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FXR Agonist (Primary Biliary Cholangitis)

Obeticholic Acid

Brand names: Ocaliva

Obeticholic acid is a farnesoid X receptor agonist used as second-line treatment for primary biliary cholangitis, usually combined with ursodeoxycholic acid when response is inadequate or as monotherapy in intolerance.

Dosing — being independently re-sourced

ClinCalc Pro is rebuilding its dose data from primary open sources — the manufacturer SmPC (eMC), the WHO Model Formulary and other official references — under clinician review. This drug's structured dose is not yet published here. Confirm all doses against the product SmPC and your local formulary before prescribing.

Clinical monograph

How it works

As a potent agonist of the nuclear farnesoid X receptor, it modulates bile acid synthesis, transport and secretion, reducing the hepatic accumulation of toxic bile acids that drives cholestatic liver injury.

Prescribing in practice

  • It is contraindicated in decompensated cirrhosis and complete biliary obstruction, and the MHRA has warned of serious liver injury and the need for careful dosing and monitoring in those with hepatic impairment.
  • Dose-related pruritus is the most common adverse effect and can limit tolerability, sometimes requiring dose adjustment or symptomatic treatment.
  • It can reduce HDL cholesterol and may require less frequent dosing in moderate to severe hepatic impairment.

Monitoring

Monitor liver biochemistry regularly to assess response and detect hepatotoxicity, and review for worsening cholestatic itch and signs of hepatic decompensation.

Counselling the patient

  • Report any worsening itching, which is common and can often be managed.
  • Seek prompt advice if you notice jaundice, dark urine, abdominal swelling or confusion.
  • Attend your blood tests so your liver function can be checked.

Evidence & guidelines

Obeticholic acid is recommended by NICE as an option for primary biliary cholangitis inadequately controlled by, or intolerant of, ursodeoxycholic acid, with MHRA safety advice on hepatic monitoring.

Reference: NICE TA443 (obeticholic acid for PBC); Nevens et al. Lancet 2016 (POISE trial); MHRA Drug Safety Update 2021 (hepatic decompensation); EASL PBC Clinical Practice Guidelines 2017; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.