Tarceva Indications and Important Safety Information
Non-small cell lung cancer (NSCLC)
Tarceva monotherapy is indicated for:
- the maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
- the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
Results from two, multicenter, placebo-controlled, randomized, Phase III trials conducted in first-line patients with locally advanced or metastatic NSCLC showed no clinical benefit with the concurrent administration of Tarceva with platinum-based chemotherapy [carboplatin and paclitaxel or gemcitabine and cisplatin] and its use is not recommended in that setting.
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
- There have been reports of serious interstitial lung disease (ILD)-like events, including fatalities, in patients receiving Tarceva for treatment of advanced NSCLC, advanced pancreatic cancer, or other advanced solid tumors.
- Cases of hepatic failure, hepatorenal syndrome, acute renal failure (all including fatalities), and renal insufficiency have been reported during use of Tarceva.
- Gastrointestinal perforation (including fatalities) has been reported in patients receiving Tarceva.
- Bullous, blistering, and exfoliative skin conditions have been reported, including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, which in some cases were fatal.
- In the pancreatic cancer trial, other serious adverse reactions associated with Tarceva plus gemcitabine and that may have included fatalities were myocardial infarction/ischemia, cerebrovascular accident, and microangiopathic hemolytic anemia with thrombocytopenia.
- Corneal perforation and ulceration have been reported during use of Tarceva.
- International Normalized Ratio (INR) elevations and bleeding events, including gastrointestinal and non-gastrointestinal bleeding (including fatalities), have been associated with concomitant warfarin administration.
- Tarceva is pregnancy category D. When receiving Tarceva therapy, women should be advised to avoid pregnancy or breastfeeding.
- The most common adverse reactions in patients with advanced NSCLC receiving single-agent Tarceva 150 mg were rash and diarrhea.
- The most common adverse reactions in patients with advanced pancreatic cancer receiving Tarceva 100 mg plus gemcitabine were 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.