ClinCalc Pro
Menu
Calculators Drugs Pathways AI Dx Donate Get the App
Farnesoid X Receptor (FXR) Agonist Pregnancy: Contraindicated — insufficient data; potential risk to fetus. Discontinue before conception.

Obeticholic Acid

Brand names: Ocaliva

Adult dose

Dose: PBC with inadequate response to UDCA (or UDCA-intolerant): 5mg once daily for first 6 months. If well tolerated, increase to 10mg once daily. UDCA-intolerant monotherapy: 10mg once daily.
Route: Oral
Frequency: Once daily
Max: 10mg once daily
Decompensated cirrhosis or Child-Pugh B/C: maximum 5mg once per week (markedly reduced hepatic clearance — risk of acute liver failure and death at standard doses). MHRA/FDA Black Box Warning: do not use at standard doses in decompensated cirrhosis. NICE TA443: recommended as add-on to UDCA or monotherapy in UDCA-intolerant patients.

Paediatric dose

Route: N/A
Frequency: N/A
Max: Not licensed in children
Not licensed in patients under 18 years. Seek specialist opinion.

Dose adjustments

Renal

No dose adjustment required.

Hepatic

CRITICAL: Decompensated cirrhosis (Child-Pugh B or C): maximum 5mg ONCE WEEKLY — not daily. Standard doses cause fatal liver failure in decompensated disease.

Clinical pearls

  • POISE trial: obeticholic acid significantly reduced ALP and total bilirubin in PBC patients with inadequate UDCA response at 12 months.
  • Pruritus management: start at 5mg and uptitrate slowly. If pruritus intolerable, add colestyramine (4–8g/day, separated from obeticholic acid by ≥4 hours) or rifampicin 150mg BD.
  • Black Box Warning: fatal liver failure reported in cirrhotic patients given standard daily doses. Dose-reduce to 5mg WEEKLY in Child-Pugh B or C.
  • NICE TA443: recommended only as second-line add-on to UDCA when ALP ≥1.67× ULN or total bilirubin above ULN after ≥12 months on adequate UDCA.

Contraindications

  • Complete biliary obstruction
  • Decompensated cirrhosis at standard doses (use maximum 5mg weekly only)

Side effects

  • Pruritus (most common — occurs in up to 70% of patients; may require dose reduction or antihistamine)
  • Fatigue
  • Abdominal pain
  • Elevated liver enzymes (transient — monitor LFTs)
  • Acute liver failure (in decompensated cirrhosis at standard doses — Black Box Warning)

Interactions

  • Bile acid sequestrants (colestyramine, colestipol): reduce obeticholic acid absorption — separate by at least 4–6 hours
  • Warfarin: may alter INR — monitor
  • CYP1A2 substrates (theophylline, tizanidine): obeticholic acid inhibits CYP1A2 — increased substrate levels

Monitoring

  • LFTs and bilirubin (baseline, monthly for first year, then every 6 months)
  • ALP and GGT (treatment response markers in PBC)
  • Pruritus severity (use VAS or NRS)
  • Child-Pugh score (hepatic decompensation surveillance)

Reference: BNFc; BNF 90; NICE TA443 (Obeticholic Acid for PBC); POISE Trial (Nevens et al, Lancet 2016); BSG PBC Guidelines 2018. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

Calculators
Pathways