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Fedratinib

Encephalopathy Including Wernicke's

  • Serious and fatal encephalopathy, including Wernicke's, has occurred in patients treated with INREBIC. Wernicke's encephalopathy is a neurologic emergency. Assess thiamine levels in all patients prior to starting INREBIC, periodically during treatment, and as clinically indicated. Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize [see DOSAGE AND ADMINISTRATION (2.6)WARNINGS AND PRECAUTIONS (5.1) and ADVERSE REACTIONS (6.1)].

Patient Counseling Information

Medication Guides

Patient Medication Guide - INREBIC

Package Inserts

Fedratinib

Updated September 2019