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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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Pediatric Labeling Date:  12/06/2017
 
Trade Name:  Jakafi
 
Generic Name or Proper Name (*):  ruxolitinib
 
Indications Studied:  Relapsed or refractory solid tumors, leukemias or myeloproliferative neoplasms
 
Label Changes Summary:  *The safety and effectiveness of Jakafi in pediatric patients have not been established. *Jakafi was evaluated in a single-arm, dose-escalation study in 27 pediatric patients with relapsed or refractory solid tumors and 20 with leukemias or myeloproliferative neoplasms. *A protocol-defined maximal tolerated dose was not observed, but since few patients were treated for multiple cycles, tolerability with continued use was not assessed adequately to establish a recommended Phase 2 dose. *The safety profile in children was similar to that observed in adults. *Information on dosing, and clinical trial.
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Incyte Corporation
 
NNPS:  FALSE
 
Therapeutic Category:  Hematology
 
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