FDA: Patients receiving incorrect Ocaliva dosage, reports of liver injury

The FDA released a report today that Ocaliva has been incorrectly prescribed to some patients with moderate to severe liver impairment and may be tied to cases of liver injury and death.

“These patients are receiving excessive dosing, particularly a higher frequency of dosing than is recommended in the drug label for them,” the FDA stated in their report. “Ocaliva may also be associated with liver injury in some patients with mild disease who are receiving the correct dose. The recommended dosing and monitoring for patients on Ocaliva are described in the current drug label. We are working with the drug manufacturer, Intercept Pharmaceuticals, to address these safety concerns.”

According to the report, patients with moderate to severe liver impairment, such as Child-Pugh score B or C, should begin Ocaliva (obeticholic acid, Intercept Pharmaceuticals) at 5 mg once weekly, rather than the daily dose of 5 mg used for other primary biliary cholangitis patients. If needed, dosage can be increased to 10 mg twice weekly.

Since Ocaliva’s approval, the FDA received reports of serious liver injury associated with Ocaliva. Of the 19 identified deaths, eight cases included cause of death. Worsening of PBC was the cause of death in seven cases and cardiovascular disease in the other. Further, seven of the eight cases described patients with moderate to severe liver impairment who received Ocaliva 5 mg daily.

In 11 cases of serious liver injury, six patients had moderate or severe liver impairment at baseline and developed serious liver injury after receiving Ocaliva 5 mg daily. Three of the six patients died, which were included in the 19 reported deaths. The other five cases of serious liver injury occurred in patients with no or mild liver impairment at baseline who also received Ocaliva 5 mg daily.

“Health care professionals should monitor patients frequently for disease progression, and reduce the dosing frequency to once- or twice-weekly for patients who progress to moderate or severe liver impairment,” the FDA wrote. “If liver injury is suspected, discontinue Ocaliva. After the patient has stabilized, weigh the benefits against the risks when deciding whether to re-initiate treatment. Educate patients on the symptoms of potential liver injury.”

Side effects involving Ocaliva can be reported to the FDA MedWatch program. – by Talitha Bennett

Reference: www.fda.gov