Indication
Obeticholic acid is indicated for the treatment of adult patients with primary biliary cholangitis (PBC) without cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension, Either in combination with Ursodeoxycholic Acid (UDCA) with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA.
Dosage and Administration
Route of administration: Orally
The usual starting dosage for PBC patients without cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension who have not achieved an adequaternbiochemical response to an appropriate dosage of Ursodeoxycholic Acid (UDCA) for at least 1 year or are intolerant to UDCA follows below:
Start with dosage of 5 mg once daily for first 3 months. After 3 months, for patients who have not achieved adequate reduction in Alkaline phosphate (ALP) and / or total bilirubin and who are tolerating Obeticholic Acid increase to the maximum dosage 10 mg once daily.
Management of patient with intolerable pruritus:
Add an antihistamine or bile acid binding resin. Reduce the dosage to 5 mg every other day, for patients intolerable to 5 mg once daily, 5 mg once daily for patients intolerant to 10 mg once daily. Temporarily interrupt dosing for up to 2 weeks followed by restart at a reduced dosage and titrate the dosage to 10 mg once daily base on biochemical response.
Or as directed by the physician.
Composition
Olic 5 Tablet: Each Box contains 2x10 Tablets in Alu-Alu blister.
Olic 10 Tablet: Each Box contains 1x10 Tablets in Alu-Alu blister.