Obeticholic Acid Dosage
Medically reviewed by Drugs.com. Last updated on March 4, 2021.
Applies to the following strengths: 5 mg; 10 mg
Usual Adult Dose for:
Additional dosage information:
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:
-This drug was approved via accelerated approval process due to ALP reductions; an improvement in survival or disease-related symptoms was not established.
-Patients and prescribers should note that continued approval may be contingent upon verification and clinical benefit in additional confirmatory trials.
-Healthcare providers should determine the Child-Pugh classification in any patient with suspected ascites prior to starting treatment.
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
Liver Dysfunction During Treatment:
-Patients with laboratory/clinical evidence of liver dysfunction: Interrupt treatment and monitor the patient's liver function.
-Patients with liver function returning to baseline: The risks versus benefits of restarting treatment should be considered; if this drug is restarted, the initial dose should be determined by the patient's Child-Pugh classification.
-Patients with clinically significant liver-related adverse reactions: Providers should consider treatment discontinuation.
IF INTOLERANT PRURITUS OCCURS DURING TREATMENT:
Mild liver dysfunction (Child-Pugh Class A):
-Add an antihistamine or bile acid binding resin
-Reduce the dose to 5 mg orally 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.
Moderate to severe liver dysfunction (Child-Pugh Class B or C) OR decompensated cirrhotic patients:
-Reduce the dose to 5 mg orally once a week (patients intolerant to a dose of 5 mg 2 times a week) OR 10 mg orally once a week (patients intolerant to a dose of 10 mg 2 times a week).
-Temporarily stop treatment for up to 2 weeks, then restart at a lower dose, with gradual increases to achieve optimal response (up to 10 mg orally 2 times a week).
-Consider discontinuation in patients with continued persistent, intolerable pruritus.
Comments:
-Patients with reduced/interrupted doses should receive dose titrations based on biochemical response and tolerability; adjustments should be made based on Child-Pugh classification.
-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 should be regularly monitored for response, disease progression, tolerability, and Child-Pugh classification should be re-evaluated to determine proper dosages are used.
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
PATIENTS WITH A PRIOR DECOMPENSATION EVENT:
-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
If Intolerant Pruritus Occurs During Treatment:
-Add an antihistamine or bile acid resin
-Temporarily stop treatment for up to 2 weeks, then restart at a lower dose
-Consider discontinuation in patients with continued persistent, intolerable pruritus
Comment: Prior decompensation events include new/worsening jaundice, spontaneous bacterial peritonitis, and/or variceal bleeding.
Precautions
CONTRAINDICATIONS: Patients with complete biliary obstruction
US BOXED WARNINGS:
HEPATIC DECOMPENSATION AND FAILURE IN INCORRECTLY DOSED PRIMARY BILIARY CHOLANGITIS (PBC) PATIENTS WITH CHILD-PUGH CLASS B OR C OR DECOMPENSATED CIRRHOSIS:
-In postmarketing reports, hepatic decompensation and failure, in some cases fatal, have been reported in PBC patients with decompensated cirrhosis or Child-Pugh Class B or C liver dysfunction when this drug was dosed more frequently than recommended.
-The recommended starting dose of this drug is 5 mg once a week for patients with Child-Pugh Class B or C liver dysfunction or a prior decompensation event.
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 to 6 hours before or after taking the bile acid resin, or they should separate administration of this drug by 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 an adequate biochemical 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 has not been established.
-The dose should be increased to 10 mg/day to achieve optimal response.
Monitoring:
-HEPATIC: Periodic liver function tests
-METABOLIC: 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.
More about obeticholic acid
- Side Effects
- During Pregnancy
- Drug Interactions
- En Español
- 2 Reviews
- Drug class: miscellaneous GI agents
- FDA Alerts (2)
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