When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to sunitinib, or if you are pregnant.

How to Use This Medicine:
Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• 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: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. Tell your doctor about any dose that you miss.
• 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:
  
  • Atazanavir, carbamazepine, clarithromycin, dexamethasone, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, phenytoin, phenobarbital, rifabutin, rifampin, rifapentine, ritonavir, saquinavir, St John's wort, telithromycin, voriconazole
  • Bisphosphonate medicine for bone problems
  • Diabetes medicine that you take by mouth
  • Medicine to treat heart rhythm problems
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding, or 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 attack, heart failure, heart rhythm problems, high blood pressure
  • Increased risk of bleeding
  • Jaw problems
  • Tumor lysis syndrome (electrolyte and metabolic problems that can be life-threatening)
  • Thrombotic microangiopathy (blood vessel damage)
  • Serious skin reactions
• 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.
• 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, nausea, unusual sweating, faintness, 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, dizziness, fainting
• Fever, confusion, vision loss, 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, fast or pounding heartbeat, lightheadedness, 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, mild nausea or vomiting, 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