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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:  03/19/2020
 
Trade Name:  Epclusa
 
Generic Name or Proper Name (*):  Sofosbuvir/velpatasvir
 
Indications Studied:  Treatment of chronic hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection in pediatric patients 6 years of age and older or weighing at least 17 kg
 
Label Changes Summary:  *The pharmacokinetics, safety, and effectiveness have been established in an open-label, multicenter clinical trial. *Safety and effectiveness for treatment of HCV genotype 5 in pediatric patients 6 years and older or weighing at least 17 kg without cirrhosis or with compensated cirrhosis are supported by sofosbuvir, GS-331007, and velpatasvir exposures in adults and pediatric patients. *In patients with severe renal impairment, including those requiring dialysis, exposures of GS-331007, the inactive metabolite of sofosbuvir, are increased. *No data are available regarding the safety in pediatric patients with renal impairment. *Safety and effectiveness have not been established in pediatric patients less than 6 years. *Information on dosing, adverse reactions, PK parameters, and clinical trials. *New 200 mg/50 mg strength tablet.
 
PREA(P):  P
 
Sponsor:  Gilead Sciences, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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