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Ocaliva, a drug for primary biliary cholangitis: boxed warning added to highlight correct dosing

The FDA ( Food and Drug Administration ) is warning that the liver disease medicine Ocaliva ( Obeticholic acid ) has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis ( PBC ), a rare chronic liver disease, increasing the risk of serious liver injury.

To ensure correct dosing and reduce the risk of liver problems, FDA is clarifying the current recommendations for screening, dosing, monitoring, and managing PBC patients with moderate to severe liver disease taking Ocaliva.
FDA is adding a new Boxed Warning, FDA’s most prominent warning, to highlight this information in the prescribing information of the drug label.
FDA is also requiring a Medication Guide for patients to inform them about this issue.

As a condition of approval, FDA has required the manufacturer of Ocaliva, Intercept Pharmaceuticals, to continue studying the medicine in patients with advanced primary biliary cholangitis.
These clinical trials are currently ongoing and FDA expects to receive results in 2023.

FDA is adding the additional warnings to the drug label after receiving reports that Ocaliva is being given to PBC patients with moderate to severe liver impairment more often than is recommended in the prescribing information, resulting in liver decompensation, liver failure, and sometimes death.


Health care professionals should follow the Ocaliva dosing regimen in the drug label, which is based on calculating a Child-Pugh score in PBC patients with suspected liver cirrhosis before treatment to determine their specific classification and starting dosage.

Dosing higher than recommended in the drug label can increase the risk for liver decompensation, liver failure, and sometimes death.

Routinely monitor all patients for biochemical response, tolerability, and PBC progression, and re-evaluate Child-Pugh classification to determine if dosage adjustment is needed.

Close monitoring is recommended for patients at an increased risk of liver decompensation, including those with laboratory evidence of worsening liver function ( e.g., total bilirubin, INR, albumin ) or progression to cirrhosis.

Educate patients and caregivers on the symptoms of worsening liver function. Temporarily stop Ocaliva in those with laboratory or clinical evidence of worsening liver function that may indicate decompensation and monitor the patient’s liver function.
If a patient’s condition returns to baseline, weigh the potential risks and benefits of restarting Ocaliva.
Re-initiate, using the recommended starting dosage based on Child Pugh classification.

Consider discontinuing Ocaliva in patients who have experienced clinically significant liver-related adverse reactions. ( Xagena )

Source: FDA, 2018