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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:  11/04/2016
 
Trade Name:  Selzentry
 
Generic Name or Proper Name (*):  maraviroc
 
Indications Studied:  Treatment of only CCR5-tropic HIV-1 infection in patients 2 years of age and older weighing at least 10 kg
 
Label Changes Summary:  *Expanded the indication from adults to pediatric patients 2 years of age and older weighing at least 10 kg. *Safety, pharmacokinetic profile, and antiviral activity were evaluated in treatment-experienced, CCR5-tropic, HIV-1-infected pediatric patients 2 to less than 18 years weighing at least 10 kg in an open-label, multicenter clinical trial. *The pharmacokinetics, safety, and efficacy in patients younger than 2 years have not been established. *Selzentry is contraindicated in pediatric patients with severe renal impairment or End Stage Renal Disease on regular hemodialysis who are receiving potent CYP3A inhibitors. *There are insufficient data to make dosing recommendations for use in pediatric patients concomitantly receiving noninteracting medications and weighing less than 30 kg or in pediatric patients concomitantly receiving potent CYP3A inducers without a potent CYP3A inhibitor. *The most common adverse reactions in treatment-experienced pediatric patients are vomiting, abdominal pain, diarrhea, nausea, and dizziness. *Information on recommended dosing, Pk parameters and clinical trial. *New oral solution and two lower dose strength tablets. *Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  P
 
Sponsor:  ViiV Healthcare
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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