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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:  08/30/2016
 
Trade Name:  Blincyo
 
Generic Name or Proper Name (*):  blinatumomab
 
Indications Studied:  Treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
 
Label Changes Summary:  *Safety and efficacy have been established in pediatric patients. *Use is supported by a single-arm trial in pediatric patients with relapsed or refractory B-cell precursor ALL. *This study included 70 pediatric patients 1 month to less than 18 years. *Adverse reactions that were observed more frequently in the pediatric population compared to the adult population were anemia (41% vs 18%), thrombocytopenia (21% vs.11%), vomiting (24% vs. 13%), pyrexia (80% vs. 62%), and hypertension (26% vs. 8%). In pediatric patients less than 2 years old (infants), the incidence of neurologic toxicities was not significantly different than for the other age groups, but its manifestations were different; the only event terms reported were agitation, headache, insomnia, somnolence, and irritability. Infants also had an increased incidence of hypokalemia (50%) compared to other pediatric age cohorts (15-20%) or adults (23%). *Information on dosing, adverse reactions, and clinical trial.
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Amgen
 
NNPS:  FALSE
 
Therapeutic Category:  Antineoplastic
 
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