Indication and Usage for Lung Cancer Patients

Tarceva monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer 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 [carboplatin and paclitaxel or gemcitabine and cisplatin] and its use is not recommended in that setting.

Important Safety Information

In clinical studies, there were infrequent reports of lung injuries similar to Interstitial Lung Disease (ILD)-like events in patients taking Tarceva for the treatment of non-small cell lung cancer (NSCLC) or other advanced solid tumors. Reports of these ILD-like lung injuries have been serious and have included deaths in some patients.

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.

Eye swelling, infection, and holes in the cornea have been reported in patients taking Tarceva. Patients should tell their doctor about eye problems, including eye pain, that get worse.

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.

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.

Common side effects of Tarceva

Rash and diarrhea were the most common side effects associated with Tarceva in a large clinical study. They were usually mild to moderate. You may also have other changes in your skin.

Always let your doctor or nurse know if you experience any side effects. Ask your doctor or nurse for the best way to handle drug-related side effects.

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

• Please see the Tarceva full prescribing information for complete safety information.