Avoid use in patients with severe hepatic impairment.
Advise patients not to breastfeed.
- TRADE NAMES: Inrebic (Impact Biomedicines); TG101348
- INDICATIONS: Treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis.
- CLASS: Janus kinase-2 inhibitor, Kinase inhibitor
- HALF-LIFE: ~114 hours
- FDA APPROVAL DATE: 08/16/2019
- CLINICALLY IMPORTANT, POTENTIALLY HAZARDOUS INTERACTIONS WITH:
CYP3A4 and CYP2C19 inhibitors, strong and moderate CYP3A4 inducers, strong CYP3A4 inhibitors - PREGNANCY: There are no available data on the use of fedratinib in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
- See adverse reactions attributed to class:
SERIOUS AND FATAL ENCEPHALOPATHY, INCLUDING WERNICKE’S, HAS OCCURRED IN PATIENTS TREATED WITH FEDRATINIB. WERNICKE’S ENCEPHALOPATHY IS A NEUROLOGIC EMERGENCY. ASSESS THIAMINE LEVELS IN ALL PATIENTS PRIOR TO STARTING FEDRATINIB, PERIODICALLY DURING TREATMENT, AND AS CLINICALLY INDICATED. DO NOT START FEDRATINIB IN PATIENTS WITH THIAMINE DEFICIENCY; REPLETE THIAMINE PRIOR TO TREATMENT INITIATION. IF ENCEPHALOPATHY IS SUSPECTED, IMMEDIATELY DISCONTINUE FEDRATINIB AND INITIATE PARENTERAL THIAMINE. MONITOR UNTIL SYMPTOMS RESOLVE OR IMPROVE AND THIAMINE LEVELS NORMALIZE.
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Page last updated 10/17/2023
