Drugs affecting biliary composition and flow (Formulary: GI)

TAM (Treatments and Medicines) NHS Highland
NHS Highland

URSODEOXYCHOLIC ACID - (First line)

Therapy notes

Tolerance can vary between individual brands; if necessary consider brand name prescribing.

Formulation and dosage details

Formulation:

  • Tablets 250mg

Indication: 

  • Primary biliary cirrhosis: 10 to 15mg/kg daily in 2 to 4 divided doses.

Formulation and dosage details

Formulation:

  • Capsules 250mg

Indication: 

  • Primary biliary cirrhosis: 10 to 15mg/kg daily in 2 to 4 divided doses.

OBETICHOLIC ACID - (Second line)

Therapy notes


MHRA advice: Obeticholic Acid (Ocaliva): risk of serious liver injury in patients with pre-existing moderate or severe hepatic impairment; reminder to adjust dosing according to liver function monitoring (April 2018) (www.gov.uk).

Note:

  • The most commonly reported adverse reaction is pruritus, which may lead patients to discontinue treatment.
  • Manufacturer information states that the majority occurred within the first month of treatment and tended to resolve over time with continued dosing.
  • To be discussed with patient with a plan for treatment, if needed. 

Formulation and dosage details

Formulation:

  • Tablets 5mg, 10mg (Restricted: Specialist recommendation only)

Initiation only on discussion and advice from the Liver MDT. All patients should be reviewed at 1 year to discontinue if no biochemical response.

Indication:

  • As per SMC 2132/17 (Ocaliva®) for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid in adults with an inadequate response to ursodeoxycholic acid or as monotherapy in adults unable to tolerate ursodeoxycholic acid.

ELAFIBRANOR - (Second line)

Therapy notes

Note: 

  • Liver function and CK should be checked at baseline and periodically during treatment. Monitor CK periodically during treatment and advise patients to promptly report an unexplained muscle symptoms, such as pain, soreness, or weakness.
  • Monitoring will be performed by the specialist service. 
  • Females of childbearing potential should use effective contraception during treatment and for at least 3 weeks after last treatment. 
  • Not recommended during pregnancy or breast feeding.

Formulation and dosage details

Formulation:

  • Tablets 80mg (Restricted: Specialist initiation only) 

Indication:

  • As per SMC 2714 (Iqirvo): for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.
Homecare is the preferred option: contact nhsh.homecare@nhs.scot

Editorial Information

Last reviewed: 30/04/2026

Author(s): Gastroenterology.

Version: 3

Approved By: TAM Subgroup of the ADTC

Reviewer name(s): Dr A Broad, Consultant Gastroenterologist, C Wheelan, Lead Pharmacist Gastroenterology.

Document Id: F229