Possible Serious and Most Common Side Effects

Indications and Usage for Advanced Pancreatic Cancer Patients

Tarceva in combination with gemcitabine 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.

There have been reports of serious 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).

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 (including deaths). It may happen more in patients who are taking certain other medicines or who have certain stomach and intestinal diseases.

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. The cornea is the clear part of the eyeball that covers the colored part of the eye and the pupil. Other eye problems such as abnormal eyelash growth, dry eyes, or changes in eyesight have also been reported.

Patients should tell their HCP about eye problems that get worse, including eye pain.

Women should not become pregnant while on treatment with Tarceva. If you are already pregnant or become pregnant while taking Tarceva, you should talk with your HCP about the benefits and risks of continuing to take 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, or vomiting
• New or worsening shortness of breath or cough
• 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.

Certain medicines and herbal supplements can affect how Tarceva works in the body. 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.

In addition, grapefruit and grapefruit juice have an effect on how Tarceva works. 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. Talk with your HCP about how to quit smoking. If you continue to smoke, you should talk with your HCP before taking Tarceva.

The most common side effects in patients who took Tarceva plus gemcitabine were fatigue (feeling tired), rash, nausea, loss of appetite, and diarrhea. Other skin changes may also be seen.

The rash from Tarceva plus gemcitabine therapy may appear on your upper body or face. Typically, rash occurs within 10 days of starting treatment, but it may occur anytime during treatment.

The rash is not an allergic reaction. It may look like acne or dry skin. It is not acne. Talk to your HCP if a rash occurs.

Typically, diarrhea may develop within 15 days of starting Tarceva plus gemcitabine therapy.

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1 (800) FDA-1088.