Possible SUTENT Side Effects

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Some SUTENT side effects may be managed

During treatment with SUTENT, you may experience some side effects. Some can be managed but others are more serious and may not be manageable. Your healthcare provider may change your dose or stop your treatment. Read about these side effects. Learn what you and your doctor can do to help manage the impact of many of these side effects.

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
Diarrhea
Fatigue (tiredness or weakness)
Nausea or vomiting
Loss of appetite
Mouth pain
Taste changes
Constipation or abdominal pain
Pain or swelling in your arms or legs
Bleeding (nosebleeds or bleeding from cuts)
Skin conditions (rash, dry skin, or hand-foot syndrome)
Upset stomach
Yellow skin or lighter hair
Cough
Shortness of breath
Fever
 

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

Skin conditions

These can include:

  • Rash or dry skin
  • Drier, thicker, callused, or cracking skin
  • Blisters or a rash on the palms of your hands and soles of your feet. This is called hand-foot syndrome

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 taking SUTENT.

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

Fatigue

While you are taking SUTENT, 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 SUTENT.

These tips may help:

  • 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

Some patients taking SUTENT 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 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 SUTENT if you have continued fever.

Nausea or vomiting

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.

If you experience nausea or vomiting, these tips may help:

  • 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.

Diarrhea

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.

If you have diarrhea, these tips may also help:

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

Upset stomach

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

If you do, these tips may help:

  • 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

Mouth pain

While taking SUTENT, 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 taking SUTENT 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 taking SUTENT.

If you have mouth pain, these tips may help:

  • 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

Taste changes

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

If you have taste changes, these tips may help:

  • 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

Loss of appetite

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.

Here are a few diet ideas you can discuss with your doctor:

  • 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

Constipation or abdominal pain

Some people taking SUTENT experience constipation. This has the potential to become a serious side effect. Left untreated, constipation can cause a blockage in your intestines, leading to dehydration and even internal damage.

Speak to your doctor if you experience constipation.

Your doctor may recommend any of the following:

  • Drinking more fluids
  • Taking a stool softener and laxative
  • Changing your dose of SUTENT
  • Adding fiber to your diet
  • Increasing physical activity
  • Getting an enema

Yellow skin or lighter hair

The medicine in SUTENT is yellow, and 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.

Pain or swelling in your arms or legs

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

There are certain things your doctor may recommend to help you manage the pain and swelling:

  • 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

Some people taking SUTENT experience coughing.

Talk with your doctor if you think SUTENT 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 SUTENT is causing your coughing, he or she may prescribe a different medicine.

Shortness of breath

Some people taking SUTENT 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 (nosebleeds or bleeding from cuts)

SUTENT 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
Liver problems that can lead to death
Heart problems that can lead to death
High blood pressure
Bleeding that can lead to death
Jaw-bone problems (osteonecrosis)
Tumor lysis syndrome (TLS)
Protein in your urine
Serious skin and mouth reactions
Hormone problems
 

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

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.

Heart problems that can lead to death

SUTENT may cause heart problems, including:

  • Heart failure
  • Heart muscle problems (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

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). 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.

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.

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.

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

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.

These are not all possible side effects of SUTENT. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 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 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.

IMPORTANT SAFETY INFORMATION

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.

SUTENT may cause serious side effects, including:

  • Serious liver problems, including death
  • Heart problems—Heart problems may include heart failure 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
  • 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 doctor 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

 

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.

Gleevec is a registered trademark of Novartis AG.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or
call 1-800-FDA-1088.

Please see patient Medication Guide and full Prescribing Information, including Boxed Warning regarding serious liver problems.

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Adrenal gland
One of a pair of small glands; one sits on top of each kidney. The adrenal glands produce hormones that help control heart rate, blood pressure, the way the body uses food, and other vital functions.
Angiogenesis (an-jee-o-JEN-ih-sis)
The growth of new blood vessels from existing ones. Tumors use this process to receive nutrients from the bloodstream and to metastasize.
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.
Chemotherapy
Cancer cells grow and multiply like normal cells, but often much more quickly. Chemotherapy uses drugs to stop these cells from multiplying. However, chemotherapy can also harm healthy cells.
Digestive system
A collection of organs that break down food into simpler components, which your body uses to make energy and repair cells.
Functional pancreatic NET
A type of tumor in the pancreas that overproduces hormones.
Gastrointestinal (GASS-tro-in-TESS-tin-nul)
Relating to your stomach and intestines.
Gastrointestinal stromal tumor (GIST)
(GASS-tro-in-TESS-tin-nul STRO-mul TOO-mor)
GIST is a cancer that occurs in the digestive system. It can grow at all levels of the gastrointestinal tract (though most often in the stomach and small intestine).
Hand-foot syndrome (hand-foot-SIN-drome)
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.
Hypertension (hy-per-TEN-shun)
A disease of the arteries involving constant high blood pressure.
Intravenous therapy (IV)
Treatment given directly into a vein.
IFNα (Interferon alfa)
A medicine prescribed to prevent tumor cells or viruses from growing. A clinical study has proven that SUTENT is more effective than interferon alfa (IFNα) in the treatment of RCC.
Kidney
One of a pair of organs that removes waste products from the blood. In the process, they make urine to help carry waste out of the body. One is on the left side of the abdomen. The other is on the right side.
Lymph node
Located throughout the body, lymph nodes filter lymph fluid. They store special cells that can trap cancer cells or bacteria that are traveling through the body in the lymph.
Metastasis (muh-TAHS-tuh-sis)
The spread of cancer from one part of the body to another through the lymphatic system or bloodstream.
Nonfunctional pancreatic NET
A type of tumor in the pancreas that does not overproduce hormones.
Pancreas
A 6-inch-long organ that stretches across the back of the abdomen. It makes pancreatic juices, which help digest food in the small intestine. The pancreas also makes insulin, which controls the amount of sugar in the blood.
Pancreatic neuroendocrine tumor (Pancreatic NET)
An uncommon tumor that starts in the hormone-producing cells of the pancreas.
Progression-free survival
The length of time during and after treatment in which a patient is living with a disease that does not get worse. Progression-free survival may be used in a clinical study or trial to help find out how well a new treatment works.
Proliferation (pro-liff-er-AY-shun)
When cells divide and multiply quickly. Tumors form when cancer cells proliferate.
Renal cell carcinoma (RCC) (REE-null SELL kar-sin-O-muh)
The most common form of cancer that starts in the kidneys.
Stroma
The tissue that supports an organ.
Tumor (TOO-mor)
A mass of cancer cells.
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The SUTENT Co-payment Card is not health insurance. For a complete list of participating pharmacies, please call the First Resource program at 1-877-744-5675. There are no membership fees to participate. Estimated savings vary and depend on the amount of SUTENT purchased and the pharmacy where purchased.

Average patient savings is $5000.

Assistance for eligible patients who reside in Massachusetts will still be available through the First Resource program. These patients will continue to receive SUTENT free of charge under Hardship Assistance. Terms and conditions apply. Speak with a First Resource counselor to learn more.

Pfizer and its agents cannot guarantee the accuracy of information provided by insurers, nor do they guarantee insurance reimbursement. Because many factors influence reimbursement, program staff cannot anticipate or resolve all issues raised by program callers. Pfizer reserves the right to modify or discontinue the program, without notice, at any time.