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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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