Tarceva and Hepatic/renal impairment

The use of erlotinib has been associated with hepatotoxicity with or without hepatic impairment including hepatic failure and hepatorenal syndrome, in some cases with fatal outcomes. Patients with hepatic impairment (total bilirubin > upper limit of normal (ULN) or Child-Pugh A, B and C) should be closely monitored during therapy with erlotinib. Treatment with erlotinib should be used with extra caution in patients with total bilirubin > 3 x ULN. Clinical monitoring of hepatic function (transaminases, bilirubin, and alkaline phosphatase) is recommended during treatment and increase frequency of monitoring is required for patients with preexisting-existing hepatic impairment or biliary obstruction. In patients with preexisting-existing hepatic impairment or biliary obstruction with doubling of bilirubin or tripling of transaminases values over baseline, erlotinib therapy should be withhold and therapy should be discontinued in patients whose abnormal liver tests meeting the above criteria do not improve significantly or resolve within three weeks. Withhold erlotinib in patients developing severe renal impairment until renal toxicity is resolved. Monitor renal function and electrolytes, particularly in patients at risk of dehydration. Withhold erlotinib for severe renal toxicity.