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Learn about the possible side effects of taking SUTENT.

POSSIBLE SIDE EFFECTS

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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. Talk with your healthcare provider before starting any new medicines.

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

 

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.