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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:  08/28/2015
 
Trade Name:  Emend
 
Generic Name or Proper Name (*):  aprepitant
 
Indications Studied:  Prevention of chemotherapy induced nausea and vomiting in patients ages 12 years to 17 years and patients less than 12 years who weigh at least 30 kg
 
Label Changes Summary:  *Indicated for the prevention of nausea and vomiting associated with highly emetogenic cancer (HEC) chemotherapy and moderately emetogenic cancer (MEC) chemotherapy in patients 12 years of age and older and patients less than 12 years who weigh at least 30 kg. *Although the safety and efficacy results from the trial in 302 pediatric patients support the use of Emend for the prevention of nausea and vomiting associated with HEC or MEC in pediatric patients 6 months to 12 years, there is no commercially available dosage form appropriate for patients less than 12 years of age and weighing less than 30 kg. *Safety and effectiveness for the prevention of nausea and vomiting associated with HEC or MEC have not been established in patients less than 6 months. *Safety and effectiveness have not been established for the prevention of postoperative nausea and vomiting in pediatric patients. *Adverse reactions were similar to those observed in adults. *Information on dosing, adverse events, PK, and clinical trial
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Merck Sharp & Dohme Corp.
 
NNPS:  FALSE
 
Therapeutic Category:  Antiemetic
 
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