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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
Therapeutic Category:  Antiviral