Important Safety Information

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
• 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.

Pregnancy and breastfeeding:

• 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
• Do not breastfeed while taking SUTENT

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.

You may have an increased risk of severe jaw bone problems (osteonecrosis) if you take SUTENT and a bisphosphonate medicine (Actonel, Aredia, Boniva, Didronel, Fosamax, Reclast, Skelid, or Zometa). Talk with your healthcare provider before starting any new medicines.

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.

Do not drink grapefruit juice, eat grapefruit, or take St. John’s Wort.

SUTENT may cause serious side effects, including:

• Serious liver problems, including death
• Heart problems—Heart problems may include heart failure, heart attack, 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
• 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:
  • Painful, swollen stomach (abdomen)
  • Vomiting blood
  • Black, sticky stools
  • Bloody urine
  • Headache or change in your mental status
  Your healthcare provider can tell you other symptoms to watch for.
• Jaw-bone problems (osteonecrosis)—Severe jaw bone problems may happen. Your healthcare provider should examine your mouth before you start SUTENT. Your healthcare provider may tell you to see your dentist before you start SUTENT
• Tumor lysis syndrome (TLS)—TLS is caused by the fast breakdown of cancer cells and may lead to death. TLS may cause you to have nausea, shortness of breath, irregular heartbeat, clouding of urine and tiredness associated with abnormal laboratory test results (high potassium, uric acid and phosphorus levels and low calcium levels in the blood) that can lead to changes in kidney function and acute kidney failure. Your healthcare provider may do blood tests to check you for TLS
• Damage to the smallest blood vessels—Damage to the smallest blood vessels known as thrombotic microangiopathy (TMA) may occur. TMA is a condition involving injury to the vessels resulting in blood clots, and is accompanied by injury to red blood cells leading to a decrease in red cells and a decrease in cells that are involved with clotting. TMA may harm organs such as the brain and kidneys. Symptoms of TMA may include fever, fatigue, tiredness, bruising; you may develop swelling, confusion, vision loss, and seizures. Your healthcare provider may tell you to stop taking SUTENT
• Protein in your urine—Your healthcare provider will check you for this problem. If there is too much protein in your urine, your healthcare provider may tell you to stop taking SUTENT
• Serious skin and mouth reactions—SUTENT can cause serious skin reactions that can cause death. This can include rash, widespread blistering or peeling of the skin and blistering and peeling on the inside of your mouth. If you develop a rash or these skin symptoms, tell your healthcare provider immediately. Your healthcare provider may tell you to stop taking SUTENT
• 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. Tell your healthcare provider if you have any of the following signs and symptoms:
  • Tiredness that worsens and does not go away
  • Loss of appetite
  • Heat intolerance
  • Feeling nervous or agitated, tremors
  • Sweating
  • Nausea or vomiting
  • Diarrhea
  • Fast heart rate
  • Weight gain or weight loss
  • Feeling depressed
  • Irregular menstrual periods or no menstrual periods
  • Headache
  • Hair loss
• Low blood sugar (hypoglycemia)—Low blood sugar can happen with SUTENT, and may cause you to become unconscious, or you may need to be hospitalized. Low blood sugar with SUTENT may be worse in people who have diabetes and take anti-diabetic medicines. Your healthcare provider should check your blood sugar levels regularly during treatment with SUTENT and may need to adjust the dose of your anti-diabetic medicines. Signs and symptoms of low blood sugar may include:
  • Headache
  • Drowsiness
  • Weakness
  • Dizziness
  • Confusion
  • Irritability
  • Hunger
  • Fast heart beat
  • Sweating
  • Feeling jittery

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
• Taste changes
• Loss of appetite
• Pain or swelling in your arms or legs
• Cough
• Shortness of breath
• Bleeding, such as nosebleeds or bleeding from cuts

Call your healthcare provider if you have any swelling or bleeding during treatment with SUTENT.

Gleevec is a registered trademark of Novartis AG.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see patient Medication Guide and full Prescribing Information, including Boxed Warning regarding serious liver problems.