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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:
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
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