Obeticholic Acid

How it works

As a semi-synthetic bile acid analogue it activates the farnesoid X receptor, reducing bile acid synthesis and increasing bile acid clearance, which lessens hepatocellular bile acid accumulation.

Prescribing in practice

• It is contraindicated in decompensated cirrhosis and complete biliary obstruction, and serious liver injury has been reported, so it must not be used in advanced hepatic impairment.
• Dosing is reduced and given less frequently in patients with moderate to severe hepatic impairment.
• Pruritus is a very common dose-limiting effect that may require dose adjustment or symptomatic treatment.

Monitoring

Monitor liver biochemistry regularly and watch for signs of hepatic decompensation, dose-adjusting or stopping if liver function deteriorates.

Counselling the patient

• Warn patients that itching is common and to report it, as it can often be managed.
• Tell patients to seek urgent help if they notice jaundice, dark urine, abdominal swelling or confusion.

Evidence & guidelines

An MHRA Drug Safety Update has highlighted the risk of serious liver injury and contraindication in cirrhosis with portal hypertension; use should follow current hepatology guidance and the SPC.