SUTENT is a prescription medicine used to treat people with:

• a rare cancer of the stomach, bowel, or esophagus called GIST (gastrointestinal stromal tumor) and when:
• the medicine Gleevec^® (imatinib mesylate) did not stop the cancer from growing, or
• you cannot take Gleevec^®
• advanced kidney cancer (advanced renal cell carcinoma or RCC)
• a type of pancreatic cancer known as pancreatic neuroendocrine tumors (pNET), 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 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 that can lead to death. 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 the 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.