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Another NameLuciObe,Obetix,Ocaliva
IndicationsIt is indicated for the treatment of adult patients with primary biliary cholangitis who have an inadequate response to or are intolerant of ursodeoxycholic acid (UDCA), and who have no cirrhosis or h
Reg No.03 L 1318/25
Inspection NO.573-25
The Lucius version of obeticholic acid is a medication option for the
treatment of specific types of liver diseases.
Detailed Introduction to Obeticholic Acid
The active ingredient of obeticholic acid is obeticholic acid, which is a farnesoid X receptor (FXR) agonist.
It is indicated for adult patients with primary biliary cholangitis (PBC) who have no cirrhosis or have compensated cirrhosis without evidence of portal hypertension, especially those with an inadequate response to or intolerance of ursodeoxycholic acid (UDCA).
The initial dose is 5 mg once daily for 3 months. If alkaline phosphatase (ALP) and/or total bilirubin levels are not significantly reduced after 3 months and the patient is well-tolerated, the dose may be increased to 10 mg once daily.
Data on use in pregnant women are limited, and animal studies have not shown teratogenicity. Lactating women should weigh the potential benefits against the risks. The safety and efficacy in pediatric patients have not been established. Dose adjustment and close monitoring are required for elderly patients and those with hepatic or renal impairment.
Overdose may lead to severe hepatic adverse reactions. Close observation and supportive care should be provided.
Store at 20°C to 25°C (68°F to 77°F), with short-term temperature excursions permitted between 15°C and 30°C (59°F to 86°F).
Obeticholic acid is rapidly absorbed after oral administration, and co-administration with food does not affect the extent of absorption. It is mainly metabolized in the liver. When used concomitantly with bile acid sequestrants, an interval of at least 4 hours should be maintained between doses.
FDA，2022.02
