Fedratinib hydrochloride

Breastfeeding
  • TRADE NAMES: TG101348; Inrebic (Impact Biomedicines)
  • 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


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.

Avoid use in patients with severe hepatic impairment.

Advise patients not to breastfeed.

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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Our database has 29 adverse reactions for this drug across the following areas

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CARDIOVASCULAR
CENTRAL NERVOUS SYSTEM
ENDOCRINE/METABOLIC
GASTROINTESTINAL/HEPATIC
GENITOURINARY
HEMATOLOGIC
NEUROMUSCULAR/SKELETAL
OTHER


Page last updated 02/03/2020

Drug Eruption Mobile Site

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Incidence info

  • <1%
  • 1-5%
  • 5-10%
  • 10-15%
  • 15-20%
  • 20-30%
  • >30%

Seriousness info

  • Hospitalization possible
  • Life threatening
  • Fatal

Warnings in other populations info

  • Breast feeding
  • Geriatric
  • Pediatric
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