Obeticholic Acid (Ocaliva) is prescribed in patients with primary biliary cholangitis (PBC). A number of fatalities have occurred, probably related to errors in dosing.
Obeticholic acid is used in patients who have either not achieved an adequate response to ursodeoxycholic acid or intolerant to ursodeoxycholic acid therapy.
Errors associated with increased risk for adverse effects:
(1) use in a patient with complete biliary obstruction (absolute contraindication)
(2) failure to reduce dosage in a patient with moderate or severe liver disease (such a patient should not receive more than 10 mg twice per week with doses 3-4 days apart)
(3) failure to monitor the patient for evidence of deterioration of liver function over time, necessitating a decrease in dosage and possibly indicating hepatotoxicity
(4) giving a dose to a patient with mild liver disease that exceeds the maximum daily dose of 10 mg
(5) using the drug in a pediatric patient
Errors affecting concurrent medications:
(1) failure to monitor drugs metabolized by the cytochrome P450 CYP1A3 pathway such as theophylline
(2) failure to monitor INR in patients being treated concurrently with warfarin/coumadin.
Errors associated with decreased effectiveness:
(1) administering a dose close to a dose of cholestyramine or other bile salt binding resin.
