Active Ingredient: Obeticholic acid
Obeticholic acid is indicated for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 5 milligrams obeticholic acid, once daily, over the duration of 6 months. Afterwards, oral, between 5 milligrams obeticholic acid and 10 milligrams obeticholic acid, once daily.
Prior to initiation of treatment with obeticholic acid the patient’s hepatic status must be known. Whether the patient has decompensated cirrhosis (including Child-Pugh Class B or C) or has had a prior decompensation event should be determined prior to initiation of treatment because obeticholic acid is contraindicated in these patients.
The starting dose of obeticholic acid is 5 mg once daily for the first 6 months.
After the first 6 months, for patients who have not achieved an adequate reduction in alkaline phosphatase (ALP) and/or total bilirubin and who are tolerating obeticholic acid, increase to a maximum dose of 10 mg once daily.
No dose adjustment of concomitant UDCA is required in patients receiving obeticholic acid.
Management strategies include the addition of bile acid binding resins or antihistamines.
For patients experiencing severe intolerability due to pruritus, one or more of the following should be considered:
Discontinuing treatment with obeticholic acid may be considered for patients who continue to experience persistent, intolerable pruritus.
For patients taking bile acid binding resins, obeticholic acid should be administered at least 4 to 6 hours before or 4 to 6 hours after taking a bile acid binding resin, or at as great an interval as possible.
If a dose is missed, the missed dose should be skipped and the normal schedule should be resumed for the following dose. A double dose should not be taken to make up for the missed dose.
It should be taken orally with or without food.
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