Hepatic Decompensation and Failure in Primary Biliary Cholangitis Patients with Cirrhosis

Hepatic decompensation and failure, sometimes fatal or resulting in liver transplant, have been reported with obeticholic acid treatment in primary biliary cholangitis (PBC) patients with either compensated or decompensated cirrhosis.

• Obeticholic acidis contraindicated in PBC patients with decompensated cirrhosis, a prior decompensation event, or with compensated cirrhosis who have evidence of portal hypertension.
• Permanently discontinue obeticholic acidin patients who develop laboratory or clinical evidence of hepatic decompensation; have compensated cirrhosis and develop evidence of portal hypertension; or experience clinically significant hepatic adverse reactions while on treatment