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What does Tarceva Treat?

Tarceva is approved for:
Maintenance Therapy and Second- or Third-Line Therapy in Advanced Non-Small Cell Lung Cancer (NSCLC):

• 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. (2nd/3rd-line treatment)
• Tarceva is not meant to be used at the same time as certain types of chemotherapy for advanced NSCLC.

Advanced Pancreatic Cancer:

• 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.

Important Safety Information

Possible Side Effects
Everyone reacts differently to Tarceva therapy. So it's important to know what the side effects are. Although some people may have a life-threatening side effect, most do not.

Your doctor will stop treatment if any serious side effects occur. Be sure to contact your healthcare team if you have symptoms related to these side effects.

• Interstitial lung disease (ILD)-like events. Problems occurring in the lungs (including deaths). Tarceva may need to be stopped if new or unexplained serious symptoms of shortness of breath, cough, and fever occur.
• Liver and/or kidney problems. Some events have included death. Let your healthcare provider (HCP) know if you have a history of liver or kidney disease.
• Gastrointestinal (GI) perforation. A hole that develops in your stomach or intestine. Some events have included death.
• Serious skin conditions. Some events have included death.
• Bleeding and clotting problems. Heart attack or stroke in patients receiving Tarceva plus gemcitabine for advanced pancreatic cancer.
• Eye disorders. Eye irritation and damage to the cornea.
• Bleeding events when taking warfarin. Some events have included death. Tell your doctor if you are taking warfarin or non-steroidal anti-inflammatory drugs (NSAIDs).
• Pregnancy problems. You should not become pregnant while on treatment with Tarceva. DO NOT breast-feed while receiving treatment with Tarceva.

Additional Safety Information
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

The most common side effects when receiving Tarceva alone for advanced NSCLC are generally mild to moderate rash and diarrhea.

The most common side effects when receiving Tarceva plus gemcitabine for advanced pancreatic cancer are fatigue (feeling tired), rash, nausea, loss of appetite and diarrhea.

Additional Important Information
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.
• 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.

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.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

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