Obeticholic Acid

Prior to initiation the patient's hepatic status must be known; determine whether the patient has decompensated cirrhosis (including Child-Pugh Class B or C) or a prior decompensation event, because obeticholic acid is contraindicated in these patients. No dose adjustment of concomitant UDCA is required. Dose adjustment for severe pruritus: the dose may be reduced to 5 mg every other day (for patients intolerant to 5 mg once daily) or to 5 mg once daily (for patients intolerant to 10 mg once daily); the dose may be temporarily interrupted for up to 2 weeks followed by restarting at a reduced dose; the dose may be increased to 10 mg once daily, as tolerated, to achieve optimal response. Discontinuation may be considered for persistent, intolerable pruritus. Bile acid binding resins: administer obeticholic acid at least 4 to 6 hours before or 4 to 6 hours after the resin, or at as great an interval as possible. Missed dose: skip the missed dose and resume the normal schedule; do not take a double dose. Elderly (>=65 years): no dose adjustment required (limited data). Hepatic impairment: contraindicated in decompensated cirrhosis (e.g. Child-Pugh Class B or C) or a prior decompensation event. Paediatric population: the SPC states 'There is no relevant use of obeticholic acid in the paediatric population in the treatment of PBC.' NOTE: the fetched SPC section 4.4 was truncated at the source-fetch limit and section 4.5 (interactions) was not retrieved — the interaction list below is therefore incomplete.