Obeticholic acid

Obeticholic acid is a prescription medication used to treat primary biliary cholangitis. 

Obeticholic acid is a semi-synthetic derivative of bile acid. This drug works by binding to a receptor in the liver, intestines, kidney, and adipose tissue and changing the body’s metabolism of lipids.

This medication is available as a tablet and is typically taken once a day, with or without food. 

Common side effects of obeticholic acid include itching, fatigue, stomach pain, joint pain, throat pain, and constipation. Obeticholic acid may cause dizziness. Do not drive or operate heavy machinery until you know this medication affects you. 

Obeticholic acid may be found in some form under the following brand names:

• Ocaliva

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose range of obeticholic acid for the treatment of primary biliary cholangitis is 5-10 mg by mouth once daily. 

The recommended dose and schedule differs based on disease state and Child-Pugh classification. 

If you are non-cirrhotic or have Child-Pugh Class A, the recommended doses are:

• Starting dosage for first 3 months: obeticholic acid 5 mg by mouth once daily
• Dose titration after first 3 months: obeticholic acid 10 mg by mouth once daily
• Maximum dosage: obeticholic acid 10 mg by mouth once daily

If you are Child-Pugh Class B or C or have had a decompensated event, the recommended doses are:

• Starting dose for first 3 months: obeticholic acid 5 mg by mouth once weekly
• Dose titration after first 3 months: obeticholic acid 5 mg by mouth twice weekly (at least 3 days apart). May increase dose to 10 mg by mouth twice weekly (at least 3 days apart) based on response and tolerability. 
• Maximum dosage: obeticholic acid 10 mg by mouth twice weekly (at least 3 days apart)

Warning: Hepatic decompensation and failure in incorrectly dosed PBC patients with Child-Pugh Class B or C or decompensated cirrhosis.

• In postmarketing reports, hepatic decompensation and failure, in some cases fatal, have been reported in patients with Primary Biliary Cholangitis (PBC) with decompensated cirrhosis or Child-Pugh Class B or C hepatic impairment when obeticholic acid was dosed more frequently than recommended.
• The recommended starting dosage of obeticholic acid is 5 mg once weekly for patients with Child-Pugh Class B or C hepatic impairment or a prior decompensation event.