Navigation and service

You are here:Rote-Hand-Briefe and Information Letters

Dear Doctor Letter (Rote-Hand-Brief) on OCALIVA® (obeticholic acid): Differential dosing recommendations in primary biliary cholangitis (PBC) patients with moderate and severe hepatic impairment

Date 2018.02.09
Active substance obeticholic acid

Due to the risk of serious liver injury in patients with moderate and severe hepatic impairment, all patients are to be monitored by way of laboratory and clinical assessment for progression of the PBC disease during treatment with obeticholic acid in order to determine whether dosage adjustment is needed.