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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:  04/03/2018
 
Trade Name:  Emend Injection
 
Generic Name or Proper Name (*):  fosaprepitant
 
Indications Studied:  Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) in pediatric patients 6 months and older
 
Label Changes Summary:  *Safety and effectiveness of a single dose regimen of Emend for injection and a 3-day IV/oral/oral Emend regimen have been established in pediatric patients 6 months to 17 years. *Use in this age group is supported by evidence from adequate and well-controlled studies of Emend for injection in adults, with additional safety, efficacy and pharmacokinetic data in pediatric patients 6 months to 17 years. Efficacy was also supported by data from an adequate and well-controlled study of a 3-day oral aprepitant regimen in pediatric patients 6 months to 17 years. *Safety and effectiveness of EMEND for the prevention of nausea and vomiting associated with HEC or MEC have not been established in patients less than 6 months of age. *Safety of Emend for injection administered on consecutive days has not been established in pediatric patients 6 months to 17 years for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of HEC and MEC. *Adverse reactions were similar to those observed in adults. *Information on dosing, PK parameters, adverse reactions and clinical trials. *Postmarketing study.
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  Merck Sharp & Dohme
 
Pediatric Exclusivity Granted Date:  03/23/2018
 
NNPS:  FALSE
 
Therapeutic Category:  Antiemetic
 
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