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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:
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
BPCA(B) and PREA(P):
B, P
Sponsor:
Merck Sharp & Dohme Corp.
NNPS:
FALSE
Therapeutic Category:
Antiemetic
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