What is SUTENT (Sunitinib malate)?
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.
It is not known if SUTENT is safe and effective in children.
What is the most important information I should know about SUTENT?
SUTENT can cause serious side effects. These serious side effects include:
- SUTENT can cause serious liver problems, including death. Tell your healthcare provider right away if you develop any of signs and symptoms of liver problems during treatment with SUTENT, such as: Itching, Yellow eyes or skin, Dark urine, and Pain or discomfort in the right upper stomach area.
- 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. Such as : Painful, Swollen stomach (abdomen), Vomiting blood, Black sticky stools, Bloody urine, Headache or change in your mental status
- Hormone problems, including thyroid and adrenal gland problems. 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
- Loss of appetite
- Heat intolerance
- Sweating
- Weight gain or weight loss
- Headache
- Headache
- Feeling nervous or agitated, tremors
- Nausea or vomiting
- Diarrhea
- Fast heart rate
- Feeling depressed
- Irregular menstrual periods or no menstrual periods
- Hair loss
- 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.
- Bleeding, such as nosebleeds or bleeding from cuts.
- Shortness of breath
- Pain or swelling in your arms or legs
- Loss of appetite
How should I take SUTENT?
- Take SUTENT exactly the way your healthcare provider tells you.
- Take SUTENT 1 time each day with or without food
- If you take SUTENT for GIST or RCC, you will usually take your medicine for 4 weeks (28 days) and then stop for 2 weeks (14 days). This is 1 cycle of treatment. You will repeat this cycle for as long as your healthcare provider tells you to
- If you take SUTENT for pNET, take it one time each day until your healthcare provider tells you to stop.
- Do not open the SUTENT capsules.
- Do not drink grapefruit juice or eat grapefruit during your treatment with SUTENT. They may cause you to have too much SUTENT in your body.
- If you miss a dose, take it as soon as you remember. Do not take it if it is close to your next dose. Just take the next dose at your regular time. Do not take more than 1 dose of SUTENT at a time. Tell your healthcare provider about any missed dose.
Important Safety Information
- SUTENT may harm an unborn baby. You should not become pregnant while taking SUTENT
- If you miss a dose, take it as soon as you remember. Do not take it if it is close to your next dose. Just take the next dose at your regular time
- Do not drink grapefruit juice or eat grapefruit during your treatment with SUTENT. They may cause you to have too much SUTENT in your body
- Do not open the SUTENT capsules
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider before taking SUTENT?
- Before taking SUTENT tell your healthcare provider if you:
- Have any heart problems
- Have high blood pressure
- Have thyroid problems
- Plan to have surgery
- Have kidney function problems (other than cancer)
- Have liver problems
- Have any bleeding problem
- Have seizures
- Have any other medical conditions
- Are pregnant, could be pregnant or plan to become pregnant. 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
- Are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take SUTENT or breastfeed. You should not do both
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.
General information about SUTENT
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SUTENT for a condition for which it was not prescribed. Do not give SUTENT to other people, even if they have the same symptoms you have. It may harm them
What are the ingredients in SUTENT?
Active ingredient: Sunitinib malate
Other ingredient: Mannitol, croscarmellose sodium, povidone (K-25), magnesium stearate