(sunitinib malate)
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Prescribing Information
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Health Professional Information

What is SUTENT?

What is SUTENT?

a rare cancer of the stomach, bowel, or esophagus called gastrointestinal stromal tumor (GIST) and when:
o
you have taken the medicine imatinib mesylate and it did not stop the cancer from growing, or
o
you cannot take imatinib mesylate.
advanced kidney cancer (advanced renal cell carcinoma or RCC).
adults with kidney cancer that has not spread (localized), and who are at high risk of RCC coming back again after having kidney surgery.
a type of pancreatic cancer called 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.

Before taking SUTENT tell your healthcare provider about all of your medical conditions, including if you:

have any heart problems
have high blood pressure
have thyroid problems
have a history of low blood sugar or diabetes
have kidney function problems (other than cancer)
have liver problems
have any bleeding problem
plan to have surgery or have had a recent surgery. You should stop taking SUTENT at least 3 weeks before planned surgery. See "What are the possible side effects of SUTENT?"
have seizures
have or have had pain in the mouth, teeth or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth
are pregnant or plan to become pregnant. SUTENT can harm your unborn baby.
Females who are able to become pregnant:
o
Your healthcare provider should do a pregnancy test before you start treatment with SUTENT.
o
You should use effective birth control (contraception) during treatment and for at least 4 weeks after your last dose of SUTENT.
o
Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with SUTENT.
 
Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment and for 7 weeks after your last dose of SUTENT.
SUTENT may cause fertility problems in males and females. Tell your healthcare provider if this is a concern for you.
are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with SUTENT and for at least 4 weeks (1 month) after the last dose.

Tell all of your healthcare providers and dentists that you are taking SUTENT. They should talk to the healthcare provider who prescribed SUTENT for you, before you have any surgery, or medical or dental procedure.

Tell your healthcare provider about all the medicines you take, including prescription medicines and over-the-counter medicines, vitamins, and herbal supplements. Using SUTENT with certain other medicines can cause serious side effects.

You may have an increased risk of severe jawbone problems (osteonecrosis) if you take SUTENT and a bisphosphonate medicine. Especially tell your healthcare provider if you are taking or have taken an osteoporosis medicine.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Additional Resources

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Pfizer Safety Reporting Site

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If you cannot use the above website to report an adverse event related to a Pfizer medication, please call (800) 438-1985.

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or by calling (800) 332-1088.