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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Cite this: Shannon Thor. Drug Safety Warnings and Updates: January-March 2018 - Medscape - May 23, 2018.
