Tarceva Indications and Important Safety Information
Advanced Non-Small Cell Lung Cancer (NSCLC)
Tarceva is indicated for:
- The first-line treatment of patients with metastatic 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.
- The maintenance treatment of patients with locally advanced or metastatic NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
- The treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.
Limitations of use:
- Tarceva is not recommended for use in combination with platinum-based chemotherapy.
- Safety and efficacy of Tarceva have not been evaluated as first-line treatment in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution.
Advanced 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
- CONTRAINDICATIONS: None
- 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 myocardial infarction/ischemia, cerebrovascular accident, and microangiopathic hemolytic anemia with thrombocytopenia were reported.
- Corneal perforation or ulceration have been reported.
- Severe and fatal hemorrhage associated with INR elevations can occur when Tarceva and warfarin are used concurrently.
- Embryo-fetal toxicity. Tarceva is pregnancy category D. 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.
- Advanced NSCLC – Maintenance and 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 accompanying full prescribing information.
Tarceva® and its logo are trademarks of OSI Pharmaceuticals, LLC, an affiliate of Astellas Pharma US, Inc.
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