INDICATIONS AND USAGE（适应症）

OCALIVA® 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（服用剂量）

Prior to the initiation of OCALIVA, healthcare providers should determine whether the patient has decompensated cirrhosis (e.g., Child-Pugh Class B or C), has had a prior decompensation event, or has compensated cirrhosis with evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia) because OCALIVA is contraindicated in these patients.

Recommended Dosage Regimen

The recommended dosage of OCALIVA 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 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 OCALIVA, increase to a maximum dosage of 10 mg once daily.

ADVERSE REACTIONS（不良反应）

Hepatic Decompensation and Failure in PBC Patients with Cirrhosis

Severe Pruritus

Reduction in HDL-C

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/cdfbe0cd-eb15-45a1-ac17-531bcda21aec/spl-doc?hl=Obeticholic

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