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Erlotinib is used for:

Treating certain types of advanced lung cancer after at least one trial of chemotherapy has failed.

Erlotinib is a tyrosine kinase inhibitor. It works by blocking growth stimulatory signals in cancer cells, which helps stop cancer cells from growing.

Do NOT use Erlotinib if:

• you are allergic to any ingredient in Erlotinib

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

Before using Erlotinib :

Some medical conditions may interact with Erlotinib . 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 had radiation therapy or chemotherapy
• if you have liver problems, previous stomach bleeding, or have or have a history of lung problems (eg, lung disease or lung infection)

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

• Atazanavir, azole antifungals (eg, ketoconazole, macrolide antibiotics (eg, clarithromycin), HIV protease inhibitors (eg, indinavir), nefazodone, verapamil, and certain other medicines that act on the liver because the actions and side effects of Erlotinib may be increased
• Carbamazepine, phenobarbital, hydantoins (eg, phenytoin), St. John's wort, or rifamycins (eg, rifampin) because the effectiveness of Erlotinib may be decreased
• Warfarin because risk of bleeding may be increased by Erlotinib

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

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

• Erlotinib should be taken at least 1 hour before or 2 hours after eating.
• Wash your hands immediately after taking Erlotinib .
• Take Erlotinib regularly to receive the most benefit from it. Taking Erlotinib at the same time each day will help you to remember to take it.
• If you miss a dose of Erlotinib , contact your doctor immediately.

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

Important safety information:

• If you experience moderate to severe diarrhea or a severe skin reaction, tell your doctor immediately. Your doctor may need to reduce your dose or interrupt treatment. Do not treat diarrhea with nonprescription (over-the-counter) medicines.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Erlotinib .
• LAB TESTS, including liver and lung function tests, may be performed to monitor your progress and to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Erlotinib with caution in the ELDERLY because they may be more sensitive to its effects.
• Erlotinib is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Erlotinib if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. If you are able to become pregnant, use effective birth control while you are taking Erlotinib and for at least 2 weeks after treatment is complete. Talk with your doctor or pharmacist about effective methods of birth control. It is unknown if Erlotinib is excreted in breast milk. Do not breast-feed while taking Erlotinib .

Possible side effects of Erlotinib :

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:

Diarrhea; dry skin; fatigue; infection; itching; loss of appetite; mouth ulcers and inflammation; nausea; stomach pain; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; cough; dry eyes; eye irritation, redness, or discharge; fever; severe or persistent diarrhea, nausea, loss of appetite, or vomiting; shortness of breath; sore throat; swelling of the hands, legs, or feet; vision problems; vomit that looks like coffee grounds; yellowing of the skin or eyes.

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 diarrhea; rash.

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

General information:

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