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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:  04/27/2012
 
Trade Name:  Lexiva
 
Generic Name or Proper Name (*):  fosamprenavir
 
Indications Studied:  Treatment of HIV-1 infection
 
Label Changes Summary:  * Expanded indication to include pediatric patients at least 4 weeks - <2 years; previously approved for use in 2  18 years *The PK, safety, tolerability, and efficacy in pediatric patients < 4 weeks have not been established *Dosing of Lexiva plus ritonavir is not recommended for protease inhibitor-experienced pediatric patients <6 months of age; data do not support twice-daily dosing of Lexiva without ritonavir in pediatric patients <2 years *Weight-adjusted apparent clearance was higher in children < 4 years, suggesting that younger children require higher mg per kg dosing of Lexiva *Vomiting and neutropenia were more frequent in pediatrics than in adults. Other adverse reactions were similar to adults * Information on dosing, clinical trials, PK and adverse reactions *New dosage regimen for patients at least 4 weeks - < 6 years; Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  ViiV Healthcare
 
Pediatric Exclusivity Granted Date:  01/10/2012
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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