Warning issued on dosing of drug for primary biliary cholangitis

Clinicians should determine baseline liver function before starting patients on obeticholic acid, the FDA said.

Some clinicians are incorrectly dosing the primary biliary cholangitis drug obeticholic acid (Ocaliva) in patients with liver impairment, the FDA warned in September. The agency has received a number of reports of patient death and serious liver injury with use of the drug, which was approved in May 2016.

Prior to starting patients on the drug, clinicians should determine baseline liver function, the FDA stated. The drug label recommends that patients with moderate to severe liver impairment (Child-Pugh classes B and C) should be started on 5 mg of the drug once weekly, rather than the 5-mg daily dosing used for other patients, due to increased risk for liver injury and death. If needed, the dose may be increased to a maximum of 10 mg twice weekly.

The drug may also be associated with liver injury in some patients with mild disease who are receiving the correct dose, according to the FDA. The agency is working with the manufacturer to address these safety concerns.