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Lapatinib 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.

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

Do NOT use Lapatinib if:

• you are allergic to any ingredient in Lapatinib

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

Before using Lapatinib :

Some medical conditions may interact with Lapatinib . 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 liver problems, heart problems, or irregular heartbeat (eg, QT prolongation)
• if you have low blood electrolyte levels

Some MEDICINES MAY INTERACT with Lapatinib . 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 risk of Lapatinib '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 Lapatinib 's effectiveness

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

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

• An extra patient leaflet is available with Lapatinib . Talk to your pharmacist if you have questions about this information.
• Take Lapatinib 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 Lapatinib .
• If you miss a dose of Lapatinib , 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 Lapatinib .

Important safety information:

• Tell your doctor or dentist that you take Lapatinib 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 Lapatinib . 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 Lapatinib . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Lapatinib should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Lapatinib 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 Lapatinib while you are pregnant. It is not known if Lapatinib is found in breast milk. Do not breast-feed while taking Lapatinib .

Possible side effects of Lapatinib :

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; 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; 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/findyour.htm), or emergency room immediately.

Store Lapatinib 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 Lapatinib out of the reach of children and away from pets.

General information:

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