Formulary
Obeticholic acid: Indications, Dosing, Side Effects and Interactions
Obeticholic acid is a selective farnesoid X receptor agonist, which decreases circulating bile acid.
MedNext Academy | 3 min read
Obeticholic acid: Indications, Dosing, Side Effects and Interactions
Obeticholic acid is a selective farnesoid X receptor agonist, which decreases circulating bile acid.
Drug action
Obeticholic acid is a selective farnesoid X receptor agonist, which decreases circulating bile acid.
Indications and dose
**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**
- **Adult** (By Mouth): 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.
Contraindications
Complete biliary obstruction
Side effects
Common or very common Arthralgia; constipation; dizziness; fatigue; fever; gastrointestinal discomfort; oropharyngeal pain; palpitations; peripheral oedema; skin reactions Frequency not known Hepatic failure
Interactions
**Other interactions (3):**
- Effect of obeticholic acid on other medicinal products Warfarin International normalised ratio (INR) is decreased following co-administration of warfarin and obeticholic acid.
- INR should be monitored and the dose of warfarin adjusted, if needed, to maintain the target INR range when co-administering obeticholic acid and warfarin.
- Therapeutic monitoring of CYP1A2 substrates with narrow therapeutic index (e.g., theophylline and tizanidine) is recommended.
Pregnancy
No evidence of harm but manufacturer advises avoid.
Breast feeding
Not known to be harmful but manufacturer advises avoid.
Hepatic impairment
Important safety information For obeticholic acid 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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Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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