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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:  12/20/2019
 
Trade Name:  Mycamine
 
Generic Name or Proper Name (*):  micafungin
 
Indications Studied:  Treatment of candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age
 
Label Changes Summary:  *Safety and effectiveness at a dose of 4 mg/kg once daily have been established in pediatric patients without meningoencephalitis and/or ocular dissemination younger than 4 months. *This use and dose are supported by evidence from adequate and well-controlled studies in adult and pediatric patients 4 months and older with additional pharmacokinetic and safety data in pediatric patients younger than 4 months of age. *Safety and effectiveness have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months as a higher dose may be needed. *Safety and effectiveness in pediatric patients younger than 4 months have not been established for (1) the treatment of esophageal candidiasis and (2) prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation. *Information on dosing, adverse reactions, PK parameters and clinical trials. *Postmarketing study.
 
PREA(P):  P
 
Sponsor:  Astellas
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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