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.

Important Safety Information

SUTENT can cause serious liver problems, including death.

Tell your healthcare provider right away if you develop any of the following during treatment with SUTENT: itching; yellow eyes or skin; dark urine; or 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.

SUTENT may cause heart problems. Heart problems may include heart failure, heart muscle problems (cardiomyopathy) or abnormal heart rhythm changes. Tell your healthcare provider if you feel dizzy, faint, very tired, have abnormal heartbeats, are short of breath, or have swollen feet and ankles while taking SUTENT.

SUTENT may cause high blood pressure. Your healthcare provider may check your blood pressure, and may treat you for high blood pressure.

SUTENT may cause bleeding sometimes leading to death. Tell your healthcare provider right away if you have any of following during treatment with SUTENT: serious bleeding; painful swollen stomach (abdomen); vomiting blood; black sticky stools; bloody urine; headache or change in your mental status.

SUTENT may cause 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.

SUTENT may harm an unborn baby (cause birth defects). Do not become pregnant. If you do, tell your healthcare provider right away. Stop taking SUTENT. Do not breastfeed while taking SUTENT.

Using SUTENT with other medicines can cause serious side effects. Tell your healthcare provider about all the medicines, vitamins, or herbal products you use.

You may have side effects or reactions to SUTENT. For most patients, these are moderate and may be managed, though some can be serious. Your healthcare provider may change your dose or stop your treatment. Some of the most common side effects include tiredness, weakness, fever, diarrhea, nausea, vomiting, mouth sores, upset stomach, abdominal pain, constipation, skin or hair changes, taste changes, swelling, loss of appetite, and bleeding, such as from the nose or cuts. Tell your healthcare provider if you have any swelling or bleeding. Be sure to tell your healthcare provider about any new side effects you have, as well as any change or increase in any side effect.

Gleevec is a registered trademark of Novartis AG.