Information for Healthcare Providers / Patients

Tarceva® (erlotinib)

Side Effect Reporting

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.

What it Treats

Tarceva is approved as a first-line treatment, maintenance treatment, and second- or third-line treatment for advanced-stage non-small cell lung cancer (NSCLC).

  • Tarceva is prescribed as initial treatment for patients with NSCLC whose cancer has spread to other parts of the body and that has certain types of epidermal growth factor receptor (EGFR) mutations. (First-line treatment)
  • Tarceva is prescribed as maintenance treatment for advanced-stage NSCLC in patients whose cancer has not spread or grown after prior treatment with certain types of chemotherapy.
  • Tarceva is prescribed as second- or third-line treatment for advanced-stage NSCLC in patients whose cancer has spread or grown after receiving at least one round of chemotherapy.
  • Tarceva is not meant to be used at the same time as certain types of chemotherapy for advanced NSCLC.
  • For initial treatment of patients with NSCLC whose cancer has spread to other parts of the body, it is not known if Tarceva is safe and effective in other EGFR mutations.

Tarceva is approved for advanced-stage 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

The following serious adverse reactions, which include deaths, were reported in patients taking Tarceva: Interstitial Lung Disease (ILD) 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; Blood, bleeding and clotting problems (Heart attack or stroke); Eye disorders (dry eyes, eye irritation, and damage to the cornea); Bleeding events when taking warfarin or non-steroidal anti-inflammatory drugs (NSAIDs); Pregnancy (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: Serious or ongoing diarrhea, nausea (feeling sick to the stomach), loss of appetite, or vomiting; New or worsening shortness of breath or cough; Eye irritation; New or worsening rash, blistering or peeling of the skin; Any changes in smoking habits.

The most common side effects include:

    • First-line NSCLC treatment: Diarrhea, weakness, rash, cough, shortness of breath, and loss of appetite.
    • Maintenance/Second- or Third-Line NSCLC treatment: Rash and diarrhea.
    • Pancreatic cancer treatment: Fatigue (feeling tired), rash, nausea, loss of appetite and diarrhea.

Patients should call their HCP for medical advice about side effects.

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

Please see the full Tarceva Product Information for additional important safety information at www.tarceva.com.

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