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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:  03/26/2012
 
Trade Name:  Intelence
 
Generic Name or Proper Name (*):  etravirine
 
Indications Studied:  Treatment of HIV-1 infection in treatment-experienced patients in combination with other antiretroviral agents
 
Label Changes Summary:  Expanded the indication from adults to pediatric patients 6 years and older Safety and efficacy have not been established in children < 6 years or in treatment naive adult or pediatric patients Adverse reactions were similar to those observed in adults except for rash which was observed more frequently in pediatric patients (15%) compared to adults (10%)Intelence tablet(s) should be swallowed whole. Patients who are unable to swallow the Intelence tablet(s) whole may disperse the tablet(s) in a glass of water Information on dosing in pediatric patients 6 - <18 years and weighing at least 16 kg, dispersing tablet in water, adverse reactions, and clinical trial Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  J&J
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiviral
 
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