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TARCEVA (erlotinib) INDICATIONS AND USAGE

Non-Small Cell Lung Cancer

Tarceva monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.

Results from two multicenter, placebo controlled, randomized, Phase III trials conducted in first-line patients with locally advanced or metastatic NSCLC showed no clinical benefit with the concurrent administration of Tarceva with platinum-based chemotherapy, and its use is not recommended in that setting.

Pancreatic Cancer

Tarceva in combination with gemcitabine is indicated for first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

Tarceva Important Safety Information

In clinical studies, there were infrequent reports of serious lung injuries similar to Interstitial Lung Disease (ILD)-like events. Reports of ILD-like events have been serious and have included deaths in patients taking Tarceva.

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

Holes that formed in the stomach, small intestine, or large bowel (including deaths) have been reported in patients taking Tarceva.

Severe blistering skin reactions including cases similar to Stevens-Johnson syndrome (including deaths) have been reported in patients taking Tarceva.

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

Eye swelling, infection, and holes in the cornea have been reported in patients taking Tarceva.

Tarceva may cause harm to an unborn baby or may cause possible risk of pregnancy loss. Women should avoid becoming pregnant and avoid breastfeeding while taking Tarceva.

You should call your doctor 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.

If you smoke, you should stop smoking while taking Tarceva, as it may affect how well Tarceva works for you. If you continue to smoke, you should speak to your doctor before taking Tarceva.

Let your doctor know if you are taking other prescription or over-the-counter drugs or herbal supplements before you start taking Tarceva. While taking Tarceva, do not start taking any new drugs or herbal supplements before talking to your doctor. Do not eat grapefruit or drink grapefruit juice while taking Tarceva. Tarceva may also affect other medications you are taking.

Rash and diarrhea were the most common side effects associated with Tarceva in the non-small cell lung cancer clinical study.

Fatigue, rash, nausea, loss of appetite, and diarrhea were the most common side effects associated with Tarceva plus gemcitabine therapy in the pancreatic cancer clinical study.

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

Please see full prescribing information.