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Important Safety Information & Indication
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.
- Rash and diarrhea.
- Advanced Pancreatic Cancer – Tarceva Administered Concurrently with Gemcitabine:
- Fatigue, rash, nausea, anorexia, and diarrhea.
- Metastatic NSCLC – First-Line Treatment of Patients With EGFR Mutations:
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.