Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Gilead Sciences
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
-
-