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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:
01/27/2017
Trade Name:
Stribild
Generic Name or Proper Name (*):
elvitegravir, cobicistat, emtricitabine/tenofovir disoproxil fumarate
Indications Studied:
HIV in pediatric patients 12 years of age and older weighing at least 35 kg
Label Changes Summary:
*Expanded the indication to pediatric patients 12 years of age and older weighing at least 35 kg; previously approved in adults. *The PK, safety, and virologic and immunologic responses were evaluated in 50 treatment-naïve, HIV-1-infected subjects aged 12 to less than 18 years weighing at least 35 kg receiving Stribild through 48 weeks in an open-label trial. The safety and efficacy in these patients was similar to that in antiretroviral treatment-naïve adults. *Safety and effectiveness in pediatric patients less than 12 years of age or weighing less than 35 kg have not been established. *Clinical trials evaluating tenofovir DF in pediatric and adolescent patients were conducted. In HIV-1-infected subjects aged 2 years to less than 18 years, bone effects were similar to those observed in adult subjects and suggest increased bone turnover. Total body BMD gain was less in the tenofovir DF-treated HIV-1-infected pediatric subjects as compared to the control groups. In all pediatric trials, skeletal growth (height) appeared to be unaffected. *Information on clinical trials, adverse reactions, and PK parameters. *Postmarketing study.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Gilead
NNPS:
FALSE
Therapeutic Category:
Antiviral
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