Sunitinib Malate Oral capsule

What is this medicine?

SUNITINIB (soo NI ti nib) is a chemotherapy drug. It targets a specific protein within cancer cells and stops the cancer cells from growing. It is used to treat specific digestive tract tumors called GISTs. It is also used to treat advanced kidney cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bleeding problems
• infection (especially a virus infection such as chickenpox, cold sores, or herpes)
• heart disease
• heart failure
• high blood pressure
• kidney disease (other than cancer)
• liver disease
• lung disease
• seizures
• an unusual or allergic reaction to sunitinib, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. Tell your doctor if you miss a dose.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• cisapride
• grapefruit juice
• pimozide
• St. John's Wort
• thioridazine

This medicine may also interact with the following medications:

• antiviral medicines for HIV or AIDS
• barbiturates for sleep or seizures
• carbamazepine
• dexamethasone
• medicines for depression, anxiety, or psychotic disturbances
• medicines for fungal infections like ketoconazole and itraconazole
• medicines for irregular heart beat like amiodarone, bepridil, dofetilide, encainide, flecainide, propafenone, quinidine
• medicines for numbness or sleep during surgery
• phenobarbital
• phenytoin
• rifabutin, rifampin, rifapentine
• some antibiotics like clarithromycin, erythromycin, levofloxacin, mefloquine, telithromycin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor for regular check ups. Talk to your doctor about any new or unusual health problems. You will need blood work done while you are taking this medicine.

Do not become pregnant while taking this medicine. Male and female patients should use effective birth control methods while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• dark urine
• feeling faint or lightheaded, falls
• fever or chills, cough, sore throat
• high blood pressure
• mouth sores
• seizures
• stomach pain
• swelling of feet, legs
• trouble passing urine or change in the amount of urine
• unusual bleeding or bruising
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• bone or muscle pain
• change in hair color (lighter)
• changes in taste
• diarrhea
• loss of appetite
• nausea, vomiting
• skin that is cracked, dry, thick, yellow or lightened
• stomach upset

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.