Indication:
• 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
• Non-alcoholic Steatohepatitis
Dosage & Administration:
Starting Dosage
The recommended starting dosage of Obeticholic Acid is 5 mg orally once daily.
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.
Preparation:
Livacol™ 10: Each box contains 10 tablets in blister pack.