Tykerb

Tykerb is used for:

Treating certain types of advanced or metastatic breast cancer in certain patients. It is used in combination with another medicine, capecitabine. It may also be used for other conditions as determined by your doctor.

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

Do NOT use Tykerb if:

• you are allergic to any ingredient in Tykerb

Contact your doctor or health care provider right away if this applies to you.

Before using Tykerb :

Some medical conditions may interact with Tykerb . 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 bone marrow problems, low white blood cell counts, or low blood platelets
• if you have a history of liver problems, lung problems, heart problems, or irregular heartbeat (eg, QT prolongation)
• if you have low blood electrolyte levels

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

• Atazanavir, azole antifungals (eg, itraconazole, ketoconazole), indinavir, ketolide antibiotics (eg, telithromycin), macrolide antibiotics (eg, clarithromycin, erythromycin), nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole because they may increase the risk of Tykerb 's side effects
• Barbiturates (eg, phenobarbital), carbamazepine, corticosteroids (eg, dexamethasone), hydantoins (eg, phenytoin), rifabutin, rifampin, rifapentine, or St. John's wort because they may decrease Tykerb 's effectiveness

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

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

• An extra patient leaflet is available with Tykerb . Talk to your pharmacist if you have questions about this information.
• Take Tykerb by mouth on an empty stomach at least 1 hour before or 1 hour after eating.
• Do not eat grapefruit or drink grapefruit juice while you use Tykerb .
• If you miss a dose of Tykerb , 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 Tykerb .

Important safety information:

• Tell your doctor or dentist that you take Tykerb before you receive any medical or dental care, emergency care, or surgery.
• 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 Tykerb . If you have questions about effective birth control, talk with your doctor.
• Lab tests, including liver function and complete blood cell counts, may be performed while you use Tykerb . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Tykerb should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Tykerb 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 Tykerb while you are pregnant. It is not known if Tykerb is found in breast milk. Do not breast-feed while taking Tykerb .

Possible side effects of Tykerb :

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:

Back pain; diarrhea; dry skin; mouth sores; nausea; redness and tingling of the hands and feet; tiredness; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; fast or irregular heartbeat; pale stools; severe or persistent cough; severe pain, redness, or swelling of hands or feet; severe stomach pain or diarrhea; severe tiredness or weakness; shortness of breath; unusual bruising or bleeding; unusual itching; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), or emergency room immediately.

Store Tykerb 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 this medicine out of the reach of children and away from pets.

General information:

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