Indication

Obecol 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, cholestatic liver disease & non-alcoholic fatty liver disease (NAFLD) including non-alcoholic steatohepatitis (NASH).


Dosage & Administration

Starting Dosage The recommended starting dosage of Obeticholic Acid is 5 mg orally once daily in adult patients who have not achieved an adequate biochemical response to an appropriate dosage of Ursodeoxycholic Acid (UDCA) for at least 1 year or are intolerant to UDCA. Dosage Titration If an adequate reduction in alkaline phosphatase (ALP) and/or total bilirubin has not been achieved after 3 months of Obeticholic Acid 5 mg once daily, and the patient is tolerating Obeticholic Acid, increase the dosage of Obeticholic Acid to 10 mg once daily. Maximum Dosage The maximum recommended dosage of Obeticholic Acid is 10 mg once daily. Management of Patients with Intolerable Pruritus on Obeticholic Acid For patients with intolerable pruritus on Obeticholic Acid, consider one or more of the following:

  • Add an antihistamine or bile acid binding resin
  • Reduce the dosage of Obeticholic Acid to:

              � 5 mg every other day, for patients intolerant to 5 mg once daily

              � 5 mg once daily, for patients intolerant to 10 mg once daily

  • Temporarily interrupt Obeticholic Acid dosing for up to 2 weeks followed by restarting at a reduced dosage Increase the dosage of Obeticholic Acid to 10 mg once daily, as tolerated, to achieve optimal response. Consider discontinuing Obeticholic Acid treatment in patients who continue to experience persistent, intolerable pruritus.


Precautions

The following clinically significant reactions are described:

  • Liver-Related Adverse Reactions
  • Severe Pruritus
  • Reduction in high density lipoprotein-cholesterol (HDL-C)

Special monitoring is essential for the patient with such type of problems.


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