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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, the pancreas, or the kidneys.

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

Sutent 12.5 mg

orange, imprinted with Pfizer, STN 12.5 mg

Sutent 50 mg

brown, imprinted with Pfizer, STN 50 mg

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 a serious side effect such as:

• chest pain, general ill feeling;
• severe dizziness, fainting, fast or pounding heartbeat;
• swelling of your ankles or feet, feeling short of breath (even with mild exertion);
• sudden numbness or weakness, especially on one side of the body;
• sudden and severe headache, confusion, problems with vision, speech, or balance;
• feeling very weak or tired, loss of appetite, weight gain or loss, hair loss, increased sensitivity to heat;
• missed menstrual periods;
• feeling agitated, depressed, or nervous;
• redness, tenderness, sunburn-like peeling of the palms of your hands or the soles of your feet;
• change in your mental state, blood in your urine or stools, black or tarry stools;
• pain and swelling in your stomach, coughing up blood or vomit that looks like coffee grounds;
• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
• fever, white patches or sores inside your mouth or on your lips; or
• nausea, upper stomach pain, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• unusual or unpleasant taste in the mouth;
• cough;
• mild nausea, vomiting, stomach pain or upset;
• diarrhea or constipation;
• dry skin, changes in skin or hair color; or
• joint pain, back 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)?

Before using sunitinib, tell your doctor if you have liver or kidney disease, high blood pressure, seizures, a bleeding or blood-clotting disorder, a thyroid disorder, heart disease, heart rhythm disorder, or if you have ever had a heart attack, congestive heart failure, a stroke, blood clots, coronary artery disease, bypass graft surgery, or transient ischemic attack (TIA).

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. Do not miss any follow-up visits to your doctor.

Stop using sunitinib and call your doctor at once if you have chest pain, severe dizziness, fast or pounding heartbeat, swelling, feeling short of breath, fainting, sudden numbness or weakness, severe headache, weight changes, tiredness, missed menstrual periods, blood in your urine or stools, coughing up blood, easy bruising or bleeding, upper stomach pain, dark urine, or jaundice (yellowing of the skin or eyes).

Tell your doctor about all other medicines you use.

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