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|Sunitinib

Sunitinib

Sunitinib is used for:

Treating certain types of stomach or intestinal tumors after the cancer has progressed or if you are unable to take other medicine (imatinib). It may be used to treat certain types of kidney cancer. It may also be used for other conditions as determined by your doctor.

Sunitinib is a multi-kinase inhibitor. It works by blocking a substance that may be involved in the growth and progression of cancer.

Do NOT use Sunitinib if:

• you are allergic to any ingredient in Sunitinib
• you are taking St. John"s wort

Contact your doctor or health care provider right away if any of these apply to you.

Before using Sunitinib :

Some medical conditions may interact with Sunitinib . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have active bleeding, a history of heart problems (eg, congestive heart failure, angina), blood vessel disease, bleeding problems, high blood pressure, adrenal gland problems, a blood clot in the lung, or an underactive thyroid, or you have had a heart attack or stroke, or you are at risk for heart problems
• if you have a severe infection, have recently been injured, or will be having surgery

Some MEDICINES MAY INTERACT with Sunitinib . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Clarithromycin, HIV protease inhibitors (eg, indinavir, ritonavir), imidazole antifungals (eg, ketoconazole), nefazodone, telithromycin, or voriconazole because they may increase the risk of side effects from Sunitinib
• Barbiturates (eg, phenobarbital), carbamazepine, dexamethasone, hydantoins (eg, phenytoin), rifabutin, rifampin, rifapentin, or St. John"s wort because they may decrease the effectiveness of Sunitinib

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sunitinib may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Sunitinib :

Use Sunitinib as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Sunitinib may be taken with or without food.
• Eating grapefruit or drinking grapefruit juice may affect the amount of Sunitinib in your blood. Talk with your doctor before including grapefruit or grapefruit juice in your diet.
• If you miss a dose of Sunitinib , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Sunitinib .

Important safety information:

• Sunitinib may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Sunitinib . Using Sunitinib alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Sunitinib may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.
• Sunitinib may lower your body"s ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Sunitinib .
• Skin or hair discoloration may occur while you are using Sunitinib . Contact your doctor with any questions or concerns.
• LAB TESTS, including complete blood cell counts and heart function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Sunitinib with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Sunitinib may cause harm to the fetus. Avoid becoming pregnant while taking Sunitinib . If you think you may be pregnant, discuss with your doctor the benefits and risks of using Sunitinib during pregnancy. It is unknown if Sunitinib is excreted in breast milk. Do not breast-feed while taking Sunitinib .

Possible side effects of Sunitinib :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Changes in taste; constipation; decreased appetite; diarrhea; dizziness; dry, thick, or cracked skin; gas; hair loss; mild bleeding of the gums; mouth pain or irritation; muscle, joint, or back pain; nausea; nosebleed; skin or hair discoloration; stomach pain or upset; tiredness; vomiting; weakness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; blistering or rash on the palms of hands and soles of feet; calf swelling or tenderness; chest pain; fever, chills, or sore throat; irregular heartbeat; lower back or flank pain; mental or mood changes; numbness of an arm or leg; numbness or tingling of the hands or feet; seizures; severe or persistent headache, dizziness, stomach pain, tiredness, or weakness; severe or recurring nosebleeds or bleeding of the gums; shortness of breath; sudden weight gain; swelling of the hands or legs; unusual or severe bruising or bleeding; vision changes; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include decreased activity; eye discharge; goose bumps; head shakes; loss of coordination; stomach pain.

Store Sunitinib at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sunitinib out of the reach of children and away from pets.

General information:

• If you have any questions about Sunitinib , please talk with your doctor, pharmacist, or other health care provider.
• Sunitinib is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Sunitinib . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.