Hepatotoxicity warning strengthened for Tarceva

Genentech and OSI have updated the labeling of Tarceva (erlotinib tablets) to include reports of hepatic failure and hepatorenal syndrome in cancer patients with moderate hepatic impairment. Patients with hepatic impairment or total bilirubin >3xULN should be closely monitored and Tarceva should be interrupted or discontinued if liver function changes are severe.

Tarceva is tyrosine kinase inhibitor indicated for non-small cell lung cancer after failure of at least one prior chemotherapy regimen or in combination with gemcitabine as a first-line treatment of pancreatic cancer.

For more information call (877) TARCEVA or visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm095059.htm.