Uses

Obeticholic acid is a farnesoid X receptor (FXR) agonist indicated for the treatment of primary biliary cholangitis (PBC) in adults, either as monotherapy in patients intolerant to ursodeoxycholic acid, or in combination with ursodeoxycholic acid in patients with an inadequate response.

Do not use if

Contraindicated in patients with complete biliary obstruction. Should not be used in patients with decompensated cirrhosis, Child-Pugh B or C, or prior hepatic decompensation events, due to risk of serious liver injury.

Side effects

The most common side effects include pruritus, fatigue, abdominal pain and discomfort, rash, arthralgia, oropharyngeal pain, dizziness, and constipation. Pruritus is the most frequently reported adverse effect.

Warnings

Risk of serious liver injury including hepatic decompensation and failure, particularly in patients with advanced cirrhosis. Liver function and bilirubin should be monitored regularly. Dose reduction is required in patients with moderate to severe hepatic impairment.

How it works

Obeticholic acid is a semi-synthetic bile acid analogue and potent FXR agonist. Activation of FXR reduces bile acid synthesis in the liver, decreases hepatic inflammation and fibrosis, and improves cholestatic liver disease by modulating bile acid homeostasis.

Storage

Store at room temperature, typically 20°C to 25°C. Keep in original packaging, protected from moisture.