Indication and Important Safety Information

Darzalex® ( daratumumab )

What is DARZALEX®?

DARZALEX® is a prescription medicine used 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 lenalidomide and dexamethasone or bortezomib and dexamethasone, in people who have received at least one prior medicine 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 to treat multiple myeloma, 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 for DARZALEX®

Do not receive DARZALEX® if you have a history of a severe allergic reaction to daratumumab or any of the ingredients in DARZALEX®. See the ingredients for DARZALEX® below.

What should I tell my healthcare provider before taking DARZALEX®?

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).
  • are pregnant or plan to become pregnant. DARZALEX® may harm your unborn baby.
    • Females who are able to become pregnant should use an effective method of birth control 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.
  • 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 reactions.
  • If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

What are the possible side effects of DARZALEX®?

DARZALEX® may cause serious reactions, including:

  • Infusion reactions. Infusion 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 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
  • trouble sleeping
  • fever
  • cough
  • muscle spasms
  • back pain
  • joint pain
  • vomiting
  • cold-like symptoms (upper respiratory infection)
  • nerve damage causing tingling, numbness or pain
  • swollen hands, ankles or feet
  • constipation
  • chills
  • dizziness

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.

What are the ingredients in DARZALEX®?
Active ingredient: daratumumab
Inactive ingredients: glacial acetic acid, mannitol, polysorbate 20, sodium acetate trihydrate, sodium chloride, and water for injection

Please see Important Product Information

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Edurant® ( rilpivirine )

About EDURANT®

  • EDURANT® (rilpivirine) is a prescription medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in people 12 years of age and older and who weigh at least 77 lbs (35 kg):
    • Have never taken HIV medicines before, and
    • Have an amount of HIV in their blood (called “viral load”) that is no more than 100,000 copies/mL
  • EDURANT® is not recommended for patients less than 12 years of age or who weigh less than 77 lbs (35 kg)

Please read Important Safety Information below, and talk to your healthcare provider to learn if EDURANT® is right for you.

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 provider before taking EDURANT®?

Before taking EDURANT®, tell your healthcare provider 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 provider if you become pregnant during treatment with EDURANT®
  • 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 provider about the best way to feed your baby during EDURANT® treatment.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider 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 provider 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 provider. Stay under the care of your healthcare provider 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 provider or go to the nearest hospital emergency room right away.

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 provider 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 provider may need to do tests to check your liver enzymes before and during treatment with EDURANT®.
  • Depression or mood changes. Tell your healthcare provider 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 provider 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 provider right away. Do not stop taking EDURANT® or any other medications without first talking to 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. You may also report side effects to Janssen Products, LP, at 1-800-JANSSEN (1-800-526-7736).

Please see accompanying full Product Information for more details.

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Erleada™ ( apalutamide )

What is ERLEADA™?

ERLEADA™ (apalutamide) is a prescription medicine used to treat prostate cancer 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 or effective in children.

Important Safety Information

Do not take ERLEADA™ (apalutamide) if you:

  • are pregnant or may become pregnant. ERLEADA™ may harm your unborn baby.
  • are female. ERLEADA™ is not for use in women.

Before taking ERLEADA™, tell your healthcare provider about all your medical conditions, including if you:

  • have a history of seizures, brain injury, stroke, or brain tumors.
  • have a partner who is pregnant or may become pregnant. Men who are sexually active with a pregnant woman must use a condom during and for 3 months after treatment with ERLEADA™. If your sexual partner may become pregnant, effective birth control (contraception) must be used during and for 3 months after treatment. Talk with your healthcare provider if you have questions about birth control.

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.
  • 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.
  • 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.
  • 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 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.
  • Your healthcare provider may do blood tests to check for side effects.

What are the possible side effects of ERLEADA™?

ERLEADA™ may cause serious side effects including:

  • Falls and fractures. 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™. Falls were not caused by loss of consciousness (fainting) or seizures. Your healthcare provider will monitor your risks for falls and fractures during treatment with ERLEADA™.
  • Seizure. If you take ERLEADA™, you may be at 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
  • high blood pressure
  • rash
  • diarrhea
  • nausea
  • decreased appetite
  • weight loss
  • joint pain
  • fall
  • hot flash
  • bone injury (fracture)
  • swollen hands, ankles, or feet

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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INTELENCE® ( etravirine )

About 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®. Rash can be serious. Call your healthcare provider right away if you get a rash. In some cases, severe rash and allergic reaction may need to be treated in a hospital and may lead to death
  • 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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Invokamet® ( canagliflozin/metformin HCl )

WHAT IS INVOKANA®?

INVOKANA® 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 heart disease

INVOKANA® is not for people with type 1 diabetes or with diabetic ketoacidosis (increased ketones in blood or urine). It is not known if INVOKANA® is safe and effective in children under 18 years of age.

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®). They are used along with diet and exercise to:

  • improve blood sugar (glucose) control in adults with type 2 diabetes

INVOKAMET®/INVOKAMET® XR is not for people with diabetic ketoacidosis (increased ketones in blood or urine). It is not known if INVOKAMET® or INVOKAMET® XR is safe and effective in children under 18 years of age.

IMPORTANT SAFETY INFORMATION

INVOKANA® and INVOKAMET®/INVOKAMET® XR can cause serious side effects, including:

  • Amputations. INVOKANA® and 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 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® or INVOKAMET®/INVOKAMET® XR for a while if you have any of these signs or symptoms. Talk to your doctor about proper foot care
  • 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. Call your doctor right away if you have any of the following symptoms, which could be signs 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.

Do not take if you:

  • INVOKANA® – are allergic to canagliflozin or any of the ingredients in INVOKANA®. Symptoms of allergic reaction may include: rash; raised red patches on your skin (hives); or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. Have severe kidney problems or are on dialysis
  • INVOKAMET®/INVOKAMET® XR – have moderate to severe kidney problems or are on dialysis, have conditions called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine). Are allergic to canagliflozin, metformin, or any of the ingredients in INVOKAMET®/INVOKAMET® XR. See the end of the Medication Guide for a list of ingredients in INVOKAMET®/INVOKAMET® XR. Symptoms of allergic reaction may include: rash; raised red patches on your skin (hives); swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing
Before you take INVOKANA® or INVOKAMET®/INVOKAMET® XR, tell your doctor if you:

have a history of amputation; have heart disease or are at risk for heart disease; have moderate to severe kidney problems; 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 INVOKANA® or INVOKAMET®/INVOKAMET® XR; are going to get an injection of dye or contrast agents for an X-ray procedure (INVOKANA® or INVOKAMET®/INVOKAMET® XR will need to be stopped for a short time); have heart problems (including congestive heart failure); are going to have surgery; are eating less due to illness, surgery, or a very low-calorie diet; have or have had problems with your pancreas; drink alcohol very often (or drink a lot of alcohol in short-term); or have any other medical conditions.

Tell your doctor if you are or plan to become pregnant, are breastfeeding, or plan to breastfeed.

INVOKANA® or INVOKAMET®/INVOKAMET® XR may harm your unborn baby. If you become pregnant while taking INVOKANA® or INVOKAMET®/INVOKAMET® XR, tell your doctor as soon as possible. If you are a premenopausal woman (before the “change of life”), who does not have periods regularly or at all, INVOKANA® or INVOKAMET®/INVOKAMET® XR may increase your chance of becoming pregnant. Talk to your doctor about birth control choices while taking INVOKANA® or INVOKAMET®/INVOKAMET® XR, if not planning to become pregnant. Tell your doctor right away if you become pregnant. INVOKANA® and INVOKAMET®/INVOKAMET® XR may pass into your breast milk and harm your baby. Do not breastfeed while taking INVOKANA® or INVOKAMET®/INVOKAMET® XR.

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® and INVOKAMET®/INVOKAMET® XR

INVOKANA® or INVOKAMET®/INVOKAMET® XR may cause serious side effects, including: 

  • Dehydration. INVOKANA® or INVOKAMET®/INVOKAMET® XR can cause some people to become dehydrated (the loss of too much body water). This may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at higher risk if you have low blood pressure, 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
  • Ketoacidosis (increased ketones in your blood or urine) has happened in people who have type 1 or type 2 diabetes, during treatment with canagliflozin. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with INVOKANA® or INVOKAMET®/INVOKAMET® XR, even if your blood sugar is less than 250 mg/dL. Stop taking INVOKANA® or 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
  • Kidney problems. Sudden kidney injury has happened to people taking INVOKANA® or INVOKAMET®/INVOKAMET® XR. Talk to your doctor right away if you: 1) reduce the amount of food or liquid you drink, if you are sick, or cannot eat or 2) you start to lose liquids from your body from vomiting, diarrhea, or being in the sun too long
  • A high amount of potassium in your blood (hyperkalemia)
  • Serious Urinary Tract Infections. May lead to hospitalization and have happened in people taking canagliflozin, one of the medicines in INVOKANA® and 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 high fever, back pain, nausea, or vomiting
  • Low blood sugar (hypoglycemia). If you take INVOKANA® or 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 INVOKANA® or 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 destroys 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 women and men who take INVOKANA® or INVOKAMET®/INVOKAMET® XR. 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 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).

Vaginal yeast infection. Women taking INVOKANA® or INVOKAMET®/INVOKAMET® XR may get vaginal yeast infections. Symptoms include: vaginal odor, white or yellowish discharge, or vaginal itching.

Yeast infection of the penis (balanitis or balanoposthitis). Men taking INVOKANA® or INVOKAMET®/INVOKAMET® XR may get a yeast infection of the skin around the penis. 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.

Serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking INVOKANA® or 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 INVOKANA® or INVOKAMET®/INVOKAMET® XR. 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 INVOKANA® and INVOKAMET®/INVOKAMET® XR include: urinary tract infection; changes in urination, including urgent need to urinate more often, in larger amounts, or at night; diarrhea, nausea and vomiting, gas, weakness, indigestion, upset stomach, or headache.

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 FDA at 1-800-FDA-1088. You may also report side effects to Janssen Scientific Affairs, LLC at 1-800-526-7736.

Please see full Product Information for INVOKANA®, INVOKAMET®, and INVOKAMET® XR, including Boxed Warnings, and Medication Guides for INVOKANA®, INVOKAMET®, and INVOKAMET® XR.

Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation.

Trademarks are those of their respective owners.                                                                                       

cp-68568v1

Invokamet® XR ( canagliflozin/metformin HCl extended-release tablets )

WHAT IS INVOKANA®?

INVOKANA® 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 heart disease

INVOKANA® is not for people with type 1 diabetes or with diabetic ketoacidosis (increased ketones in blood or urine). It is not known if INVOKANA® is safe and effective in children under 18 years of age.

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®). They are used along with diet and exercise to:

  • improve blood sugar (glucose) control in adults with type 2 diabetes

INVOKAMET®/INVOKAMET® XR is not for people with diabetic ketoacidosis (increased ketones in blood or urine). It is not known if INVOKAMET® or INVOKAMET® XR is safe and effective in children under 18 years of age.

IMPORTANT SAFETY INFORMATION

INVOKANA® and INVOKAMET®/INVOKAMET® XR can cause serious side effects, including:

  • Amputations. INVOKANA® and 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 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® or INVOKAMET®/INVOKAMET® XR for a while if you have any of these signs or symptoms. Talk to your doctor about proper foot care
  • 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. Call your doctor right away if you have any of the following symptoms, which could be signs 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.

Do not take if you:

  • INVOKANA® – are allergic to canagliflozin or any of the ingredients in INVOKANA®. Symptoms of allergic reaction may include: rash; raised red patches on your skin (hives); or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. Have severe kidney problems or are on dialysis
  • INVOKAMET®/INVOKAMET® XR – have moderate to severe kidney problems or are on dialysis, have conditions called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine). Are allergic to canagliflozin, metformin, or any of the ingredients in INVOKAMET®/INVOKAMET® XR. See the end of the Medication Guide for a list of ingredients in INVOKAMET®/INVOKAMET® XR. Symptoms of allergic reaction may include: rash; raised red patches on your skin (hives); swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing
Before you take INVOKANA® or INVOKAMET®/INVOKAMET® XR, tell your doctor if you:

have a history of amputation; have heart disease or are at risk for heart disease; have moderate to severe kidney problems; 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 INVOKANA® or INVOKAMET®/INVOKAMET® XR; are going to get an injection of dye or contrast agents for an X-ray procedure (INVOKANA® or INVOKAMET®/INVOKAMET® XR will need to be stopped for a short time); have heart problems (including congestive heart failure); are going to have surgery; are eating less due to illness, surgery, or a very low-calorie diet; have or have had problems with your pancreas; drink alcohol very often (or drink a lot of alcohol in short-term); or have any other medical conditions.

Tell your doctor if you are or plan to become pregnant, are breastfeeding, or plan to breastfeed.

INVOKANA® or INVOKAMET®/INVOKAMET® XR may harm your unborn baby. If you become pregnant while taking INVOKANA® or INVOKAMET®/INVOKAMET® XR, tell your doctor as soon as possible. If you are a premenopausal woman (before the “change of life”), who does not have periods regularly or at all, INVOKANA® or INVOKAMET®/INVOKAMET® XR may increase your chance of becoming pregnant. Talk to your doctor about birth control choices while taking INVOKANA® or INVOKAMET®/INVOKAMET® XR, if not planning to become pregnant. Tell your doctor right away if you become pregnant. INVOKANA® and INVOKAMET®/INVOKAMET® XR may pass into your breast milk and harm your baby. Do not breastfeed while taking INVOKANA® or INVOKAMET®/INVOKAMET® XR.

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® and INVOKAMET®/INVOKAMET® XR

INVOKANA® or INVOKAMET®/INVOKAMET® XR may cause serious side effects, including: 

  • Dehydration. INVOKANA® or INVOKAMET®/INVOKAMET® XR can cause some people to become dehydrated (the loss of too much body water). This may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at higher risk if you have low blood pressure, 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
  • Ketoacidosis (increased ketones in your blood or urine) has happened in people who have type 1 or type 2 diabetes, during treatment with canagliflozin. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with INVOKANA® or INVOKAMET®/INVOKAMET® XR, even if your blood sugar is less than 250 mg/dL. Stop taking INVOKANA® or 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
  • Kidney problems. Sudden kidney injury has happened to people taking INVOKANA® or INVOKAMET®/INVOKAMET® XR. Talk to your doctor right away if you: 1) reduce the amount of food or liquid you drink, if you are sick, or cannot eat or 2) you start to lose liquids from your body from vomiting, diarrhea, or being in the sun too long
  • A high amount of potassium in your blood (hyperkalemia)
  • Serious Urinary Tract Infections. May lead to hospitalization and have happened in people taking canagliflozin, one of the medicines in INVOKANA® and 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 high fever, back pain, nausea, or vomiting
  • Low blood sugar (hypoglycemia). If you take INVOKANA® or 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 INVOKANA® or 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 destroys 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 women and men who take INVOKANA® or INVOKAMET®/INVOKAMET® XR. 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 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).

Vaginal yeast infection. Women taking INVOKANA® or INVOKAMET®/INVOKAMET® XR may get vaginal yeast infections. Symptoms include: vaginal odor, white or yellowish discharge, or vaginal itching.

Yeast infection of the penis (balanitis or balanoposthitis). Men taking INVOKANA® or INVOKAMET®/INVOKAMET® XR may get a yeast infection of the skin around the penis. 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.

Serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking INVOKANA® or 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 INVOKANA® or INVOKAMET®/INVOKAMET® XR. 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 INVOKANA® and INVOKAMET®/INVOKAMET® XR include: urinary tract infection; changes in urination, including urgent need to urinate more often, in larger amounts, or at night; diarrhea, nausea and vomiting, gas, weakness, indigestion, upset stomach, or headache.

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 FDA at 1-800-FDA-1088. You may also report side effects to Janssen Scientific Affairs, LLC at 1-800-526-7736.

Please see full Product Information for INVOKANA®, INVOKAMET®, and INVOKAMET® XR, including Boxed Warnings, and Medication Guides for INVOKANA®, INVOKAMET®, and INVOKAMET® XR.

Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation.

Trademarks are those of their respective owners.                                                                                       

cp-68568v1

Invokana® ( canagliflozin )

WHAT IS INVOKANA®?

INVOKANA® 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 heart disease

INVOKANA® is not for people with type 1 diabetes or with diabetic ketoacidosis (increased ketones in blood or urine). It is not known if INVOKANA® is safe and effective in children under 18 years of age.

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®). They are used along with diet and exercise to:

  • improve blood sugar (glucose) control in adults with type 2 diabetes

INVOKAMET®/INVOKAMET® XR is not for people with diabetic ketoacidosis (increased ketones in blood or urine). It is not known if INVOKAMET® or INVOKAMET® XR is safe and effective in children under 18 years of age.

IMPORTANT SAFETY INFORMATION

INVOKANA® and INVOKAMET®/INVOKAMET® XR can cause serious side effects, including:

  • Amputations. INVOKANA® and 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 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® or INVOKAMET®/INVOKAMET® XR for a while if you have any of these signs or symptoms. Talk to your doctor about proper foot care
  • 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. Call your doctor right away if you have any of the following symptoms, which could be signs 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.

Do not take if you:

  • INVOKANA® – are allergic to canagliflozin or any of the ingredients in INVOKANA®. Symptoms of allergic reaction may include: rash; raised red patches on your skin (hives); or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. Have severe kidney problems or are on dialysis
  • INVOKAMET®/INVOKAMET® XR – have moderate to severe kidney problems or are on dialysis, have conditions called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine). Are allergic to canagliflozin, metformin, or any of the ingredients in INVOKAMET®/INVOKAMET® XR. See the end of the Medication Guide for a list of ingredients in INVOKAMET®/INVOKAMET® XR. Symptoms of allergic reaction may include: rash; raised red patches on your skin (hives); swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing
Before you take INVOKANA® or INVOKAMET®/INVOKAMET® XR, tell your doctor if you:

have a history of amputation; have heart disease or are at risk for heart disease; have moderate to severe kidney problems; 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 INVOKANA® or INVOKAMET®/INVOKAMET® XR; are going to get an injection of dye or contrast agents for an X-ray procedure (INVOKANA® or INVOKAMET®/INVOKAMET® XR will need to be stopped for a short time); have heart problems (including congestive heart failure); are going to have surgery; are eating less due to illness, surgery, or a very low-calorie diet; have or have had problems with your pancreas; drink alcohol very often (or drink a lot of alcohol in short-term); or have any other medical conditions.

Tell your doctor if you are or plan to become pregnant, are breastfeeding, or plan to breastfeed.

INVOKANA® or INVOKAMET®/INVOKAMET® XR may harm your unborn baby. If you become pregnant while taking INVOKANA® or INVOKAMET®/INVOKAMET® XR, tell your doctor as soon as possible. If you are a premenopausal woman (before the “change of life”), who does not have periods regularly or at all, INVOKANA® or INVOKAMET®/INVOKAMET® XR may increase your chance of becoming pregnant. Talk to your doctor about birth control choices while taking INVOKANA® or INVOKAMET®/INVOKAMET® XR, if not planning to become pregnant. Tell your doctor right away if you become pregnant. INVOKANA® and INVOKAMET®/INVOKAMET® XR may pass into your breast milk and harm your baby. Do not breastfeed while taking INVOKANA® or INVOKAMET®/INVOKAMET® XR.

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® and INVOKAMET®/INVOKAMET® XR

INVOKANA® or INVOKAMET®/INVOKAMET® XR may cause serious side effects, including: 

  • Dehydration. INVOKANA® or INVOKAMET®/INVOKAMET® XR can cause some people to become dehydrated (the loss of too much body water). This may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at higher risk if you have low blood pressure, 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
  • Ketoacidosis (increased ketones in your blood or urine) has happened in people who have type 1 or type 2 diabetes, during treatment with canagliflozin. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with INVOKANA® or INVOKAMET®/INVOKAMET® XR, even if your blood sugar is less than 250 mg/dL. Stop taking INVOKANA® or 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
  • Kidney problems. Sudden kidney injury has happened to people taking INVOKANA® or INVOKAMET®/INVOKAMET® XR. Talk to your doctor right away if you: 1) reduce the amount of food or liquid you drink, if you are sick, or cannot eat or 2) you start to lose liquids from your body from vomiting, diarrhea, or being in the sun too long
  • A high amount of potassium in your blood (hyperkalemia)
  • Serious Urinary Tract Infections. May lead to hospitalization and have happened in people taking canagliflozin, one of the medicines in INVOKANA® and 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 high fever, back pain, nausea, or vomiting
  • Low blood sugar (hypoglycemia). If you take INVOKANA® or 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 INVOKANA® or 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 destroys 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 women and men who take INVOKANA® or INVOKAMET®/INVOKAMET® XR. 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 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).

Vaginal yeast infection. Women taking INVOKANA® or INVOKAMET®/INVOKAMET® XR may get vaginal yeast infections. Symptoms include: vaginal odor, white or yellowish discharge, or vaginal itching.

Yeast infection of the penis (balanitis or balanoposthitis). Men taking INVOKANA® or INVOKAMET®/INVOKAMET® XR may get a yeast infection of the skin around the penis. 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.

Serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking INVOKANA® or 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 INVOKANA® or INVOKAMET®/INVOKAMET® XR. 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 INVOKANA® and INVOKAMET®/INVOKAMET® XR include: urinary tract infection; changes in urination, including urgent need to urinate more often, in larger amounts, or at night; diarrhea, nausea and vomiting, gas, weakness, indigestion, upset stomach, or headache.

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 FDA at 1-800-FDA-1088. You may also report side effects to Janssen Scientific Affairs, LLC at 1-800-526-7736.

Please see full Product Information for INVOKANA®, INVOKAMET®, and INVOKAMET® XR, including Boxed Warnings, and Medication Guides for INVOKANA®, INVOKAMET®, and INVOKAMET® XR.

Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation.

Trademarks are those of their respective owners.                                                                                       

cp-68568v1

Prezcobix® ( darunavir 800 mg/cobicistat 150 mg )

WHAT IS PREZCOBIX® USED FOR?

PREZCOBIX® is a prescription HIV-1 (Human Immunodeficiency Virus 1) medicine always used with other antiretroviral medicines to treat HIV-1 infection in adults. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). PREZCOBIX® contains prescription medicines PREZISTA® (darunavir) and TYBOST® (cobicistat). PREZCOBIX® 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. PREZCOBIX® should be taken once daily with food.

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. 

Who should not take PREZCOBIX®?

  • 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, lomitapide, lovastatin, lurasidone, methylergonovine, oral midazolam, 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 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, or plan to become pregnant. PREZCOBIX® should not be used in pregnant individuals because you may not have enough PREZCOBIX® in your body during pregnancy. Your healthcare provider will prescribe different medicines if you become pregnant while taking PREZCOBIX®. It is unknown if PREZCOBIX® will harm your unborn baby.
  • are breastfeeding, or plan to breastfeed. You should not breastfeed if you have HIV-1 because of the risk of passing HIV to your baby. It is unknown if PREZCOBIX® can pass 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. 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:

  • 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 are:

  • Diarrhea
  • Nausea
  • Rash
  • Headache
  • Stomach area (abdominal) pain
  • Vomiting

These are not all the possible side effects of PREZCOBIX®. Tell your healthcare provider if any side effect bothers you or does not go away. 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.

cp-33793v3

Prezista® ( darunavir )

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), lomitapide, lovastatin, lurasidone, midazolam, when taken by mouth, 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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Procrit® ( epoetin alfa )

INDICATIONS

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).
  • 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.
  • Sever 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.

080072 - 170908

Remicade® ( infliximab )

What conditions is REMICADE® used to treat?

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 caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. 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 TNF-blocker medicines. Hepatosplenic T-cell lymphoma, a rare form of fatal lymphoma, has occurred mostly in teenage or young adult males 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.

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 or coccidioidomycosis 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 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:

  • Infections (like TB, blood infections, pneumonia)—fever, tiredness, cough, flu, 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 your 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, right-sided abdominal pain, fever, or severe tiredness.
  • Blood disorders—fever that doesn’t go away, bruising, bleeding or severe paleness.
  • Nervous system disorders—numbness, weakness, tingling, changes in your vision or seizures.
  • 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 the 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 most common side effects of REMICADE® include respiratory infections (that may include sinus infections and sore throat), headache, rash, 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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Simponi® ( golimumab )

INDICATIONS AND DOSING

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 people using TNF blockers, including 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.

cp-51591v1

Simponi Aria® ( golimumab )

INDICATION

SIMPONI ARIA® is for adults with:

  • Moderate to severe rheumatoid arthritis, used in combination with methotrexate
  • Active psoriatic arthritis
  • Active ankylosing spondylitis

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, 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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Spravato™ ( esketamine ) Nasal Spray CIII

What Is SPRAVATO™?

SPRAVATO™ is a prescription medicine, used along with an antidepressant taken by mouth, for treatment-resistant depression (TRD) in adults.

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 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 and to patients enrolled in the program.
  • Increased risk of suicidal thoughts or actions. SPRAVATO™ may cause worsening of depression and suicidal thoughts and behaviors, especially during the first few months of treatment and when the dose is changed. 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?
    • 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 have any of the following symptoms, especially if they are new, worse, or worry you:
    • attempts to commit suicide
    • thoughts about suicide or dying
    • worsening depression
    • other unusual changes in behavior or mood

​ SPRAVATO™ is not for use in children.

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.

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: dissociation, dizziness, nausea, sedation, spinning sensation, reduced sense of touch and sensation, anxiety, lack of energy, increased blood pressure, vomiting, and feeling drunk.

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.

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Stelara® ( ustekinumab )

What is STELARA®?

STELARA® is a prescription medicine used to treat adults 18 years and older with moderately to severely active Crohn’s disease who have already taken other medicine that did not work well enough or they could not tolerate it.

STELARA® is a prescription medicine used to treat adults and children 12 years and older with moderate or severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).

STELARA® is a prescription medicine approved to treat adults 18 years and older with active psoriatic arthritis, either alone or with methotrexate.

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
  • 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). 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.

Reversible posterior leukoencephalopathy syndrome (RPLS)

RPLS is a rare condition that affects the brain and can cause death. The cause of RPLS is not known. If RPLS 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 RPLS.
  • 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.
  • STELARA® is intended for use under the guidance and supervision of your doctor. In children 12 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: upper respiratory infections, headache, and tiredness in psoriasis patients; joint pain and nausea in psoriatic arthritis patients; and upper respiratory infections, redness at the injection site, vaginal yeast infections, itching, urinary tract infections, and vomiting in Crohn’s disease patients. 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.

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Symtuza® ( darunavir/cobicistat/emtricitabine/tenofovir alafenamide )  

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 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).

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 sometime 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), lovastatin or a product that contains lovastatin, lurasidone, oral midazolam (when taken by mouth), 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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Tremfya® ( guselkumab )

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 light or UV light).

Important Safety Information

What is the most important information I should know about TREMFYA®?

TREMFYA® may cause serious side effects, including infections. TREMFYA® is a prescription medicine that 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

    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, and herpes simplex infections.

    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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    Xarelto® ( rivaroxaban )

    WHAT IS XARELTO®?

    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

    XARELTO® is also used with low dose aspirin to:

    • reduce the risk of serious heart problems, heart attack and stroke in patients with coronary artery disease (a condition where the blood supply to the heart is reduced or blocked) or peripheral arterial disease (a condition where the blood flow to the legs is reduced)

    It is not known if XARELTO® is safe and effective in children.

    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 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 people with artificial heart valves.

    ​​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
    • 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. You and your doctor should decide if you will take XARELTO® or breastfeed.

    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.
    • If you take XARELTO® for:​
      • 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.
      • 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 15-mg and 20-mg doses, XARELTO® should be taken with food.
        • For the 10-mg dose, XARELTO® may be taken with or without food.
        • Take your XARELTO® doses at the same time each day.
        • 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.​
      • 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.
      • Reducing the risk of serious heart problems, heart attack and stroke in coronary artery disease or peripheral arterial disease:
        • Take XARELTO® 2 times a day with or without food.
        • If you miss a dose of XARELTO®, take your next dose at your regularly scheduled time.
    • If you have difficulty swallowing the XARELTO® tablet whole, talk to your doctor about other ways to take XARELTO®.
    • Your doctor will decide how long you should take XARELTO®.
    • XARELTO® may need to be stopped, if possible for one or more days before any surgery or medical/dental procedure. If you need to stop taking XARELTO® for any reason, talk to your doctor to find out when you should stop taking it. Do not stop taking XARELTO® without first talking to the doctor who prescribed it to you. Your doctor will tell you when to start taking XARELTO® again after your surgery or procedure.
    • Do not run out of XARELTO®. Refill your prescription for XARELTO® before you run out. When leaving the hospital following a hip or knee replacement, be sure that you 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.

    WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO®?

    • The most common side effect of XARELTO® was bleeding.
    • See “What is the most important information I should know about XARELTO®?”

    Call your doctor for medical advice about side effects. You may report side effects to 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 see full Prescribing Information, including Boxed Warnings, and Medication Guide.

    Trademarks are those of their respective owners.

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    Yondelis® ( trabectedin )

    INDICATION

    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.
    • 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.
    • 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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    Zytiga® ( abiraterone acetate )

    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.

    ZYTIGA® is not for use in women.

    It is not known if ZYTIGA® is safe or effective in children.

    Important Safety Information

    Who should not take ZYTIGA® (abiraterone acetate)?

    ZYTIGA® is not for use in women.

    Do not take ZYTIGA® if you are pregnant or may become pregnant. ZYTIGA® may harm your unborn baby. Women who are pregnant or may become pregnant should not touch ZYTIGA® 250-mg uncoated tablets or other ZYTIGA® tablets if broken, crushed, or damaged without protection, such as gloves.

    ZYTIGA® is not for use in women or children. Keep ZYTIGA® and all medicines out of the reach of children.

    Before you take ZYTIGA®, tell your healthcare provider if you:

    • Have heart problems
    • Have liver problems
    • Have a history of adrenal problems
    • Have a history of pituitary problems
    • Have any other medical conditions
    • Plan to become pregnant (See "Who should not take ZYTIGA®?")
    • Are breastfeeding or plan to breastfeed. It is not known if ZYTIGA® passes into your breast milk. You and your healthcare provider should decide if you will take ZYTIGA® or breastfeed. You should not do both. (See "Who should not take ZYTIGA®?")
    • Take any other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ZYTIGA® can interact with many other medicines.

    If you are taking 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 stop taking your prescribed dose of ZYTIGA® or prednisone without talking to your healthcare provider first.
    • Take ZYTIGA® on an empty stomach, either 1 hour before or 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.
    • Men who are sexually active with a pregnant woman must use a condom during and for 3 weeks after treatment with ZYTIGA®. If their female partner may become pregnant, a condom and another form of birth control must be used during and for 3 weeks after treatment with ZYTIGA®. Talk with your healthcare provider if you have any questions about birth control.
    • 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.

    ZYTIGA® may cause serious side effects including:

    • High blood pressure (hypertension), low blood potassium levels (hypokalemia), and fluid retention (edema).

      Tell your healthcare provider if you get any of the following symptoms:

      • Dizziness
      • Fast 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.
    • 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 if you notice any of the following changes:
      • Yellowing of the skin or eyes
      • Darkening of the urine
      • Severe nausea or vomiting

    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
    • Cough
    • Headache
    • Low red blood cells (anemia)
    • High blood cholesterol and triglycerides
    • High blood sugar levels
    • Certain other abnormal 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 ZYTIGA®.

    FOR MORE INFORMATION, ASK YOUR HEALTHCARE PROVIDER OR PHARMACIST.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

    ZYTIGA® can interact with other medicines.

    You should not start or stop any medicine before you talk with the healthcare provider who 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.

    Call your doctor for medical advice about side effects. 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 (1-800-332-1088).

    Please read the full Prescribing Information and Patient Information for ZYTIGA® and discuss any questions you have with your doctor.

    cp-52365v1