Erlotinib: hepatic failure and hepatorenal syndrome.(Safety and Efficacy Issues)

United States of America -- Healthcare professionals have been informed of cases of hepatic failure and hepatorenal syndrome, including fatalities, reported during use of erlotinib (Tarceva[R]), particularly in patients with baseline hepatic impairment. Patients with hepatic impairment receiving erlotinib should be closely monitored during therapy and the product should be used with extra caution in patients with total bilirubin >3x ULN.

Dosing should be interrupted or discontinued if changes in liver …