Sunitinib Malate (soo-NI-ti-nib MAL-ate)

Treats cancer, including kidney cancer, gastrointestinal stromal tumor (GIST), and pancreatic neuroendocrine tumor (pNET).

Brand Name(s):

Sutent

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the capsule whole. Do not crush, break, chew, or open it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose and it is less than 12 hoursfrom your regular time, take it as soon as possible. If you miss a dose and it is more than 12 hours, skip the missed dose and take your next dose at the regular time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how sunitinib works. Tell your doctor if you are using any of the following:
  • Ketoconazole, rifampin
  • Bisphosphonate medicine for bone problems
  • Diabetes medicine
  • Medicine that may cause heart rhythm problems
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 4 weeks after the last dose. Males who are taking this medicine, with female partners who can become pregnant must use effective birth control during treatment and for at least 7 weeks after the last dose.
• Do not breastfeed during treatment with this medicine and for at least 4 weeks after the last dose.
• Tell your doctor if you have kidney disease, liver disease, bleeding problems, dental problems, diabetes, thyroid problems, or a history of seizures. Tell your doctor if you have heart disease, heart failure, heart rhythm problems, high blood pressure, or a history of heart attack. Tell your doctor if you recently had any severe infection, trauma, or surgery, including dental surgery.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine may cause the following problems:
  • Liver problems
  • Heart problems (including heart attack, heart failure, heart rhythm problems, high blood pressure, cardiomyopathy)
  • Increased risk of bleeding
  • Tumor lysis syndrome (electrolyte and metabolic problems that can be life-threatening)
  • Thrombotic microangiopathy (blood vessel damage)
  • Serious skin reactions (including erythema multiforme, Stevens-Johnson syndrome, necrotizing fasciitis, and toxic epidermal necrolysis)
  • Reversible posterior leukoencephalopathy syndrome (brain problem)
  • Thyroid problems (including hyperthyroidism or hypothyroidism)
  • Hypoglycemia (low blood sugar)
  • Jaw problems
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests. This medicine can cause slow wound healing.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Blood in your vomit or stools, nosebleeds, or other unusual bleeding or bruising
• Chest pain that may spread, trouble breathing, coughing up blood
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow eyes or skin
• Decrease in how much or how often you urinate, cloudy urine
• Fast, slow, pounding, or uneven heartbeat, lightheadedness, dizziness, fainting
• Fever, confusion, seizures
• Heavy feeling, swelling, numbness, or pain in your jaw, or a loose tooth
• Numbness or weakness in your arm or leg, pain in your lower leg, sudden or severe headache, problems with vision, speech, or walking
• Rapid weight gain, swelling in your hands, ankles, or feet
• Shaking, trembling, sweating, hunger, confusion

If you notice these less serious side effects, talk with your doctor:

• Back, muscle, or joint pain, weakness, tiredness
• Changes in sense of taste
• Diarrhea, constipation, gas, stomach upset
• Dry skin, changes in skin or hair color
• Sores or white patches on your lips, mouth, or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088