Obeticholic acid

LuciObe, a farnesoid & receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC)

Without cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension, either in combination with ursodeoxycholic acid (UDCA) with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA.

This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

DOSAGE AND ADMINISTRATION

Recommended Dosage Regimen

The recommended starting dosage of LuciObe, for PBC patients without cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension, who have not achieved an adequate biochemical response to an appropriate dosage of UDCA for at least 1 year or who are intolerant to UDCA follows below:

• Start with a dosage of 5 mg once daily for the first 3 months.

• After the first 3 months, for patients who have not achieved an adequate reduction in ALP and/or total bilirubin and who are tolerating LuciObe, increase to a maximum dosage of 10 mg daily 

Routinely monitor patients during LuciObe treatment for biochemical response, tolerability, and progression of PBC.

Management of Patients with Intolerable Pruritus

• See full prescribing information for management options.

Administration Instructions

• Take with or without food.
• For patients taking bile acid binding resins, take LuciObe at least 4 hours before or 4 hours after taking a bile acid binding resin, or at as great an interval as possible.

DOSAGE FORMS AND STRENGTHS

Tablets: 5 mgx30 tablets