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Important Safety Information & Indication

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Indications

Metastatic Non-Small Cell Lung Cancer (NSCLC)

Tarceva is indicated for:

  • The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen.

Limitations of use:

  • Safety and efficacy of Tarceva have not been established in patients with NSCLC whose tumors have other EGFR mutations.
  • Tarceva is not recommended for use in combination with platinum-based chemotherapy.

Pancreatic Cancer

Tarceva in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable, or metastatic pancreatic cancer.

Important Safety Information

  • WARNINGS AND PRECAUTIONS:
    • Cases of serious interstitial lung disease (ILD), including fatal cases, have been reported.
    • Hepatic failure, hepatorenal syndrome, and severe acute renal failure (all including fatal cases) and renal insufficiency have been reported.
    • Gastrointestinal perforation (including fatal cases) has been reported.
    • Bullous, blistering and exfoliative skin conditions, including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, which in some cases were fatal, have been reported.
    • In the pooled incidences in the 3 monotherapy lung studies and the pancreatic carcinoma trial, serious adverse reactions, including fatal cases, such as cerebrovascular accident and microangiopathic hemolytic anemia with thrombocytopenia were reported.
    • Decreased tear production, abnormal eyelash growth, keratoconjunctivitis sicca or keratitis can occur and can lead to corneal perforation or ulceration.
    • Severe and fatal hemorrhage associated with International Normalized Ratio (INR) elevations can occur when Tarceva and warfarin are used concurrently.
    • Embryo-fetal toxicity. Women should be advised to avoid pregnancy or breastfeeding.
  • MOST COMMON ADVERSE REACTIONS:
    • Metastatic NSCLC – First-Line Treatment of Patients With EGFR Mutations:
      • Diarrhea, asthenia, rash, cough, dyspnea, and decreased appetite.
    • Metastatic NSCLC – Maintenance Treatment:
      • Rash and diarrhea.
    • Metastatic NSCLC – Second/Third-line Treatment:
      • Rash and diarrhea.
    • Advanced Pancreatic Cancer – Tarceva Administered Concurrently with Gemcitabine:
      • Fatigue, rash, nausea, anorexia, and diarrhea.

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.