Drug Safety Warnings and Updates: January-March 2018

Shannon Thor, PharmD, MS

Disclosures

May 23, 2018

Editorial Collaboration

Medscape &

In This Article

Obeticholic Acid (Ocaliva)

For more on this Drug Safety Labeling Change, click here.

For full prescribing information, click here.

New Boxed Warning

WARNING: HEPATIC DECOMPENSATION AND FAILURE IN INCORRECTLY DOSED PBC PATIENTS WITH CHILD-PUGH CLASS B OR C OR DECOMPENSATED CIRRHOSIS

In postmarketing reports, hepatic decompensation and failure, in some cases fatal, have been reported in patients with primary biliary cholangitis (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 5 mg once weekly for patients with Child-Pugh Class B or C hepatic impairment or a prior decompensation event.

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