Obeticholic Acid Dosage

Usual Adult Dose for Biliary Cirrhosis

Initial dose: 5 mg orally once a day
Maintenance dose: 5 mg orally once a day; if adequate reduction in alkaline phosphatase (ALP) and/or total bilirubin is not achieved after 3 months, increase the dosage to 10 mg orally once a day
Maximum dose: 10 mg/day

Comments:

Uses: For the treatment of primary biliary cholangitis:
-As monotherapy in adults unable to tolerate ursodeoxycholic acid (UDCA)
-In combination with UDCA in adults with an inadequate response to UDCA

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Mild liver dysfunction (Child Pugh Class A): No adjustment recommended.
Moderate to severe liver dysfunction (Child Pugh Class B and C):
-Initial dose: 5 mg orally once a week
-Maintenance dose: 5 mg orally once a week; if adequate reduction in ALP and/or total bilirubin is not achieved after 3 months, increase the dosage to 5 mg 2 times a week (at least 3 days apart), and subsequently to 10 mg 2 times a week (at least 3 days apart) depending on response and tolerability
-Maximum dose: 10 mg/day

Comments;
-Patients should be monitored for the occurrence of liver-related adverse reactions
-The potential risks should be weighed against benefits in patients with a history of clinically significant liver-related adverse reactions.

Dose Adjustments

Patients with intolerant pruritus:
-Add an antihistamine or bile acid binding resin
-Reduce the dosage to 5 mg every other day (patients intolerant to a daily dose of 5 mg) or 5 mg orally once a day (patients intolerant to a daily dose of 10 mg)
-Temporarily stop treatment for up to 2 weeks, then restart at a lower dose
-Consider discontinuation in patients with continued persistent, intolerable pruritus

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-This drug may be taken with or without food.
-Patients taking concomitant bile acid binding resins should allow at least 4 hours before or after taking the bile acid resin, or as great an interval as possible.

Storage requirements:
-The manufacturer product information should be consulted.

General:
-This drug is indicated for patients who have not achieved adequate biochemical response to an appropriate response to UDCA for at least 1 year or are intolerant of UDCA.
-Approval of this drug is based on a reduction in ALP levels; improvements in survival/disease-related symptoms have not been established.
-The dose should be increased to 10 mg/day to achieve optimal response.

Monitoring:
-Periodic liver function tests
-Periodic HDL levels

Patient advice:
-Instruct patients to immediately report any signs/symptoms of severe pruritus, hepatitis/jaundice, or hypersensitivity reactions.
-Patients should be advised to speak to a healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.
-Patients should be advised to report all concurrent prescription and nonprescription medications or herbal products they are taking.