Gleevec

Gleevec is used for:

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Treating certain types of leukemia (eg, chronic myeloid leukemia) and certain intestinal tumors (eg, gastrointestinal stromal tumors). It may also be used for other conditions as determined by your doctor.

Gleevec is a protein-tyrosine kinase inhibitor. It works by preventing the growth of cancer cells.

Do NOT use Gleevec if:

• you are allergic to any ingredient in Gleevec

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

Before using Gleevec :

Some medical conditions may interact with Gleevec . 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 liver, kidney, heart, or lung problems
• if you have bone marrow problems, low white blood cell counts, or low blood platelets
• if you have other cancers

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

• Anticoagulants (eg, warfarin) because side effects, including the risk of bleeding, may be increased by Gleevec
• Azole antifungals (eg, itraconazole, ketoconazole), ketolide antibiotics (eg, telithromycin), or macrolide antibiotics (eg, clarithromycin, erythromycin) because they may increase the risk of Gleevec 's side effects
• Barbiturates (eg, phenobarbital), carbamazepine, corticosteroids (eg, dexamethasone), hydantoins (eg, phenytoin), rifampin, or St. John's wort because they may decrease Gleevec 's effectiveness
• Acetaminophen, benzodiazepines (eg, alprazolam), calcium channel blockers (eg, nifedipine), cyclosporine, HMG-CoA reductase inhibitors (eg, simvastatin), or pimozide because the risk of their side effects may be increased by Gleevec
• Levothyroxine because its effectiveness may be decreased by Gleevec

This may not be a complete list of all interactions that may occur. Ask your health care provider if Gleevec 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 Gleevec :

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

• Take Gleevec by mouth with a meal and a full glass of water (8 oz/240 mL).
• If you have trouble swallowing tablets whole, talk with your doctor or pharmacist. You may dissolve your dose in a glass of water or apple juice. The amount of liquid will vary depending on your dose. Ask your doctor or pharmacist for instructions. Stir the mixture well and drink immediately.
• If you miss a dose of Gleevec , 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 Gleevec .

Important safety information:

• Gleevec may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Gleevec with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Tell your doctor or dentist that you take Gleevec before you receive any medical or dental care, emergency care, or surgery.
• Gleevec may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• Do not receive a live vaccine (eg, measles, mumps) while you are taking Gleevec . Talk with your doctor before you receive any vaccine.
• Check your weight every morning and keep a log. Report any 3 to 5 pound weight gain to your doctor.
• If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
• If you may become pregnant, you must use an effective form of birth control while you take Gleevec . If you have questions about effective birth control, talk with your doctor.
• Lab tests, including liver function, kidney function, and complete blood cell counts, may be performed while you use Gleevec . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Gleevec with caution in the ELDERLY; they may be more sensitive to its effects, especially swelling and fluid retention.
• Gleevec should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Gleevec may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Gleevec while you are pregnant. It is not known if Gleevec is found in breast milk. Do not breast-feed while taking Gleevec .

Possible side effects of Gleevec :

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:

Anxiety; constipation; cough; diarrhea; dizziness; gas; headache; increased tear production; loss of appetite; muscle cramps; nausea; night sweats; nose and throat irritation; stomach pain or upset; taste changes; tiredness; trouble sleeping; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; blistered, peeling, reddened, scaling, or swollen skin; bone pain; change in the amount of urine produced; chest pain; chills, fever, or sore throat; confusion; dark urine; depression; fast or irregular heartbeat; joint or muscle pain; severe or persistent headache; severe stomach pain; severe tiredness or weakness; shortness of breath; slurred speech; sudden unusual weight gain; swelling of the hands, feet, ankles, or around the eyes; unusual bruising or bleeding; vision problems; vomit that looks like coffee grounds; yellowing of the eyes or skin.

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 / dnn / Resources / FindLocalPoisonCenters / tabid / 130 / Default.aspx), or emergency room immediately.

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

General information:

• If you have any questions about Gleevec , please talk with your doctor, pharmacist, or other health care provider.
• Gleevec 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 Gleevec . 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.

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