Obeticholic Acid

Adults: Important dosage and administration instructions come first. Before starting Obeticholic acid, the doctor should find out whether the patient has decompensated cirrhosis (for example Child-Pugh Class B or C), has had a prior decompensation event, or has compensated cirrhosis with evidence of portal hypertension (for example ascites, gastroesophageal varices, persistent thrombocytopenia). Obeticholic acid is contraindicated in these patients. The recommended dosage regimen is for PBC patients without cirrhosis, or with compensated cirrhosis who have no evidence of portal hypertension. These patients have not achieved an adequate biochemical response to an appropriate dosage of UDCA for at least 1 year, or they are intolerant to UDCA. Start with 5 mg once daily for the first 3 months. After the first 3 months, if the patient has not achieved an adequate reduction in ALP and/or total bilirubin and is tolerating Obeticholic acid, increase to a maximum dosage of 10 mg once daily. Monitoring is how you assess safety and the need for Obeticholic acid discontinuation. Routinely monitor patients during treatment for biochemical response, tolerability and progression of PBC. Closely monitor patients with compensated cirrhosis, concomitant hepatic disease (for example autoimmune hepatitis, alcoholic liver disease) and/or severe intercurrent illness. Look for new evidence of portal hypertension (for example ascites, gastroesophageal varices, persistent thrombocytopenia) or increases above the upper limit of normal in total bilirubin, direct bilirubin or prothrombin time. Permanently discontinue Obeticholic acid in patients who develop laboratory or clinical evidence of hepatic decompensation, have compensated cirrhosis and develop evidence of portal hypertension, experience clinically significant hepatic adverse reactions, or develop complete biliary obstruction. For the management of intolerable pruritus on Obeticholic acid, consider one or more of these strategies. Add an antihistamine or bile acid-binding resin. Reduce the dosage to 5 mg every other day for patients intolerant to 5 mg once daily, or to 5 mg once daily for patients intolerant to 10 mg once daily. Another option is to temporarily interrupt dosing for up to 2 weeks and then restart at a reduced dosage. When the dosage has been reduced or interrupted, titrate it based on biochemical response and tolerability. If a patient still has persistent, intolerable pruritus despite these strategies, consider discontinuing Obeticholic acid.