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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
BPCA(B):
B
Sponsor:
Incyte Corporation
NNPS:
FALSE
Therapeutic Category:
Hematology
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