Pearl of daily medication: obeticholic acid (Ocaliva)

Obeticholic acid (Ocaliva) is indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults intolerant to UDCA. UDCA.

Pearl of the day medication: 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 monotherapy in adults unable to tolerate UDCA.

Insight:

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

Source:

LABEL (fda.gov)

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