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 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

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 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 on the first day 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. Your healthcare provider may temporarily stop your infusion or completely stop treatment with DARZALEX® if you have infusion reactions. Tell your healthcare provider 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. 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
  • constipation
  • vomiting
  • muscle spasms
  • joint pain
  • back pain
  • fever
  • chills
  • dizziness
  • insomnia
  • cough
  • shortness of breath
  • swollen hands, ankles or feet
  • nerve damage causing tingling, numbness or pain
  • cold-like symptoms (upper respiratory infection)

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.

Please see Important Product Information

074830-170707

Doxil® (doxorubicin HCl liposome injection)

INDICATIONS

DOXIL® is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.

DOXIL® in combination with bortezomib is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.

DOXIL® is administered intravenously by your healthcare professional.

Important Safety Information

Serious and possibly permanent heart-related side effects that may lead to congestive heart failure can occur in patients treated with DOXIL®. Inform your doctor of any history of heart disease, radiation to your chest, or prior anticancer therapy. Your doctor will monitor your heart function.

Infusion reactions may also occur during administration. Be sure to tell your doctor if you have any symptoms during infusion, including: flushing, shortness of breath, facial swelling, headaches, chills, back pain, tightness in your chest or throat, dizziness, or lightheadedness. For most patients, these reactions have resolved within several hours to a day once the infusion is stopped, or for some patients with slowing of the infusion rate. However, in some cases, these reactions may be serious and sometimes life-threatening and may be fatal.

You should not take DOXIL® if you have a prior history of allergic reactions to doxorubicin or other ingredients found in the formulation. Please inform your doctor about your history of allergic reactions to medications or other substances.

DOXIL® may severely reduce the number of blood cells (red blood cells, white blood cells, and cells that prevent bleeding called platelets) in your body that may potentially increase risk of infections, anemia, and bleeding. Speak to your doctor if you notice any changes in your health such as a new onset fever or symptoms of infection. Your doctor will monitor your blood laboratory results.

Hand-Foot Syndrome may occur while taking DOXIL®. This may lead to tingling or burning, redness,flaking, bothersome swelling, small blisters, or small sores on palms of hands or soles of feet. In certain cases, this reaction can be more severe leading to serious infections, interfering with walking and other daily activities.

Cases of oral cancer have been reported in people who had taken DOXIL® for more than one year. The oral cancer was diagnosed during treatment and up to 6 years after the last dose. Your doctor will examine you at regular times for the signs and symptoms of oral cancer.

If you are pregnant, planning to become pregnant, or nursing, inform your doctor. DOXIL® can cause fetal harm. Nursing should be discontinued during treatment with DOXIL®. Females and males of reproductive potential should use effective contraception during and for 6 months following treatment with DOXIL®. DOXIL® may cause temporary or permanent infertility.

The most common side effects reported in at least 20% of patients treated with DOXIL® during clinical studies were: weakness, tiredness, fever, nausea, stomatitis (painful redness, swelling, or sores in the mouth), vomiting, diarrhea, constipation, loss of appetite, hand-foot syndrome, rash, low white blood cell count, low platelet count, and anemia. Tell your doctor if you experience these or other side effects.

In the treatment of multiple myeloma, nerve damage called peripheral neuropathy, which may lead to pain, numbness, burning sensation, tingling, and more serious symptoms, was reported in >40% of patients. Be sure to tell your doctor immediately if you experience any of these or other symptoms.

Following administration, DOXIL® may turn urine and other bodily fluids a reddish-orange color. This is due to the color of DOXIL® and will go away as the drug leaves the body.

Your doctor may prescribe antinausea medications before or during your DOXIL® treatment.

Talk to your doctor if you have a history of heart disease or liver disease, or have received prior radiation therapy and/or anticancer therapy.

Please talk to your doctor or nurse if you have any additional questions regarding DOXIL®.

For more information about DOXIL® therapy, please visit www.DOXIL.com.

Please see full Product Information for more details.

030068-150417

Edurant® (rilpivirine)

About EDURANT®

  • EDURANT® (rilpivirine) is a prescription HIV medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1)
    in patients:
    • Who have never taken HIV medicines before, and
    • Who have an amount of HIV in their blood (called “viral load”) that is no more than 100,000 copies/mL. Your healthcare professional will measure your viral load
  • EDURANT® should be taken in combination with other HIV medicines. Your healthcare professional will work with you to find the right combination of HIV medicines
  • It is important that you remain under the care of your healthcare professional during treatment with EDURANT®
  • EDURANT® is not recommended for patients less than 12 years of age

EDURANT® does not cure HIV infection or AIDS. You should remain on your HIV medications without stopping to ensure that you control your HIV infection and decrease the risk of HIV-related illnesses. Ask your healthcare professional about how to prevent passing HIV to other people.

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

Important Safety Information

Can EDURANT® be taken with other medicines?

EDURANT® may affect the way other medicines work and other medicines may affect how EDURANT® works and may cause serious side effects. If you take certain medicines with EDURANT®, the amount of EDURANT® in your body may be too low and it may not work to help control your HIV infection, and the HIV virus in your body may become resistant to EDURANT® or other HIV medicines that are like it. To help get the right amount of medicine in your body, you should always take EDURANT® with a meal. A protein drink alone does not replace a meal.

Do not take EDURANT® if:

  • Your HIV infection has been previously treated with HIV medicines
  • You are taking any of the following medicines:
    • Anti-seizure medicines: carbamazepine (Carbatrol®, Equetro®, Tegretol®, Tegretol-XR®, Teril®, Epitol®), oxcarbazepine (Trileptal®), phenobarbital (Luminal®), phenytoin (Dilantin®, Dilantin-125®, Phenytek®)
    • Anti-tuberculosis (anti-TB) medicines: rifampin (Rifater®, Rifamate®, Rimactane®, Rifadin®), rifapentine (Priftin®)
    • Proton pump inhibitor (PPI) medicine for certain stomach or intestinal problems: esomeprazole (Nexium®, Vimovo®), lansoprazole (Prevacid®), omeprazole (Prilosec®, Zegerid®), pantoprazole sodium (Protonix®), rabeprazole (Aciphex®)
    • More than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate
    • St. John’s wort (Hypericum perforatum)

Especially tell your doctor if you take:

  • Rifabutin (Mycobutin®), a medicine to treat some bacterial infections. Talk to your doctor or pharmacist about the right amount of EDURANT® you should take if you also take rifabutin
  • Medicines used to treat HIV
  • An antacid medicine that contains aluminum, magnesium hydroxide, or calcium carbonate. Take antacids at least 2 hours before or at least 4 hours after you take EDURANT®
  • Medicines to block acid in your stomach, including cimetidine (Tagamet®), famotidine (Pepcid®), nizatidine (Axid®), or ranitidine hydrochloride (Zantac®). Take these medicines at least 12 hours before or at least 4 hours after you take EDURANT®
  • Any of these medicines (if taken by mouth or injection): clarithromycin (Biaxin®), erythromycin (E-Mycin®, Eryc®, Ery-Tab®, PCE®, Pediazole®, Ilosone®), fluconazole (Diflucan®), itraconazole (Sporanox®), ketoconazole (Nizoral®), methadone (Dolophine®), posaconazole (Noxafil®), telithromycin (Ketek®), voriconazole (Vfend®)

This is not a complete list of medicines. Before starting EDURANT®, be sure to tell your healthcare professional about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Before taking EDURANT®, also tell your healthcare professional if you have had or currently have liver problems (including hepatitis B or C), have ever had a mental health problem, are pregnant or planning to become pregnant, or breastfeeding. It is not known if EDURANT® will harm your unborn baby. You and your healthcare professional will need to decide if taking EDURANT® is right for you.

  • Do not breastfeed if you are taking EDURANT®. You should not breastfeed if you have HIV because of the chance of passing HIV to your baby.

What are the possible side effects of EDURANT®?
EDURANT® can cause serious side effects including:

  • Severe skin rash and allergic reactions. Call your doctor right away if you get a rash. Stop taking EDURANT® and seek medical help right away if you get a rash with any of the following symptoms: severe allergic reaction causing swelling of the face, eyes, lips, mouth, tongue, or throat (which may lead to difficulty swallowing or breathing); mouth sores or blisters on your body; inflamed eye (conjunctivitis); fever; dark urine; or pain on the right side of the stomach area (abdominal pain)
  • Depression or mood changes. Tell your doctor 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
  • Liver problems. 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. Liver problems were also reported during treatment in some people without a history of liver disease. Your healthcare professional may need to do tests to check liver function before and during treatment
  • Changes in body shape or body fat have been seen in some patients taking HIV medicines. The exact cause and long-term health effects of these conditions are not known
  • Changes in your immune system (immune reconstitution syndrome). Your immune system may get stronger and begin to fight infections. Tell your healthcare professional right away if you start having any new symptoms of infection

Other common side effects of EDURANT® include depression, headache, trouble sleeping (insomnia), and rash.

This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare professional right away. Do not stop taking EDURANT® or any other medications without first talking to your healthcare professional.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also report side effects to Janssen Products, LP, at 1-800-JANSSEN (1-800-526-7736).

Please see full Product Information for more details.

039972-151112

Intelence® ( etravirine )

About INTELENCE® (etravirine)

  • INTELENCE® (etravirine) is a prescription HIV (human immunodeficiency virus) medicine that is used with other HIV medicines to treat HIV infection in adults and children 6 years of age and older. HIV is the virus that causes AIDS (acquired immune deficiency syndrome). INTELENCE® is a type of HIV medicine called a non-nucleoside reverse transcriptase inhibitor (NNRTI), also known as a non-nuke
  • INTELENCE® must be taken in combination with other HIV medicines. INTELENCE® is used in people who are already taking or have taken an NNRTI and other HIV medicines and these medicines are not controlling their HIV infection
    • The use of other medicines active against your HIV in combination with INTELENCE® may increase the likelihood of your overall treatment response. If a non-nuke regimen has stopped working for you in the past, INTELENCE® should not be taken with only nucleoside/nucleotide reverse transcriptase inhibitors, also known as nukes. Your healthcare professional will work with you to find the right combination of HIV medicines to combine with INTELENCE®
    • It is important that you remain under the care of your healthcare professional during treatment with INTELENCE®
  • It is not known if INTELENCE® is safe and effective in children less than 6 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 professional 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, in general, is a common side effect of INTELENCE® and was seen more commonly in children than adults in clinical studies. Rash was also seen more commonly in females than males. Rash can be serious and may potentially lead to death. If you get a rash with any of the following symptoms, stop taking INTELENCE® and call your healthcare professional right away: hives or sores in your mouth, or your skin blisters and peels; trouble swallowing or breathing; swelling of your face, eyes, lips, tongue, or throat; fever; yellowing of the skin or whites of the eyes; dark urine; or pain on the right side of the stomach area (abdominal pain)
  • Changes in body shape or body fat. The cause and long-term health effects of these conditions are not known at this time
  • 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 adults, common side effects of INTELENCE® include tingling, numbness, or pain in hands or feet
  • In children, diarrhea is a common side effect of INTELENCE®

This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare professional right away.

What should I tell my doctor before I take INTELENCE®?

  • Before taking INTELENCE®, tell your healthcare professional if you have liver problems, including hepatitis B or C, have any other medical conditions, or if you are pregnant, planning to become pregnant, or breastfeeding
    • It is not known if INTELENCE® can cause harm to your unborn baby. Do not breastfeed if you are taking INTELENCE®. You should not breastfeed if you have HIV because of the risk of passing HIV to your baby
  • Tell your healthcare professional about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements
  • Taking INTELENCE® with certain medicines may cause serious side effects or may result in loss of its effectiveness (which could increase your risk for developing resistance to INTELENCE® or other HIV medicines). Dolutegravir (Tivicay®, Triumeq®) is one HIV medication that may have loss of effectiveness when taken with INTELENCE®. Tell your healthcare professional about all other HIV medications you are taking
  • Do not take INTELENCE® if you are taking the following medicines:
    • HIV: tipranavir/ritonavir (Aptivus®), fosamprenavir/ritonavir (Lexiva®), full-dose ritonavir (Norvir® 600 mg twice a day), unboosted protease inhibitors (without ritonavir), nevirapine (Viramune®), efavirenz (Sustiva®), or delavirdine (Rescriptor®)
    • Other: carbamazepine (Tegretol®, Tegretol-XR®, Carbatrol®, Equetro®, Teril®, Epitol®), phenobarbital (Luminal®, Solfoton®), phenytoin (Dilantin®, Dilantin-125®, Phenytek®), rifabutin (Mycobutin®), rifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®), rifapentine (Priftin®), or products containing St. John’s wort (Hypericum perforatum)

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.

Please see the full Product Information in PDF format for more details.

021134-140910

Invokamet® (canagliflozin/metformin HCl)

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 when treatment with both canagliflozin and metformin is appropriate. 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

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

  • Amputations. INVOKANA® may increase your risk of lower-limb amputations. Amputations mainly involve removal of the toe or part of the foot, however, amputations involving the leg, below and above the knee, have also occurred. Some people had more than one amputation, some on both sides of the body. You may be at a higher risk of lower-limb amputation if you: have a history of amputation, have heart disease or are at risk for heart disease, have had blocked or narrowed blood vessels (usually in leg), have damage to the nerves (neuropathy) in the leg, or have had diabetic foot ulcers or sores.  

Call your doctor right away if you have new pain or tenderness, any sores, ulcers, or infections in your leg or foot. Your doctor may decide to stop your 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 INVOKAMET®/INVOKAMET® XR if you:

  • 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 INVOKAMET®/INVOKAMET® XR, tell your doctor if you: have a history of amputation; have heart disease or are at risk for heart disease; have had blocked or narrowed blood vessels (usually in leg); have damage to the nerves (neuropathy) in your leg; have had diabetic foot ulcers or sores; have moderate to severe kidney problems; have liver problems; have a history of urinary tract infections or problems with urination; are on a low sodium (salt) diet; have ever had an allergic reaction to INVOKAMET®/INVOKAMET® XR; are going to get an injection of dye or contrast agents for an X-ray procedure (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. INVOKAMET®/INVOKAMET® XR may harm your unborn baby. If you become pregnant while taking 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, INVOKAMET®/INVOKAMET® XR may increase your chance of becoming pregnant. Talk to your doctor about birth control choices while taking INVOKAMET®/INVOKAMET® XR, if not planning to become pregnant. Tell your doctor right away if you become pregnant. INVOKAMET®/INVOKAMET® XR may pass into your breast milk and harm your baby. Do not breastfeed while taking 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 INVOKAMET®/INVOKAMET® XR

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

  • Dehydration: 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 INVOKAMET®/INVOKAMET® XR, even if your blood sugar is less than 250 mg/dL. Stop taking INVOKAMET®/INVOKAMET® XR and call your doctor right away if you get any of the following symptoms: nausea, vomiting, stomach-area pain, tiredness, or trouble breathing
  • Kidney problems. Sudden kidney injury has happened to people taking 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 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 INVOKAMET®/INVOKAMET® XR with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while taking INVOKAMET®/INVOKAMET® XR.

Signs and symptoms of low blood sugar may include: headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, shaking or feeling jittery.

Vaginal yeast infection: Women taking 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 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.

Serious allergic reaction: If you have any symptoms of a serious allergic reaction, stop taking INVOKAMET®/INVOKAMET® XR and call your doctor right away or go to the nearest hospital emergency room.

Broken Bones (fractures): Bone fractures have been seen in patients taking 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 INVOKAMET®/INVOKAMET® XR include: 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 INVOKAMET® and INVOKAMET® XR, including Boxed Warnings, and Medication Guides for INVOKAMET® and INVOKAMET® XR.

Please see full Product Information, including Boxed Warning, and Medication Guide for INVOKANA®.

Trademarks are those of their respective owners.

076355-170717

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

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 when treatment with both canagliflozin and metformin is appropriate. 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

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

  • Amputations. INVOKANA® may increase your risk of lower-limb amputations. Amputations mainly involve removal of the toe or part of the foot, however, amputations involving the leg, below and above the knee, have also occurred. Some people had more than one amputation, some on both sides of the body. You may be at a higher risk of lower-limb amputation if you: have a history of amputation, have heart disease or are at risk for heart disease, have had blocked or narrowed blood vessels (usually in leg), have damage to the nerves (neuropathy) in the leg, or have had diabetic foot ulcers or sores.  

Call your doctor right away if you have new pain or tenderness, any sores, ulcers, or infections in your leg or foot. Your doctor may decide to stop your 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 INVOKAMET®/INVOKAMET® XR if you:

  • 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 INVOKAMET®/INVOKAMET® XR, tell your doctor if you: have a history of amputation; have heart disease or are at risk for heart disease; have had blocked or narrowed blood vessels (usually in leg); have damage to the nerves (neuropathy) in your leg; have had diabetic foot ulcers or sores; have moderate to severe kidney problems; have liver problems; have a history of urinary tract infections or problems with urination; are on a low sodium (salt) diet; have ever had an allergic reaction to INVOKAMET®/INVOKAMET® XR; are going to get an injection of dye or contrast agents for an X-ray procedure (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. INVOKAMET®/INVOKAMET® XR may harm your unborn baby. If you become pregnant while taking 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, INVOKAMET®/INVOKAMET® XR may increase your chance of becoming pregnant. Talk to your doctor about birth control choices while taking INVOKAMET®/INVOKAMET® XR, if not planning to become pregnant. Tell your doctor right away if you become pregnant. INVOKAMET®/INVOKAMET® XR may pass into your breast milk and harm your baby. Do not breastfeed while taking 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 INVOKAMET®/INVOKAMET® XR

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

  • Dehydration: 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 INVOKAMET®/INVOKAMET® XR, even if your blood sugar is less than 250 mg/dL. Stop taking INVOKAMET®/INVOKAMET® XR and call your doctor right away if you get any of the following symptoms: nausea, vomiting, stomach-area pain, tiredness, or trouble breathing
  • Kidney problems. Sudden kidney injury has happened to people taking 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 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 INVOKAMET®/INVOKAMET® XR with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while taking INVOKAMET®/INVOKAMET® XR.

Signs and symptoms of low blood sugar may include: headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, shaking or feeling jittery.

Vaginal yeast infection: Women taking 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 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.

Serious allergic reaction: If you have any symptoms of a serious allergic reaction, stop taking INVOKAMET®/INVOKAMET® XR and call your doctor right away or go to the nearest hospital emergency room.

Broken Bones (fractures): Bone fractures have been seen in patients taking 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 INVOKAMET®/INVOKAMET® XR include: 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 INVOKAMET® and INVOKAMET® XR, including Boxed Warnings, and Medication Guides for INVOKAMET® and INVOKAMET® XR.

Please see full Product Information, including Boxed Warning, and Medication Guide for INVOKANA®.

Trademarks are those of their respective owners.

076355-170717

Invokana® ( canagliflozin )

WHAT IS INVOKANA®?

INVOKANA® is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. 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.

IMPORTANT SAFETY INFORMATION

INVOKANA® can cause important side effects, including:

  • Amputations. INVOKANA® may increase your risk of lower-limb amputations. Amputations mainly involve removal of the toe or part of the foot; however, amputations involving the leg, below and above the knee, have also occurred. Some people had more than one amputation, some on both sides of the body. You may be at a higher risk of lower-limb amputation if you: have a history of amputation, have heart disease or are at risk for heart disease, have had blocked or narrowed blood vessels (usually in leg), have damage to the nerves (neuropathy) in the leg, or have had diabetic foot ulcers or sores. Call your doctor right away if you have new pain or tenderness, any sores, ulcers, or infections in your leg or foot. Your doctor may decide to stop your INVOKANA®. Talk to your doctor about proper foot care
  • Dehydration. INVOKANA® can cause some people to become dehydrated (the loss of too much body water), which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at higher risk of dehydration if you have low blood pressure, take medicines to lower your blood pressure (including diuretics [water pills]), are on a low sodium (salt) diet, have kidney problems, or are 65 years of age or older
  • Vaginal yeast infection. Women who take INVOKANA® may get vaginal yeast infections. Symptoms include: vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), or vaginal itching
  • Yeast infection of the penis (balanitis or balanoposthitis). Men who take INVOKANA® may get a yeast infection of the skin around the penis. Symptoms include: redness, itching, or swelling of the penis; rash of the penis; foul-smelling discharge from the penis; or pain in the skin around penis

Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis.

Do not take INVOKANA® if you:

  • are allergic to canagliflozin or any of the ingredients in INVOKANA®. Symptoms of allergic reaction 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

Before you take INVOKANA®, tell your doctor if you have a history of amputation; heart disease or are at risk for heart disease; blocked or narrowed blood vessels (usually in leg); damage to the nerves (neuropathy) of your leg; diabetic foot ulcers or sores; kidney problems; liver problems; history of urinary tract infections or problems with urination; are on a low sodium (salt) diet; are going to have surgery; are eating less due to illness, surgery, or change in diet; pancreas problems; drink alcohol very often (or drink a lot of alcohol in short-term); ever had an allergic reaction to INVOKANA®; or have other medical conditions.

Tell your doctor if you are or plan to become pregnant, are breastfeeding, or plan to breastfeed. INVOKANA® may harm your unborn baby. If you become pregnant while taking INVOKANA®, tell your doctor right away. INVOKANA® may pass into your breast milk and may harm your baby. Do not breastfeed while taking INVOKANA®.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take diuretics (water pills), rifampin (used to treat or prevent tuberculosis), phenytoin or phenobarbital (used to control seizures), ritonavir (Norvir®, Kaletra® – used to treat HIV infection), or digoxin (Lanoxin® – used to treat heart problems).

Possible Side Effects of INVOKANA®
INVOKANA® may cause serious side effects, including:

  • Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 or type 2 diabetes, during treatment with INVOKANA®. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with INVOKANA® even if your blood sugar is less than 250 mg/dL. Stop taking INVOKANA® and call your doctor right away if you get any of the following symptoms: nausea, vomiting, stomach-area pain, tiredness, or trouble breathing
  • Kidney problems. Sudden kidney injury has happened to people taking INVOKANA®. 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 INVOKANA®. 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® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take INVOKANA®

Signs and symptoms of low blood sugar may include: headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, shaking, or feeling jittery.

Serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking INVOKANA® and call your doctor right away or go to the nearest hospital emergency room.

Broken Bones (fractures): Bone fractures have been seen in patients taking INVOKANA®. Talk to your doctor about factors that may increase your risk of bone fracture.

The most common side effects of INVOKANA® include: vaginal yeast infections and yeast infections of the penis; changes in urination, including urgent need to urinate more often, in larger amounts, or at night. 

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, including Boxed Warning, and Medication Guide for INVOKANA®. 

Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation.

Trademarks are those of their respective owners.

076190-170713 

Olysio® ( simeprevir )

What is OLYSIO®?

  • OLYSIO® is a prescription medicine used with other antiviral medicines to treat chronic (lasting a long time) hepatitis C virus genotype 1 infection. OLYSIO® should not be taken alone. OLYSIO® is not for people with certain types of liver problems. It is not known if OLYSIO® is safe and effective in children under 18 years of age.

Important Safety Information

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

OLYSIO® can cause serious side effects, including:

  • Hepatitis B virus reactivation: Before starting treatment with OLYSIO®, your healthcare provider will do blood tests to check for hepatitis B virus infection. If you have ever had hepatitis B virus infection, the hepatitis B virus could become active again during or after treatment of hepatitis C virus with OLYSIO®. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure and death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop taking OLYSIO®.

  • OLYSIO® combination treatment with sofosbuvir (Sovaldi®) may result in slowing of the heart rate (pulse) along with other symptoms when taken with amiodarone (Cordarone®, Nexterone®, Pacerone®), a medicine used to treat certain heart problems.
    If you are taking OLYSIO® with sofosbuvir and amiodarone and you get any of the following symptoms, or if you have a slow heart rate call your healthcare provider right away:
    • fainting or near‐fainting
    • dizziness or lightheadedness
    • weakness, extreme tiredness
    • chest pain, shortness of breath
    • confusion or memory problems

  • OLYSIO® may cause severe liver problems in some people. These severe liver problems may lead to liver failure or death.
    Your healthcare provider may do blood tests to check your liver function during treatment with OLYSIO®.
    Your healthcare provider may tell you to stop taking OLYSIO® if you develop signs and symptoms of liver problems.

      Tell your healthcare provider right away if you develop any of the following symptoms, or if they worsen during treatment with OLYSIO®:

    • tiredness
    • weakness
    • loss of appetite
    • nausea and vomiting
    • yellowing of your skin or eyes
    • color changes in your stools

  • OLYSIO® combination treatment may cause rashes and skin reactions to sunlight. These rashes and skin reactions to sunlight can be severe and you may need to be treated in a hospital. Rashes and skin reactions to sunlight are most common during the first 4 weeks of treatment, but can happen at any time during combination treatment with OLYSIO®.
    • Limit sunlight exposure during treatment with OLYSIO®.
    • Use sunscreen and wear a hat, sunglasses, and protective clothing during treatment with OLYSIO®.
    • Avoid use of tanning beds, sunlamps, or other types of light therapy during treatment with OLYSIO®.
    • Call your healthcare provider right away if you get any of the following symptoms:
      • burning, redness, swelling or blisters on your skin
      • mouth sores or ulcers
      • red or inflamed eyes, like “pink eye” (conjunctivitis)

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

Before taking OLYSIO®,  tell your healthcare provider about all of your medical conditions, including if you:

  • have ever had hepatitis B virus infection
  • have liver problems other than hepatitis C virus infection
  • have ever taken any medicine to treat hepatitis C virus infection
  • had a liver transplant
  • are receiving phototherapy
  • have any other medical condition
  • are pregnant or plan to become pregnant. It is not known if OLYSIO® will harm your unborn baby. Do not take OLYSIO® in combination with ribavirin if you are pregnant, or your sexual partner is pregnant.
    • Females who take OLYSIO® in combination with ribavirin should avoid becoming pregnant during treatment and for 6 months after stopping ribavirin. Call your healthcare provider right away if you think you may be pregnant or become pregnant during treatment with OLYSIO® in combination with ribavirin.
    • Males and females who take OLYSIO® with ribavirin should read the ribavirin Medication Guide for important pregnancy, contraception, and infertility information.
  • are breastfeeding. It is not known if OLYSIO® passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with OLYSIO®.

Tell your healthcare provider about all the medicines you take, including prescription and over‐the‐counter medicines, vitamins, and herbal supplements. Some medicines may interact with OLYSIO®. This can cause you to have too much or not enough OLYSIO® or other medicines in your body, which may affect the way OLYSIO® or your other medicines work, or may cause side effects. Keep a list of your medicines and show it to your healthcare provider and pharmacist.

  • You can ask your healthcare provider or pharmacist for a list of medicines that interact with OLYSIO®.
  • Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take OLYSIO® with other medicines.

What are the possible side effects of OLYSIO®?

  • OLYSIO® can cause serious side effects, including hepatitis B virus reactivation. See “What is the most important information I should know about OLYSIO®?”
  • The most common side effects in combination with sofosbuvir are tiredness, headache, and nausea.
  • The most common side effects in combination with peginterferon alfa and ribavirin are skin rash, itching, and nausea.
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of OLYSIO®. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1‐800‐FDA‐1088. You may also report side effects to Janssen Products, LP at 1‐800‐JANSSEN (1‐800‐526‐7736).

Important: You should not take OLYSIO® alone. OLYSIO® should be used together with other antiviral medicines to treat chronic hepatitis C virus infection. When taking OLYSIO® in combination with peginterferon alfa and ribavirin you should also read those Medication Guides. When taking OLYSIO® in combination with sofosbuvir, you should also read its Patient Information leaflet.

Please see full Prescribing Information, including Boxed Warning, and Patient Information for more details.

041677-170215

Prezcobix® (darunavir 800 mg/cobicistat 150 mg)

WHAT IS PREZCOBIX®?

  • PREZCOBIX® is a prescription HIV-1 (Human Immunodeficiency Virus 1) medicine 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 the prescription medicines PREZISTA® (darunavir) and TYBOST® (cobicistat).
  • It is not known if PREZCOBIX® is safe and effective in children under 18 years of age.
  • When used with other antiretroviral medicines to treat HIV-1 infection, PREZCOBIX® 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.
  • PREZCOBIX® is always taken in combination with other HIV medications for the treatment of HIV-1 infection in adults. PREZCOBIX® should be taken once daily with food.
  • PREZCOBIX® does not cure HIV-1 infection or AIDS, and you may still experience illnesses associated with HIV-1 infection. 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 below and talk to your healthcare provider to learn if PREZCOBIX® is right for you.

Important Safety Information

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

  • PREZCOBIX® may cause liver problems. Some people taking PREZCOBIX® may develop liver problems which may be life-threatening. Your healthcare provider should do blood tests before and during your treatment with PREZCOBIX®.
    • Chronic hepatitis B or C infection may increase your chance of developing liver problems. Your healthcare provider should check your blood tests more often.
    • Signs and symptoms of liver problems include 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, or loss of appetite. Tell your healthcare provider if you develop any of these symptoms.
  • PREZCOBIX® 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. Call your healthcare provider right away if you develop a rash.
    • Stop taking PREZCOBIX® and call your healthcare provider right away if you develop any skin changes with symptoms such as 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 certain other medicines, can cause new or worse kidney problems, including kidney failure. Your healthcare provider should check your kidneys before you start and while you are taking PREZCOBIX®.

Who should not take PREZCOBIX®?

  • Do not take PREZCOBIX® with any of the following medicines: alfuzosin (Uroxatral®), carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®, Tegretol-XR®, Teril®), cisapride (Propulsid®), colchicine (Colcrys®, Mitigare®, if you have liver or kidney problems), dronedarone (Multaq®), elbasvir and grazoprevir (Zepatier®), dihydroergotamine (D.H.E.45®, Migranal®), ergotamine tartrate (Cafergot®, Ergomar®, Ergostat®, Medihaler®, Migergot®, Wigraine®, Wigrettes®), methylergonovine (Methergine®), lovastatin or a product that contains lovastatin  (Altoprev®, Advicor®, Mevacor®), lurasidone (Latuda®), oral midazolam (Versed®), phenobarbital (Luminal®), phenytoin (Dilantin®, Dilantin-125®, Phenytek®), pimozide (Orap®), ranolazine (Ranexa®), rifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®), sildenafil (Revatio®) when used for pulmonary arterial hypertension (PAH), simvastatin or a product that contains simvastatin (Simcor®, Vytorin®, Zocor®), St. John’s Wort (Hypericum perforatum) or a product that contains St. John’s Wort, or triazolam (Halcion®).
  • Serious problems can happen if you take any of these medicines with PREZCOBIX®.

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

  • About all health problems. 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, breastfeeding, or plan to become pregnant or breastfeed. Tell your healthcare provider if you become pregnant while taking PREZCOBIX®.
  • About all medicines you take. 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. Your healthcare provider can tell you if it is safe to take PREZCOBIX® with other medicines.

What are the possible side effects of PREZCOBIX®?

  • The most common side effects of darunavir, one of the medicines in PREZCOBIX®, include diarrhea, nausea, rash, headache, stomach area (abdominal) pain, and vomiting.
  • Other possible side effects include:
    • High blood sugar, diabetes or worsening diabetes, and increased bleeding in people with hemophilia have been reported in patients taking protease inhibitor medicines, including PREZCOBIX®.
    • Changes in body fat can happen in people who take HIV-1 medicines. The exact cause and long-term health effects of these changes 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.

These are not all of the possible side effects of PREZCOBIX®. 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.

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 see full Product Information for more details.

060627-161017

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® if you are taking the following medicines: alfuzosin (Uroxatral®), ergot-containing medicines: dihydroergotamine (D.H.E. 45®, Embolex®, Migranal®), ergotamine tartrate (Cafergot®, Ergomar®, Ergostat®, Medihaler ergotamin®, Migergot®, Wigraine®, Wigrettes®), methylergonovine (Ergotrate®, Methergine®), cisapride (Propulside®, Propulsid® Quicksolv), colchicine (Colcrys®, Mitigare®), if you have liver or kidney problems, dronedarone (Multaq®), lurasidone (Latuda®), pimozide (Orap®), midazolam (Versed®), when taken by mouth, ranolazine (Ranexa®), St. John’s Wort (Hypericum perforatum) or a product that contains St. John’s Wort, lovastatin or a product that contains lovastatin (Altoprev®, Advicor®, Mevacor®), simvastatin or a product that contains simvastatin (Simcor®, Vytorin®, Zocor®), rifampin or a product that contains rifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®), sildenafil (Revatio®), when used for the treatment of pulmonary arterial hypertension (PAH), or triazolam (Halcion®).

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.

This is not a complete list of all possible side effects. If you experience these or other side effects, talk to your healthcare provider. 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 see full Product Information for more details.

060861-160928

Procrit® (epoetin alfa)

INDICATIONS

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.

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® has not been proven to improve quality of life, fatigue, or well-being.

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.

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. 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.
  • 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 breast-feeding or planning to breast-feed. 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.

Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider when you get a new medicine.

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 rash over your whole body, 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.
  • 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. 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
  • Rash
  • Nausea
  • Vomiting
  • Soreness of mouth
  • Itching
  • Headache
  • Redness and pain in the skin where PROCRIT® shots were given

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.

071421-170419

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.
  • Lymphoma, or any other cancers in adults and children.
  • Skin cancer—any changes in or growths on your skin.
  • Heart failure—new or worsening symptoms, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.
  • Reactivation of HBV—feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.
  • 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.
  • Allergic reactions during or after the infusion—hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills.
  • Lupus-like syndrome—chest discomfort or pain that does not go away, shortness of breath, joint pain, rash on the cheeks or arms that gets worse in the sun.
  • Psoriasis—new or worsening psoriasis such as red scaly patches or raised bumps on the skin that are filled with pus.

The more common side effects with REMICADE® are respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing and stomach pain.

Please read the Medication Guide for REMICADE® and discuss it with your doctor. (Requires Adobe® Acrobat® Reader®. Click here to download.)

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.

039671-150902

Simponi® ( golimumab )

What is SIMPONI® (golimumab)?

SIMPONI® is a prescription medicine for adults with:

  • Moderate to severe rheumatoid arthritis (RA), with the medicine methotrexate (MTX)
  • Active psoriatic arthritis (PsA), alone or with the medicine MTX
  • Active ankylosing spondylitis (AS)
  • Moderately to severely active ulcerative colitis (UC) when certain other UC medicines have not worked well enough or cannot be tolerated, or if it is necessary to continue taking steroid medicines:
    • To begin helping some of your symptoms
    • In people who respond to SIMPONI®, to get their UC under control (induce remission) and keep UC under control (sustain remission)
    • To begin to improve the way the lining of your large intestine looks to your doctor during colonoscopy

MTX is used as directed.

For RA, PsA, and AS: SIMPONI® 50 mg is given as an injection under the skin (subcutaneous injection) once a month.

For UC: SIMPONI® begins with 3 starter injections under the skin (subcutaneous injection): Two 100-mg injections on the first day of treatment, followed by one 100-mg injection 2 weeks later. After these 3 starter injections, SIMPONI® requires one 100-mg injection every 4 weeks.

Once you and your doctor are comfortable with the self-injection process, you will inject SIMPONI® under the skin.

Important Safety Information

SERIOUS INFECTIONS

SIMPONI® (golimumab) is a prescription medicine. SIMPONI® can lower your ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor will test you for TB before starting SIMPONI® and will monitor you for signs of TB during treatment. Tell your doctor if you have been in close contact with people with TB. Tell your doctor if you have been in a region (such as the Ohio and Mississippi River Valleys and the Southwest) where certain fungal infections like histoplasmosis or coccidioidomycosis are common.

You should not start SIMPONI® if you have any kind of infection. Tell your doctor if you are prone to or have a history of infections or have diabetes, HIV or a weak immune system. You should also tell your doctor if you are currently being treated for an infection or if you have or develop any signs of an infection such as:

  • fever, sweat, or chills

  • muscle aches

  • cough

  • shortness of breath

  • blood in phlegm

  • weight loss

  • warm, red, or painful skin or sores on your body

  • diarrhea or stomach pain

  • burning when you urinate or urinate more than normal

  • feel very tired

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.

042501-151027

Simponi Aria® ( golimumab )

INDICATION

SIMPONI ARIA® is for adults with moderate to severe rheumatoid arthritis taken with methotrexate.

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
CANCER

Unusual cancers have been reported in children and teenage patients taking 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
  • clay-colored bowel movements
  • dark urine
  • fevers
  • skin or eyes look yellow
  • little or no appetite
  • vomiting
  • muscle aches
  • 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 or are breastfeeding 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, 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.

042590-151029

Stelara® ( ustekinumab )

What is STELARA®?

STELARA® is a prescription medicine approved to treat adults 18 years and older with moderate or severe plaque psoriasis that involves large areas or many areas of their body, 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.

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.

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 your 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 who has 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 such as: feeling faint, swelling of your face, eyelids, tongue, or throat, chest tightness, or skin rash.

Before receiving STELARA®, tell your doctor 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 vaccine. The viruses used in some types of 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 taking STELARA® or one year after you stop taking 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.
  • have any other medical conditions.
  • are pregnant or plan to become pregnant. It is not known if STELARA® will harm your unborn baby. You and your doctor should decide if you will take STELARA®.
  • are breast‐feeding or plan to breast‐feed. It is thought that STELARA® passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take 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 prescribed by your doctor.
  • 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®. Do not try to inject STELARA® yourself until you or your
 caregiver has 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.

061408-161010

Sylvant® (siltuximab)

What is SYLVANT®?

SYLVANT® (siltuximab) is a prescription medicine used to treat people with multicentric Castleman’s disease (MCD) who do not have human immunodeficiency virus (HIV) and human herpesvirus-8 (HHV-8) infection.

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

Important Safety Information

Who should not receive SYLVANT®? 

Do not receive SYLVANT® if you have had a severe allergic reaction to siltuximab or any of the ingredients in SYLVANT®. 

What should I tell my healthcare provider before receiving SYLVANT®? 

Before you receive SYLVANT®, tell your healthcare provider about all of your medical conditions, including if you: 

  • have an infection. You should not receive SYLVANT® if you have a severe infection. 
  • have had a recent vaccination or are scheduled to receive any vaccinations. You should not receive a live vaccine during your treatment with SYLVANT®. 
  • have or have had any stomach or bowel (intestine) problems, such as diverticulitis or ulcers. Tell your healthcare provider if you have pain in your stomach area. 
  • are pregnant or plan to become pregnant. It is not known if SYLVANT® will harm your unborn baby. You should not become pregnant while receiving treatment with SYLVANT®. Females who are able to become pregnant should use effective birth control during treatment with SYLVANT® and for 3 months after stopping treatment. 
  • are breastfeeding or plan to breastfeed. It is not known if SYLVANT® passes into your breast milk. You and your healthcare provider should decide if you will take SYLVANT® or breastfeed. You should not do both. 

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

What are the possible side effects of SYLVANT®? 

SYLVANT® may cause serious side effects, including: 

  • Infections. SYLVANT® may lower your ability to fight infections. Tell your healthcare provider right away if you have any signs or symptoms of an infection during treatment with SYLVANT®.
  • Infusion and allergic reactions. If you have an infusion or allergic reaction while receiving SYLVANT®, your healthcare provider will stop your infusion and treat your reaction. If you have a severe infusion or allergic reaction your healthcare provider may stop your treatment completely. Tell your healthcare provider or get medical help right away if you have any of these symptoms during or after your infusion of SYLVANT®: trouble breathing, chest tightness, wheezing, dizziness or light-headedness, swelling of the lips, or skin rash. 

The most common side effects of SYLVANT® include: rash, itching, upper respiratory tract infection, weight gain, and increased blood level of uric acid.

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 SYLVANT®. 

Call your doctor for medical advice about side effects. 

General information about the safe and effective use of SYLVANT® 

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 SYLVANT® that is written for health professionals. 

Report any signs of new or worsening medical conditions 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 (1-800-332-1088). 

Please click here to read Important Product Information for SYLVANT® and discuss any questions you have with your doctor.

012916-160609 


 

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 the Medication Guide for TREMFYA™, 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.

Requires Adobe® Reader®. Click here to download

075142-170622

Xarelto® ( rivaroxaban )

WHAT IS XARELTO®?

XARELTO® is a prescription medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem. For patients currently well managed on warfarin, there is limited information on how XARELTO® and warfarin compare in reducing the risk of stroke.

XARELTO® is also a prescription medicine used to treat deep vein thrombosis and pulmonary embolism, and to help reduce the risk of these conditions occurring again.

XARELTO® is also a prescription medicine used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO®?

  • For people taking XARELTO® for atrial fibrillation:

    People with atrial fibrillation (an irregular heart beat) 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.

  • XARELTO® can cause bleeding, which can be serious, and rarely may lead to death. This is because XARELTO® is a blood thinner medicine that reduces blood clotting. While you take 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
  • 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 that 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 patients with artificial heart valves.

WHO SHOULD NOT TAKE XARELTO®?

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®.

 

WHAT SHOULD I TELL MY DOCTOR BEFORE OR WHILE TAKING XARELTO®?

Before taking XARELTO®, tell your doctor if you:

  • Have ever had bleeding problems
  • Have liver or kidney problems
  • Have any other medical condition
  • 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 while taking XARELTO®. If you take XARELTO® during pregnancy, tell your doctor right away if you have bleeding or symptoms of blood loss.
  • Are breastfeeding or plan to breastfeed. It is not known if XARELTO® passes 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 nonprescription medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way XARELTO® works. Certain medicines may increase your risk of bleeding. See “What is the most important information I should know about XARELTO®?”

Especially tell your doctor if you take:

  • Ketoconazole (Nizoral®)
  • Itraconazole (Onmel™, Sporanox®)
  • Ritonavir (Norvir®)
  • Lopinavir/ritonavir (Kaletra®)
  • Indinavir (Crixivan®)
  • Carbamazepine (Carbatrol®, Equetro®, Tegretol®, Tegretol®-XR, Teril™, Epitol®)
  • Phenytoin (Dilantin-125®, Dilantin®)
  • Phenobarbital (Solfoton™)
  • Rifampin (Rifater®, Rifamate®, Rimactane®, Rifadin®)
  • St. John's wort (Hypericum perforatum)

Ask your doctor if you are not sure if your medicine is one listed above. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

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 will tell you how much XARELTO® to take and when to take it.
  • Your doctor may change your dose if needed.

 

If you take XARELTO® for:

  • Atrial Fibrillation: 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® once or twice a day as prescribed by your doctor.
    • Take XARELTO® with food at the same time each day.
    • If you miss a dose of XARELTO®:
      • and take XARELTO® 2 times a 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.
      • and 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.

 

  • If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take XARELTO®.
  • Your doctor will decide how long you should take XARELTO®. Do not stop taking XARELTO® without talking to your doctor first.
  • Your doctor may stop XARELTO® for a short time before any surgery, medical or dental procedure. 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®?

Please see "What is the most important information I should know about XARELTO®?"

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You are also encouraged to report side effects to the FDA: visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).

Please see full Prescribing Information, including Boxed Warnings, and Medication Guide.

Trademarks are those of their respective owners.

052839-160508

 

Yondelis® (trabectedin)

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.

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

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.

Please see Important Product Information.

072958-170515

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 castration-resistant prostate cancer (prostate cancer that is resistant to medical or surgical treatments that lower testosterone) that has spread to other parts of the body.

Important Safety Information

Who should not take ZYTIGA® (abiraterone acetate)?

Do not take ZYTIGA® if you are pregnant or may become pregnant. ZYTIGA® may harm your unborn baby. Women who are pregnant or who may become pregnant should not touch ZYTIGA® 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. 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.
  • No food should be eaten 2 hours before and 1 hour after taking ZYTIGA®.
  • Swallow ZYTIGA® tablets whole. Do not crush or chew tablets.
  • Take ZYTIGA® tablets with water.
  • Your healthcare provider will do blood tests to check for side effects.
  • Men who are sexually active with a pregnant woman must use a condom during and for one week 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 one week 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.

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:

  • Weakness
  • Joint swelling or pain
  • Swelling in your legs or feet
  • Hot flushes
  • Diarrhea
  • Vomiting
  • Cough
  • High blood pressure
  • Shortness of breath
  • Urinary tract infection
  • Bruising
  • Low red blood cells (anemia) and low blood potassium levels
  • High blood sugar levels, high blood cholesterol and triglycerides
  • 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 that prescribed ZYTIGA®.

Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist when you get a new medicine.

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).

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