Tarceva® (erlotinib)

• Full Prescribing Information

Indication

TARCEVA is a kinase inhibitor indicated for:

• 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. (1.1)
• Treatment of locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. (1.1)
• First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine.

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. Tarceva therapy should be interrupted for acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, and fever. If ILD is diagnosed, Tarceva should be discontinued and appropriate treatment instituted as needed.
• Cases of hepatic failure, hepatorenal syndrome, acute renal failure (all including fatalities), and renal insufficiency have been reported during use of Tarceva. Treatment with Tarceva should be used with extra caution in patients with total bilirubin >3 x ULN. Tarceva dosing should be interrupted or discontinued if changes in liver function are severe. Patients should be closely monitored during therapy with Tarceva.
• Gastrointestinal perforation (including fatalities) has been reported in patients receiving Tarceva. Permanently discontinue Tarceva in patients who develop gastrointestinal perforation.
• 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. Interrupt or discontinue Tarceva treatment if the patient develops severe bullous, blistering, or exfoliating conditions.
• 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. Interrupt or discontinue Tarceva therapy if patients present with acute/worsening ocular disorders such as eye pain.
• International Normalized Ratio (INR) elevations and bleeding events, including gastrointestinal and non-gastrointestinal bleeding (including fatalities), have been associated with concomitant warfarin administration. Patients taking warfarin or other coumarin derivative anticoagulants should be monitored regularly for changes in prothrombin time or INR.
• 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. In the 2nd/3rd line study, severe rash and diarrhea(9% and 6% NCI-CTC Grades 3/4, respectively) were reported. Rash and diarrhea each resulted in dose reductions (6% and 1%, respectively) and discontinuation in 1% of Tarceva-treated patients. In the maintenance study, severe rash and diarrhea (6.0% and 1.8% NCI-CTC Grades 3/4, respectively) were reported. Rash and diarrhea resulted in dose reductions or interruption (5.1% and 2.8%, respectively) and discontinuation (1.2% and 0.5%, respectively) of Tarceva-treated patients.
• The most common adverse reactions in patients with advanced pancreatic cancer receiving Tarceva 100 mg plus gemcitabine were fatigue, rash, nausea, anorexia, and diarrhea. Severe rash and diarrhea (5% and 5% NCI-CTC Grades 3/4, respectively) were reported. Rash and diarrhea each resulted in dose reductions in 2% of patients and discontinuation in up to 1% of patients receiving Tarceva plus gemcitabine.

For additional Important Safety Information, please see the full prescribing Information at www.tarceva.com.