Finished product reference
Obeticholic Acid
Tablet · Oral · 5 mg
- List code
- 53628
- Pharmacologic class
- Farnesoid X receptor (FXR) agonist; semi-synthetic bile acid analogue
What it is and how it works
Obeticholic acid is a selective FXR agonist that suppresses de novo bile acid synthesis from cholesterol and increases bile acid transport out of hepatocytes, reducing hepatic exposure to bile acids.
Indications
Primary biliary cholangitis in combination with ursodeoxycholic acid in adults with inadequate response, or as monotherapy in those intolerant of ursodeoxycholic acid (EU conditional authorisation was revoked in 2024; availability varies by country).
Dosage and administration (summary)
Oral: 5 mg once daily, increased to 10 mg once daily after 6 months if tolerated and response is inadequate; reduced dosing applies in hepatic impairment per label.
Contraindications
Decompensated cirrhosis (Child-Pugh B or C) or prior decompensation events, and complete biliary obstruction.
Warnings and precautions
Hepatic decompensation and failure, sometimes fatal, have been reported, particularly with incorrect dosing in cirrhosis; monitor liver function and clinical status. Pruritus is common and dose-related. May reduce HDL-cholesterol.
Pregnancy
Avoid in pregnancy because data are limited.
Storage and supply
Store below 25–30 °C.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
Tell us the quantity, the market and the timing.
Send the molecule or ingredient, the specification and the destination. We reply from Tehran with the questions, the documents and the next step.