Obeticholic acid

Cholagogue & Hepatic Preps · Farnesoid X receptor agonist

Indications

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.

Dosage

Adults: Initially 5 mg once daily for 6 mths, then increased to 10 mg once daily if necessary and if tolerated. For dose alterations due to severe pruritus, see product literature. Children: Not recommended.

Adverse Effects

GI upset, pruritus, fever, eczema, rash, fatigue, constipation, peripheral oedema, pyrexia, dizziness, palpitations, oropharyngeal pain, arthralgia, abnormal thyroid function.

Risk Factor (Pregnancy/Lactation)

Contraindications: Complete biliary obstruction. Precautions: Moderate to severe hepatic impairment. Monitor LFTs. Reduction in HDL-C: Monitor for changes in serum lipid levels during treatment.

Interactions

Warfarin, CYP1A2 substrates (eg: theophylline and tizanidine), bile acid sequestrants.

Advice to Patient

Take with or without meals. For patients taking bile acid binding resins, take medication at least 4 hrs before or 4 hrs after taking a bile acid binding resin, or at as great an interval as possible. Contact healthcare provider immediately if you experience symptoms of disease progression or worsening liver function, such as ascites, jaundice, gastrointestinal bleeding or worsening of hepatic encephalopathy. Contact healthcare provider immediately if you experience vomiting, abdominal pain, diarrhea, weight loss, fever and chills, worsening or new fatigue, weakness, loss of appetite or dehydration. Report new onset or worsening severe pruritus.

Pharmacokinetics

Metabolism: Hepatic. Time to peak, plasma: 1.5 hrs. Excretion: Faeces (87%). Urine (<3%).

Compiled by Healify Pharmacy from published drug references. How we compile it →

Always consult a pharmacist or doctor.