Drug Action
Obeticholic acid is a selective farnesoid X Gastro-intestinal system receptor agonist, which decreases circulating bile acid.
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Drug reference
Obeticholic acid is a selective farnesoid X Gastro-intestinal system receptor agonist, which decreases circulating bile acid.
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Primary biliary cholangitis in combination with ursodeoxycholic acid when response to ursodeoxycholic acid has been inadequate, or as monotherapy in patients intolerant of ursodeoxycholic acid ▶BY MOUTH ▶Adult: Initially 5 mg once daily for 6 months, then increased to 10 mg once daily if necessary and if tolerated, for dose adjustments due to severe pruritus, consult product literature
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Complete biliary obstruction
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NICE decisions ▶Obeticholic acid for treating primary biliary cholangitis (April 2017) NICE TA443 Obeticholic acid (Ocaliva ®) is recommended as an option for treating primary biliary cholangitis, in combination with ursodeoxycholic acid when response to ursodeoxycholic acid is inadequate, or as monotherapy when ursodeoxycholic acid is not tolerated and only if the manufacturer provides obeticholic acid with the discount agreed in the patient access scheme. Response to obeticholic acid should be assessed after 12 months and treatment continued only if there is evidence of clinical benefit. www.nice.org.uk/guidance/ta443 Scottish Medicines Consortium (SMC) decisions The Scottish Medicines Consortium has advised (June 2017) that obeticholic acid (Ocaliva ®) is accepted for use within NHS Scotland for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid when response to ursodeoxycholic acid is inadequate, or as monotherapy when ursodeoxycholic acid is not tolerated. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
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MHRA/CHM 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) The MHRA is aware of reports of serious liver injuries and deaths in patients with primary biliary cholangitis with pre-existing moderate or severe liver impairment who were not adequately dose-adjusted. Follow dose reduction and monitoring advice in these patients to reduce the risk of serious liver injury; for further information, see Hepatic impairment and Monitoring.
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→Appendix 1: obeticholic acid
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▶Common or very common Arthralgia. constipation. dizziness. fatigue. fever. gastrointestinal discomfort. oropharyngeal pain. palpitations. peripheral oedema. skin reactions ▶Frequency not known Hepatic failure
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Dose adjustments No evidence of harm but manufacturer advises avoid.
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Not known to be harmful but manufacturer advises avoid.
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Manufacturer advises caution in moderate to severe impairment or decompensated cirrhosis (risk of increased exposure). Dose adjustments Manufacturer advises initial dose reduction to 5 mg once weekly in moderate to severe impairment or decompensated cirrhosis; titrate dose according to alkaline phosphatase and/or total bilirubin level—consult product literature.
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Manufacturer advises assess hepatic status before treatment initiation and then monitor for progression of primary biliary cholangitis with laboratory and clinical assessment to evaluate the need for dose reduction; patients at an increased risk of hepatic decompensation, including those with laboratory evidence of worsening liver function and/or progression to cirrhosis, should be monitored more closely.
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There can be variation in the licensing of different medicines containing the same drug. Tablet ▶Ocaliva (Intercept Pharma UK & Ireland Ltd) A Obeticholic acid 5 mg Ocaliva 5mg tablets | 30 tablet P £2,384.04 (Hospital only) Obeticholic acid 10 mg Ocaliva 10mg tablets | 30 tablet P £2,384.04 (Hospital only)
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Initially 5 mg once daily for 6 months, then
First-line fragment. Read the complete Indications and Dose section above.
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