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Tarceva (erlotinib) tablets INDICATIONS AND USAGE

Maintenance NSCLC: Tarceva is prescribed for patients with advance-stage non-small cell lung cancer (NSCLC) whose cancer has not spread or grown after initial treatment with certain types of chemotherapy

Second/Third-line NSCLC: Tarceva is prescribed for patients with advanced-stage non-small cell lung cancer (NSCLC) whose cancer has spread or grown after receiving at least 1 chemotherapy regimen.

Tarceva is not meant to be used at the same time as certain types of chemotherapy for NSCLC.

Pancreatic Cancer: Tarceva in combination is prescribed for patients with advanced-stage pancreatic cancer whose cancer has spread, grown or cannot be surgically removed, and who have not received previous chemotherapy.

Important Safety Information
There have been reports of serious adverse events involving the lungs in a small number of patients taking Tarceva (including deaths). The medical name for these events is interstitial (in-tur-STISH-ul) lung disease-like events (or ILD-like events).

Liver and/or kidney problems (including deaths) have been reported in some patients taking Tarceva. Let your healthcare provider (HCP) know if you have a history of liver or kidney disease.

Some patients taking Tarceva have developed a hole in the lining of their stomach or intestines.

Some patients taking Tarceva have developed serious skin conditions. Some patients have died from these conditions.

Patients taking Tarceva plus gemcitabine were more likely to experience bleeding and clotting problems such as heart attack or stroke.

Some patients taking Tarceva have developed eye irritation and damage to the cornea.

Women should not become pregnant while on treatment with Tarceva. DO NOT breast-feed while receiving treatment with Tarceva.

Call your HCP right away if you have these signs or symptoms: new or worsening skin rash; serious or ongoing diarrhea, nausea, loss of appetite, vomiting, or stomach pain; new or worsening shortness of breath or cough; fever; eye irritation.

Some patients taking Tarceva have experienced difficulty with blood clotting, and bleeding events, including gastrointestinal and non-gastrointestinal bleeding. Patients taking blood thinners (Coumadin^®, warfarin or other coumarin-derivatives) should be monitored regularly.

It is important that you tell your HCP about all of the medicines and herbal supplements you are taking. DO NOT start taking any new medicines or herbal supplements before talking with your HCP. Tarceva may also affect other medications you are taking. DO NOT eat grapefruit or drink grapefruit juice while on treatment with Tarceva, except under the care of your HCP.

Smoking may affect how well Tarceva works for you. If you smoke, you should stop smoking before starting treatment with Tarceva. If you continue to smoke, you should talk to your HCP before taking Tarceva.

The most common side effects in patients who took Tarceva for non-small cell lung cancer (NSCLC) were mild to moderate rash and diarrhea.

The most common side effects in patients who took Tarceva plus gemcitabine for pancreatic cancer were fatigue [feeling tired], rash, nausea, loss of appetite and diarrhea.

Always let your HCP know if you have any side effects, and ask about the best way to handle them.

Tarceva is not right for everyone. Ask your HCP if once-daily Tarceva is right for you.

For additional important safety information, please see full prescribing information.

Tarceva^® and its logo are trademarks of OSI Pharmaceuticals, Inc.
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