Ocaliva®▼ (obeticholic acid): New contraindication for the treatment of primary biliary cholangitis (PBC) in patients with decompensated liver cirrhosis or a history of prior hepatic decompensation.

Summary: 
Taking into consideration the inability to establish the safety and efficacy of obeticholic acid through clinical trials in patients with PBC with decompensated liver cirrhosis, or with a prior history of hepatic decompensation, as well as new safety information from post-marketing reports, the use of obeticholic acid is now contraindicated in patients with PBC with decompensated cirrhosis (including Child-Pugh Class B or C) or a prior decompensation event.

• Treatment should be discontinued in patients with PBC with decompensated cirrhosis currently receiving obeticholic acid. 
• Patients should be routinely monitored for progression of PBC and treatment with obeticholic acid should be permanently discontinued in patients with laboratory or clinical evidence of hepatic decompensation including progression to Child-Pugh class B or C.
• Treatment with obeticholic acid should not be started if the patient has decompensated cirrhosis or a history of a decompensation event prior to treatment initiation. 
• The SmPC and the patient leaflet are being updated to reflect this new contraindication and additional warnings based on newly available safety data.