FDA Approves Fedratinib for Intermediate-2 or High-Risk Myelofibrosis
On August 16, 2019, the Food and Drug Administration approved fedratinib (Inrebic, Impact Biomedicines, Inc.) for adults with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).
The prescribing information for fedratinib includes a Boxed Warning to advise healthcare professionals and patients about the risk of serious and fatal encephalopathy, including Wernicke’s encephalopathy. Healthcare professionals are advised to assess thiamine levels in all patients prior to starting fedratinib, periodically during treatment, and as clinically indicated. If encephalopathy is suspected, fedratinib should be immediately discontinued and parenteral thiamine initiated.
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