Tarceva® (erlotinib)

• Full Prescribing Information

What it Treats

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

• Serious side effects (including deaths) in patients taking Tarceva include Interstitial Lung Disease (ILD)-like events; liver and/or kidney problems; gastrointestinal (GI) perforations (the development of a hole in the stomach, small intestine, or large intestine); serious skin conditions; and bleeding events including gastrointestinal and non-gastrointestinal bleeding when taking warfarin or non-steroidal anti-inflammatory drugs (NSAIDs).
• Patients taking Tarceva plus gemcitabine were more likely to experience bleeding and clotting problems such as heart attack or stroke.
• Eye irritation and damage to the cornea have been reported in patients taking Tarceva.
• Women should avoid becoming pregnant and avoid breastfeeding while taking Tarceva.
• Patients should call their doctor right away if they 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; or eye irritation.
• Rash and diarrhea were the most common side effects associated with Tarceva in the non-small cell lung cancer clinical studies.
• Fatigue, rash, nausea, loss of appetite, and diarrhea were the most common side effects associated with Tarceva plus gemcitabine therapy in the advanced pancreatic cancer clinical study.

View full prescribing information for additional safety information.