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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:
11/05/2015
Trade Name:
Genvoya
Generic Name or Proper Name (*):
elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide
Indications Studied:
Treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older
Label Changes Summary:
*Indicated for adults and pediatric patients 12 years and older weighing at least 35 kg. *The pharmacokinetics, safety, and virologic and immunologic responses were evaluated in 23 treatment-naïve, HIV-1 infected patients 12 to less than 18 years through 24 weeks in an open-label trial *Safety and effectiveness in pediatric patients less than 12 years have not been established.*Among the 23 pediatric patients receiving Genvoya for 24 weeks, 2 patients had significant (greater than 4%) lumbar spine BMD loss at Week 24.*Information on dosing, PK, adverse reactions and clinical trials *New drug
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Gilead Sciences
NNPS:
FALSE
Therapeutic Category:
Antiviral
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