such as diarrhea, nausea, stomatitis, dyspepsia, and vomiting were the most commonly reported gastrointestinal events occurring in patients who received SUTENT. Supportive care for gastrointestinal adverse events requiring treatment may include anti-emetic or anti-diarrheal medication.
17.2Skin Effects
Skin discoloration possibly due to the drug color (yellow) occurred in approximately one third of patients. Patients should be advised that depigmentation of the hair or skin may occur during treatment with SUTENT. Other possible dermatologic effects may include dryness, thickness or cracking of skin, blister or rash on the palms of the hands and soles of the feet.
17.3Other Common Events
Other commonly reported adverse events included fatigue, high blood pressure, bleeding, swelling, mouth pain/irritation and taste disturbance.
17.4Concomitant Medications
Patients should be advised to inform their health care providers of all concomitant medications, including over-the-counter medications and dietary supplements [see Drug Interactions (7)].
17.5FDA-Approved Patient Labeling
LAB-0317-15
MEDICATION GUIDE
SUTENT (su TENT)
(sunitinib malate)
capsules
Read the Medication Guide that comes with SUTENT before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about SUTENT, ask your healthcare provider or pharmacist.
What is the most important information I should know about SUTENT?
SUTENT can cause serious liver problems, including death.
Tell your healthcare provider right away if you develop any of the following signs and symptoms of liver problems during treatment with SUTENT:
itching
yellow eyes or skin,
dark urine, and
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.
What is SUTENT?
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 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, includin |
