Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
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
-
-