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Before initiating treatment with Obeticholic Acid Tablets (OCALIVA®), healthcare providers should confirm whether patients have the following conditions: decompensated cirrhosis (e.g., Child-Pugh Class B or C), a history of decompensation events related to cirrhosis, or compensated cirrhosis with evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia). This is because Obeticholic Acid Tablets (OCALIVA®) are contraindicated in the aforementioned patients.
For adult patients with primary biliary cholangitis (PBC) who have no cirrhosis or have compensated cirrhosis without evidence of portal hypertension, and meet one of the following criteria, the recommended dosing regimen for Obeticholic Acid Tablets (OCALIVA®) is as follows:
Having received an adequate dose of ursodeoxycholic acid (UDCA) for at least 1 year without achieving a sufficient biochemical response;
Being intolerant to ursodeoxycholic acid (UDCA) treatment.
Specific Dosing Regimen:
For the first 3 months of treatment: the initial dose is 5 mg once daily.
After 3 months of treatment: if the patient’s alkaline phosphatase (ALP) and/or total bilirubin levels have not been sufficiently reduced, and the patient is well-tolerated to Obeticholic Acid Tablets (OCALIVA®), the dose may be increased to 10 mg once daily (maximum recommended dose).
During treatment with Obeticholic Acid Tablets (OCALIVA®), patients should be monitored regularly for the following: biochemical response, tolerability, and disease progression of primary biliary cholangitis (PBC). For patients with compensated cirrhosis, concomitant liver diseases (e.g., autoimmune hepatitis, alcoholic liver disease) and/or severe comorbidities, close monitoring is required for the emergence of new evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia), or elevations of total bilirubin, direct bilirubin, and prothrombin time beyond the upper limit of normal.
Permanent discontinuation of Obeticholic Acid Tablets (OCALIVA®) is required if any of the following occurs:
Development of laboratory or clinical evidence of hepatic decompensation;
New onset of portal hypertension evidence in patients with compensated cirrhosis;
Occurrence of clinically significant hepatic adverse reactions;
Development of complete biliary obstruction.
For patients who experience intolerable pruritus during treatment with Obeticholic Acid Tablets (OCALIVA®), one or more of the following management strategies may be considered:
Addition of antihistamines or bile acid sequestrants;
Dose reduction of Obeticholic Acid Tablets (OCALIVA®), with specific adjustments as follows:
For patients intolerant to the 5 mg once-daily dose: adjust to 5 mg once every two days;
For patients intolerant to the 10 mg once-daily dose: adjust to 5 mg once daily;
Temporary interruption of Obeticholic Acid Tablets (OCALIVA®) administration for a maximum duration of 2 weeks, with re-initiation of treatment at a reduced dose.
For patients with dose reduction or treatment interruption, the dose should be readjusted based on their biochemical response and tolerability. If the patient continues to experience intolerable pruritus despite the above management strategies, discontinuation of Obeticholic Acid Tablets (OCALIVA®) should be considered.
Obeticholic Acid Tablets (OCALIVA®) may be taken with or without food.
For patients who need to take bile acid sequestrants, the time of administration of Obeticholic Acid Tablets (OCALIVA®) should be separated from that of bile acid sequestrants by at least 4 hours (it may be taken 4 hours before or after bile acid sequestrants), or the interval between administrations should be extended as much as possible.
FDA，2022.02
