Adverse Reactions

Tarceva (erlotinib) has no known contraindications, and its safety profile has been established in more than 2,000 patients in completed clinical trials.¹ Experience with Tarceva has been gained through its use in over 10,000 trial patients worldwide.²

• Adverse reactions, regardless of causality, that occurred in at least 10% of patients treated with single-agent TARCEVA at 150 mg and at least 3% more often than in the placebo group in the randomized trial of patients with NSCLC are summarized by NCI-CTC (version 2.0) Grade.^{1, 2}
• The most common adverse reactions in patients receiving single-agent TARCEVA 150 mg were rash and diarrhea. Grade 3/4 rash and diarrhea occurred in 9% and 6%, respectively, in TARCEVA-treated patients. Rash and diarrhea each resulted in study discontinuation in 1% of TARCEVA-treated patients. Six percent and 1% of patients needed dose reduction for rash and diarrhea, respectively. The median time to onset of rash was 8 days, and the median time to onset of diarrhea was 12 days.^{1, 2}

Adverse Reactions Occurring More Frequently (≥3%) in the Single-agent TARCEVA Group than in the Placebo Group and in ≥10% of Patients in the TARCEVA Group.

Liver function test abnormalities (including elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin) were observed in patients receiving single-agent TARCEVA 150 mg. These elevations were mainly transient or associated with liver metastases. Grade 2 (>2.5 - 5.0 x ULN) ALT elevations occurred in 4% and <1% of TARCEVA and placebo treated patients, respectively. Grade 3 (>5.0 - 20.0 x ULN) elevations were not observed in TARCEVA-treated patients. TARCEVA dosing should be interrupted or discontinued if changes in liver function are severe.

Please see ADVERSE REACTIONS section in the full package insert.

• 1. Tarceva® (erlotinib) full prescribing information,OSI Pharmaceuticals,Inc., 2009.
• 2. Data on file, OSI Pharmaceuticals, Inc.