About obeticholic acid
Farnesoid X receptor agonist
Used for
- Used with ursodeoxycholic acid for primary biliary cholangitis when response is inadequate.
- Used alone for primary biliary cholangitis when ursodeoxycholic acid is not tolerated.
Usual adult dose
Usually 5 mg once daily; increase to 10 mg once daily after 3 months if needed and tolerated. Liver impairment may require less frequent dosing.
Common side effects
- Itching
- Fatigue
- Abdominal pain or discomfort
- Rash
Important warnings
- Can cause serious liver injury, including liver failure, especially with advanced cirrhosis.
- Not for people with decompensated cirrhosis or compensated cirrhosis with portal hypertension.
- Monitor liver tests and symptoms of worsening liver disease.
- May worsen itching; dose reduction or interruption may be needed.
Pregnancy
Human pregnancy data are limited; potential risks are uncertain.
Breastfeeding
It is unknown whether obeticholic acid passes into human milk; effects on infants are uncertain.
Interactions
- Bile acid binding resins can reduce absorption; separate doses by at least 4 hours.
- May increase exposure to warfarin; monitor INR.
- May increase exposure to theophylline; monitor concentrations.
- May increase exposure to CYP1A2 substrates such as tizanidine.
AI-generated from general medical knowledge, not from this product's official leaflet. It may be incomplete or out of date. Not medical advice — ask a pharmacist or doctor before making any decision.