Obeticholic acid (Ocaliva) is licensed in the UK for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
The starting dose is 5mg once daily. However in those with moderate (Child-Pugh Class B) and severe (Child-Pugh Class C) hepatic impairment, a lower initial dose of 5mg once weekly is recommended; this can be subsequently increased to 5mg twice weekly and then to 10mg twice weekly depending on response and tolerability.
The FDA Drug Safety Communication discusses reports of serious liver injury or death associated with obeticholic acid that have been submitted to the FDA. Some of these cases involved patients with moderate to severe decreased liver function who received 5mg daily, instead of a dose no greater than 10 mg twice weekly as recommended in the prescribing information.