POSSIBLE SUTENT SIDE EFFECTS

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Some SUTENT side effects may be managed

It's important that you know and understand the side effects you may experience while taking SUTENT® (sunitinib malate). Some of these side effects you and your doctor may be able to manage. Other side effects may not be manageable.

Be sure to pay attention to all your side effects. They may be signs that let you and your doctor know what is happening in your body. Work with your healthcare team to determine when to call with questions or concerns. The sooner your team knows about your side effects, the sooner they can help you manage them if possible.

Click each of these common side effects to learn more and, where tips are available, find out how to best address the side effect.

COMMON SUTENT SIDE EFFECTS

WATCH AN INTRODUCTION TO THIS SECTIONWITH NURSE TRISH CREEL

Click the list of side effects on the left
to learn more.

LEARN ABOUT THIS SIDE EFFECT WITH ONCOLOGY NURSE TRISH CREEL

Yellow skin or lighter skin/hair

You and your doctor may be able to manage some side effects. Others, however, may not be manageable. In some cases, your doctor may adjust your dose or interrupt your treatment.

  • Because your medicine is yellow, it may make your skin look yellow. Your skin and hair may get lighter in color
  • While this side effect usually poses no health risks, yellow skin can be a sign of a more serious side effect. Discuss this side effect with your doctor so he or she can perform a
    full evaluation

LEARN ABOUT THIS SIDE EFFECT WITH ONCOLOGY NURSE TRISH CREEL

Fatigue

You and your doctor may be able to manage some side effects. Others, however, may not be manageable. In some cases, your doctor may adjust your dose or interrupt your treatment.

While you are on your treatment, you may feel tired or weak. Fatigue is common during treatment for cancer. But it may also indicate a more serious medical problem. Call your doctor or nurse for a full evaluation if you feel tired or weak while on your treatment.

  • Take short naps or breaks
  • Eat well and drink plenty of fluids
  • Take short walks or do light exercise if you feel up to it
  • Do things that are relaxing, such as listening to music
    or reading
  • Ask your doctor if there are over-the-counter or prescription medications that may help you manage your condition

Fever

You and your doctor may be able to manage some side effects. Others, however, may not be manageable. In some cases, your doctor may adjust your dose or interrupt your treatment.

Some patients on treatment experience fever. It’s important to call your doctor for a full evaluation at the first sign of fever.

Here are some treatments your doctor may consider:

  • Adding Intravenous therapy (IV)Treatment given directly into a vein.intravenous fluids
  • Suggesting diet changes
  • Prescribing antibiotics (if the doctor thinks the fever is the result of an infection)
  • Prescribing nonsteroidal anti-inflammatory drugs (NSAIDs)
    or acetaminophen

Your doctor may take you off your dose if you have continued fever.

LEARN ABOUT THIS SIDE EFFECT WITH ONCOLOGY NURSE TRISH CREEL

Diarrhea

You and your doctor may be able to manage some side effects. Others, however, may not be manageable. In some cases, your doctor may adjust your dose or interrupt your treatment.

Diarrhea is defined as 3 or more loose or watery stools/bowel movements in one day. If you have these symptoms, call your doctor or nurse. It is important for you and your doctor to try to manage diarrhea as soon as it begins. Ask your doctor or nurse if you can be treated with over-the-counter medications.

  • Avoid spicy foods, fatty foods, caffeine, and fruit
  • Eat only mild foods
  • Drink water often—but only in small sips

LEARN ABOUT THIS SIDE EFFECT WITH ONCOLOGY NURSE TRISH CREEL

Nausea/vomiting

You and your doctor may be able to manage some side effects. Others, however, may not be manageable. In some cases, your doctor may adjust your dose or interrupt your treatment.

It is best to call your doctor or nurse at the first sign of nausea or vomiting. This is especially important if these symptoms keep you from taking your oral medications. Your doctor may prescribe a medicine for these symptoms.

  • Eat small meals
  • Avoid foods that are sweet, fried, or fatty
  • Drink lots of fluids, but in small amounts

If you vomit, start with small amounts of water, broth, or other clear liquids when you are ready to eat again. If that stays down, then try soft foods. Some examples include gelatin, yogurt, strained soup, or cream of wheat. Slowly work up to eating solid food. Make sure that you do not eat any food that you are allergic to.

LEARN ABOUT THIS SIDE EFFECT WITH ONCOLOGY NURSE TRISH CREEL

Mouth pain/sores

You and your doctor may be able to manage some side effects. Others, however, may not be manageable. In some cases, your doctor may adjust your dose or interrupt your treatment.

While on your treatment, you may develop mouth pain. Your symptoms may include mouth sores, redness, a white coating of the tongue, bleeding gums, or trouble swallowing. Call your doctor or nurse if you experience any of these problems.

Mouth pain as a result of treatment does not usually pose a health risk. However, blistering and peeling on the inside of your mouth may be a sign of a more serious side effect. If you develop mouth pain, tell your doctor immediately. He or she may tell you to stop your treatment.

  • Avoid hot, spicy, or acidic foods
  • Eat foods that are soft
  • Use a straw for drinking liquids
  • Ask your doctor to recommend a mouthwash. He or she may suggest an alcohol-free mouthwash, or that you rinse your mouth often with water
  • Avoid toothpastes with whiteners (ie, peroxide) and use
    a soft toothbrush
  • Ask your doctor if there are over-the-counter or prescription medications that may help you manage your condition

LEARN ABOUT THIS SIDE EFFECT WITH ONCOLOGY NURSE TRISH CREEL

Upset stomach

You and your doctor may be able to manage some side effects. Others, however, may not be manageable. In some cases, your doctor may adjust your dose or interrupt your treatment.

Upset stomach is common for people who are being treated for cancer. While on your treatment, you may have this problem. Call your doctor or nurse if you have an upset stomach.

  • Avoid heavy meals, coffee, and alcohol
  • Sleep in a more upright position, propped up on a pillow
  • Ask your doctor if there are over-the-counter or prescription medications that may help you manage your condition
  • Reduce your stress with meditation, yoga, or music

Abdominal pain

You and your doctor may be able to manage some side effects. Others, however, may not be manageable. In some cases, your doctor may adjust your dose or interrupt your treatment.

Your RCC treatment may cause you to experience abdominal pain. In some cases, abdominal pain may have a specific cause such as constipation. (Please review the tips for constipation in this website.)

Speak to your doctor if you are experiencing abdominal pain.

LEARN ABOUT THIS SIDE EFFECT WITH ONCOLOGY NURSE TRISH CREEL

Constipation

You and your doctor may be able to manage some side effects. Others, however, may not be manageable. In some cases, your doctor may adjust your dose or interrupt your treatment.

Some people taking your treatment experience constipation.

  • Drink more fluids
  • Take a stool softener and laxative
  • Change your dose
  • Add fiber to your diet
  • Increase physical activity
  • Get an enema

LEARN ABOUT THIS SIDE EFFECT WITH ONCOLOGY NURSE TRISH CREEL

Rash or other skin changes

You and your doctor may be able to manage some side effects. Others, however, may not be manageable. In some cases, your doctor may adjust your dose or interrupt your treatment.

These can include:

  • Rash or dry skin
  • Drier, thicker, callused, or cracking skin
  • Dryness, thickening, or cracking of the skin on the palms of the hands and soles of the feet. It can sometimes include blisters or a rash.

Tell your doctor or nurse if you start to develop skin problems. He or she may give you specific treatments, which may include lotions or moisturizers or pain medicines such as ibuprofen or acetaminophen.

Skin conditions as a result of taking SUTENT do not usually pose health risks. However, a rash or widespread blistering or peeling of the skin may be a sign of a more serious side effect. If you develop these symptoms, tell your doctor immediately. He or she may tell you to stop your treatment.

LEARN ABOUT THIS SIDE EFFECT WITH ONCOLOGY NURSE TRISH CREEL

Blisters/rash on hands/feet

You and your doctor may be able to manage some side effects. Others, however, may not be manageable. In some cases, your doctor may adjust your dose or interrupt your treatment.

These can include:

  • Blisters or a rash on the palms of your hands and soles of your feet. This is called Hand-foot syndrome (hand-foot-SIN-drome) hand-foot syndromeDryness, thickening, or cracking of the skin on the palms of the hands and soles of the feet. It can sometimes include blisters or a rash.

Tell your doctor or nurse if you start to develop skin problems. He or she may give you specific treatments, which may include lotions or moisturizers or pain medicines such as ibuprofen or acetaminophen.

Skin conditions as a result of taking SUTENT do not usually pose health risks. However, a rash or widespread blistering or peeling of the skin may be a sign of a more serious side effect. If you develop these symptoms, tell your doctor immediately. He or she may tell you to stop your treatment.

You may be able to prevent or minimize the effects of hand-foot syndrome with the following tips:

  • Wear thick cotton gloves and/or socks
  • Avoid constrictive footwear and excessive friction
  • Avoid hot water when washing hands, bathing, or showering

LEARN ABOUT THIS SIDE EFFECT WITH ONCOLOGY NURSE TRISH CREEL

Taste changes

You and your doctor may be able to manage some side effects. Others, however, may not be manageable. In some cases, your doctor may adjust your dose or interrupt your treatment.

You may notice a change in the way food tastes while you are taking your treatment. Call your doctor or nurse if you experience taste changes.

  • Cold or frozen foods may taste better than hot foods
  • Flavor your food with herbs, sugar, or sauces
  • Keep a clean and healthy mouth by brushing and flossing often

LEARN ABOUT THIS SIDE EFFECT WITH ONCOLOGY NURSE TRISH CREEL

Loss of appetite

You and your doctor may be able to manage some side effects. Others, however, may not be manageable. In some cases, your doctor may adjust your dose or interrupt your treatment.

During treatment, you may have less desire to eat. But maintaining good nutrition and a healthy weight are important to your treatment. Protein and calories are even more vital to someone with cancer.

  • Eat several small meals a day—5 or 6 isn't out of the question
  • When you are hungry, eat
  • Enjoy snacks and strive to make them nutritious. Find calories and protein in dried fruits, nuts, cheeses, and even milkshakes
  • For added protein and calories, it can be a good idea to add gravy, butter, or cheese to your favorite foods
  • Drink fluids between meals rather than filling up with them during meals
  • If you are too tired to cook, ask a friend or family member to make you something. You may be surprised how many people you have to help
  • If the smell of a certain food is bothering you, it may help to eat it cold or at room temperature
  • If you're having trouble tasting your favorite foods, try adding herbs or condiments
  • A registered dietitian (RD) may have more ideas to offer you

Pain/swelling in arms/legs

You and your doctor may be able to manage some side effects. Others, however, may not be manageable. In some cases, your doctor may adjust your dose or interrupt your treatment.

Swelling, or edema, occurs in some patients on treatment. If you have swelling of your face or mouth while taking your treatment, it may be a sign of a serious side effect. Ask your doctor to perform a full evaluation.

  • Taking a diuretic may help. This decreases the amount of water in your body through urination
  • Maintain a balanced diet, while cutting down on salt
  • Walking and other exercises can help increase circulation and reduce swelling
  • Wearing compression socks or elastic sleeves can help with your circulation
  • Elevating your arms or legs when sitting or lying down can help

Don't stop drinking water and other fluids without talking to your doctor first.

Cough

You and your doctor may be able to manage some side effects. Others, however, may not be manageable. In some cases, your doctor may adjust your dose or interrupt your treatment.

Talk with your doctor if you think your dose may be causing you to cough. Your doctor may suggest something to reduce your coughing, including drinking more fluids, taking steamy showers, or using a vaporizer.

If your doctor decides your dose is causing you to cough, he or she may prescribe a different medicine.

Shortness of breath

You and your doctor may be able to manage some side effects. Others, however, may not be manageable. In some cases, your doctor may adjust your dose or interrupt your treatment.

Some people on treatment feel shortness of breath. This can feel like you can’t get enough air, or it can just be uncomfortable to breathe normally.

Your doctor may recommend some of the following:

  • Extra oxygen. This can be as simple as sitting in front of a fan
  • Taking an opioid medication, such as morphine
  • Breathing clean, cool air. Cooler temperatures and fresh air can make a big difference
  • Keeping your head up. If you are in bed, raise your head and back with pillows so you are closer to sitting up
  • Relaxation techniques such as meditation may also help

Bleeding

You and your doctor may be able to manage some side effects. Others, however, may not be manageable. In some cases, your doctor may adjust your dose or interrupt your treatment.

Your treatment can cause bleeding disorders in some patients. When this happens, the blood does not clot normally. This can cause prolonged or excessive bleeding.

Your doctor may select a treatment, including:

  • Vitamin K injections
  • Clotting agents
  • Blood plasma or platelet transfusions
  • Medication for platelet problems

Call your doctor if you have any swelling or bleeding during treatment with SUTENT.

Some side effects are more serious than others. Discuss these potential side effects with your doctor. Let your doctor know if you experience any of the warning signs in this section.

SERIOUS SIDE EFFECTS

WATCH AN INTRODUCTION
TO THIS SECTION

Click the list of side effects on the left
to learn more.

LEARN ABOUT THIS SIDE EFFECT

Liver problems that can lead to death

SUTENT can cause serious liver problems, including death.

Tell your doctor right away if you develop any of the following during treatment with SUTENT:

  • Itching
  • Yellow eyes or skin
  • Dark urine
  • Pain or discomfort in the right upper stomach area

Your doctor should do blood tests to check your liver function before you start taking SUTENT and during treatment.

LEARN ABOUT THIS SIDE EFFECT

Heart problems that can lead to death

SUTENT may cause heart problems, including:

  • Heart failure
  • Heart attack
  • Heart muscle problems (Cardiomyopathy (kahr-dee-oh-my-OP-uh-thee)A disease that weakens and enlarges your heart muscle and makes it harder for your heart to pump blood and deliver it to the rest of your body.cardiomyopathy)
    • Tell your doctor if you feel dizzy, faint, very tired, have abnormal heartbeats, are short of breath, or have swollen feet and ankles
  • Abnormal heart rhythm changes
    • Your doctor may do electrocardiograms and blood tests to watch for these problems during your treatment with SUTENT. Tell your doctor if you feel dizzy, faint, or have abnormal heartbeats while taking SUTENT

 

LEARN ABOUT THIS SIDE EFFECT

High blood pressure

SUTENT may cause your blood pressure to rise. Your doctor may check your blood pressure while you are being treated with SUTENT. If there are issues, you may also receive treatment for high blood pressure (Hypertension (hy-per-TEN-shun)A disease of the arteries involving constant high blood pressure.hypertension). Tell your doctor or nurse if you have high blood pressure or a history of heart disease.

If you already have high blood pressure and are receiving treatment, your doctor may change it as needed. Your doctor may also ask you to track your blood pressure regularly in a diary. Follow the advice of your doctor or nurse—especially if you have any questions or concerns.

LEARN ABOUT THIS SIDE EFFECT

Bleeding that can lead to death

SUTENT may cause bleeding sometimes leading to death.

Tell your doctor right away if you have any of the following symptoms:

  • Serious bleeding problem
  • Painful swollen stomach (abdomen)
  • Vomiting blood
  • Black, sticky stools
  • Bloody urine
  • Headache or change in your mental status

Your doctor can tell you other symptoms to watch for.

Call your doctor if you have any swelling or bleeding during treatment with SUTENT.

LEARN ABOUT THIS SIDE EFFECT

Jaw-bone problems (osteonecrosis)

Severe jaw bone problems may happen. Your healthcare provider should examine your mouth before you start SUTENT. Your healthcare provider may tell you to see your dentist before you start SUTENT.

LEARN ABOUT THIS SIDE EFFECT

Tumor lysis syndrome (TLS)

TLS is caused by the fast breakdown of cancer cells and may lead to death. TLS may cause you to have nausea, shortness of breath, irregular heartbeat, clouding of urine and tiredness associated with abnormal laboratory test results (high potassium, uric acid and phosphorus levels and low calcium levels in the blood) that can lead to changes in kidney function and acute kidney failure. Your healthcare provider may do blood tests to check you for TLS.

LEARN ABOUT THIS SIDE EFFECT

Damage to the smallest blood vessels

Damage to the smallest blood vessels known as thrombotic microangiopathy (TMA) may occur. TMA is a condition involving injury to the vessels resulting in blood clots, and is accompanied by injury to red blood cells leading to a decrease in red cells and a decrease in cells that are involved with clotting. TMA may harm organs such as the brain and kidneys. Symptoms of TMA may include fever, fatigue, tiredness, bruising; you may develop swelling, confusion, vision loss, and seizures. Your healthcare provider may tell you to stop taking SUTENT.

LEARN ABOUT THIS SIDE EFFECT

Protein in your urine

Your healthcare provider will check you for this problem.
If there is too much protein in your urine, your healthcare provider may tell you to stop taking SUTENT.

LEARN ABOUT THIS SIDE EFFECT

Serious skin and mouth reactions

SUTENT can cause serious skin reactions that can cause death. This can include rash, widespread blistering or peeling of the skin and blistering and peeling on the inside of your mouth. If you develop a rash or these skin symptoms, tell your healthcare provider immediately. Your healthcare provider may tell you to stop taking SUTENT.

LEARN ABOUT THIS SIDE EFFECT

Hormone problems, including thyroid and adrenal gland problems

Your healthcare provider may do tests to check your thyroid and adrenal gland function during SUTENT treatment.

Tell your doctor if you have any of the following signs and symptoms:

  • Tiredness that worsens and does not go away
  • Loss of appetite
  • Heat intolerance
  • Feeling nervous or agitated, tremors
  • Sweating
  • Nausea or vomiting
  • Diarrhea
  • Fast heart rate
  • Weight gain or weight loss
  • Feeling depressed
  • Irregular menstrual periods or no menstrual periods
  • Headache
  • Hair loss

LEARN ABOUT THIS SIDE EFFECT

Low blood sugar (hypoglycemia)

Low blood sugar can happen with SUTENT, and may cause you to become unconscious, or you may need to be hospitalized. Low blood sugar with SUTENT may be worse in people who have diabetes and take anti-diabetic medicines. Your healthcare provider should check your blood sugar levels regularly during treatment with SUTENT and may need to adjust the dose of your anti-diabetic medicines. Signs and symptoms of low blood sugar may include:

  • Headache
  • Drowsiness
  • Weakness
  • Dizziness
  • Confusion
  • Irritability
  • Hunger
  • Fast heart beat
  • Sweating
  • Feeling jittery

Patients should always ask their doctors for medical advice about adverse events.

You may report an adverse event related to Pfizer products by calling 1-800-438-1985 (US only). If you prefer, you may contact the US Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch where healthcare professionals and consumers can report serious problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit MedWatch or call 1-800-FDA-1088.

You may have had some of the side effects listed above before starting treatment with SUTENT.
Be sure to tell your doctor if there is any change or increase in your side effects.

There are many things you can do to make sure you have the best treatment possible. Find out
more in the next section of this website.

SUTENT can cause serious liver problems, including death.

Tell your healthcare provider right away if you develop any of the following signs and symptoms of liver problems during treatment with SUTENT:

  • Itching
  • Yellow eyes or skin
  • Dark urine
  • Pain or discomfort in the right upper stomach area

Your healthcare provider should do blood tests to check your liver function before you start taking SUTENT and during treatment.

Pregnancy and breastfeeding:

  • SUTENT may harm an unborn baby. You should not become pregnant while taking SUTENT. Tell your healthcare provider right away if you become pregnant while taking SUTENT
  • Do not breastfeed while taking SUTENT

Tell your healthcare provider about all the medicines you take, including prescription medicines and nonprescription medicines, vitamins, and herbal supplements. Using SUTENT with certain other medicines can cause serious side effects.

You may have an increased risk of severe jaw bone problems (osteonecrosis) if you take SUTENT and a bisphosphonate medicine (Actonel, Aredia, Boniva, Didronel, Fosamax, Reclast, Skelid, or Zometa). Talk with your healthcare provider before starting any new medicines.

Tell all of your healthcare providers and dentists that you are taking SUTENT. They should talk to the healthcare provider who prescribed SUTENT for you, before you have any surgery, or medical or dental procedure.

Do not drink grapefruit juice, eat grapefruit, or take St. John's Wort.

SUTENT may cause serious side effects, including:

  • Serious liver problems, including death
  • Heart problems—Heart problems may include heart failure, heart attack, and heart muscle problems (cardiomyopathy) that can lead to death. Tell your healthcare provider if you feel very tired, are short of breath, or have swollen feet and ankles
  • Abnormal heart rhythm changes—Your healthcare provider may do electrocardiograms and blood tests to watch for these problems during your treatment with SUTENT. Tell your healthcare provider if you feel dizzy, faint, or have abnormal heartbeats
  • High blood pressure—Your healthcare provider may check your blood pressure during treatment with SUTENT. Your healthcare provider may prescribe medicine for you to treat high blood pressure, if needed
  • Bleeding sometimes leading to death—Tell your healthcare provider right away if you have any of these symptoms or a serious bleeding problem:
    • Painful, swollen stomach (abdomen)
    • Bloody urine
    • Vomiting blood
    • Headache or change in your mental status
    • Black, sticky stools
    Your healthcare provider can tell you other symptoms to watch for.
  • Jaw-bone problems (osteonecrosis)—Severe jaw bone problems may happen. Your healthcare provider should examine your mouth before you start SUTENT. Your healthcare provider may tell you to see your dentist before you start SUTENT
  • Tumor lysis syndrome (TLS)—TLS is caused by the fast breakdown of cancer cells and may lead to death. TLS may cause you to have nausea, shortness of breath, irregular heartbeat, clouding of urine and tiredness associated with abnormal laboratory test results (high potassium, uric acid and phosphorus levels and low calcium levels in the blood) that can lead to changes in kidney function and acute kidney failure. Your healthcare provider may do blood tests to check you for TLS
  • Damage to the smallest blood vessels—Damage to the smallest blood vessels known as thrombotic microangiopathy (TMA) may occur. TMA is a condition involving injury to the vessels resulting in blood clots, and is accompanied by injury to red blood cells leading to a decrease in red cells and a decrease in cells that are involved with clotting. TMA may harm organs such as the brain and kidneys. Symptoms of TMA may include fever, fatigue, tiredness, bruising; you may develop swelling, confusion, vision loss, and seizures. Your healthcare provider may tell you to stop taking SUTENT
  • Protein in your urine—Your healthcare provider will check you for this problem. If there is too much protein in your urine, your healthcare provider may tell you to stop taking SUTENT
  • Serious skin and mouth reactions—SUTENT can cause serious skin reactions that can cause death. This can include rash, widespread blistering or peeling of the skin and blistering and peeling on the inside of your mouth. If you develop a rash or these skin symptoms, tell your healthcare provider immediately. Your healthcare provider may tell you to stop taking SUTENT
  • Hormone problems, including thyroid and adrenal gland problems—Your healthcare provider may do tests to check your thyroid and adrenal gland function during SUTENT treatment. Tell your healthcare provider if you have any of the following signs and symptoms:
    • Tiredness that worsens and does not go away
    • Fast heart rate
    • Loss of appetite
    • Weight gain or weight loss
    • Heat intolerance
    • Feeling depressed
    • Feeling nervous or agitated, tremors
    • Irregular menstrual periods or no menstrual periods
    • Sweating
    • Headache
    • Nausea or vomiting
    • Hair loss
    • Diarrhea
  • Low blood sugar (hypoglycemia)—Low blood sugar can happen with SUTENT, and may cause you to become unconscious, or you may need to be hospitalized. Low blood sugar with SUTENT may be worse in people who have diabetes and take anti-diabetic medicines. Your healthcare provider should check your blood sugar levels regularly during treatment with SUTENT and may need to adjust the dose of your anti-diabetic medicines. Signs and symptoms of low blood sugar may include:
    • Headache
    • Irritability
    • Drowsiness
    • Hunger
    • Weakness
    • Fast heart beat
    • Dizziness
    • Sweating
    • Confusion
    • Feeling jittery

Common side effects of SUTENT include:

  • The medicine in SUTENT is yellow, and it may make your skin look yellow. Your skin and hair may get lighter in color
  • Tiredness
  • Weakness
  • Fever
  • Gastrointestinal symptoms, including diarrhea, nausea, vomiting, mouth sores, upset stomach, abdominal pain, and constipation. Talk with your healthcare provider about ways to handle these problems
  • Rash or other skin changes, including drier, thicker, or cracking skin
  • Blisters or a rash on the palms of your hands and soles of your feet
  • Taste changes
  • Loss of appetite
  • Pain or swelling in your arms or legs
  • Cough
  • Shortness of breath
  • Bleeding, such as nosebleeds or bleeding from cuts

Call your healthcare provider if you have any swelling or bleeding during treatment with SUTENT.

INDICATIONS

SUTENT is used to treat advanced kidney cancer (advanced renal cell carcinoma or RCC).

*SUTENT is used to treat GIST (gastrointestinal stromal tumor). This is a rare cancer of the stomach, bowel, or esophagus. SUTENT is used when the medicine Gleevec® (imatinib mesylate) did not stop the cancer from growing, or when you cannot take Gleevec.

SUTENT is used to treat a type of pancreatic cancer known as pancreatic neuroendocrine tumors (pancreatic NET), that has progressed and cannot be treated with surgery.

Gleevec is a registered trademark of Novartis AG.

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.

Scroll for Important Safety Information and Indications.

 

SUTENT can cause serious liver problems, including death.

Tell your healthcare provider right away if you develop any of the following signs and symptoms of liver problems during treatment with SUTENT:

  • Itching
  • Yellow eyes or skin
  • Dark urine
  • Pain or discomfort in the right upper stomach area

Your healthcare provider should do blood tests to check your liver function before you start taking SUTENT and during treatment.

Pregnancy and breastfeeding:

  • SUTENT may harm an unborn baby. You should not become pregnant while taking SUTENT. Tell your healthcare provider right away if you become pregnant while taking SUTENT
  • Do not breastfeed while taking SUTENT

Tell your healthcare provider about all the medicines you take, including prescription medicines and nonprescription medicines, vitamins, and herbal supplements. Using SUTENT with certain other medicines can cause serious side effects.

You may have an increased risk of severe jaw bone problems (osteonecrosis) if you take SUTENT and a bisphosphonate medicine (Actonel, Aredia, Boniva, Didronel, Fosamax, Reclast, Skelid, or Zometa). Talk with your healthcare provider before starting any new medicines.

Tell all of your healthcare providers and dentists that you are taking SUTENT. They should talk to the healthcare provider who prescribed SUTENT for you, before you have any surgery, or medical or dental procedure.

Do not drink grapefruit juice, eat grapefruit, or take St. John's Wort.

SUTENT may cause serious side effects, including:

  • Serious liver problems, including death
  • Heart problems—Heart problems may include heart failure, heart attack, and heart muscle problems (cardiomyopathy) that can lead to death. Tell your healthcare provider if you feel very tired, are short of breath, or have swollen feet and ankles
  • Abnormal heart rhythm changes—Your healthcare provider may do electrocardiograms and blood tests to watch for these problems during your treatment with SUTENT. Tell your healthcare provider if you feel dizzy, faint, or have abnormal heartbeats
  • High blood pressure—Your healthcare provider may check your blood pressure during treatment with SUTENT. Your healthcare provider may prescribe medicine for you to treat high blood pressure, if needed
  • Bleeding sometimes leading to death—Tell your healthcare provider right away if you have any of these symptoms or a serious bleeding problem:
    • Painful, swollen stomach (abdomen)
    • Bloody urine
    • Vomiting blood
    • Headache or change in your mental status
    • Black, sticky stools
    Your healthcare provider can tell you other symptoms to watch for.
  • Jaw-bone problems (osteonecrosis)—Severe jaw bone problems may happen. Your healthcare provider should examine your mouth before you start SUTENT. Your healthcare provider may tell you to see your dentist before you start SUTENT
  • Tumor lysis syndrome (TLS)—TLS is caused by the fast breakdown of cancer cells and may lead to death. TLS may cause you to have nausea, shortness of breath, irregular heartbeat, clouding of urine and tiredness associated with abnormal laboratory test results (high potassium, uric acid and phosphorus levels and low calcium levels in the blood) that can lead to changes in kidney function and acute kidney failure. Your healthcare provider may do blood tests to check you for TLS
  • Damage to the smallest blood vessels—Damage to the smallest blood vessels known as thrombotic microangiopathy (TMA) may occur. TMA is a condition involving injury to the vessels resulting in blood clots, and is accompanied by injury to red blood cells leading to a decrease in red cells and a decrease in cells that are involved with clotting. TMA may harm organs such as the brain and kidneys. Symptoms of TMA may include fever, fatigue, tiredness, bruising; you may develop swelling, confusion, vision loss, and seizures. Your healthcare provider may tell you to stop taking SUTENT
  • Protein in your urine—Your healthcare provider will check you for this problem. If there is too much protein in your urine, your healthcare provider may tell you to stop taking SUTENT
  • Serious skin and mouth reactions—SUTENT can cause serious skin reactions that can cause death. This can include rash, widespread blistering or peeling of the skin and blistering and peeling on the inside of your mouth. If you develop a rash or these skin symptoms, tell your healthcare provider immediately. Your healthcare provider may tell you to stop taking SUTENT
  • Hormone problems, including thyroid and adrenal gland problems—Your healthcare provider may do tests to check your thyroid and adrenal gland function during SUTENT treatment. Tell your healthcare provider if you have any of the following signs and symptoms:
    • Tiredness that worsens and does not go away
    • Fast heart rate
    • Loss of appetite
    • Weight gain or weight loss
    • Heat intolerance
    • Feeling depressed
    • Feeling nervous or agitated, tremors
    • Irregular menstrual periods or no menstrual periods
    • Sweating
    • Headache
    • Nausea or vomiting
    • Hair loss
    • Diarrhea
  • Low blood sugar (hypoglycemia)—Low blood sugar can happen with SUTENT, and may cause you to become unconscious, or you may need to be hospitalized. Low blood sugar with SUTENT may be worse in people who have diabetes and take anti-diabetic medicines. Your healthcare provider should check your blood sugar levels regularly during treatment with SUTENT and may need to adjust the dose of your anti-diabetic medicines. Signs and symptoms of low blood sugar may include:
    • Headache
    • Irritability
    • Drowsiness
    • Hunger
    • Weakness
    • Fast heart beat
    • Dizziness
    • Sweating
    • Confusion
    • Feeling jittery

Common side effects of SUTENT include:

  • The medicine in SUTENT is yellow, and it may make your skin look yellow. Your skin and hair may get lighter in color
  • Tiredness
  • Weakness
  • Fever
  • Gastrointestinal symptoms, including diarrhea, nausea, vomiting, mouth sores, upset stomach, abdominal pain, and constipation. Talk with your healthcare provider about ways to handle these problems
  • Rash or other skin changes, including drier, thicker, or cracking skin
  • Blisters or a rash on the palms of your hands and soles of your feet
  • Taste changes
  • Loss of appetite
  • Pain or swelling in your arms or legs
  • Cough
  • Shortness of breath
  • Bleeding, such as nosebleeds or bleeding from cuts

Call your healthcare provider if you have any swelling or bleeding during treatment with SUTENT.

INDICATIONS

SUTENT is used to treat advanced kidney cancer (advanced renal cell carcinoma or RCC).

*SUTENT is used to treat GIST (gastrointestinal stromal tumor). This is a rare cancer of the stomach, bowel, or esophagus. SUTENT is used when the medicine Gleevec® (imatinib mesylate) did not stop the cancer from growing, or when you cannot take Gleevec.

SUTENT is used to treat a type of pancreatic cancer known as pancreatic neuroendocrine tumors (pancreatic NET), that has progressed and cannot be treated with surgery.

Gleevec is a registered trademark of Novartis AG.

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.