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:  06/18/2019
 
Trade Name:  Biktarvy
 
Generic Name or Proper Name (*):  bictegravir, emtricitabine, and tenofovir alafenamide
 
Indications Studied:  HIV-1 infected pediatric patients weighing at least 25 kg
 
Label Changes Summary:  *Safety and effectiveness were established in pediatric patients with body weight greater than or equal to 25 kg. *Use in pediatric patients between the ages of 6 to less than 18 years and weighing at least 25 kg is supported by trials in adults and by an open-label trial of 100 pediatric patients. *Safety and effectiveness in pediatric patients weighing less than 25 kg have not been established. *There was no clinically significant change in exposure for the components of Biktarvy. *Adverse reactions in pediatric patients were similar to those observed in adults. *Information on dosing, adverse reactions, clinical trials, and PK parameters. *Postmarketing study.
 
PREA(P):  P
 
Sponsor:  Gilead
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
-
-