can lead to death
- Neuroleptic Malignant Syndrome (NMS). NMS is a rare but very serious problem that can happen in people who receive INVEGA SUSTENNA®. NMS can cause death and must be treated in a hospital. Call your healthcare professional right away if you become severely ill and have any of these symptoms: high fever; severe muscle stiffness; confusion; loss of consciousness; changes in your breathing, heartbeat, and blood pressure
- problems with your heartbeat. These heart problems can cause death. Call your healthcare professional right away if you have any of these symptoms: passing out or feeling like you will pass out; dizziness; or feeling as if your heart is pounding or missing beats
- uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia)
- metabolic changes. Metabolic changes may include high blood sugar (hyperglycemia), diabetes mellitus and changes in the fat levels in your blood (dyslipidemia), and weight gain
- low blood pressure and fainting
- changes in your blood cell counts
- high level of prolactin in your blood (hyperprolactinemia). INVEGA SUSTENNA® may cause a rise in the blood levels of a hormone called prolactin (hyperprolactinemia) that may cause side effects including missed menstrual periods, leakage of milk from the breasts, development of breasts in men, or problems with erection
- problems thinking clearly and moving your body
- seizures
- difficulty swallowing that can cause food or liquid to get into your lungs
- prolonged or painful erection lasting more than 4 hours. Call your healthcare professional or go to your nearest emergency room right away if you have an erection that lasts more than 4 hours
- problems with control of your body temperature, especially when you exercise a lot or spend time doing things that make you warm. It is important for you to drink water to avoid dehydration
The most common side effects of INVEGA SUSTENNA® include: injection site reactions; sleepiness or drowsiness; dizziness; feeling restlessness or needing to be constantly moving; abnormal muscle movements, including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of your eyes.
Tell your healthcare professional if you have any side effect that bothers you or does not go away. These are not all the possible side effects of INVEGA SUSTENNA®. For more information, ask your healthcare professional or pharmacist.
Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
General information about the safe and effective use of INVEGA SUSTENNA®.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use INVEGA SUSTENNA® for a condition for which it was not prescribed. Do not give INVEGA SUSTENNA® to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare professional for information about INVEGA SUSTENNA® that is written for healthcare professionals.
This Patient Information leaflet summarizes the most important information about INVEGA SUSTENNA®. If you would like more information, talk with your healthcare professional.
You can ask your healthcare professional or pharmacist for more information that is written for healthcare professionals. For more information, go to www.invegasustenna.com or call 1-800-526-7736.
Please read the full Prescribing Information, including Boxed WARNING, for INVEGA SUSTENNA® and discuss any questions you have with your healthcare professional.
cp-64205v2
What is INVEGA TRINZA®?
INVEGA TRINZA® (3-month paliperidone palmitate) is a prescription medicine given by injection every 3 months by a healthcare professional and used to treat schizophrenia. INVEGA TRINZA® is used in people who have been treated with INVEGA SUSTENNA® (1-month paliperidone palmitate) for at least 4 months in adults.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about INVEGA TRINZA®?
INVEGA TRINZA® can cause serious side effects, including an increased risk of death in elderly people who are confused, have memory loss, and have lost touch with reality (dementia-related psychosis). INVEGA TRINZA® is not approved for treating dementia-related psychosis.
Do not receive INVEGA TRINZA® if you are allergic to paliperidone palmitate, risperidone, or any of the ingredients in INVEGA TRINZA®. See end of the Patient Information leaflet in the full Prescribing Information for a complete list of INVEGA TRINZA® ingredients.
Before you receive INVEGA TRINZA®, tell your healthcare professional about all your medical conditions, including if you:
- have had Neuroleptic Malignant Syndrome (NMS)
- have or have had heart problems, including a heart attack, heart failure, abnormal heart rhythm, or long QT syndrome
- have or have had low levels of potassium or magnesium in your blood
- have or have had uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia)
- have or have had kidney or liver problems
- have diabetes or have a family history of diabetes
- have had a low white blood cell count
- have had problems with dizziness or fainting or are being treated for high blood pressure
- have or have had seizures or epilepsy
- have any other medical conditions
-
are pregnant or plan to become pregnant. It is not known if INVEGA TRINZA® will harm your unborn baby
- If you become pregnant while taking INVEGA TRINZA®, talk to your healthcare professional about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
- Infants born to women who are treated with INVEGA TRINZA® may experience symptoms such as tremors, irritability, excessive sleepiness, eye twitching, muscle spasms, decreased appetite, difficulty breathing, or abnormal movement of arms and legs. Let your healthcare professional know if these symptoms occur.
- are breastfeeding or plan to breastfeed. INVEGA TRINZA® can pass into your breast milk. Talk to your healthcare professional about the best way to feed your baby if you receive INVEGA TRINZA®.
Patients (particularly the elderly) taking antipsychotics with certain health conditions or those on long-term therapy should be evaluated by their healthcare professional for the potential risk of falls.
Tell your healthcare professional about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show to your healthcare professional or pharmacist when you get a new medicine.
What should I avoid while receiving INVEGA TRINZA®?
- INVEGA TRINZA® may affect your ability to make decisions, think clearly, or react quickly. Do not drive, operate heavy machinery, or do other dangerous activities until you know how INVEGA TRINZA® affects you.
- Avoid getting overheated or dehydrated.
INVEGA TRINZA® may cause serious side effects, including:
- See “What is the most important information I should know about INVEGA TRINZA®?”
- stroke in elderly people (cerebrovascular problems) that can lead to death
- Neuroleptic Malignant Syndrome (NMS). NMS is a rare but very serious problem that can happen in people who receive INVEGA TRINZA®. NMS can cause death and must be treated in a hospital. Call your healthcare professional right away if you become severely ill and have any of these symptoms: high fever; severe muscle stiffness; confusion; loss of consciousness; changes in your breathing, heartbeat, and blood pressure.
- problems with your heartbeat. These heart problems can cause death. Call your healthcare professional right away if you have any of these symptoms: passing out or feeling like you will pass out, dizziness, or feeling as if your heart is pounding or missing beats.
- uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia)
- metabolic changes. Metabolic changes may include high blood sugar (hyperglycemia), diabetes mellitus and changes in the fat levels in your blood (dyslipidemia), and weight gain.
- low blood pressure and fainting
- changes in your blood cell counts
- high level of prolactin in your blood (hyperprolactinemia). INVEGA TRINZA® may cause a rise in the blood levels of a hormone called prolactin (hyperprolactinemia) that may cause side effects including missed menstrual periods, leakage of milk from the breasts, development of breasts in men, or problems with erection.
- problems thinking clearly and moving your body
- seizures
- difficulty swallowing that can cause food or liquid to get into your lungs
- prolonged or painful erection lasting more than 4 hours. Call your healthcare professional or go to your nearest emergency room right away if you have an erection that lasts more than 4 hours.
- problems with control of your body temperature, especially when you exercise a lot or spend time doing things that make you warm. It is important for you to drink water to avoid dehydration.
The most common side effects of INVEGA TRINZA® include: injection site reactions, weight gain, headache, upper respiratory tract infections, feeling restlessness or difficulty sitting still, slow movements, tremors, stiffness, and shuffling walk.
Tell your healthcare professional if you have any side effect that bothers you or does not go away. These are not all the possible side effects of INVEGA TRINZA®. For more information, ask your healthcare professional or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects of prescription drugs to the FDA at 1-800-FDA-1088.
General information about the safe and effective use of INVEGA TRINZA®.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use INVEGA TRINZA® for a condition for which it was not prescribed. Do not give INVEGA TRINZA® to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare professional for information about INVEGA TRINZA® that is written for health professionals.
The Patient Information leaflet summarizes the most important information about INVEGA TRINZA®. If you would like more information, talk with your healthcare professional.
You can ask your healthcare professional or pharmacist for more information that is written for healthcare professionals. For more information, go to www.invegatrinzahcp.com or call 1-800-526-7736.
Please read the full Prescribing Information, including Boxed WARNING, for INVEGA TRINZA® and discuss any questions you have with your healthcare professional.
cp-64209v2
WHAT IS INVOKAMET®/INVOKAMET® XR?
INVOKAMET® contains two prescription medicines called canagliflozin (INVOKANA®) and metformin hydrochloride (GLUCOPHAGE®). INVOKAMET® XR contains two prescription medicines called canagliflozin (INVOKANA®) and metformin hydrochloride extended-release (GLUMETZA®).
-
INVOKAMET®/INVOKAMET® XR can be used:
- along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes
- in adults with type 2 diabetes who have known cardiovascular disease and INVOKANA® is needed to reduce the risk of major cardiovascular events such as heart attack, stroke, or death
- in adults with type 2 diabetes and diabetic kidney disease (nephropathy) with a certain amount of protein in the urine, and canagliflozin is needed to reduce the risk of end-stage kidney disease (ESKD), worsening of kidney function, cardiovascular death, and hospitalization for heart failure
- INVOKAMET®/INVOKAMET® XR is not for people with type 1 diabetes. It may increase their risk of diabetic ketoacidosis (increased ketones in blood or urine).
- It is not known if INVOKAMET®/INVOKAMET® XR is safe and effective in children under 18 years of age.
IMPORTANT SAFETY INFORMATION
INVOKAMET®/INVOKAMET® XR can cause serious side effects, including:
-
Lactic acidosis. Metformin, one of the medicines in INVOKAMET®/INVOKAMET® XR, can cause a rare but serious condition called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital. Stop taking INVOKAMET®/INVOKAMET® XR and call your doctor right away if you have any of the following symptoms of lactic acidosis: feel cold in your hands or feet; feel very weak or tired; have unusual (not normal) muscle pain; have trouble breathing; have unusual sleepiness or sleep longer than usual; have stomach pains, nausea, or vomiting; feel dizzy or lightheaded; or have a slow/irregular heartbeat
You have a higher chance of getting lactic acidosis with INVOKAMET®/INVOKAMET® XR if you have conditions such as: severe kidney problems, or your kidneys are affected by certain X-ray tests that use injectable dye; liver problems; drink alcohol very often (or drink a lot of alcohol in short-term); get dehydrated; have surgery; have a heart attack, severe infection, or stroke; are 65 years of age or older.
- Amputations. INVOKAMET®/INVOKAMET® XR may increase your risk of lower-limb amputations. Amputations mainly involve removal of the toe or part of the foot; however, amputations involving the leg, below and above the knee, have also occurred. Some people had more than one amputation, some on both sides of the body. You may be at a higher risk of lower-limb amputation if you: have a history of amputation, have heart disease or are at risk for heart disease, have had blocked or narrowed blood vessels (usually in leg), have damage to the nerves (neuropathy) in the leg, or have had diabetic foot ulcers or sores. Call your doctor right away if you have new pain or tenderness, any sores, ulcers, or infections in your leg or foot. Your doctor may decide to stop your INVOKAMET®/INVOKAMET® XR for a while if you have any of these signs or symptoms. Talk to your doctor about proper foot care
- Dehydration. INVOKAMET®/INVOKAMET® XR can cause some people to become dehydrated (the loss of too much body water), which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). There have been reports of sudden worsening of kidney function in people with type 2 diabetes who are taking canagliflozin, one of the medicines in INVOKAMET®/INVOKAMET® XR. You may be at higher risk if you take medicines to lower blood pressure, are on a low sodium (salt) diet, have kidney problems, or are 65 years of age or older. Talk to your doctor about ways to prevent dehydration including how much fluid you should drink on a daily basis. Call your healthcare provider right away if you reduce the amount of food or liquid you drink, for example if you cannot eat or you start to lose liquids from your body, for example from vomiting, diarrhea, or being in the sun too long
- Ketoacidosis (increased ketones in your blood or urine) has happened in people who have type 1 or type 2 diabetes, during treatment with canagliflozin, one of the medicines in INVOKAMET®/INVOKAMET® XR, or in people with diabetes who were sick or who had surgery during treatment with INVOKAMET®/INVOKAMET® XR. Ketoacidosis is a serious condition, which needs to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with INVOKAMET®/INVOKAMET® XR, even if your blood sugar is less than 250 mg/dL. Stop taking INVOKAMET®/INVOKAMET® XR and call your doctor right away if you get any of the following symptoms: nausea, vomiting, stomach-area pain, tiredness, or trouble breathing. If you get any of these symptoms during treatment with INVOKAMET®/INVOKAMET® XR, if possible, check for ketones in your urine, even if your blood sugar is less than 250 mg/dL
- Vaginal yeast infection. Symptoms of a vaginal yeast infection include: vaginal odor, white or yellowish discharge, or vaginal itching
- Yeast infection of the skin around the penis (balanitis or balanoposthitis). Swelling of an uncircumcised penis may develop that makes it difficult to pull back the skin around the tip of the penis. Other symptoms include: redness, itching, or swelling of the penis; rash; foul smelling discharge; or pain in the skin around penis
Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis.
Do not take INVOKAMET®/INVOKAMET® XR if you:
- have severe kidney problems, are on kidney dialysis, have a condition called metabolic acidosis, or are allergic to canagliflozin, metformin, or any of the ingredients in INVOKAMET®/INVOKAMET® XR. Symptoms of an allergic reaction may include: rash; raised red patches on your skin (hives); swelling of the face, lips, mouth, tongue, and throat that may cause difficulty in breathing or swallowing
Before taking INVOKAMET®/INVOKAMET® XR, tell your doctor if you: have a history of amputation; have heart disease or are at risk for heart disease; have had blocked or narrowed blood vessels, usually in your leg; have damage to the nerves (neuropathy) in your leg; have had diabetic foot ulcers or sores; have moderate to severe kidney problems; have liver problems; have a history of urinary tract infections or problems with urination; are on a low sodium (salt) diet; have ever had an allergic reaction to INVOKAMET®/INVOKAMET® XR; are going to get an injection of dye or contrast agents for an x-ray procedure; have heart problems, including congestive heart failure; are going to have surgery (your doctor may stop your INVOKAMET®/INVOKAMET® XR before you have surgery; talk to your doctor if you are having surgery about when to stop taking and when to start it again); are eating less or there is a change in your diet; have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas; drink alcohol very often or drink a lot of alcohol in the short-term; have low levels of vitamin B12 or calcium in your blood.
Tell your doctor if you are or plan to become pregnant, are breastfeeding, or plan to breastfeed. INVOKAMET®/INVOKAMET® XR may harm your unborn baby. If you become pregnant while taking INVOKAMET®/INVOKAMET® XR, tell your doctor as soon as possible. Talk with your doctor about the best way to control your blood sugar while you are pregnant.
If you are premenopausal (before the “change of life”), and do not have periods regularly or at all, INVOKAMET®/INVOKAMET® XR may increase your chance of becoming pregnant. Talk to your doctor about birth control choices while taking INVOKAMET®/INVOKAMET® XR, if you are not planning to become pregnant. Tell your doctor right away if you become pregnant while taking INVOKAMET®/INVOKAMET® XR.
INVOKAMET®/INVOKAMET® XR may pass into your breast milk and may harm your baby. Talk with your doctor about the best way to feed your baby if you are taking INVOKAMET®/INVOKAMET® XR. Do not breastfeed while taking INVOKAMET®/INVOKAMET® XR.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take: diuretics (water pills), rifampin (used to treat or prevent tuberculosis), phenytoin or phenobarbital (used to control seizures), ritonavir (Norvir®, Kaletra®– used to treat HIV infection), or digoxin (Lanoxin®– used to treat heart problems).
Possible Side Effects of INVOKAMET®/INVOKAMET® XR
INVOKAMET®/INVOKAMET® XR may cause serious side effects, including:
- Serious urinary tract infections. May lead to hospitalization and have happened in people taking canagliflozin, one of the medicines in INVOKAMET®/INVOKAMET® XR. Tell your doctor if you have signs or symptoms of a urinary tract infection such as: burning feeling while urinating, need to urinate often or right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Some people may also have a fever, back pain, nausea, or vomiting
- Low blood sugar (hypoglycemia). If you take INVOKAMET®/INVOKAMET® XR with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while taking INVOKAMET®/INVOKAMET® XR. Signs and symptoms of low blood sugar may include: headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, shaking, or feeling jittery
- A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum). Necrotizing fasciitis of the perineum has happened in people who take canagliflozin. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries to remove affected tissues, and may lead to death. Seek medical attention immediately if you have a fever or you are feeling very weak, tired, or uncomfortable (malaise) and you develop any of the following symptoms in the area between and around your anus and genitals: pain or tenderness, swelling, or redness of the skin (erythema)
- Serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking INVOKAMET®/INVOKAMET® XR and call your doctor right away or go to the nearest hospital emergency room
- Broken bones (fractures). Bone fractures have been seen in patients taking canagliflozin. Talk to your doctor about factors that may increase your risk of bone fracture
- Low vitamin B12 (vitamin B12 deficiency). Using metformin for long periods of time may cause a decrease in the amount of vitamin B12 in your blood. Your doctor may do blood tests to check your levels
The most common side effects of INVOKAMET®/INVOKAMET® XR include: nausea and vomiting; diarrhea; weakness; gas; upset stomach; indigestion; headache; changes in urination, including urgent need to urinate more often, in larger amounts, or at night.
These are not all the possible side effects of INVOKAMET®/INVOKAMET® XR.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Janssen Scientific Affairs, LLC at 1-800-526-7736.
Please read full Product Information, including Boxed Warning, and Medication Guide for INVOKAMET® and INVOKAMET® XR.
Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation.
Trademarks are those of their respective owners.
cp-06259v6
WHAT IS INVOKAMET®/INVOKAMET® XR?
INVOKAMET® contains two prescription medicines called canagliflozin (INVOKANA®) and metformin hydrochloride (GLUCOPHAGE®). INVOKAMET® XR contains two prescription medicines called canagliflozin (INVOKANA®) and metformin hydrochloride extended-release (GLUMETZA®).
-
INVOKAMET®/INVOKAMET® XR can be used:
- along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes
- in adults with type 2 diabetes who have known cardiovascular disease and INVOKANA® is needed to reduce the risk of major cardiovascular events such as heart attack, stroke, or death
- in adults with type 2 diabetes and diabetic kidney disease (nephropathy) with a certain amount of protein in the urine, and canagliflozin is needed to reduce the risk of end-stage kidney disease (ESKD), worsening of kidney function, cardiovascular death, and hospitalization for heart failure
- INVOKAMET®/INVOKAMET® XR is not for people with type 1 diabetes. It may increase their risk of diabetic ketoacidosis (increased ketones in blood or urine).
- It is not known if INVOKAMET®/INVOKAMET® XR is safe and effective in children under 18 years of age.
IMPORTANT SAFETY INFORMATION
INVOKAMET®/INVOKAMET® XR can cause serious side effects, including:
-
Lactic acidosis. Metformin, one of the medicines in INVOKAMET®/INVOKAMET® XR, can cause a rare but serious condition called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital. Stop taking INVOKAMET®/INVOKAMET® XR and call your doctor right away if you have any of the following symptoms of lactic acidosis: feel cold in your hands or feet; feel very weak or tired; have unusual (not normal) muscle pain; have trouble breathing; have unusual sleepiness or sleep longer than usual; have stomach pains, nausea, or vomiting; feel dizzy or lightheaded; or have a slow/irregular heartbeat
You have a higher chance of getting lactic acidosis with INVOKAMET®/INVOKAMET® XR if you have conditions such as: severe kidney problems, or your kidneys are affected by certain X-ray tests that use injectable dye; liver problems; drink alcohol very often (or drink a lot of alcohol in short-term); get dehydrated; have surgery; have a heart attack, severe infection, or stroke; are 65 years of age or older.
- Amputations. INVOKAMET®/INVOKAMET® XR may increase your risk of lower-limb amputations. Amputations mainly involve removal of the toe or part of the foot; however, amputations involving the leg, below and above the knee, have also occurred. Some people had more than one amputation, some on both sides of the body. You may be at a higher risk of lower-limb amputation if you: have a history of amputation, have heart disease or are at risk for heart disease, have had blocked or narrowed blood vessels (usually in leg), have damage to the nerves (neuropathy) in the leg, or have had diabetic foot ulcers or sores. Call your doctor right away if you have new pain or tenderness, any sores, ulcers, or infections in your leg or foot. Your doctor may decide to stop your INVOKAMET®/INVOKAMET® XR for a while if you have any of these signs or symptoms. Talk to your doctor about proper foot care
- Dehydration. INVOKAMET®/INVOKAMET® XR can cause some people to become dehydrated (the loss of too much body water), which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). There have been reports of sudden worsening of kidney function in people with type 2 diabetes who are taking canagliflozin, one of the medicines in INVOKAMET®/INVOKAMET® XR. You may be at higher risk if you take medicines to lower blood pressure, are on a low sodium (salt) diet, have kidney problems, or are 65 years of age or older. Talk to your doctor about ways to prevent dehydration including how much fluid you should drink on a daily basis. Call your healthcare provider right away if you reduce the amount of food or liquid you drink, for example if you cannot eat or you start to lose liquids from your body, for example from vomiting, diarrhea, or being in the sun too long
- Ketoacidosis (increased ketones in your blood or urine) has happened in people who have type 1 or type 2 diabetes, during treatment with canagliflozin, one of the medicines in INVOKAMET®/INVOKAMET® XR, or in people with diabetes who were sick or who had surgery during treatment with INVOKAMET®/INVOKAMET® XR. Ketoacidosis is a serious condition, which needs to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with INVOKAMET®/INVOKAMET® XR, even if your blood sugar is less than 250 mg/dL. Stop taking INVOKAMET®/INVOKAMET® XR and call your doctor right away if you get any of the following symptoms: nausea, vomiting, stomach-area pain, tiredness, or trouble breathing. If you get any of these symptoms during treatment with INVOKAMET®/INVOKAMET® XR, if possible, check for ketones in your urine, even if your blood sugar is less than 250 mg/dL
- Vaginal yeast infection. Symptoms of a vaginal yeast infection include: vaginal odor, white or yellowish discharge, or vaginal itching
- Yeast infection of the skin around the penis (balanitis or balanoposthitis). Swelling of an uncircumcised penis may develop that makes it difficult to pull back the skin around the tip of the penis. Other symptoms include: redness, itching, or swelling of the penis; rash; foul smelling discharge; or pain in the skin around penis
Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis.
Do not take INVOKAMET®/INVOKAMET® XR if you:
- have severe kidney problems, are on kidney dialysis, have a condition called metabolic acidosis, or are allergic to canagliflozin, metformin, or any of the ingredients in INVOKAMET®/INVOKAMET® XR. Symptoms of an allergic reaction may include: rash; raised red patches on your skin (hives); swelling of the face, lips, mouth, tongue, and throat that may cause difficulty in breathing or swallowing
Before taking INVOKAMET®/INVOKAMET® XR, tell your doctor if you: have a history of amputation; have heart disease or are at risk for heart disease; have had blocked or narrowed blood vessels, usually in your leg; have damage to the nerves (neuropathy) in your leg; have had diabetic foot ulcers or sores; have moderate to severe kidney problems; have liver problems; have a history of urinary tract infections or problems with urination; are on a low sodium (salt) diet; have ever had an allergic reaction to INVOKAMET®/INVOKAMET® XR; are going to get an injection of dye or contrast agents for an x-ray procedure; have heart problems, including congestive heart failure; are going to have surgery (your doctor may stop your INVOKAMET®/INVOKAMET® XR before you have surgery; talk to your doctor if you are having surgery about when to stop taking and when to start it again); are eating less or there is a change in your diet; have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas; drink alcohol very often or drink a lot of alcohol in the short-term; have low levels of vitamin B12 or calcium in your blood.
Tell your doctor if you are or plan to become pregnant, are breastfeeding, or plan to breastfeed. INVOKAMET®/INVOKAMET® XR may harm your unborn baby. If you become pregnant while taking INVOKAMET®/INVOKAMET® XR, tell your doctor as soon as possible. Talk with your doctor about the best way to control your blood sugar while you are pregnant.
If you are premenopausal (before the “change of life”), and do not have periods regularly or at all, INVOKAMET®/INVOKAMET® XR may increase your chance of becoming pregnant. Talk to your doctor about birth control choices while taking INVOKAMET®/INVOKAMET® XR, if you are not planning to become pregnant. Tell your doctor right away if you become pregnant while taking INVOKAMET®/INVOKAMET® XR.
INVOKAMET®/INVOKAMET® XR may pass into your breast milk and may harm your baby. Talk with your doctor about the best way to feed your baby if you are taking INVOKAMET®/INVOKAMET® XR. Do not breastfeed while taking INVOKAMET®/INVOKAMET® XR.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take: diuretics (water pills), rifampin (used to treat or prevent tuberculosis), phenytoin or phenobarbital (used to control seizures), ritonavir (Norvir®, Kaletra®– used to treat HIV infection), or digoxin (Lanoxin®– used to treat heart problems).
Possible Side Effects of INVOKAMET®/INVOKAMET® XR
INVOKAMET®/INVOKAMET® XR may cause serious side effects, including:
- Serious urinary tract infections. May lead to hospitalization and have happened in people taking canagliflozin, one of the medicines in INVOKAMET®/INVOKAMET® XR. Tell your doctor if you have signs or symptoms of a urinary tract infection such as: burning feeling while urinating, need to urinate often or right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Some people may also have a fever, back pain, nausea, or vomiting
- Low blood sugar (hypoglycemia). If you take INVOKAMET®/INVOKAMET® XR with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while taking INVOKAMET®/INVOKAMET® XR. Signs and symptoms of low blood sugar may include: headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, shaking, or feeling jittery
- A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum). Necrotizing fasciitis of the perineum has happened in people who take canagliflozin. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries to remove affected tissues, and may lead to death. Seek medical attention immediately if you have a fever or you are feeling very weak, tired, or uncomfortable (malaise) and you develop any of the following symptoms in the area between and around your anus and genitals: pain or tenderness, swelling, or redness of the skin (erythema)
- Serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking INVOKAMET®/INVOKAMET® XR and call your doctor right away or go to the nearest hospital emergency room
- Broken bones (fractures). Bone fractures have been seen in patients taking canagliflozin. Talk to your doctor about factors that may increase your risk of bone fracture
- Low vitamin B12 (vitamin B12 deficiency). Using metformin for long periods of time may cause a decrease in the amount of vitamin B12 in your blood. Your doctor may do blood tests to check your levels
The most common side effects of INVOKAMET®/INVOKAMET® XR include: nausea and vomiting; diarrhea; weakness; gas; upset stomach; indigestion; headache; changes in urination, including urgent need to urinate more often, in larger amounts, or at night.
These are not all the possible side effects of INVOKAMET®/INVOKAMET® XR.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Janssen Scientific Affairs, LLC at 1-800-526-7736.
Please read full Product Information, including Boxed Warning, and Medication Guide for INVOKAMET® and INVOKAMET® XR.
Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation.
Trademarks are those of their respective owners.
cp-06259v6
WHAT IS INVOKANA®?
-
INVOKANA® (canagliflozin) is a prescription medicine used:
- along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes
- to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes who have known cardiovascular disease
- to reduce the risk of end-stage kidney disease (ESKD), worsening of kidney function, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic kidney disease (nephropathy) with a certain amount of protein in the urine
- INVOKANA® is not for people with type 1 diabetes. It may increase their risk of diabetic ketoacidosis (increased ketones in blood or urine).
- INVOKANA® is not used to lower blood sugar (glucose) in adults with type 2 diabetes with severe kidney problems.
- It is not known if INVOKANA® is safe and effective in children under 18 years of age.
IMPORTANT SAFETY INFORMATION
INVOKANA® can cause serious side effects, including:
- Amputations. INVOKANA® may increase your risk of lower-limb amputations. Amputations mainly involve removal of the toe or part of the foot; however, amputations involving the leg, below and above the knee, have also occurred. Some people had more than one amputation, some on both sides of the body. You may be at a higher risk of lower-limb amputation if you: have a history of amputation, have heart disease or are at risk for heart disease, have had blocked or narrowed blood vessels (usually in leg), have damage to the nerves (neuropathy) in the leg, or have had diabetic foot ulcers or sores. Call your doctor right away if you have new pain or tenderness, any sores, ulcers, or infections in your leg or foot. Your doctor may decide to stop your INVOKANA® for a while if you have any of these signs or symptoms. Talk to your doctor about proper foot care.
- Dehydration. INVOKANA® can cause some people to become dehydrated (the loss of too much body water), which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). There have been reports of sudden worsening of kidney function in people with type 2 diabetes who are taking INVOKANA®. You may be at higher risk of dehydration if you take medicines to lower your blood pressure (including diuretics [water pills]), are on a low sodium (salt) diet, have kidney problems, or are 65 years of age or older. Talk to your doctor about what you can do to prevent dehydration including how much fluid you should drink on a daily basis. Call your healthcare provider right away if you reduce the amount of food or liquid you drink, for example if you cannot eat or you start to lose liquids from your body, for example from vomiting, diarrhea, or being in the sun too long.
- Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 or type 2 diabetes, during treatment with INVOKANA®. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with INVOKANA®. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with INVOKANA® even if your blood sugar is less than 250 mg/dL. Stop taking INVOKANA® and call your doctor right away if you get any of the following symptoms: nausea, vomiting, stomach-area pain, tiredness, or trouble breathing. If you get any of these symptoms during treatment with INVOKANA®, if possible, check for ketones in your urine, even if your blood sugar is less than 250 mg/dL.
- Vaginal yeast infection. Symptoms of a vaginal yeast infection include: vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), or vaginal itching.
- Yeast infection of the skin around the penis (balanitis or balanoposthitis). Swelling of an uncircumcised penis may develop that makes it difficult to pull back the skin around the tip of the penis. Other symptoms include: redness, itching, or swelling of the penis; rash of the penis; foul-smelling discharge from the penis; or pain in the skin around penis.
Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis.
Do not take INVOKANA® if you:
- are allergic to canagliflozin or any of the ingredients in INVOKANA®. Symptoms of allergic reaction to INVOKANA® may include: rash; raised red patches on your skin (hives); swelling of the face, lips, mouth, tongue, and throat that may cause difficulty in breathing or swallowing
- are on kidney dialysis
Before taking INVOKANA®, tell your doctor if you: have a history of amputation; have heart disease or are at risk for heart disease; have had blocked or narrowed blood vessels (usually in leg); have damage to the nerves (neuropathy) in your leg; have had diabetic foot ulcers or sores; have kidney problems; have liver problems; have a history of urinary tract infections or problems with urination; are on a low sodium (salt) diet; are going to have surgery (your doctor may stop your INVOKANA® before you have surgery; talk to your doctor if you are having surgery about when to stop taking INVOKANA® and when to start it again); are eating less or there is a change in diet; have or have had pancreas problems; drink alcohol very often (or drink a lot of alcohol in the short-term); or ever had an allergic reaction to INVOKANA®.
Tell your doctor if you are or plan to become pregnant, are breastfeeding, or plan to breastfeed. INVOKANA® may harm your unborn baby. If you become pregnant while taking INVOKANA®, tell your doctor right away. INVOKANA® may pass into your breast milk and may harm your baby. Do not breastfeed while taking INVOKANA®.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take diuretics (water pills), rifampin (used to treat or prevent tuberculosis), phenytoin or phenobarbital (used to control seizures), ritonavir (Norvir®, Kaletra®– used to treat HIV infection), or digoxin (Lanoxin®– used to treat heart problems).
Possible Side Effects of INVOKANA®
INVOKANA® may cause serious side effects, including:
- Serious Urinary Tract Infections: may lead to hospitalization and have happened in people taking INVOKANA®. Tell your doctor if you have any signs or symptoms of a urinary tract infection such as: burning feeling while urinating, need to urinate often or right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Some people may also have fever, back pain, nausea, or vomiting
- Low blood sugar (hypoglycemia). If you take INVOKANA® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take INVOKANA®. Signs and symptoms of low blood sugar may include: headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, shaking, or feeling jittery
- A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum). Necrotizing fasciitis of the perineum has happened in people who take INVOKANA®. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries, and may lead to death. Seek medical attention immediately if you have fever or you are feeling very weak, tired, or uncomfortable (malaise) and you develop any of the following symptoms in the area between and around your anus and genitals: pain or tenderness, swelling, or redness of the skin (erythema)
- Serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking INVOKANA® and call your doctor right away or go to the nearest hospital emergency room
- Broken Bones (fractures): Bone fractures have been seen in patients taking INVOKANA®. Talk to your doctor about factors that may increase your risk of bone fracture
The most common side effects of INVOKANA® include: vaginal yeast infections and yeast infections of the penis; changes in urination, including urgent need to urinate more often, in larger amounts, or at night.
These are not all the possible side effects of INVOKANA®.
Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Janssen Scientific Affairs, LLC at 1-800-526-7736.
Please read full Product Information and Medication Guide for INVOKANA®.
Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation.
Trademarks are those of their respective owners.
cp-68573v4
What is OPSUMIT® (macitentan)?
OPSUMIT® is a prescription medicine used to treat pulmonary arterial hypertension (PAH, WHO Group 1). PAH is high blood pressure in the arteries of your lungs. OPSUMIT® can:
- Improve your ability to exercise as measured by the 6-minute walk distance (6MWD). In a clinical study of mainly WHO FC II-III patients, those taking OPSUMIT® walked, on average, 22 meters farther at Month 6 than patients not taking it
- Improve some of your symptoms
- Help slow down the progression of your disease
- Lower your chance of being hospitalized for PAH
It is not known if OPSUMIT® is safe and effective in children.
IMPORTANT SAFETY INFORMATION
The most important information about OPSUMIT® (macitentan)
Do not take OPSUMIT® if you are pregnant or trying to get pregnant. OPSUMIT® can cause serious birth defects if taken while pregnant.
Women who are able to get pregnant must have negative pregnancy tests:
- Before starting OPSUMIT®
- Each month while taking OPSUMIT®
- For 1 month after stopping OPSUMIT®
Your doctor will decide when you should take pregnancy tests.
You are medically able to get pregnant if you are a woman who fits all of the following guidelines:
- has started puberty, even if you have not had a menstrual period yet
- has a uterus
- has not gone through menopause (menopause means you have not had a menstrual period for at least 12 months for natural reasons, or have had your ovaries removed)
You are not medically able to get pregnant if you are a woman who fits at least 1 of the following guidelines:
- has not started puberty
- does not have a uterus
- has gone through menopause (you have not had a menstrual period for at least 12 months for natural reasons, or have had your ovaries removed)
- is infertile for other medical reasons and this infertility is permanent and cannot be reversed
While taking OPSUMIT®, and for 1 month after stopping OPSUMIT®, women who are able to get pregnant must use 2 acceptable forms of birth control. Women who have had a tubal sterilization, a progesterone implant, or have an IUD (intrauterine device) do not need a second form of birth control. Talk to your doctor or gynecologist about which birth control to use while on OPSUMIT®. If you decide to change your form of birth control, talk with your doctor or gynecologist. This way you can be sure to choose another acceptable form of birth control. Also review the Medication Guide for acceptable birth control options.
It’s important not to have unprotected sex while taking OPSUMIT®. Tell your doctor right away if you have unprotected sex, think your birth control has failed, miss a menstrual period, or think you may be pregnant. He or she may recommend using a form of emergency birth control.
If you are the parent or caregiver of a female child who started taking OPSUMIT® before reaching puberty, check with your child regularly for any signs of puberty. Your child may reach puberty before having her first menstrual period. Talk to your doctor if you think your child is showing signs of puberty or if you have any questions about the signs of puberty.
Before starting OPSUMIT®, women must enroll in a program called the OPSUMIT® Risk Evaluation and Mitigation Strategy (REMS). If you are a woman who is able to get pregnant, you must talk to your doctor to learn the benefits and risks of OPSUMIT®. You must also agree to all of the instructions in the program. Men who are prescribed OPSUMIT® do not need to enroll in this program.
Who should not take OPSUMIT®?
Do not take OPSUMIT® if you are pregnant, plan to become pregnant, or become pregnant during treatment with OPSUMIT®. OPSUMIT® can cause serious birth defects. See “The most important information about OPSUMIT®.”
Talk to your doctor about all your medical conditions, as well as all the medicines, vitamins, and supplements you take. OPSUMIT® and other medicines may affect each other causing side effects. Tell your doctor right away if you take an HIV medicine. Do not start any new medicine until you check with your doctor.
What should I avoid while taking OPSUMIT®?
- Do not get pregnant. OPSUMIT® can cause serious birth defects. See “The most important information about OPSUMIT®.” If you miss a menstrual period or think you may be pregnant, call your doctor right away
- You should not breastfeed if you take OPSUMIT®. It is not known if OPSUMIT® passes into your breast milk. Talk to your doctor about the best way to feed your baby
What are the possible side effects of OPSUMIT®?
OPSUMIT® can cause serious side effects, including:
- Serious birth defects. See “The most important information about OPSUMIT®”
-
Some medicines that are like OPSUMIT® can cause liver problems. Your doctor should do blood tests to check your liver before you start OPSUMIT®. Tell your doctor if you have any of these symptoms, which could be a sign of liver problems while on OPSUMIT®:
- Nausea or vomiting
- Pain in the upper right stomach
- Feeling tired
- Loss of appetite
- Your skin or the whites of your eyes turn yellow
- Dark urine
- Fever
- Itching
- Fluid retention could happen during the first weeks after starting OPSUMIT®. Tell your doctor right away if you notice unusual weight gain or swelling in your ankles or legs. Your doctor will look for the cause
- Low red blood cell levels (anemia) can happen while taking OPSUMIT®, usually during the first weeks after starting OPSUMIT®. In some cases a blood transfusion may be needed, but this is not common. Your doctor will do blood tests to check for anemia before you start OPSUMIT®. You may also need to do these blood tests while taking OPSUMIT®
- Decreased sperm counts. OPSUMIT®, and other medicines like OPSUMIT®, may cause decreased sperm counts in men who take these medicines. If fathering a child is important to you, tell your doctor
The most common side effects are:
- Stuffy nose or sore throat
- Irritation of the airways (bronchitis)
- Headache
- Flu
- Urinary tract infection
Talk to your doctor if you have a side effect that bothers you or does not go away. These are not all the possible side effects of OPSUMIT®. For more information, ask your doctor or pharmacist.
You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please read the full Prescribing Information and Medication Guide for OPSUMIT®, including an Important Warning about Serious Birth Defects.
cp-113980
What is PONVORY™?
PONVORY™ is a prescription medicine that is used to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
It is not known if PONVORY™ is safe and effective in children.
IMPORTANT SAFETY INFORMATION
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT PONVORY™?
PONVORY™ may cause serious side effects, including:
-
Infections - PONVORY™ can increase your risk of serious infections that can be life-threatening and cause death. PONVORY™ lowers the number of white blood cells (lymphocytes) in your blood. This will usually go back to normal within 1 to 2 weeks of stopping treatment. Your healthcare provider should review a recent blood test of your white blood cells before you start taking PONVORY™. Call your healthcare provider right away if you have any of these symptoms of an infection during treatment and for 1 to 2 weeks after your last dose of PONVORY™:
- fever
- tiredness
- body aches
- chills
- nausea
- vomiting
- headache with fever, neck stiffness, sensitivity to light, nausea, or confusion (these may be symptoms of meningitis, an infection of the lining around your brain and spine)
Your healthcare provider may delay starting or may stop your PONVORY™ treatment if you have an infection.
-
Slow heart rate (bradycardia or bradyarrhythmia) when you start taking PONVORY™. PONVORY™ can cause your heart rate to slow down, especially after you take your first dose. You should have a test to check the electrical activity of your heart called an electrocardiogram (ECG) before you take your first dose.
Only Start your treatment with PONVORY™ using the Starter Pack. You must use the PONVORY™ Starter Pack by slowly increasing the dose over a 14-day period to help reduce the effect of slowing of your heart rate. It is important to follow the recommended dosing instructions.
Call your healthcare provider if you experience the following symptoms of slow heart rate:- dizziness
- lightheadedness
- feeling like your heart is beating slowly or skipping beats
- shortness of breath
- confusion
- chest pain
- tiredness
Do not take PONVORY™ if you:
- have had a heart attack, chest pain called unstable angina, stroke or mini-stroke (transient ischemic attack or TIA), or certain types of heart failure in the last 6 months.
- have certain types of heart block or irregular or abnormal heartbeat (arrhythmia) unless you have a pacemaker.
Talk to your healthcare provider if you have any of these conditions, or do not know if you have any of these conditions.
Before you take PONVORY™, tell your healthcare provider about all your medical conditions, including if you:
- have a fever or infection, or you are unable to fight infections due to a disease or taking medicines that lower your immune system.
- have had chicken pox or have received the vaccine for chicken pox. Your healthcare provider may do a blood test for chicken pox virus. You may need to get the full course of vaccine for chicken pox and then wait 1 month before you start taking PONVORY™.
- have slow heart rate.
- have an irregular or abnormal heartbeat (arrhythmia).
- have a history of stroke.
- have heart problems, including a heart attack or chest pain.
- have high blood pressure.
- have breathing problems, including during your sleep (sleep apnea).
- have liver problems.
- had or now have a type of skin cancer called basal cell carcinoma (BCC), melanoma, or squamous cell carcinoma
- have eye problems, especially an inflammation of the eye called uveitis.
- have diabetes.
- are pregnant or plan to become pregnant. PONVORY™ may harm your unborn baby. Talk with your healthcare provider if you are pregnant or plan to become pregnant. If you are a woman who can become pregnant, you should use effective birth control during your treatment with PONVORY™ and for 1 week after you stop taking PONVORY™. Talk to your healthcare provider about what method of birth control is right for you during this time. Tell your healthcare provider right away if you do become pregnant while taking PONVORY™ or within 1 week after you stop taking PONVORY™.
- are breastfeeding or plan to breastfeed. It is not known if PONVORY™ passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take PONVORY™.
Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.
Using PONVORY™ and other medicines together may affect each other causing serious side effects. Especially tell your healthcare provider if you take or have taken: Medicines to control your heart rhythm (antiarrhythmics), or blood pressure (antihypertensives), or heart-beat (such as calcium channel blockers or beta-blockers); medicines that affect your immune system, such as alemtuzumab; and medicines such as rifampin, phenytoin, or carbamazepine.
You should not receive live vaccines during treatment with PONVORY™, for at least 1 month before taking PONVORY™, and for 1 to 2 weeks after you stop taking PONVORY™. If you receive a live vaccine, you may get the infection the vaccine was meant to prevent. Vaccines may not work as well when given during treatment with PONVORY™.
Talk with your healthcare provider if you are not sure if you take any of these medicines.
HOW SHOULD I TAKE PONVORY™?
- Take PONVORY™ exactly as your healthcare provider tells you to take it.
- Take PONVORY™ 1 time each day.
- Swallow PONVORY™ tablets whole.
- Take PONVORY™ with or without food.
- Do not stop taking PONVORY™ without talking with your healthcare provider first.
- Do not skip a dose.
- Start taking PONVORY™ with a 14-day starter pack.
- If you miss taking 1, 2, or 3 tablets in a row of PONVORY™ in the 14-day starter pack, continue treatment by taking the first dose you missed. Take 1 tablet as soon as you remember. Then, take 1 tablet a day to continue with the starter pack dose as planned.
- If you miss taking 1, 2, or 3 tablets in a row of PONVORY™ while taking the 20 mg maintenance dose, continue treatment with the 20 mg maintenance dose.
- If you miss taking 4 or more tablets in a row of PONVORY™, while taking the 14-day starter pack or the 20 mg maintenance dose, you need to restart treatment with a new 14-day starter pack. Call your healthcare provider if you miss 4 or more doses of PONVORY™. Do not restart PONVORY™ after stopping it for 4 or more days in a row without talking to your healthcare provider. If you have certain heart conditions, you may need to be monitored by your healthcare provider for at least 4 hours when you take your next dose.
What are the possible side effects of PONVORY™?
PONVORY™ may cause serious side effects, including:
- breathing problems. Some people who take PONVORY™ have shortness of breath. Call your healthcare provider right away if you have new or worsening breathing problems.
-
liver problems. PONVORY™ may cause liver problems. Your healthcare provider should do blood tests to check your liver before you start taking PONVORY™. Call your healthcare provider right away if you have any of the following symptoms of liver problems:
- unexplained nausea
- vomiting
- stomach (abdominal) pain
- tiredness
- loss of appetite
- yellowing of the whites of your eyes or skin
- dark urine
- increased blood pressure. Your healthcare provider should check your blood pressure during treatment.
- types of skin cancer called basal cell carcinoma (BCC), melanoma, and squamous cell carcinoma. Certain types of skin cancer have happened with drugs in the same class. Tell your healthcare provider if you have any changes in the appearance of your skin, including changes in a mole, a new darkened area on your skin, a sore that does not heal, or growths on your skin, such as a bump that may be shiny, pearly white, skin-colored, or pink. Your doctor should check your skin for any changes during treatment with PONVORY™. Limit the amount of time you spend in sunlight and ultraviolet (UV) light. Wear protective clothing and use a sunscreen with a high sun protection factor.
-
a problem with your vision called macular edema. Tell your healthcare provider about any changes in your vision. Your healthcare provider should test your vision before you start taking PONVORY™ and any time you notice vision changes during treatment with PONVORY™. Your risk of macular edema is higher if you have diabetes or have had an inflammation of your eye called uveitis.
Call your healthcare provider right away if you have any of the following symptoms:- blurriness or shadows in the center of your vision
- a blind spot in the center of your vision
- sensitivity to light
- unusually colored (tinted) vision
-
swelling and narrowing of the blood vessels in your brain. A condition called Posterior Reversible Encephalopathy Syndrome (PRES) has happened with drugs in the same class. Symptoms of PRES usually get better when you stop taking PONVORY™. However, if left untreated, it may lead to a stroke. Call your healthcare provider right away if you have any of the following symptoms:
- sudden severe headache
- sudden confusion
- sudden loss of vision or other changes in vision
- seizure
-
severe worsening of multiple sclerosis (MS) after stopping PONVORY™.
When PONVORY™ is stopped, symptoms of MS may return and become worse compared to before or during treatment. Always talk to your healthcare provider before you stop taking PONVORY™ for any reason. Tell your healthcare provider if you have worsening symptoms of MS after stopping PONVORY™.
The most common side effects of PONVORY™ include:
- upper respiratory tract infections
- elevated liver enzymes (abnormal liver tests)
- high blood pressure (hypertension)
These are not all the possible side effects of PONVORY™. For more information, ask your healthcare provider or pharmacist. See “What is the most important information I should know about PONVORY™?”
Tell your doctor if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You are also encouraged to report side effects to the FDA: visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).
Please see full Prescribing Information and Medication Guide.
Trademarks are those of their respective owners.
cp-214883v1
WHAT IS PREZCOBIX®?
PREZCOBIX® is a prescription medicine that is used with other HIV-1 medicines to treat HIV-1 infection in adults and in children who weigh at least 88 pounds (40 kg). HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). PREZCOBIX® contains prescription medicines darunavir and cobicistat. It is not known if PREZCOBIX® is safe and effective in children weighing less than 88 pounds (40 kg).
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about PREZCOBIX®?
-
PREZCOBIX® may cause liver problems which may be life-threatening. Tell your healthcare provider right away if you have any symptoms such as:
- Dark (tea-colored) urine
- Yellowing of your skin or the whites of your eyes
- Pale-colored stools (bowel movements)
- Nausea
- Vomiting
- Pain or tenderness on your right side below your ribs
- Loss of appetite
-
PREZCOBIX® may cause severe or life-threatening skin reactions or rashes. Stop taking PREZCOBIX® and call your healthcare provider right away if you develop any skin changes with symptoms below:
- Fever
- Tiredness
- Muscle or joint pain
- Blisters or skin lesions
- Mouth sores or ulcers
- Red or inflamed eyes, like "pink eye" (conjunctivitis)
- PREZCOBIX®, when taken with some other medications, can cause new or worse kidney problems, including kidney failure.
- Do not take PREZCOBIX® with any medicine that contains: alfuzosin, carbamazepine, cisapride, colchicine (if you have liver or kidney problems), dronedarone, elbasvir and grazoprevir, dihydroergotamine, ergotamine tartrate, ivabradine, lomitapide, lovastatin, lurasidone, methylergonovine, midazolam (when taken by mouth), naloxegol, phenobarbital, phenytoin, pimozide, ranolazine, rifampin, St. John's wort (Hypericum perforatum), sildenafil when used for pulmonary arterial hypertension (PAH), simvastatin, or triazolam.
- Serious problems can happen if you take any of these medicines with PREZCOBIX®.
What should I tell my healthcare provider before taking PREZCOBIX®?
Tell your healthcare provider about all your medical conditions, including if you:
- have liver problems, including hepatitis B or hepatitis C, have kidney problems, are allergic to sulfa (sulfonamide), have diabetes, or have hemophilia.
-
are pregnant, or plan to become pregnant. It is not known if PREZCOBIX® will harm your unborn baby. PREZCOBIX® should not be used during pregnancy because the PREZCOBIX® levels in your blood may be lower during pregnancy and may not control your HIV-1. Tell your healthcare provider right away if you become pregnant during treatment with PREZCOBIX®. Your healthcare provider will prescribe different medicines if you become pregnant during treatment with PREZCOBIX®.
- Hormonal forms of birth control, such as injections, vaginal rings or implants, contraceptive patches, and some birth control pills may not work during treatment with PREZCOBIX®. Talk to your healthcare provider about forms of birth control that may be used during treatment with PREZCOBIX®.
- are breastfeeding, or plan to breastfeed. You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. It is not known if PREZCOBIX® can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with PREZCOBIX®. Keep a list of your medicines to show your healthcare provider and pharmacist. Do not start taking a new medicine without telling your healthcare provider.
What are the possible side effects of PREZCOBIX®?
PREZCOBIX® may cause serious side effects including:
- See “What is the most important information I should know about PREZCOBIX®?”
- Diabetes and high blood sugar
- Changes in body fat can happen in people taking HIV-1 medications
- Immune system changes can happen in people who start HIV medications
- Increased bleeding can occur in people with hemophilia who are taking PREZCOBIX®
The most common side effects include:
- Diarrhea
- Nausea
- Rash
- Headache
- Stomach area (abdominal) pain
- Vomiting
These are not all the possible side effects of PREZCOBIX®. Call your doctor for medical advice about side effects. For more information, ask your healthcare provider.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
You may also report side effects to Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736).
Please read full Product Information for PREZCOBIX® for more details.
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What is PREZISTA®?
PREZISTA® (darunavir) is a prescription HIV‑1 (Human Immunodeficiency Virus type‑1) medicine used with NORVIR® (ritonavir) and other antiretroviral medicines to treat HIV-1 infection in adults. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
PREZISTA® should not be used in children under 3 years of age.
When used with other antiretroviral medicines to treat HIV‑1 infection, PREZISTA® may help:
- reduce the amount of HIV-1 in your blood. This is called "viral load."
- increase the number of CD4+ (T) cells in your blood that help fight off other infections.
PREZISTA® is always taken with and at the same time as NORVIR® (ritonavir) in combination with other HIV‑1 medicines for the treatment of HIV‑1 infection in adults. PREZISTA® should also be taken with food.
PREZISTA® does not cure HIV‑1 infection or AIDS. You must keep taking HIV‑1 medicines to control HIV‑1 infection and decrease HIV-related illnesses.
Ask your healthcare provider if you have any questions on how to prevent passing HIV to other people.
Please read the Important Safety Information and talk to your healthcare provider to learn if PREZISTA® is right for you.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about PREZISTA®?
- PREZISTA® can interact with other medicines and cause serious side effects. See “Who should not take PREZISTA®?”
- PREZISTA® may cause liver problems. Some people taking PREZISTA®, together with NORVIR® (ritonavir), have developed liver problems which may be life-threatening. Your healthcare provider should do blood tests before and during your combination treatment with PREZISTA®. If you have chronic hepatitis B or C infection, your healthcare provider should check your blood tests more often because you have an increased chance of developing liver problems.
- Tell your healthcare provider if you have any of these signs and symptoms of liver problems: dark (tea‑colored) urine, yellowing of your skin or whites of your eyes, pale‑colored stools (bowel movements), nausea, vomiting, pain or tenderness on your right side below your ribs, loss of appetite, or tiredness.
- PREZISTA® may cause severe or life‑threatening skin reactions or rash. Sometimes these skin reactions and skin rashes can become severe and require treatment in a hospital. You should call your healthcare provider immediately if you develop a rash. Stop taking PREZISTA® and ritonavir combination treatment and call your healthcare provider immediately if you develop any skin changes with these symptoms: fever, tiredness, muscle or joint pain, blisters or skin lesions, mouth sores or ulcers, red or inflamed eyes, like “pink eye.” Rash occurred more often in people taking PREZISTA® and raltegravir together than with either drug separately, but was generally mild.
Who should not take PREZISTA®?
Do not take PREZISTA® with any medicine that contains: alfuzosin, cisapride, colchicine (if you have liver or kidney problems), dronedarone, elbasvir and grazoprevir, ergot‑containing medicines (dihydroergotamine, ergotamine tartrate, methylergonovine), ivabradine, lomitapide, lovastatin, lurasidone, midazolam (when taken by mouth), naloxegol, pimozide, ranolazine, rifampin, sildenafil, when used for the treatment of pulmonary arterial hypertension (PAH), simvastatin, St. John’s wort (Hypericum perforatum), or triazolam.
Serious problems can happen if you or your child takes any of these medicines with PREZISTA®.
What should I tell my healthcare provider before taking PREZISTA®?
Before taking PREZISTA®, tell your healthcare provider if you:
- have liver problems (including hepatitis B or C), allergy to sulfa medicines, high blood sugar (diabetes), hemophilia, or any other medical conditions.
- are pregnant or planning to become pregnant. Tell your healthcare provider if you become pregnant while taking PREZISTA®.
- are breastfeeding or plan to breastfeed. Do not breastfeed if you take PREZISTA®. You should not breastfeed if you have HIV because of the risk of passing HIV to your baby. It is not known if PREZISTA® can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby.
Tell your healthcare provider about all the medicines you take, including prescription and over‑the‑counter medicine, vitamins, and herbal supplements. Some medicines interact with PREZISTA®. Keep a list of your medicines to show your healthcare provider and pharmacist. Do not start taking a new medicine without telling your healthcare provider.
What are the possible side effects of PREZISTA®?
PREZISTA® may cause serious side effects, including:
- High blood sugar, diabetes or worsening of diabetes, and increased bleeding in people with hemophilia have been reported in patients taking protease inhibitor medicines, including PREZISTA®.
- Changes in body fat can happen in people who take HIV medicines. The exact cause and long‑term health effects of these conditions are not known.
- Changes in your immune system can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time.
The most common side effects of PREZISTA® include diarrhea, nausea, rash, headache, stomach pain, and vomiting.
These are not all the possible side effects of PREZISTA®. For more information, ask your healthcare provider. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Do not change your dose or stop treatment with PREZISTA® without talking to your healthcare provider.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also report side effects to Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736).
Please refer to the NORVIR® (ritonavir) Patient Information Leaflet for additional information on precautionary measures.
Please read full Product Information for PREZISTA® for more details.
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WHAT IS PROCRIT®?
PROCRIT® (epoetin alfa) is used to treat a lower than normal number of red blood cells (anemia) caused by:
- Chronic kidney disease in patients on dialysis and not on dialysis.
- Chemotherapy that will be used for at least 2 months after starting PROCRIT®.
- A medicine called zidovudine (AZT) used to treat HIV infection.
PROCRIT® may also be used to reduce the chance you will need red blood cell transfusions if you are scheduled for certain surgeries where a lot of blood loss is expected.
If your hemoglobin level stays too high or if your hemoglobin goes up too quickly, this may lead to serious health problems which may result in death. These serious health problems may happen if you take PROCRIT®, even if you do not have an increase in your hemoglobin level.
PROCRIT® has not been proven to improve quality of life, fatigue, or well-being.
PROCRIT® should not be used for treatment of anemia:
- If you have cancer and you will not be receiving chemotherapy that may cause anemia.
- If you have a cancer that has a high chance of being cured.
- If your anemia caused by chemotherapy treatment can be managed by RBC transfusion.
- In place of emergency treatment for anemia (red blood cell transfusions).
PROCRIT® should not be used to reduce the chance of red blood cell transfusions if:
- You are scheduled for surgery on your heart or blood vessels.
- You are able and willing to donate blood prior to surgery.
It is not known if PROCRIT® is safe and effective in treating anemia in children less than 1 month old who have chronic kidney disease and in children less than 5 years old who have anemia caused by chemotherapy.
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IMPORTANT SAFETY INFORMATION
What is the most important information I should know about PROCRIT® (epoetin alfa)?
PROCRIT® may cause serious side effects that can lead to death, including:
For people with cancer:
Your tumor may grow faster and you may die sooner if you choose to take PROCRIT®. Your healthcare provider will talk with you about these risks.
For all people who take PROCRIT®, including patients with cancer or chronic kidney disease:
- Serious heart problems, such as heart attack or heart failure, and stroke. You may die sooner if you are treated with PROCRIT® to increase red blood cells (RBCs) to near the same level found in healthy people.
- Blood Clots. Blood clots may happen at any time while taking PROCRIT®. If you are receiving PROCRIT® for any reason and you are going to have surgery, talk to your healthcare provider about whether or not you need to take a blood thinner to lessen the chance of blood clots during or following surgery. Blood clots can form in blood vessels (veins), especially in your leg (deep venous thrombosis or DVT). Pieces of a blood clot may travel to the lungs and block the blood circulation in the lungs (pulmonary embolus).
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Call your healthcare provider or get medical help right away if you have any of these symptoms:
- Chest pain
- Trouble breathing or shortness of breath
- Pain in your legs, with or without swelling
- A cool or pale arm or leg
- Sudden confusion, trouble speaking, or trouble understanding others' speech
- Sudden numbness or weakness in your face, arm, or leg, especially on one side of your body
- Sudden trouble seeing
- Sudden trouble walking, dizziness, loss of balance or coordination
- Loss of consciousness (fainting)
- Hemodialysis vascular access stops working
If you decide to take PROCRIT®, your healthcare provider should prescribe the smallest dose of PROCRIT® that is necessary to reduce your chance of needing red blood cell transfusions.
Who should not take PROCRIT®?
Do not take PROCRIT® if you:
- Have cancer and have not been counseled by your healthcare provider about treatment with PROCRIT®.
- Have high blood pressure that is not controlled (uncontrolled hypertension).
- Have been told by your healthcare provider that you have or have ever had a type of anemia called Pure Red Cell Aplasia (PRCA) that starts after treatment with PROCRIT® or other erythropoietin protein medicines.
- Have had a serious allergic reaction to PROCRIT®.
Do not give PROCRIT® from multiple-dose vials to:
- Pregnant or breastfeeding women
- Babies
What should I tell my healthcare provider before taking PROCRIT®?
PROCRIT® may not be right for you. Tell your healthcare provider about all your health conditions, including if you:
- Have heart disease.
- Have high blood pressure.
- Have had a seizure (convulsion) or stroke.
- Receive dialysis treatment.
- Have any other medical conditions.
- Are pregnant or planning to become pregnant. It is not known if PROCRIT® may harm your unborn baby. Talk with your healthcare provider about possible pregnancy and birth control choices that are right for you.
- Are breastfeeding or planning to breastfeed. It is not known if PROCRIT® passes into breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
What are the possible side effects of PROCRIT®?
PROCRIT® may cause serious side effects.
- See "What is the most important information I should know about PROCRIT®?"
- High blood pressure. High blood pressure is a common side effect of PROCRIT® in patients with chronic kidney disease. Your blood pressure may go up or be difficult to control with blood pressure medicine while taking PROCRIT®. This can happen even if you have never had high blood pressure before. Your healthcare provider should check your blood pressure often. If your blood pressure does go up, your healthcare provider may prescribe new or more blood pressure medicine.
- Seizures. If you have any seizures while taking PROCRIT®, get medical help right away and tell your healthcare provider.
- Antibodies to PROCRIT®. Your body may make antibodies to PROCRIT®. These antibodies can block or lessen your body's ability to make red blood cells and cause you to have severe anemia. Call your healthcare provider if you have unusual tiredness, lack of energy, dizziness, or fainting. You may need to stop taking PROCRIT®.
- Serious allergic reactions. Serious allergic reactions can cause a skin rash, itching, shortness of breath, wheezing, dizziness and fainting because of a drop in blood pressure, swelling around your mouth or eyes, fast pulse, or sweating. If you have a serious allergic reaction, stop using PROCRIT® and call your healthcare provider or get medical help right away.
- Severe skin reactions. Signs and symptoms of severe skin reactions with PROCRIT® may include: skin rash with itching, blisters, skin sores, peeling, or areas of skin coming off. If you have any signs or symptoms of a severe skin reaction, stop using PROCRIT® and call your healthcare provider or get medical help right away.
- Dangers of using PROCRIT® from multiple-dose vials in newborns, infants, and pregnant or breastfeeding women. Do not use PROCRIT® from multiple-dose vials in newborns, infants, pregnant or breastfeeding women because the PROCRIT® in these vials contains benzyl alcohol. Benzyl alcohol has been shown to cause brain damage, other serious side effects, and death in newborn and premature babies. If you use PROCRIT® from multiple-dose vials, you should not breastfeed for at least 2 weeks after the last dose. PROCRIT® that comes in single-dose vials does not contain benzyl alcohol. See "Who should not take PROCRIT®?".
Common side effects of PROCRIT® include:
- Joint, muscle, or bone pain
- Fever
- Cough
- Dizziness
- High blood sugar
- Low potassium levels in the blood
- Chills
- Redness and pain at the PROCRIT® injection site
- Rash
- Nausea
- Vomiting
- Blood vessel blockage
- Low white blood cells
- Trouble sleeping
- Difficulty swallowing
- Soreness of mouth
- Itching
- Headache
- Respiratory infection
- Weight decrease
- Depression
- Muscle spasm
These are not all of the possible side effects of PROCRIT®. Your healthcare provider can give you a more complete list. Tell your healthcare provider about any side effects that bother you or that do not go away.
Please read the Medication Guide for PROCRIT® (epoetin alfa) and discuss it with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
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What is REMICADE®?
REMICADE® is a prescription medication used to treat:
Crohn's Disease
- Can reduce signs and symptoms and induce and maintain remission in adult patients with moderately to severely active Crohn’s disease who haven't responded well to other therapies
Pediatric Crohn's Disease
- Can reduce signs and symptoms and induce and maintain remission in children (ages 6-17) with moderately to severely active Crohn's disease who haven't responded well to other therapies
Ulcerative Colitis
- Can reduce signs and symptoms, induce and maintain remission, promote intestinal healing, and reduce or stop the need for steroids in adult patients with moderately to severely active ulcerative colitis who haven't responded well to other therapies
Pediatric Ulcerative Colitis
- Can reduce signs and symptoms and induce and maintain remission in children (ages 6-17) with moderately to severely active ulcerative colitis who haven’t responded well to other therapies
Rheumatoid Arthritis
- Can reduce signs and symptoms, help stop further joint damage, and improve physical function in patients with moderately to severely active rheumatoid arthritis, in combination with methotrexate
Psoriatic Arthritis
- Can reduce signs and symptoms of active arthritis, help stop further joint damage, and improve physical function in patients with psoriatic arthritis
Ankylosing Spondylitis
- Can reduce signs and symptoms in patients with active ankylosing spondylitis
Plaque Psoriasis
- Approved for the treatment of adult patients with chronic severe (extensive and/or disabling) plaque psoriasis under the care of a physician who will determine if REMICADE® is appropriate considering other available therapies
IMPORTANT SAFETY INFORMATION
Only your doctor can recommend a course of treatment after checking your health condition. REMICADE® (infliximab) can cause serious side effects such as lowering your ability to fight infections. Some patients, especially those 65 years and older, have had serious infections which include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body or caused infections in certain areas (such as skin). Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with REMICADE®.
Unusual cancers have been reported in children and teenage patients taking tumor necrosis factor (TNF) blocker medicines. Hepatosplenic T-cell lymphoma, a rare form of fatal lymphoma, has occurred mostly in male teenagers or young men with Crohn’s disease or ulcerative colitis who were taking REMICADE® and azathioprine or 6-mercaptopurine. For children and adults taking TNF blockers, including REMICADE®, the chances of getting lymphoma or other cancers may increase. You should discuss any concerns about your health and medical care with your doctor.
It is not known if REMICADE® is safe and effective in children under 6 years of age.
What should I tell my doctor before I take REMICADE®?
You should let your doctor know if you have or ever had any of the following:
- Tuberculosis (TB) or have been near someone who has TB. Your doctor will check you for TB with a skin test. If you have latent (inactive) TB, you will begin TB treatment before you start REMICADE®.
- Lived in a region where certain fungal infections like histoplasmosis, coccidioidomycosis, or blastomycosis are common.
- Infections that keep coming back, have diabetes or an immune system problem.
- Any type of cancer or a risk factor for developing cancer, for example, chronic obstructive pulmonary disease (COPD) or had phototherapy for psoriasis.
- Heart failure or any heart condition. Many people with heart failure should not take REMICADE®.
- Hepatitis B virus (HBV) infection or think you may be a carrier of HBV. Your doctor will test you for HBV.
- Nervous system disorders (like multiple sclerosis or Guillain-Barré syndrome).
Also tell your doctor if you:
- Use the medicines Kineret (anakinra), Orencia (abatacept) or Actemra (tocilizumab) or other medicines called biologics used to treat the same problems as REMICADE®.
- Are pregnant, plan to become pregnant, are breast-feeding or plan to breastfeed, or have a baby and were using REMICADE® during your pregnancy. Tell your baby’s doctor about your REMICADE® use. If your baby receives a live vaccine within 6 months after birth, your baby may develop infections with serious complications that can lead to death.
- Recently received or are scheduled to receive a vaccine. Adults and children taking REMICADE® should not receive live vaccines or treatment with a weakened bacteria (such as BCG for bladder cancer) while taking REMICADE®.
What should I watch for and talk to my doctor about before or while taking REMICADE®?
The following serious (sometimes fatal) side effects have been reported in people taking REMICADE®.
You should tell your doctor right away if you have any of the signs listed below:
- Serious infections (like TB, blood infections, pneumonia)—fever, tiredness, cough, flu-like symptoms, or warm, red or painful skin or any open sores. REMICADE® can make you more likely to get an infection or make any infection that you have worse.
- Reactivation of HBV—feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.
- Lymphoma, or any other cancers in adults and children.
- Skin cancer—any changes in or growths on your skin.
- Cervical cancer—your doctor may recommend that you be regularly screened. Some women with rheumatoid arthritis, particularly those over 60, have developed cervical cancer.
- Heart failure—new or worsening symptoms, such as shortness of breath, swelling of ankles or feet, or sudden weight gain.
- Other heart problems within 24 hours of infusion, including heart attack, low blood flow to the heart, or abnormal heart rhythm—chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea, vomiting, fluttering or pounding in your chest, and/or a fast or a slow heartbeat.
- Liver injury—jaundice (yellow skin and eyes), dark brown urine, pain on the right side of your stomach area, fever, or severe tiredness.
- Blood problems—fever that doesn’t go away, bruising, bleeding or severe paleness.
- Nervous system disorders—changes in your vision, numbness or tingling in any part of your body, seizures, or weakness in your arms or legs.
- Stroke within 24 hours of infusion—numbness or weakness of the face, arm or leg, especially on one side of the body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes; sudden trouble walking; dizziness; loss of balance or coordination; or a sudden, severe headache.
- Allergic reactions during or after infusion—hives, difficulty breathing, chest pain, high or low blood pressure, and fever or chills.
- Delayed allergic reactions (3 to 12 days after infusion) —fever, rash, headache, sore throat, muscle or joint pain, swelling of the face and hands, or difficulty swallowing.
- Lupus-like syndrome—chest discomfort or pain that does not go away, shortness of breath, joint pain, rash on the cheeks or arms that gets worse in the sun.
- Psoriasis—new or worsening psoriasis such as red scaly patches or raised bumps on the skin that are filled with pus.
The more common side effects of REMICADE® include respiratory infections (such as sinus infections and sore throat), headache, coughing and stomach pain.
Please read the full Prescribing Information and Medication Guide for REMICADE® and discuss any questions you have with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
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What is RISPERDAL CONSTA®?
RISPERDAL CONSTA® (risperidone) is used for the treatment of schizophrenia and for the longer-term treatment of Bipolar I Disorder.
IMPORTANT SAFETY INFORMATION
RISPERDAL CONSTA® can cause serious side effects, including an increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). RISPERDAL CONSTA® is not for treating dementia-related psychosis.
Do not receive RISPERDAL CONSTA® if you are allergic to paliperidone, risperidone, or any of the ingredients in RISPERDAL CONSTA®.
Cerebrovascular problems (stroke) that can lead to death have been reported in elderly patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS) is a rare but very serious problem that can happen in people who receive RISPERDAL CONSTA®. NMS can cause death and must be treated in a hospital. Call your healthcare provider right away if you become severely ill and have any of these symptoms: high fever, severe muscle stiffness, confusion, loss of consciousness, or changes in your breathing, heartbeat and blood pressure.
Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with RISPERDAL CONSTA® and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. Elderly female patients appear to be at increased risk for TD, although it is impossible to predict which patients will develop the syndrome. This condition can develop after a brief period of therapy at low doses, although this is much less common. Symptoms may go away partially or completely if therapy is stopped.
Atypical antipsychotic drugs have been associated with metabolic changes that can increase cardiovascular/cerebrovascular risks. These changes may include:
High blood sugar and diabetes have been reported with RISPERDAL CONSTA® and similar medicines. If you already have diabetes or have risk factors such as being overweight or a family history of diabetes, blood sugar testing should be done at the beginning and during the treatment. The complications of diabetes can be serious and even life-threatening. Call your healthcare professional if you develop signs of high blood sugar or diabetes, such as being thirsty all the time, having to urinate or “pass urine” more often than usual, or feeling weak or hungry.
Changes in cholesterol and triglycerides have been noted in patients taking atypical antipsychotics. Check with your healthcare professional while on treatment.
Weight gain has been reported in patients taking atypical antipsychotics. Monitor weight gain while on treatment.
RISPERDAL CONSTA® and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and problems with erection.
Some people taking RISPERDAL CONSTA® may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your healthcare professionalʼs dosing instructions, this side effect can be reduced.
Patients (particularly the elderly) taking antipsychotics with certain health conditions or those on longterm therapy should be evaluated by their healthcare professional for the potential risk of falls.
Blood problems such as low numbers of white blood cells have been reported in patients taking risperidone and similar medications. In some cases it has been serious and life-threatening. Depending upon your medical condition, your healthcare professional may choose to test your blood as you start therapy with RISPERDAL CONSTA®.
RISPERDAL CONSTA® may affect your ability to make decisions, think clearly, or react quickly. Do not drive, operate heavy machinery, or do other dangerous activities until you know how RISPERDAL CONSTA® affects you.
RISPERDAL CONSTA® should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.
RISPERDAL CONSTA® may increase difficulty in swallowing that may cause food or liquid to get into your lungs.
Painful, long lasting erections have been reported with the use of RISPERDAL CONSTA®. Call your healthcare professional immediately if you think you are having this problem.
Tell your healthcare professional if you are pregnant or plan to become pregnant. It is not known if RISPERDAL CONSTA® will harm your unborn baby. If you become pregnant while taking RISPERDAL CONSTA®, talk to your healthcare professional about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry. Infants born to women who are treated with RISPERDAL CONSTA® may experience symptoms such as tremors, irritability, excessive sleepiness, eye twitching, muscle spasms, decreased appetite, difficulty breathing, or abnormal movement of arms and legs. Let your healthcare professional know if these symptoms occur. Tell your healthcare professional if you are breastfeeding or plan to breastfeed. RISPERDAL CONSTA® can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you receive RISPERDAL CONSTA®.
RISPERDAL CONSTA® may impair fertility, which is reversible. Speak to your healthcare provider if you plan to become pregnant.
RISPERDAL CONSTA® may make you more sensitive to heat. You may have trouble cooling off, or be more likely to become dehydrated, so take care when exercising or when doing things that make you warm.
Some medications interact with RISPERDAL CONSTA®. Please inform your healthcare professional of any medications or supplements that you are taking. Avoid alcohol while taking RISPERDAL CONSTA®.
In studies of people taking RISPERDAL CONSTA®, the most common side effects in the treatment of schizophrenia were headache, slow movements (including tremor [shaking], stiffness, and a shuffling walk), dizziness; feeling of inner restlessness or needing to be constantly moving; tiredness, constipation, indigestion, sleepiness, weight gain, pain in the limbs, and dry mouth.
In studies of people taking RISPERDAL CONSTA®, the most common side effects in the treatment of bipolar disorder were weight gain (when used alone) and slow movements (including with tremor [shaking], stiffness, and a shuffling walk) and tremor (when used with lithium or valproate).
This is not a complete list of all possible side effects. Ask your healthcare professional or treatment team if you have any questions or want more information.
If you have any questions about RISPERDAL CONSTA® or your therapy, talk with your healthcare professional.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please read the full Prescribing Information, including Boxed WARNING, for RISPERDAL CONSTA® and discuss any questions you have with your healthcare professional.
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What is SIMPONI® (golimumab)?
SIMPONI® is a prescription medicine for adults with:
- Moderate to severe rheumatoid arthritis (RA), with the medicine methotrexate (MTX)
- Active psoriatic arthritis (PsA), alone or with the medicine MTX
- Active ankylosing spondylitis (AS)
-
Moderately to severely active ulcerative colitis (UC) when certain other UC medicines have not worked well enough or cannot be tolerated, or if it is necessary to continue taking steroid medicines:
- To begin helping some of your symptoms
- In people who respond to SIMPONI®, to get their UC under control (induce remission) and keep UC under control (sustain remission)
- To begin to improve the way the lining of your large intestine looks to your doctor during colonoscopy
MTX is used as directed.
For RA, PsA, and AS: SIMPONI® 50 mg is given as an injection under the skin (subcutaneous injection) once a month.
For UC: SIMPONI® begins with 3 starter injections under the skin (subcutaneous injection): Two 100-mg injections on the first day of treatment, followed by one 100-mg injection 2 weeks later. After these 3 starter injections, SIMPONI® requires one 100-mg injection every 4 weeks.
Once you and your doctor are comfortable with the self-injection process, you will inject SIMPONI® under the skin.
IMPORTANT SAFETY INFORMATION
SERIOUS INFECTIONS
SIMPONI® (golimumab) is a prescription medicine. SIMPONI® can lower your ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor will test you for TB before starting SIMPONI® and will monitor you for signs of TB during treatment. Tell your doctor if you have been in close contact with people with TB. Tell your doctor if you have been in a region (such as the Ohio and Mississippi River Valleys and the Southwest) where certain fungal infections like histoplasmosis or coccidioidomycosis are common.
You should not start SIMPONI® if you have any kind of infection. Tell your doctor if you are prone to or have a history of infections or have diabetes, HIV or a weak immune system. You should also tell your doctor if you are currently being treated for an infection or if you have or develop any signs of an infection such as:
-
fever, sweat, or chills
-
muscle aches
-
cough
-
shortness of breath
-
blood in phlegm
-
weight loss
-
warm, red, or painful skin or sores on your body
-
diarrhea or stomach pain
-
burning when you urinate or urinate more than normal
-
feel very tired
Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with SIMPONI® and during treatment with SIMPONI®. Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are taking SIMPONI®. People who had a negative TB skin test before receiving SIMPONI® have developed active TB. Tell your doctor if you have any of the following symptoms while taking or after taking SIMPONI®:
-
cough that does not go away
-
low grade fever
-
weight loss
-
loss of body fat and muscle (wasting)
CANCER
Unusual cancers have been reported in children and teenage patients taking TNF‑blocker medicines. For children and adults taking TNF blockers, including SIMPONI®, the chances for getting lymphoma or other cancers may increase. Hepatosplenic T-cell lymphoma, a rare and fatal lymphoma, has occurred mostly in teenage or young adult males with Crohn’s disease or ulcerative colitis who were taking other TNF blockers with azathioprine or 6‑mercaptopurine. You should tell your doctor if you have had or develop lymphoma or other cancers.
Some people treated with SIMPONI® have developed certain kinds of skin cancer. If any changes in the appearance of your skin or growths on your skin occur during or after your treatment with SIMPONI®, tell your doctor.
USE WITH OTHER DRUGS
Tell your doctor about all the medications you take including ORENCIA® (abatacept), KINERET® (anakinra), ACTEMRA® (tocilizumab), RITUXAN® (rituximab), or another TNF blocker, or if you are scheduled to or recently received a vaccine. People taking SIMPONI® should not receive live vaccines or treatment with a weakened bacteria (such as BCG for bladder cancer).
HEPATITIS B INFECTION
Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF-blocker medicines, such as SIMPONI®. Some of these cases have been fatal. Your doctor should do blood tests before and after you start treatment with SIMPONI®. Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as:
-
feel very tired
-
dark urine
-
skin or eyes look yellow
-
little or no appetite
-
vomiting
-
muscle aches
-
clay-colored bowel movements
-
fevers
-
chills
-
stomach discomfort
-
skin rash
HEART FAILURE
Heart failure can occur or get worse in people who use TNF blockers, including SIMPONI®. If you develop new or worsening heart failure with SIMPONI®, you may need treatment in a hospital, and it may result in death. Your doctor will closely monitor you if you have heart failure. Tell your doctor right away if you get new or worsening symptoms of heart failure like shortness of breath, swelling of your lower legs or feet, or sudden weight gain.
NERVOUS SYSTEM PROBLEMS
Rarely, people using TNF blockers, including SIMPONI®, can have nervous system problems such as multiple sclerosis or Guillain-Barré syndrome. Tell your doctor right away if you have symptoms like vision changes, weakness in your arms or legs, or numbness or tingling in any part of your body.
IMMUNE SYSTEM PROBLEMS
Rarely, people using TNF blockers have developed lupus-like symptoms. Tell your doctor if you have any symptoms such as a rash on your cheeks or other parts of the body, sensitivity to the sun, new joint or muscle pain, becoming very tired, chest pain or shortness of breath, swelling of the feet, ankles, and/or legs.
LIVER PROBLEMS
Serious liver problems can happen in people using TNF blockers, including SIMPONI®. Contact your doctor immediately if you develop symptoms such as feeling very tired, skin or eyes look yellow, poor appetite or vomiting, or pain on the right side of your stomach.
BLOOD PROBLEMS
Low blood counts have been seen with SIMPONI®. If this occurs, your body may not make enough blood cells to help fight infections or help stop bleeding. Your doctor will check your blood counts before and during treatment. Tell your doctor if you have signs such as fever, bruising, bleeding easily, or paleness.
OTHER CONSIDERATIONS TO TELL YOUR DOCTOR
Tell your doctor if you are allergic to rubber or latex. The needle cover contains dry natural rubber.
Tell your doctor if you are pregnant, planning to become pregnant or are breastfeeding or have a baby and were using SIMPONI® during pregnancy. Tell your baby’s doctor before your baby receives any vaccine because of an increased risk of infection for up to 6 months after birth.
ALLERGIC REACTIONS
Allergic reactions can happen in people who use TNF-blocker medicines, including SIMPONI®. Tell your doctor if you have any symptoms of an allergic reaction while taking SIMPONI® such as hives, swollen face, breathing trouble, or chest pain. Some reactions can be serious and life-threatening.
Common side effects of SIMPONI® include: upper respiratory tract infection, reaction at site of injection, and viral infections.
PSORIASIS
New or worse psoriasis symptoms may occur. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus.
Please read the full Prescribing Information and Medication Guide for SIMPONI® and discuss any questions you have with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
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WHAT IS SIMPONI ARIA® (golimumab)?
SIMPONI ARIA® is a prescription medicine used to treat:
- Moderate to severe rheumatoid arthritis (RA) in adults, used in combination with methotrexate
- Active psoriatic arthritis (PsA) in people 2 years of age and older
- Active ankylosing spondylitis (AS) in adults
- Active polyarticular juvenile idiopathic arthritis (pJIA) in people 2 years of age and older
IMPORTANT SAFETY INFORMATION
SERIOUS INFECTIONS
SIMPONI ARIA® (golimumab) is a prescription medicine. SIMPONI ARIA® can lower your ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor will test you for TB before starting SIMPONI ARIA® and will closely monitor you for signs of TB during treatment. Tell your doctor if you have been in close contact with people with TB. Tell your doctor if you have been in a region (such as the Ohio and Mississippi River Valleys and the Southwest) where certain fungal infections like histoplasmosis or coccidioidomycosis are common.
You should not receive SIMPONI ARIA® if you have any kind of infection. Tell your doctor if you are prone to or have a history of infections or have diabetes, HIV or a weak immune system. You should also tell your doctor if you are currently being treated for an infection or if you have or develop any signs of an infection such as:
- fever, sweat, or chills
- muscle aches
- cough
- shortness of breath
- blood in phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning when you urinate or urinate more than normal
- feel very tired
Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with SIMPONI ARIA® and during treatment with SIMPONI ARIA®. Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are taking SIMPONI ARIA®. People who had a negative TB skin test before receiving SIMPONI ARIA® have developed active TB. Tell your doctor if you have any of the following symptoms while taking or after taking SIMPONI ARIA®:
- cough that does not go away
- low grade fever
- weight loss
- loss of body fat and muscle (wasting)
CANCER
Unusual cancers have been reported in children and teenage patients taking Tumor Necrosis Factor (TNF)-blocker medicines. For children and adults receiving TNF blockers, including SIMPONI ARIA®, the chances for getting lymphoma or other cancers may increase. Hepatosplenic T-cell lymphoma, a rare and fatal lymphoma, has occurred mostly in teenage or young adult males with Crohn’s disease or ulcerative colitis who were taking a TNF blocker with azathioprine or 6-mercaptopurine. You should tell your doctor if you have had or develop lymphoma or other cancers.
Some people treated with SIMPONI ARIA® developed skin cancer. Tell your doctor if any changes in the appearance of your skin or growths on your skin occur during or after your treatment with SIMPONI ARIA®. Your doctor should periodically examine your skin, especially if you have a history of skin cancer.
USE WITH OTHER DRUGS
Tell your doctor about all the medications you take including ORENCIA® (abatacept), KINERET® (anakinra), ACTEMRA® (tocilizumab), RITUXAN® (rituximab), or another TNF blocker, or if you are scheduled to or recently received a vaccine. People receiving SIMPONI ARIA® should not receive live vaccines or treatment with a weakened bacteria (such as BCG for bladder cancer).
HEPATITIS B INFECTION
Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are receiving TNF-blocker medicines, such as SIMPONI ARIA®. Some of these cases have been fatal. Your doctor should do blood tests before and after you start treatment with SIMPONI ARIA®. Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as:
- feel very tired
- dark urine
- skin or eyes look yellow
- little or no appetite
- vomiting
- muscle aches
- clay-colored bowel movements
- fever
- chills
- stomach discomfort
- skin rash
HEART FAILURE
Heart failure can occur or get worse in people who use TNF blockers, including SIMPONI ARIA®. If you develop new or worsening heart failure with SIMPONI ARIA®, you may need treatment in a hospital, and it may result in death. Your doctor will closely monitor you if you have heart failure. Tell your doctor right away if you get new or worsening symptoms of heart failure like shortness of breath, swelling of your lower legs or feet, or sudden weight gain.
NERVOUS SYSTEM PROBLEMS
Rarely, people using TNF blockers, including SIMPONI ARIA®, can have nervous system problems such as multiple sclerosis or Guillain-Barré syndrome. Tell your doctor right away if you have symptoms like vision changes, weakness in your arms or legs, or numbness or tingling in any part of your body.
IMMUNE SYSTEM PROBLEMS
Rarely, people using TNF blockers have developed lupus-like symptoms. Tell your doctor if you have any symptoms such as a rash on your cheeks or other parts of the body, sensitivity to the sun, new joint or muscle pain, becoming very tired, chest pain or shortness of breath, or swelling of the feet, ankles or legs.
LIVER PROBLEMS
Serious liver problems can happen in people using TNF blockers, including SIMPONI ARIA®. Contact your doctor immediately if you develop symptoms such as feeling very tired, skin or eyes look yellow, poor appetite or vomiting, or pain on the right side of your stomach.
BLOOD PROBLEMS
Low blood counts have been seen with people using TNF blockers, including SIMPONI ARIA®. If this occurs, your body may not make enough blood cells to help fight infections or help stop bleeding. Your doctor will check your blood counts before and during treatment. Tell your doctor if you have signs such as fever, bruising, bleeding easily, or paleness.
ALLERGIC REACTIONS
Allergic reactions can happen in people who use TNF-blocker medicines, including SIMPONI ARIA®. Tell your doctor if you have any symptoms of an allergic reaction while receiving SIMPONI ARIA® such as hives, swollen face, breathing trouble, or chest pain. Some reactions can be serious and life-threatening.
OTHER CONSIDERATIONS TO TELL YOUR DOCTOR
Tell your doctor if you have psoriasis.
Tell your doctor if you are pregnant, planning to become pregnant, are breastfeeding, or plan to breastfeed, or have a baby and received SIMPONI ARIA® during pregnancy. Tell your baby’s doctor before your baby receives any vaccine because of an increased risk of infection for up to 6 months after birth.
COMMON SIDE EFFECTS
The most common side effects of SIMPONI ARIA® include: upper respiratory infection, abnormal liver tests, decreased blood cells that fight infection, viral infections, bronchitis, high blood pressure, and rash.
Please read the full Prescribing Information and Medication Guide for SIMPONI ARIA® and discuss any questions you have with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
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What is SPRAVATO® (esketamine) CIII nasal spray?
SPRAVATO® is a prescription medicine, used along with an antidepressant taken by mouth to treat:
- Adults with treatment-resistant depression (TRD)
- Depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions
SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if SPRAVATO® is safe or effective as an anesthetic medicine.
It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions. SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®.
It is not known if SPRAVATO® is safe and effective in children.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SPRAVATO®?
SPRAVATO® can cause serious side effects, including:
-
Sedation and dissociation. SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation).
- Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out.
- Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO®. Your healthcare provider will decide when you are ready to leave the healthcare setting.
-
Abuse and misuse. There is a risk for abuse and physical and psychological dependence with SPRAVATO® treatment. Your healthcare provider should check you for signs of abuse and dependence before and during treatment with SPRAVATO®.
- Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
- Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
- SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS Program. Patients treated in outpatient healthcare settings (e.g., medical offices and clinics) must be enrolled in the program.
-
Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.
SPRAVATO® is not for use in children- Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions.
-
How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
- Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
- Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.
-
Tell your healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:
- suicide attempts
- thoughts about suicide or dying
- worsening depression
- other unusual changes in behavior or mood
Do not take SPRAVATO® if you:
- have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs)
- have an abnormal connection between your veins and arteries (arteriovenous malformation)
- have a history of bleeding in the brain
- are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO®.
If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO®.
Before you take SPRAVATO®, tell your healthcare provider about all of your medical conditions, including if you:
-
have heart or brain problems, including:
- high blood pressure (hypertension)
- slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting
- history of heart attack
- history of stroke
- heart valve disease or heart failure
- history of brain injury or any condition where there is increased pressure in the brain
- have liver problems
- have ever had a condition called “psychosis” (see, feel, or hear things that are not there, or believe in things that are not true).
-
are pregnant or plan to become pregnant. SPRAVATO® may harm your baby. You should not take SPRAVATO® if you are pregnant.
- Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO®.
- If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATO®.
- There is a pregnancy registry for women who are exposed to SPRAVATO® during pregnancy. The purpose of the registry is to collect information about the health of women exposed to SPRAVATO® and their baby. If you become pregnant during treatment with SPRAVATO®, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
- are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with SPRAVATO®.
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATO® with certain medicine may cause side effects.
Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicines. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How will I take SPRAVATO®?
- You will take SPRAVATO® nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO® nasal spray device.
- Your healthcare provider will tell you how much SPRAVATO® you will take and when you will take it.
- Follow your SPRAVATO® treatment schedule exactly as your healthcare provider tells you to.
- During and after each use of the SPRAVATO® nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting.
- You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO®.
- If you miss a SPRAVATO® treatment, your healthcare provider may change your dose and treatment schedule.
- Some people taking SPRAVATO® get nausea and vomiting. You should not eat for at least 2 hours before taking SPRAVATO® and not drink liquids at least 30 minutes before taking SPRAVATO®.
- If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at least 1 hour before taking SPRAVATO®.
What should I avoid while taking SPRAVATO®?
Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. Do not take part in these activities until the next day following a restful sleep. See “What is the most important information I should know about SPRAVATO®?”
What are the possible side effects of SPRAVATO®?
SPRAVATO® may cause serious side effects including:
- See “What is the most important information I should know about SPRAVATO®?”
- Increased blood pressure. SPRAVATO® can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATO® and for at least 2 hours after you take SPRAVATO®. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO®.
- Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering.
- Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night.
The most common side effects of SPRAVATO® when used along with an antidepressant taken by mouth include:
- feeling disconnected from yourself, your thoughts, feelings and things around you
- dizziness
- nausea
- feeling sleepy
- spinning sensation
- decreased feeling of sensitivity (numbness)
- feeling anxious
- lack of energy
- increased blood pressure
- vomiting
- feeling drunk
- feeling very happy or excited
If these common side effects occur, they usually happen right after taking SPRAVATO® and go away the same day.
These are not all the possible side effects of SPRAVATO®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO® and discuss any questions you may have with your healthcare provider.
cp-170363v1
What is STELARA®?
STELARA® is a prescription medicine used to treat:
- adults and children 6 years and older with moderate to severe psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).
- adults 18 years and older with active psoriatic arthritis. STELARA® can be used alone or with the medicine methotrexate.
- adults 18 years and older with moderately to severely active Crohn’s disease.
- adults 18 years and older with moderately to severely active ulcerative colitis.
IMPORTANT SAFETY INFORMATION
STELARA® is a prescription medicine that affects your immune system. STELARA® can increase your chance of having serious side effects including:
Serious Infections
STELARA® may lower your ability to fight infections and may increase your risk of infections. While taking STELARA®, some people have serious infections, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.
- Your doctor should check you for TB before starting STELARA® and watch you closely for signs and symptoms of TB during treatment with STELARA®.
- If your doctor feels that you are at risk for TB, you may be treated for TB before and during treatment with STELARA®.
You should not start taking STELARA® if you have any kind of infection unless your doctor says it is okay.
Before starting STELARA®, tell your doctor if you:
-
think you have an infection or have symptoms of an infection such as:
- fever, sweats, or chills
- muscle aches
- cough
- shortness of breath
- blood in phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning when you urinate or urinate more often than normal
- feel very tired
- are being treated for an infection or have any open cuts.
- get a lot of infections or have infections that keep coming back.
- have TB, or have been in close contact with someone with TB.
After starting STELARA®, call your doctor right away if you have any symptoms of an infection (see above). These may be signs of infections such as chest infections, or skin infections or shingles that could have serious complications. STELARA® can make you more likely to get infections or make an infection that you have worse. People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL‐12) and interleukin 23 (IL‐23) are at a higher risk for certain serious infections that can spread throughout the body and cause death. People who take STELARA® may also be more likely to get these infections.
Cancers
STELARA® may decrease the activity of your immune system and increase your risk for certain types of cancer. Tell your doctor if you have ever had any type of cancer. Some people who had risk factors for skin cancer developed certain types of skin cancers while receiving STELARA®. Tell your doctor if you have any new skin growths.
Posterior Reversible Encephalopathy Syndrome (PRES)
PRES is a rare condition that affects the brain and can cause death. The cause of PRES is not known. If PRES is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including: headache, seizures, confusion, and vision problems.
Serious Allergic Reactions
Serious allergic reactions can occur. Stop using STELARA® and get medical help right away if you have any symptoms of a serious allergic reaction such as: feeling faint, swelling of your face, eyelids, tongue, or throat, chest tightness, or skin rash.
Lung Inflammation
Cases of lung inflammation have happened in some people who receive STELARA® and may be serious. These lung problems may need to be treated in a hospital. Tell your doctor right away if you develop shortness of breath or a cough that doesn’t go away during treatment with STELARA®.
Before receiving STELARA®, tell your doctor about all of your medical conditions, including if you:
- have any of the conditions or symptoms listed above for serious infections, cancers, or PRES.
- ever had an allergic reaction to STELARA® or any of its ingredients. Ask your doctor if you are not sure.
- are allergic to latex. The needle cover on the prefilled syringe contains latex.
- have recently received or are scheduled to receive an immunization (vaccine). People who take STELARA® should not receive live vaccines. Tell your doctor if anyone in your house needs a live vaccine. The viruses used in some types of live vaccines can spread to people with a weakened immune system, and can cause serious problems. You should not receive the BCG vaccine during the one year before receiving STELARA® or one year after you stop receiving STELARA®.
- have any new or changing lesions within psoriasis areas or on normal skin.
- are receiving or have received allergy shots, especially for serious allergic reactions.
- receive or have received phototherapy for your psoriasis.
- are pregnant or plan to become pregnant. It is not known if STELARA® can harm your unborn baby. You and your doctor should decide if you will receive STELARA®.
- are breastfeeding or plan to breastfeed. It is thought that STELARA® passes into your breast milk.
- talk to your doctor about the best way to feed your baby if you receive STELARA®.
Tell your doctor about all the medicines you take, including prescription and over‐the‐counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
When prescribed STELARA®:
- Use STELARA® exactly as your doctor tells you to.
- STELARA® is intended for use under the guidance and supervision of your doctor. In children 6 years and older, it is recommended that STELARA® be administered by a healthcare provider. If your doctor decides that you or a caregiver may give your injections of STELARA® at home, you should receive training on the right way to prepare and inject STELARA®. Your doctor will determine the right dose of STELARA® for you, the amount for each injection, and how often you should receive it. Do not try to inject STELARA® yourself until you or your caregiver have been shown how to inject STELARA® by your doctor or nurse.
Common side effects of STELARA® include: nasal congestion, sore throat, and runny nose, upper respiratory infections, fever, headache, tiredness, itching, nausea and vomiting, redness at the injection site, vaginal yeast infections, urinary tract infections, sinus infection, bronchitis, diarrhea, stomach pain, and joint pain. These are not all of the possible side effects with STELARA®. Tell your doctor about any side effect that you experience. Ask your doctor or pharmacist for more information.
Please read the full Prescribing Information and Medication Guide for STELARA® and discuss any questions you have with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
cp-124932v3
WHAT IS SYMTUZA®?
SYMTUZA® is a prescription medicine that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults and in children who weigh at least 88 pounds (40 kg) who:
- have not received anti-HIV-1 medicines in the past, or
- when their healthcare provider determines that they meet certain requirements.
HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). It is not known if SYMTUZA® is safe and effective in children weighing less than 88 pounds (40 kg).
IMPORTANT SAFETY INFORMATION
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT SYMTUZA®?
SYMTUZA® can cause serious side effects including:
-
Worsening of hepatitis B virus infection. Your healthcare provider will test you for hepatitis B virus (HBV) before starting treatment with SYMTUZA®. If you have HBV infection and take SYMTUZA®, your HBV may get worse (flare-up) if you stop taking SYMTUZA®.
- Do not stop taking SYMTUZA® without first talking to your healthcare provider.
- Do not run out of SYMTUZA®. Refill your prescription or talk to your healthcare provider before your SYMTUZA® is all gone.
- If you stop taking SYMTUZA®, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection or give you a medicine to treat your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking SYMTUZA®.
- Change in liver enzymes. People with a history of hepatitis B or C virus infection or who have certain liver enzyme changes may have an increased risk of developing new or worsening liver problems during treatment with SYMTUZA®. Liver problems can also happen during treatment with SYMTUZA® in people without a history of liver disease. Your healthcare provider may need to do tests to check your liver enzymes before and during treatment with SYMTUZA®.
-
Severe liver problems. In rare cases, severe liver problems can happen that can lead to death. Tell your healthcare provider right away if you get these symptoms:
- Skin or the white part of your eyes turn yellow
- Dark "tea-colored" urine
- Light-colored stools
- Loss of appetite for several days or longer
- Nausea
- Vomiting
- Stomach area pain
SYMTUZA® may cause severe or life-threatening skin reactions or rashes which may sometimes require treatment in a hospital. Call your healthcare provider right away if you develop a rash. Stop taking SYMTUZA® and call your healthcare provider right away if you develop any skin changes with symptoms below:
- Fever
- Tiredness
- Muscle or joint pain
- Blisters or skin lesions
- Mouth sores or ulcers
- Red or inflamed eyes, like "pink eye" (conjunctivitis)
Who should not take SYMTUZA®?
- Do not take SYMTUZA® with any of the following medicines: alfuzosin, carbamazepine, cisapride, colchicine (if you have liver or kidney problems), dronedarone, elbasvir and grazoprevir, ergot-containing medicines (such as: dihydroergotamine, ergotamine tartrate, methylergonovine), ivabradine, lomitapide, lovastatin or a product that contains lovastatin, lurasidone, midazolam (when taken by mouth), naloxegol, phenobarbital, phenytoin, pimozide, ranolazine, rifampin, St. John's wort (Hypericum perforatum) or a product that contains St. John's wort, sildenafil when used for pulmonary arterial hypertension (PAH), simvastatin or a product that contains simvastatin, or triazolam.
- Serious problems can happen if you take any of these medicines with SYMTUZA®.
Before taking SYMTUZA®, tell your healthcare provider about all of your medical conditions, including if you:
- have liver problems (including hepatitis B or hepatitis C), have kidney problems, are allergic to sulfa (sulfonamide), have diabetes, have hemophilia, or have any other medical condition.
-
are pregnant (if you become pregnant while taking SYMTUZA®), or plan to become pregnant. It is unknown if SYMTUZA® will harm your unborn baby.
- SYMTUZA® should not be used during pregnancy.
- are breastfeeding or plan to breastfeed. Do not breastfeed if you take SYMTUZA®.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with SYMTUZA®. Keep a list of your medicines to show your healthcare provider and pharmacist. Do not start taking a new medicine without telling your healthcare provider.
HOW SHOULD I TAKE SYMTUZA®?
- Take SYMTUZA® 1 time a day with food.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF SYMTUZA®?
SYMTUZA® may cause serious side effects including:
- See "What is the most important information I should know about SYMTUZA®?"
- Immune system changes can happen in people who start HIV medications.
-
New or worse kidney problems, including kidney failure.
- Your healthcare provider should do blood and urine tests to check your kidneys before you start and while you are taking SYMTUZA®.
-
Too much lactic acid in your blood (lactic acidosis).
- Too much lactic acid is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat.
- Diabetes and high blood sugar (hyperglycemia). Some people who take protease inhibitors including SYMTUZA® can get high blood sugar, develop diabetes, or your diabetes can get worse. Tell your healthcare provider if you notice an increase in thirst or if you start urinating more often while taking SYMTUZA®.
- Changes in body fat can happen in people taking HIV-1 medications.
- Increased bleeding can occur in people with hemophilia who are taking SYMTUZA®.
The most common side effects of SYMTUZA® are: Diarrhea, rash, nausea, fatigue, headache, stomach problems, and gas.
These are not all of the possible side effects of SYMTUZA®.
Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736).
Please see full Product Information, including Boxed Warning for SYMTUZA®.
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What is TRACLEER® (bosentan)?
TRACLEER® is a prescription medicine indicated for patients with certain types of pulmonary arterial hypertension (PAH, WHO Group 1), which is high blood pressure in the vessels of the lungs. TRACLEER® can improve your ability to exercise as measured by 6-minute walk test and can slow the worsening of your physical condition and symptoms.
- In two different studies, TRACLEER® improved 6-minute walk distance by 35 and 76 meters. These studies focused on patients with WHO Functional Class III-IV.
- Clinical worsening was defined as any one of the following: a need to go to the hospital for PAH, stopping treatment because of worsening of PAH, a need for intravenous (IV) treatment (epoprostenol), or death.
Studies showing TRACLEER® is effective in adults included mainly patients with WHO Functional Class II-IV PAH. In these patients, PAH was caused by: unidentified or hereditary factors (60%); connective tissue disease (21%); being born with a hole in the heart between the left and right sides (18%).
TRACLEER® is also indicated in pediatric patients 3 years and older with PAH caused by unidentified or hereditary factors to improve a certain kind of blood flow to the heart called peripheral vascular resistance (PVR). Studies showing TRACLEER® is effective in pediatric patients included mainly patients with WHO Functional Class II-III.
TRACLEER® is only:
- Prescribed by healthcare professionals who are enrolled in the Bosentan REMS Program
- Available to people who understand and agree to enroll in the Bosentan REMS Program
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about TRACLEER®?
TRACLEER® is only available through the Bosentan REMS Program. Before you begin taking TRACLEER®, you must read and agree to all of the instructions in the Bosentan REMS Program. Because of potential liver damage and in an effort to make the chance of fetal exposure to TRACLEER® as small as possible, TRACLEER® may be prescribed only through the Bosentan REMS Program.
Liver damage:
- Liver damage may not cause symptoms at first. Only a blood test can show if you have early liver damage. So you must have your blood tested to check your liver function before you start TRACLEER® and each month after that. Your healthcare professional will order these tests. Regular blood tests are important because they will help your healthcare professional adjust or stop your treatment before there is permanent damage.
- TRACLEER® can cause serious liver damage, including in rare cases liver failure. Even in situations with regular liver testing, rare cases of unexplained liver cirrhosis (scar tissue in the liver) have developed in patients with other medical conditions and taking other medications in addition to TRACLEER® for over 12 months.
-
Tell your healthcare provider if you have had liver problems, including liver problems while taking other medicines. Call your healthcare provider right away if you have any of these symptoms of liver problems while taking TRACLEER®:
- nausea
- vomiting
- stomach area (abdominal) pain
- fever
- unusual tiredness
- yellowing of the skin or the whites of your eyes (jaundice)
Serious birth defects:
-
TRACLEER® can cause serious birth defects if taken during pregnancy. You must not be pregnant when you start taking TRACLEER® or during TRACLEER® treatment. Serious birth defects from TRACLEER® can happen early in pregnancy. Females who are able to get pregnant must have a negative pregnancy test before starting treatment with TRACLEER®, each month during treatment with TRACLEER®, and 1 month after stopping treatment with TRACLEER®.
-
Talk to your healthcare provider about your menstrual cycle. Your healthcare provider will decide when to do a pregnancy test and will order a pregnancy test for you depending on your menstrual cycle.
-
Females who are able to get pregnant are females who:
- have entered puberty, even if they have not started their menstrual period, and
- have a uterus, and
- have not gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed.
-
Females who are not able to get pregnant are females who:
- have not yet entered puberty, or
- do not have a uterus, or
- have gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed or
- are infertile for other medical reasons and this infertility is permanent and cannot be reversed.
-
Females who are able to get pregnant are females who:
-
Talk to your healthcare provider about your menstrual cycle. Your healthcare provider will decide when to do a pregnancy test and will order a pregnancy test for you depending on your menstrual cycle.
-
Females who are able to get pregnant must use two acceptable forms of birth control during treatment with TRACLEER®, and for one month after stopping TRACLEER® because the medicine may still be in the body.
- If you have had a tubal sterilization or have an IUD (intrauterine device), these methods can be used alone and no other form of birth control is needed.
- Talk with your healthcare provider or gynecologist (a doctor who specializes in female reproduction) to find out about options for acceptable birth control that you may use to prevent pregnancy during treatment with TRACLEER®.
- If you decide that you want to change the form of birth control that you use, talk with your healthcare provider or gynecologist to be sure that you choose another acceptable form of birth control.
- Do not have unprotected sex. Talk to your healthcare provider or pharmacist right away if you have unprotected sex or if you think your birth control has failed. Your healthcare provider may talk with you about using emergency birth control.
- Tell your healthcare provider right away if you miss a menstrual period or think you may be pregnant.
If you are the parent or caregiver of a female child who started taking TRACLEER® before reaching puberty, you should check your child regularly to see if she is developing signs of puberty. Tell your healthcare provider right away if you notice that she is developing breast buds or any pubic hair. Your healthcare provider should decide if your child has reached puberty. Your child may reach puberty before having her first menstrual period.
Who should not take TRACLEER®?
Do not take TRACLEER® if you:
- Are pregnant, plan to become pregnant, or become pregnant during TRACLEER® treatment. TRACLEER® can cause serious birth defects. All females should read the birth defects section of "What is the most important information I should know about TRACLEER®?"
-
Take one of these medicines:
- cyclosporine A used to treat psoriasis and rheumatoid arthritis, and to prevent rejection of heart, liver, and kidney transplants
- glyburide used to treat diabetes
- Are allergic to bosentan or any of the ingredients in TRACLEER®. If you have a rash, hives or your lips swell after taking TRACLEER®, it may be a sign of an allergy. You should stop taking your TRACLEER® and talk to your healthcare provider.
What are the possible side effects of TRACLEER®?
TRACLEER® can cause serious side effects, including:
- Fluid retention and swelling of ankles and legs. TRACLEER® can cause your body to hold too much water, and you may get swelling of your ankles and legs. Tell your healthcare professional if you have swelling of your ankles and legs that happens either with or without weight gain, or if you have more trouble with your breathing than normal. Your healthcare professional will look for the cause of this.
- Lower sperm count. Some men who take TRACLEER® may have lower sperm counts. This may affect your ability to father a child. Tell your healthcare professional if fertility is a concern for you.
- Low red blood cell levels (anemia). Your healthcare professional will do blood tests to check your red blood cells during treatment with TRACLEER®.
The most common side effects of TRACLEER® include:
- respiratory tract infection
- headache
- fainting
- flushing
- low blood pressure
- inflamed nose passages (sinusitis)
- joint pain
- irregular heart beats
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of TRACLEER®. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or by calling Actelion at 1-866-228-3546.
Please read the full Prescribing Information and Medication Guide for TRACLEER®, including BOXED WARNING about liver injury and birth defects.
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WHAT IS TREMFYA®?
TREMFYA® is a prescription medicine used to treat adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light).
TREMFYA® is a prescription medicine used to treat adults with active psoriatic arthritis.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about TREMFYA®?
TREMFYA® is a prescription medicine that may cause serious side effects, including:
-
Serious Allergic Reactions. Stop using TREMFYA® and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction:
- fainting, dizziness, feeling lightheaded (low blood pressure)
- swelling of your face, eyelids, lips, mouth, tongue or throat
- trouble breathing or throat tightness
- chest tightness
- skin rash, hives
- itching
-
Infections. TREMFYA® may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA® and may treat you for TB before you begin treatment with TREMFYA® if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA®.
Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:
- fever, sweats, or chills
- muscle aches
- weight loss
- cough
- warm, red, or painful skin or sores on your body different from your psoriasis
- diarrhea or stomach pain
- shortness of breath
- blood in your phlegm (mucus)
- burning when you urinate or urinating more often than normal
Do not take TREMFYA® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA®.
Before using TREMFYA®, tell your healthcare provider about all of your medical conditions, including if you:
- have any of the conditions or symptoms listed in the section “What is the most important information I should know about TREMFYA®?”
- have an infection that does not go away or that keeps coming back.
- have TB or have been in close contact with someone with TB.
- have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA®.
- are pregnant or plan to become pregnant. It is not known if TREMFYA® can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if TREMFYA® passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of TREMFYA®?
TREMFYA® may cause serious side effects. See “What is the most important information I should know about TREMFYA®?”
The most common side effects of TREMFYA® include: upper respiratory infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, and bronchitis.
These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects.
Use TREMFYA® exactly as your healthcare provider tells you to use it.
Please read the full Prescribing Information, including Medication Guide for TREMFYA®, and discuss any questions that you have with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
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What is UPTRAVI® (selexipag)?
UPTRAVI® (selexipag) is a prescription medicine used to treat pulmonary arterial hypertension (PAH, WHO Group 1), which is high blood pressure in the arteries of your lungs.
UPTRAVI® can help delay (slow down) the progression of your disease and lower your risk of being hospitalized for PAH.
It is not known if UPTRAVI® is safe and effective in children.
IMPORTANT SAFETY INFORMATION
What is the most important information about UPTRAVI®?
Who should not take UPTRAVI®?
- Do not take UPTRAVI® if you take gemfibrozil because this medicine may affect how UPTRAVI® works and cause side effects
What should I tell my doctor before taking UPTRAVI®?
Tell your doctor if you:
- Have liver problems
- Have narrowing of the pulmonary veins (veins in your lungs). This is called pulmonary veno-occlusive disease (PVOD)
- Are pregnant or plan to become pregnant. It is not known if UPTRAVI® will harm your unborn baby
- Are breastfeeding or plan to breastfeed. It is not known if UPTRAVI® passes into your breast milk. You and your doctor should decide if you will take UPTRAVI® or breastfeed. You should not do both
- Have any other medical conditions
- Are taking any other prescription or over-the-counter medicines, vitamins, or herbal supplements
What are the possible side effects of UPTRAVI®?
The most common side effects are:
- Headache
- Diarrhea
- Jaw pain
- Nausea
- Muscle pain
- Vomiting
- Pain in arms or legs
- Temporary reddening of the skin (flushing)
- Joint pain
- Low red blood cell count
- Less appetite than usual
- Rash
Talk to your doctor if you have a side effect that bothers you or does not go away. These are not all the possible side effects of UPTRAVI®. For more information, ask your doctor or pharmacist.
You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Keep UPTRAVI® and all other medicines away from children.
What other medicines might interact with UPTRAVI®?
- UPTRAVI® and other medicines may affect each other, causing side effects. Tell your doctor about all the medicines you are taking. Do not start any new medicine until you check with your doctor
How should I take UPTRAVI®?
- Take UPTRAVI® exactly as your doctor tells you to take it. Usually, your doctor will have you take UPTRAVI® twice a day. Taking UPTRAVI® with food may help you tolerate UPTRAVI® better
- Swallow UPTRAVI® tablets whole. Do not split, crush, or chew tablets
- Tell your doctor if you have any form of liver disease. Your doctor may need to change your dose of UPTRAVI®
-
UPTRAVI® is measured in micrograms (mcg). Tablets come in the following strengths:
200, 400, 600, 800, 1000, 1200, 1400, and 1600 mcg
Please read the full Prescribing Information and Patient Product Information for UPTRAVI®.
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What is VELETRI® (epoprostenol) for Injection?
VELETRI® is a prescription medicine that is given intravenously (in a vein). It is used to treat adults with certain kinds of severe pulmonary arterial hypertension (PAH) (WHO Group 1), a condition in which blood pressure is too high in the blood vessels between the heart and the lungs. VELETRI® may improve your ability to exercise as measured by how far you can walk in 6 minutes (6-minute walk test).
Studies showing VELETRI® is effective included mainly patients with NYHA Functional Class III-IV PAH. In these patients, PAH was caused by unidentified or hereditary factors or connective tissue disease.
IMPORTANT SAFETY INFORMATION
Who should not take VELETRI®?
VELETRI® should not be used if you have heart failure due to severe left heart disease, if you develop fluid in the lungs (pulmonary edema) when starting therapy, or if you are allergic to epoprostenol.
Some medications may interact with VELETRI®. Please talk to your doctor about all of your medications.
What is the most important information I should know about VELETRI®?
It is important to use VELETRI® as directed by your doctor. VELETRI® should be used only with Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. Do not mix VELETRI® with other intravenous medications. Each vial is for single use only; discard any unused medication. Use at room temperature (77°F/25°C). Do not expose VELETRI® to direct sunlight.
When you take epoprostenol for the first time, you must be in a setting (hospital or clinic) where you can be monitored for any serious side effects or in case of emergency. Your blood pressure and heart rate should also be monitored with any dose changes. If you are taking VELETRI®, your doctor may prescribe another kind of medicine used to prevent blood clots. It is the use of these medications concomitantly (in combination) with VELETRI® that may potentially cause an increase in the risk of bleeding.
Sudden and dramatic changes in dose may lead to unstable blood pressure, a return of pulmonary hypertension symptoms, or fatal low blood pressure (hypotension). Do not stop using VELETRI® without first talking to your doctor.
To reduce the risk of infection in the bloodstream, it is important to know how to properly care for the catheter and infusion pump.
What are the possible side effects of VELETRI®?
You may have side effects at the start of treatment or with dose increases. The most common side effects seen in at least 1% of patients were:
- flushing
- headache
- nausea/vomiting
- low blood pressure
- anxiety/nervousness
- chest pain
- dizziness
- slow heartbeat
- abdominal pain
- pain in the muscles and/or ligaments and bones
- shortness of breath
- back pain
- sweating
- upset stomach
- numbness/increased sensitivity
- fast heartbeat
The most common side effects in patients with PAH due to unidentified or hereditary factors with at least 10% difference between the group that received epoprostenol and the group that received conventional therapy alone were:
- flu-like symptoms
- fast heartbeat
- flushing
- diarrhea
- nausea/vomiting
- jaw pain
- pain in the muscles and/or ligaments and bones
- anxiety/nervousness
- dizziness
- headache
- numbness/increased sensitivity/tingling
The most common side effects in patients with PAH due to connective tissue disease with at least 10% difference between the group that received epoprostenol and the group that received conventional therapy alone were:
- flushing
- low blood pressure
- lack of appetite
- nausea/vomiting
- diarrhea
- jaw pain
- neck/joint pain
- headache
- skin ulcer
- rash
Talk to your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of VELETRI®. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please read the full Prescribing Information for VELETRI®.
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What is VENTAVIS® (iloprost)?
VENTAVIS® (iloprost) Inhalation Solution is a prescription medicine used to treat adults with certain kinds of severe pulmonary arterial hypertension (PAH), a condition in which blood pressure is too high in the blood vessels between the heart and the lungs. VENTAVIS® may improve your ability to exercise and your symptoms for a short time by lowering your blood pressure and opening up the blood vessels in your lungs.
The study showing VENTAVIS® is effective included mainly patients with NYHA Functional Class III-IV PAH. In these patients, PAH was caused by unidentified or hereditary factors (65%) or connective tissue diseases (23%).
VENTAVIS® has not been studied in children younger than 18 years old.
IMPORTANT SAFETY INFORMATION
What should I tell my doctor before taking VENTAVIS®?
VENTAVIS® may not be right for you. Before taking VENTAVIS®, tell your doctor about all of your medical conditions, including if you:
- have liver or kidney problems. Your doctor may need to give you a lower dose of VENTAVIS®.
- are pregnant, or plan to become pregnant. It is not known if VENTAVIS® can harm your unborn baby. VENTAVIS® should only be used during pregnancy if the benefit to you is worth the possible risk to your baby.
- are breastfeeding. It is not known if VENTAVIS® passes into your breast milk. You and your doctor should decide if you will take VENTAVIS® or breastfeed.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
VENTAVIS® and other medicines may affect each other, causing side effects. VENTAVIS® may affect the way other medicines work, and other medicines may affect how VENTAVIS® works.
Especially tell your doctor if you take:
- medicines used to treat high blood pressure or heart problems
- medicines that lessen blood clotting (warfarin, Coumadin, Jantoven)
Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get
a new medicine.
How should I take VENTAVIS®?
- Take VENTAVIS® exactly as your doctor tells you to take it. Your doctor may change your dose if needed.
- You should not take VENTAVIS® more than every 2 hours. The benefits of VENTAVIS® may not last 2 hours, so you may adjust the times that you use it to cover planned activities.
- Do not drink VENTAVIS®.
- Do not let VENTAVIS® solution come into contact with your skin or eyes. If it does, rinse your skin or eyes with water right away.
- Do not allow other people to be exposed to VENTAVIS® while you are breathing it, especially babies.
- If you take too much VENTAVIS®, you may have a headache, red face, dizziness, nausea, vomiting and diarrhea. If this happens stop taking VENTAVIS®. If your symptoms do not go away, call your doctor or get emergency help right away.
What are the possible side effects of VENTAVIS®?
VENTAVIS® may cause side effects, including feeling dizzy, lightheaded and faint. If you have any of these side effects, you should stand up slowly when you get out of chairs or bed. Tell your doctor if your fainting gets worse during treatment with VENTAVIS®. Your doctor may need to change your dose or your treatment.
Do not drive a car or operate any tools or machines if dizziness or fainting from low blood pressure is a problem for you.
You may have trouble breathing after taking VENTAVIS® because it may cause the muscles around your airway to tighten (bronchospasm). Get emergency help right away if you have trouble breathing.
Other important side effects of VENTAVIS® include:
- bleeding
- red face (flushing)
- increased cough
- low blood pressure
- headaches
- nausea
- spasm of your jaw muscles that makes it hard to open your mouth
Talk to your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of VENTAVIS®. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please read the full Prescribing Information for VENTAVIS®.
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WHAT IS XARELTO® (rivaroxaban)?
XARELTO® is a prescription medicine used to:
- reduce the risk of stroke and blood clots in people who have a medical condition called atrial fibrillation that is not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can lead to the formation of blood clots, which can travel to the brain, causing a stroke, or to other parts of the body
- treat blood clots in the veins of your legs (deep vein thrombosis or DVT) or lungs (pulmonary embolism or PE)
- reduce the risk of blood clots happening again in people who continue to be at risk for DVT or PE after receiving treatment for blood clots for at least 6 months
- help prevent a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery
- help prevent blood clots in certain people hospitalized for an acute illness and after discharge, who are at risk of getting blood clots because of the loss of or decreased ability to move around (mobility) and other risks for getting blood clots, and who do not have a high risk of bleeding
XARELTO® is used with low dose aspirin to:
- reduce the risk of serious heart problems, heart attack and stroke in people with coronary artery disease (a condition where the blood supply to the heart is reduced or blocked) or peripheral artery disease (a condition where the blood flow to the legs is reduced)
It is not known if XARELTO® is safe and effective in children.
IMPORTANT SAFETY INFORMATION
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO®?
XARELTO® may cause serious side effects, including:
-
Increased risk of blood clots if you stop taking XARELTO®. People with atrial fibrillation (an irregular heart beat) that is not caused by a heart valve problem (nonvalvular) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. XARELTO® lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO®, you may have increased risk of forming a clot in your blood.
Do not stop taking XARELTO® without talking to the doctor who prescribes it for you. Stopping XARELTO® increases your risk of having a stroke. If you have to stop taking XARELTO®, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming.
-
Increased risk of bleeding. XARELTO® can cause bleeding which can be serious, and may lead to death. This is because XARELTO® is a blood thinner medicine (anticoagulant) that lowers blood clotting. During treatment with XARELTO® you are likely to bruise more easily, and it may take longer for bleeding to stop. You may be at higher risk of bleeding if you take XARELTO® and have certain other medical problems.
You may have a higher risk of bleeding if you take XARELTO® and take other medicines that increase your risk of bleeding, including:
- Aspirin or aspirin-containing products
- Long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs)
- Warfarin sodium (Coumadin®, Jantoven®)
- Any medicine that contains heparin
- Clopidogrel (Plavix®)
- Selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)
-
Other medicines to prevent or treat blood clots
Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.
Call your doctor or get medical help right away if you develop any of these signs or symptoms of bleeding:
-
Unexpected bleeding or bleeding that lasts a long time, such as:
- Nosebleeds that happen often
- Unusual bleeding from gums
- Menstrual bleeding that is heavier than normal, or vaginal bleeding
- Bleeding that is severe or you cannot control
- Red, pink, or brown urine
- Bright red or black stools (looks like tar)
- Cough up blood or blood clots
- Vomit blood or your vomit looks like “coffee grounds”
- Headaches, feeling dizzy or weak
-
Pain, swelling, or new drainage at wound sites
-
Spinal or epidural blood clots (hematoma). People who take a blood thinner medicine (anticoagulant) like XARELTO®, and have medicine injected into their spinal and epidural area, or have a spinal puncture, have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if:
- A thin tube called an epidural catheter is placed in your back to give you certain medicine
- You take NSAIDs or a medicine to prevent blood from clotting
- You have a history of difficult or repeated epidural or spinal punctures
-
You have a history of problems with your spine or have had surgery on your spine
If you take XARELTO® and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain, tingling, numbness, muscle weakness (especially in your legs and feet), or loss of control of the bowels or bladder (incontinence).
XARELTO® is not for use in people with artificial heart valves.
XARELTO® is not for use in people with antiphospholipid syndrome (APS), especially with positive triple antibody testing.
Do not take XARELTO® if you:
- Currently have certain types of abnormal bleeding. Talk to your doctor before taking XARELTO® if you currently have unusual bleeding.
- Are allergic to rivaroxaban or any of the ingredients of XARELTO®.
Before taking XARELTO®, tell your doctor about all your medical conditions, including if you:
- Have ever had bleeding problems
- Have liver or kidney problems
- Have antiphospholipid syndrome (APS)
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Are pregnant or plan to become pregnant. It is not known if XARELTO® will harm your unborn baby.
- Tell your doctor right away if you become pregnant during treatment with XARELTO®. Taking XARELTO® while you are pregnant may increase the risk of bleeding in you or in your unborn baby.
- If you take XARELTO® during pregnancy, tell your doctor right away if you have any signs or symptoms of bleeding or blood loss. See “What is the most important information I should know about XARELTO®?” for signs and symptoms of bleeding.
- Are breastfeeding or plan to breastfeed. XARELTO® may pass into your breast milk. Talk to your doctor about the best way to feed your baby during treatment with XARELTO®.
Tell all of your doctors and dentists that you are taking XARELTO®. They should talk to the doctor who prescribed XARELTO® for you before you have any surgery, medical or dental procedure.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Some of your other medicines may affect the way XARELTO® works, causing side effects. Certain medicines may increase your risk of bleeding. See “What is the most important information I should know about XARELTO®?”
HOW SHOULD I TAKE XARELTO®?
- Take XARELTO® exactly as prescribed by your doctor.
- Do not change your dose or stop taking XARELTO® unless your doctor tells you to. Your doctor may change your dose if needed.
- Your doctor will decide how long you should take XARELTO®.
- XARELTO® may need to be stopped for one or more days before any surgery or medical or dental procedure. Your doctor will tell you when to stop taking XARELTO® and when to start taking XARELTO® again after your surgery or procedure.
- If you need to stop taking XARELTO® for any reason, talk to the doctor who prescribed XARELTO® to you to find out when you should stop taking it. Do not stop taking XARELTO® without first talking to the doctor who prescribes it to you.
- If you have difficulty swallowing XARELTO® tablets whole, talk to your doctor about other ways to take XARELTO®.
- Do not run out of XARELTO®. Refill your prescription of XARELTO® before you run out. When leaving the hospital following a hip or knee replacement, be sure that you will have XARELTO® available to avoid missing any doses.
- If you take too much XARELTO®, go to the nearest hospital emergency room or call your doctor right away.
If you take XARELTO® for:
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Atrial Fibrillation that is not caused by a heart valve problem:
- Take XARELTO® 1 time a day with your evening meal.
- If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time.
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Blood clots in the veins of your legs or lungs:
- Take XARELTO® 1 or 2 times a day as prescribed by your doctor.
- For the 10-mg dose, XARELTO® may be taken with or without food.
- For the 15-mg and 20-mg doses, take XARELTO® with food at the same time each day.
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If you miss a dose:
- If you take the 15-mg dose of XARELTO® 2 times a day (a total of 30 mg of XARELTO® in 1 day): Take XARELTO® as soon as you remember on the same day. You may take 2 doses at the same time to make up for the missed dose. Take your next dose at your regularly scheduled time.
- If you take XARELTO® 1 time a day: Take XARELTO® as soon as you remember on the same day. Take your next dose at your regularly scheduled time.
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Hip or knee replacement surgery:
- Take XARELTO® 1 time a day with or without food.
- If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time.
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Blood clots in people hospitalized for an acute illness:
- Take XARELTO® 1 time a day, with or without food, while you are in the hospital and after you are discharged as prescribed by your doctor.
- If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time.
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Reducing the risk of serious heart problems, heart attack and stroke in coronary artery disease or peripheral artery disease:
- Take XARELTO® 2.5 mg 2 times a day with or without food.
- If you miss a dose of XARELTO®, take your next dose at your regularly scheduled time.
- Take aspirin 75 to 100 mg once daily as instructed by your doctor.
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Atrial Fibrillation that is not caused by a heart valve problem:
WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO®?
XARELTO® may cause serious side effects:
- See “What is the most important information I should know about XARELTO®?”
The most common side effect of XARELTO® was bleeding.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).
Please read full Prescribing Information, including Boxed Warnings, and Medication Guide for XARELTO®.
Trademarks are those of their respective owners.
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What is YONDELIS® (trabectedin)?
YONDELIS® is a prescription medicine used to treat people with liposarcoma or leiomyosarcoma that:
- cannot be treated with surgery or has spread to other areas of the body, and
- who have received treatment with certain other medicines.
It is not known if YONDELIS® is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Who should not receive YONDELIS®?
You will not be given YONDELIS® if you have had a severe allergic reaction to trabectedin, the active ingredient in YONDELIS®. See the end of this leaflet for a complete list of ingredients in YONDELIS®.
What should I tell my healthcare provider before receiving YONDELIS®?
Before receiving YONDELIS®, tell your healthcare provider about all of your medical conditions, including if you:
- have liver or kidney problems.
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are pregnant or plan to become pregnant. YONDELIS® can harm your unborn baby. You should not become pregnant during treatment with YONDELIS®.
- Females who are able to become pregnant should use an effective form of birth control during treatment with YONDELIS® and for 2 months after your last dose of YONDELIS®.
- Males should use an effective form of birth control when having sex with female partners who are able to become pregnant, during your treatment with YONDELIS® and for 5 months after your last dose of YONDELIS®.
- are breastfeeding or plan to breastfeed. It is not known if YONDELIS® passes into your breast milk. You should not breastfeed during treatment with YONDELIS®.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive YONDELIS®?
- YONDELIS® is given by an intravenous (IV) infusion into a vein over 24 hours. To help avoid irritation at the site where it is infused, YONDELIS® is given to you into a large vein through a type of IV line called a central venous line.
- YONDELIS® is usually given every 3 weeks.
- Your healthcare provider may decrease your dose or delay doses if you have certain side effects. If you have any side effects that are severe, your healthcare provider may stop your treatment with YONDELIS®.
- Before each treatment with YONDELIS®, you will receive a steroid medicine to help reduce your risk of getting certain side effects.
- Your healthcare provider will decide how long you will continue treatment with YONDELIS®.
- Your healthcare provider may do certain tests while you are receiving YONDELIS® to check you for side effects, and to see how well you respond to the treatment.
What are the possible side effects of YONDELIS®?
YONDELIS® may cause serious side effects, including:
- Severe infections due to decreased white blood cells. Decreased low white blood cell count is common with YONDELIS®, but it can also lead to severe infections and death. Your healthcare provider may need to decrease your dose of YONDELIS®, delay or stop your treatment, if your white blood cell count is too low or you get a serious infection. Call your healthcare provider right away if you develop fever or other signs of infection.
- Severe muscle problems (rhabdomyolysis). YONDELIS® can cause muscle problems that can be severe and lead to death. Tell your healthcare provider right away if you have severe muscle pain or weakness.
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Liver problems, including liver failure. Tell your healthcare provider right away if you get:
- yellowing of your skin and whites of your eyes
- pain in your upper right stomach‐area (abdomen)
- nausea
- vomiting
- generally do not feel well
- problem with concentration
- confusion
- sleepiness
- Heart muscle problems, including heart failure. Your healthcare provider will do a test to check your heart function before you start YONDELIS®, and during treatment. If you develop heart muscle problems or heart failure during treatment with YONDELIS®, your healthcare provider may stop your treatment. Tell your healthcare provider right away if you develop new chest pain, shortness of breath, tiredness, swelling of your legs, ankles, or feet, or heart palpitations.
- Leakage of YONDELIS® out of your vein during the infusion. If YONDELIS® leaks into the tissues around your infusion site, it can cause damage and death of tissue cells around the infusion site. You may need to have surgery to remove any dead tissue. Tell your healthcare provider right away if you see any YONDELIS® leaking out of your vein or around the catheter during your infusion, or if you notice any redness, swelling, itching, or discomfort at the infusion site at any time.
- Some people have had allergic reactions to YONDELIS®. Some of these reactions were severe. Your healthcare provider may need to stop your treatment with YONDELIS®, and may give you medicines to treat the allergic reaction. Signs of an allergic reaction can include: difficulty breathing, chest tightness, wheezing, swelling of the lips, or skin rash.
- Capillary leak syndrome. YONDELIS® can cause fluid to leak from the blood vessels into the body’s tissues. This condition is called “Capillary Leak Syndrome” (CLS). CLS can cause you to have symptoms that may lead to death. Tell your healthcare provider right away if you develop swelling, dizziness or lightheadedness with or without a sudden drop in blood pressure.
The most common side effects of YONDELIS® include:
- nausea
- tiredness
- vomiting
- constipation
- decreased appetite
- diarrhea
- swelling of your hands, ankles, or feet
- shortness of breath
- headache
- decreased red cell count (cells which carry oxygen in the blood). Tell your healthcare provider if you feel more tired than usual or look pale.
- decreased platelet cell counts (cells which help blood to clot). Tell your healthcare provider if you bruise easily or have bleeding.
- changes in liver and kidney function blood tests
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of YONDELIS®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of YONDELIS®
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider or pharmacist for information about YONDELIS® that is written for health professionals.
What are the ingredients in YONDELIS®?
Active ingredient: trabectedin
Inactive ingredients: potassium dihydrogen phosphate, sucrose, phosphoric acid and potassium hydroxide
Please click here to read Important Product Information
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WHAT IS ZYTIGA®?
ZYTIGA® (abiraterone acetate) is a prescription medicine that is used along with prednisone. ZYTIGA® is used to treat men with prostate cancer that has spread to other parts of the body.
It is not known if ZYTIGA® is safe and effective in females or children.
IMPORTANT SAFETY INFORMATION
Before taking ZYTIGA®, tell your healthcare provider about all of your medical conditions, including if you:
- Have heart problems
- Have liver problems
- Have diabetes
- Have a history of adrenal problems
- Have a history of pituitary problems
- Are receiving any other treatment for prostate cancer
- Are pregnant or plan to become pregnant. ZYTIGA® can cause harm to your unborn baby and loss of pregnancy (miscarriage). Females who are or may become pregnant should not handle ZYTIGA® uncoated tablets or other ZYTIGA® tablets if broken, crushed, or damaged without protection, such as gloves
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Have a partner who is pregnant or may become pregnant
- Males who have female partners who are able to become pregnant should use effective birth control (contraception) during treatment with ZYTIGA® and for 3 weeks after the last dose of ZYTIGA®
- Are breastfeeding or plan to breastfeed. It is not known if ZYTIGA® passes into your breast milk
Tell your healthcare provider about all the medicines you take or treatments you receive including prescription and over-the-counter medicines, vitamins, and herbal supplements. ZYTIGA® can interact with many other medicines.
You should not start or stop any medicine before you talk with the healthcare provider that prescribed ZYTIGA®.
Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist when you get a new medicine.
How should I take ZYTIGA®?
- Take ZYTIGA® and prednisone exactly as your healthcare provider tells you
- Take your prescribed dose of ZYTIGA® one time a day. Your healthcare provider may change your dose if needed
- Do not change or stop taking your prescribed dose of ZYTIGA® or prednisone without talking to your healthcare provider first
- Take ZYTIGA® on an empty stomach, at least 1 hour before or at least 2 hours after a meal. Do not take ZYTIGA® with food. Taking ZYTIGA® with food may cause more of the medicine to be absorbed by the body than is needed and this may cause side effects
- Swallow ZYTIGA® tablets whole. Do not crush or chew tablets
- Take ZYTIGA® tablets with water
- If you miss a dose of ZYTIGA® or prednisone, take your prescribed dose the following day. If you miss more than 1 dose, tell your healthcare provider right away
- Your healthcare provider will do blood tests to check for side effects
What are the possible side effects of ZYTIGA®?
ZYTIGA® may cause serious side effects including:
- High blood pressure (hypertension), low blood potassium levels (hypokalemia), fluid retention (edema), and irregular heartbeats can happen during treatment with ZYTIGA®. This can be life-threatening. To decrease the chance of this happening, you must take prednisone with ZYTIGA® exactly as your healthcare provider tells you. Your healthcare provider will check your blood pressure, do blood tests to check your potassium levels, and check for any signs and symptoms of fluid retention every month during treatment with ZYTIGA®
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Tell your healthcare provider if you get any of the following symptoms:
- Dizziness
- Fast or irregular heartbeats
- Feel faint or lightheaded
- Headache
- Confusion
- Muscle weakness
- Pain in your legs
- Swelling in your legs or feet
- Adrenal problems may happen if you stop taking prednisone, get an infection, or are under stress
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Severe liver problems. You may develop changes in liver function blood tests. Your healthcare provider will do blood tests to check your liver before treatment with ZYTIGA® and during treatment with ZYTIGA®. Liver failure may occur, which can lead to death. Tell your healthcare provider right away if you notice any of the following changes:
- Yellowing of the skin or eyes
- Darkening of the urine
- Severe nausea or vomiting
- Increased risk of bone fracture and death when ZYTIGA® and prednisone or prednisolone is used in combination with a type of radiation called radium Ra 223 dichloride. Tell your healthcare provider about any other treatments you are taking for prostate cancer
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Severe low blood sugar (hypoglycemia). Severe low blood sugar with ZYTIGA® can happen in people who have diabetes and take certain antidiabetic medicines. You and/or your healthcare provider should check your blood sugar levels regularly during treatment with ZYTIGA® and after you stop treatment. Your healthcare provider may also need to change the dose of your antidiabetic medicines. Signs and symptoms of low blood sugar may include:
- Headache
- Drowsiness
- Weakness
- Dizziness
- Confusion
- Irritability
- Hunger
- Fast heartbeat
- Sweating
- Feeling jittery
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The most common side effects of ZYTIGA® include:
- Feeling very tired
- Joint pain
- High blood pressure
- Nausea
- Swelling in your legs or feet
- Low blood potassium levels
- Hot flushes
- Diarrhea
- Vomiting
- Infected nose, sinuses, or throat (cold)
- Cough
- Headache
- Low red blood cells (anemia)
- High blood cholesterol and triglycerides
- High blood sugar levels
- Certain other abnormal blood tests
ZYTIGA® may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility.
THESE ARE NOT ALL THE POSSIBLE SIDE EFFECTS OF ZYTIGA®.
Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Please see the full Prescribing Information and Patient Information for ZYTIGA® and discuss any questions you have with your doctor.
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