Obeticholic Acid

Hepatic Decompensation and Failure in Incorrectly Dosed PBC Patients with Child-Puch Class B or C or Decompensated Cirrhosis

• In postmarketing reports, hepatic decompensation and failure, in some cases fatal, have been reported in patients with primary biliary cholangitis (PBC) with decompensated cirrhosis or Child-Pugh Class B or C hepatic impairment when OCALIVA was dosed more frequently than recommended 
• The recommended starting dosage of OCALIVA is 5 mg once weekly for patients with Child-Pugh Class B or C hepatic impairment or a prior decompensation event

FDA and Industry Communications

Index to FDA Safety Information

Patient Counseling Information

• OCALIVA

Medication Guides

Patient Medication Guide - OCALIVA

Package Inserts

Obeticholic Acid