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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:  02/06/2015
 
Trade Name:  Dutrebis
 
Generic Name or Proper Name (*):  lamivudine and raltegravir
 
Indications Studied:  Treatment of HIV-1 infection
 
Label Changes Summary:  *Indicated in adults and pediatric patients 6 - 16 years and weighing at least 30 kg *Should not be used in children below 6 years or in patients weighing less than 30 kg due to weight based dosing requirements in this patient population *Use with caution in pediatric patients with a history of pancreatitis or other significant risk factors for pancreatitis. Discontinue treatment as clinically appropriate *The PK of Dutrebis in the pediatric population has not been studied in clinical trials. Based on modeling and simulation using raltegravir PK data in adults, the PK of raltegravir in Dutrebis in children was projected to result in exposures that have been previously shown to be safe and efficacious in adults *Information on dosing *New drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Merck Sharp & Dohme Corp.
 
Therapeutic Category:  Antiviral
 
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