Important:
Therapy notes
MHRA advice: Obeticholic Acid (Ocaliva): risk of serious liver injury in patients with pre-existing moderate or severe hepatic impairment; reminder to adjust dosing according to liver function monitoring (April 2018) (www.gov.uk).
Important:
Formulation and dosage details
Formulation:
Tablets (Ocaliva®) 5mg, 10mg (Specialist recommendation only)
Dosage:
Primary biliary cirrhosis/cholangitis in combination with ursodeoxycholic acid in adults with an inadequate response to ursodeoxycholic acid or as monotherapy in adults unable to tolerate ursodeoxycholic acid as per SMC 2132/17.
Initiation only on discussion and advice from the Liver MDT. All patients should be reviewed at 1 year to discontinue if no biochemical response.
Note: The most commonly reported adverse reaction is pruritus, which may lead patients to discontinue treatment. Manufacturer information states that the majority occurred within the first month of treatment and tended to resolve over time with continued dosing. To be discussed with patient with a plan for treatment, if needed.