FDA adds Boxed Warning to highlight correct dosing of Ocaliva (obeticholic acid) for patients with a rare chronic liver disease

1ST FEB 2018

The Food and Drug Administration (FDA) has warned 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, the FDA are clarifying the current recommendations for screening, dosing, monitoring, and managing PBC patients with moderate to severe liver disease taking Ocaliva. The FDA are adding a new Boxed Warning, FDA’s most prominent warning, to highlight this information in the prescribing information of the drug label. They are also requiring a Medication Guide for patients to inform them about this issue.

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 (see Table below).  

Table below is for illustration only, please always refer to the drug label for confirmation.

Staging / Classification

Non-Cirrhotic or
Child-Pugh Class A

Child-Pugh Class B or C or 
Patients with a Prior 
Decompensation Eventa

Starting OCALIVA Dosage for first 3 months

5 mg once daily

5 mg once weekly

OCALIVA Dosage Titration after first 3 months, for patients who have not achieved an adequate reduction in ALP and/or total bilirubin and who are tolerating OCALIVAb

10 mg once daily

5 mg twice weekly (at least 3 days apart)

Titrate to 10 mg twice weekly (at least 3 days apart) based on response and tolerability

Maximum OCALIVA Dosage

10 mg once daily

10 mg twice weekly 
(at least 3 days apart)

a Gastroesophageal variceal bleeding, new or worsening jaundice, spontaneous bacterial peritonitis, etc.
b Prior to dosage adjustment, re-calculate the Child-Pugh classification