-2%
Obeticholic Acid 5-
Pediatric Use:
Safety and efficacy have not been established in children.
Geriatric Use:
No major differences in safety or effectiveness were observed in elderly patients (≥65 years), although increased sensitivity cannot be ruled out.
Hepatic Impairment:
Ocaliva is contraindicated in patients with decompensated cirrhosis or portal hypertension. Dose-related hepatic reactions have been observed in clinical studies; close biochemical monitoring is mandatory.
Ocaliva is prescribed for the treatment of adult patients with primary biliary cholangitis (PBC) who:
Do not have cirrhosis, or
Have compensated cirrhosis without any clinical evidence of portal hypertension.
It is recommended for use:
In combination with ursodeoxycholic acid (UDCA) in patients showing an inadequate response to UDCA, or
As monotherapy in patients intolerant to UDCA.
High doses (25–50 mg daily, 2.5–5× the recommended limit) have been associated with hepatotoxicity, ascites, jaundice, and PBC flare-ups.
If overdose occurs, discontinue Ocaliva immediately and provide supportive management with close observation of hepatic parameters.