Drugs

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

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Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. This is Lesley Navin, Advanced Practice Nurse.

On February 1, 2018 FDA is warning that the medicine Ocaliva (active ingredient obeticholic acid) has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis (or PBC), a rare chronic liver disease, increasing the risk of serious liver injury. To ensure correct dosing and reduce the risk of liver problems, we are clarifying the current recommendations for screening, dosing, monitoring, and managing PBC patients with moderate to severe liver disease taking Ocaliva. We are adding a new Boxed Warning, FDA’s most prominent warning, to highlight this information in the prescribing information of the drug label and are also requiring a Medication Guide for patients to inform them about this issue.

Ocaliva works by increasing bile flow from the liver, suppressing bile acid production in the liver and reducing the exposure of the liver to toxic levels of bile acids. Progressive PBC can lead to liver failure or death. Treatment of PBC with Ocaliva may delay or prevent progression of the disease.

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. Close monitoring is recommended for patients at an increased risk of liver decompensation.

Educate patients and caregivers on the symptoms of worsening liver function. Temporarily stop Ocaliva in patients 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 risks and benefits of restarting Ocaliva. Re-initiate using the recommended starting dosage based on Child-Pugh classification.

As a condition of approval, FDA required the manufacturer of Ocaliva, Intercept Pharmaceuticals, to continue studying the medicine in patients with advanced PBC. FDA expects to receive results from these clinical trials in 2023. FDA will continue to monitor this medicine and update the public if new information becomes available.

Report side effects involving Ocaliva and other medicines to the FDA MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing information for health care professionals including Ocaliva dosage regimen by patient population can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

And follow us on Twitter @FDA_Drug_Infodisclaimer icon for up to the minute important drug information. Thank you for listening.

Page Last Updated: 02/07/2018
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