Obeticholic acid (Ocaliva)

SELF ADMINISTRATION

FDA Approved Indications:
  • Treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UCDA, or as monotherapy in adults unable to tolerate UDCA.
Patients must meet the following criteria for the indication(s) above:
  • Confirmed diagnosis of primary biliary cholangitis by medical record documentation with baseline ALP and total bilirubin, AND
  • Patient is at least 18 years of age, AND
  • Patient is currently taking (for at least one year) or has tried and is unable to tolerate an appropriate dosage of urosdeoxycholic acid, AND
  • Patient does not have complete biliary obstruction
Dosing:
  • Starting Dose: 5 mg orally once daily in adults who have not achieved an adequate response to an appropriate dosage of UDCA for at least 1 year or are intolerant to UDCA
  • Dose Titration: If adequate reduction in ALP and/or total bilirubin has not been achieved after 3 months of Ocaliva 5 mg once daily and the patient is tolerating Ocaliva, increase dosage to 10mg once daily.
  • Maximum Dose: 10 mg once daily
  • If patient experiences intolerable pruritis, an antihistamine or bile acid resin may be added, and/or the dose of Ocaliva may be reduced or temporarily interrupted for up to 2 weeks
  • Patients with moderate (Child-Pugh Class B) and severe (Child-Pugh Class C) hepatic impairment may be started at 5mg once weekly
  • Ocaliva may increase the exposure to concomitant drugs that are CYP1A2 substrates (monitor therapy of CYP1A2 substrates with narrow therapeutic index)
Approval:
  • Initial: 3 months
  • Renewal: 1 year