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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  08/12/2013
 
Trade Name:  Tivicay
 
Generic Name or Proper Name (*):  dolutegravir
 
Indications Studied:  Treatment of HIV-1 infection
 
Label Changes Summary:  "*Indicated in combination with other antiretroviral agents in adults and children aged 12 years and older and weighing at least 40 kg *Not recommended in pediatric patients <12 years or weighing < 40 kg *Safety and efficacy have not been established in pediatric patients who are integrase strand transfer ibitor (INSTI)-experienced with documented or clinically suspected resistance to other INSTIs (raltegravir, elvitegravir) *The safety, virologic, and unologic were evaluated in 23 treatment-experienced, INSTI-naïve, HIV-1 infected patients aged 12 - < 18 years in an open-label, multicenter, dose-finding clinical trial *Adverse reactions were similar to those observed in adults * Information on dosing, clinical trial, and PK *New drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  ViiV Healthcare
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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