FDA adds boxed warning, requires medication guide for PBC drug Ocaliva

The FDA has added a new boxed warning to Ocaliva, a treatment for primary biliary cholangitis, to clarify current recommendations, according to a release from the agency. The FDA will also require a medication guide for patients, as incorrect dosage can lead to liver injury.

“Following extensive review of postmarketing data, we remain confident in Ocaliva's safety profile and the benefit it provides when used as directed in patients with PBC, a devastating disease that is one of the leading causes of liver failure in women,” Mark Pruzanski, MD, president and CEO of Ocaliva’s manufacturer Intercept, said in a company press release. “The focus of our label update is to aid physicians in identifying and appropriately dosing Ocaliva in the most vulnerable PBC patients with advanced cirrhosis.”

An FDA report from September 2017 showed that when patients with cirrhosis incorrectly received a prescription for Ocaliva (obeticholic acid), it led to severe liver impairment. Incorrect prescription may have also been the cause of liver injury and death in certain cases.

The FDA recommends that prescribing physicians monitor patients on Ocaliva for biochemical response, tolerability, PBC progression and Child-Pugh score. Physicians should closely monitor patients at risk for liver decompensation, such as those with evidence of worsening total bilirubin, international normalized ratio and albumin levels.

Additionally, prescribing physicians should educate patients and caregivers on the symptoms of worsening liver function. Patients with evidence of worsening liver function should temporarily discontinue Ocaliva. Reinitiation should begin with the recommended starting dosage based on Child-Pugh score.

A condition of the FDA’s approval of Ocaliva included continued clinical trials. The FDA expects the results in 2023.

According to Intercept’s recent press release, the company is also working with the European Medicines Agency to update Ocaliva’s European Summary of Product Characteristics and will issue a Direct Healthcare Professional Communication to educate physicians on appropriate dosage for patients with advanced cirrhosis.

Reference: www.fda.gov; www.interceptpharma.com