Ocaliva Prescribing Information Updated to Reinforce Correct Dosing

A new Boxed Warning has been added to the labeling for Ocaliva
A new Boxed Warning has been added to the labeling for Ocaliva

The prescribing information for Ocaliva (obeticholic acid; Intercept) has been updated to clarify the recommendations for screening, dosing, monitoring, and managing primary biliary cholangitis (PBC) patients with moderate to severe liver disease. The update comes after the Food and Drug Administration (FDA) received several reports of serious liver injury and death associated with Ocaliva; many of these cases included patients with moderate to severe hepatic impairment who received the wrong dose.

A new Boxed Warning has been added to labeling and includes the following information:

  • In postmarketing reports, hepatic decompensation and failure, in some cases fatal, have been reported in patients with PBC with decompensated cirrhosis or Child-Pugh Class B or C hepatic impairment when Ocaliva was dosed more frequently than recommended.
  • The recommended starting dosage of Ocaliva is 5mg once weekly for patients with Child-Pugh Class B or C hepatic impairment or a prior decompensation event.

In addition, the updated labeling includes a table to provide recommended dosages based on disease stage and Child-Pugh classification. Clinicians are urged to routinely monitor patients for biochemical response, tolerability, and PBC progression as well as re-evaluate Child-Pugh classification to determine if a change in dose is necessary. For patients at increased risk for liver decompensation or progression to cirrhosis, close monitoring is recommended. 

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Intercept will continue studying Ocaliva in patients with advanced PBC; the results of these trials are expected in 2023. In the meantime, clinicians are encouraged to report any potential side effects related to Ocaliva to the FDA MedWatch program.

For more information visit FDA.gov.