Indications and Usage for Advanced Non-Small Cell Lung Cancer Patients

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

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 (second/third-line treatment).

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

Important Safety Information

Possible effects on the lungs

There have been reports of serious adverse events involving the lungs in a small number of patients taking Tarceva. These events have included death in some patients. The medical name for these types of events is interstitial (in-tur STISH-ul) lung disease-like events (or ILD-like events).

Possible effects on the kidneys and liver

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.

Possible effects on the stomach and intestines

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

Possible effects on the skin

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

Possible effects on the eye

Some patients taking Tarceva have developed eye irritation and damage to the cornea. Patients should tell their HCP about eye problems that get worse, including eye pain.

Tarceva and pregnancy and breast-feeding

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

When to call your HCP

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

Before you start taking Tarceva

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.

Taking other medicines and herbal supplements with Tarceva

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

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

Common side effects of Tarceva

The most common side effects in patients who took Tarceva were mild to moderate rash and diarrhea. You may also have other changes in your skin.

Hair and nail changes have been seen with Tarceva.

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.

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