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Brand Names: Sutent

Generic Name: sunitinib (Pronunciation: soo NIT in ib)

• What is sunitinib (Sutent)?
• What are the possible side effects of sunitinib (Sutent)?
• What is the most important information I should know about sunitinib (Sutent)?
• What should I discuss with my healthcare provider before using sunitinib (Sutent)?
• How should I take sunitinib (Sutent)?
• What happens if I miss a dose (Sutent)?
• What happens if I overdose (Sutent)?
• What should I avoid while taking sunitinib (Sutent)?
• What other drugs will affect sunitinib (Sutent)?
• Where can I get more information?

What is sunitinib (Sutent)?

Sunitinib is a cancer medicine that helps the body slow down the growth and reproduction of certain cells, including tumor cells.

Sunitinib is used to treat certain types of advanced or progressive tumors of the digestive system or the kidneys.

Sunitinib may also be used for other purposes not listed in this medication guide.

What are the possible side effects of sunitinib (Sutent)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using sunitinib and call your doctor at once if you have any of these serious side effects:

• chest pain, general ill feeling;
• uneven heart rate;
• feeling short of breath, even with mild exertion;
• swelling of your ankles or feet;
• weakness, tired feeling, loss of appetite, weight loss;
• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, problems with vision, speech, or balance;
• redness, tenderness, sunburn-like peeling of the palms of your hands or the soles of your feet;
• bloody, or black, tarry stools;
• coughing up blood or vomit that looks like coffee grounds;
• easy bruising or bleeding, unusual weakness; or
• white patches or sores inside your mouth or on your lips.

Less serious side effects may include:

• unusual or unpleasant taste in the mouth;
• nausea, vomiting, stomach pain or upset;
• diarrhea or constipation;
• skin rash, hair loss, changes in skin or hair color; or
• headache, joint or muscle pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about sunitinib (Sutent)?

Do not use this medication if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Before using sunitinib, tell your doctor if you have high blood pressure, a thyroid disorder, a heart rhythm disorder, or if you have ever had a heart attack, congestive heart failure, a stroke, or blood clots.

To be sure this medication is helping your condition and is not causing certain side effects, your blood and blood pressure may need to be tested at the beginning of each 4-week treatment cycle. Your heart function may also need to be tested with an electrocardiogram (ECG or EKG) on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Stop using sunitinib and call your doctor at once if you have chest pain, shortness of breath, sudden numbness or weakness, sudden headache or vision problems, or any unusual bruising or bleeding.