Daily Medication Pearl: Obeticholic Acid (Ocaliva)

Medication Pearl of the Day: Obeticholic Acid (Ocaliva)

Indication: Obeticholic acid (Ocaliva), a farnesoid X receptor (FXR) agonist, is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.

Insight:

• Dosing: The recommended starting dosage of Ocaliva is 5 mg orally once daily in adults who have not achieved an adequate response to an appropriate dosage of UDCA for at least 1 year or are intolerant to UDCA.
• Dosage forms: Tablets 5 mg, 10 mg
• Adverse events: Most common adverse reactions (≥ 5%) are pruritus, fatigue, abdominal pain and discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality, and eczema.
• Mechanism of action: Obeticholic acid is an agonist for FXR, a nuclear receptor expressed in the liver and intestine. FXR is a key regulator of bile acid, inflammatory, fibrotic, and metabolic pathways. FXR activation decreases the intracellular hepatocyte concentrations of bile acids by suppressing de novo synthesis from cholesterol as well as by increased transport of bile acids out of the hepatocytes.
• Manufacturer: Intercept Pharma

Source:

LABEL (fda.gov)