PMID- 23958810
OWN - NLM
STAT- MEDLINE
DCOM- 20140613
LR  - 20240407
IS  - 1532-0987 (Electronic)
IS  - 0891-3668 (Print)
IS  - 0891-3668 (Linking)
VI  - 32
IP  - 11
DP  - 2013 Nov
TI  - Safety and pharmacokinetic profiles of repeated-dose micafungin in children and 
      adolescents treated for invasive candidiasis.
PG  - e419-25
LID - 10.1097/INF.0b013e31829efd14 [doi]
AB  - BACKGROUND: Micafungin is an echinocandin with proven efficacy against a broad 
      range of fungal infections, including those caused by Candida spp. OBJECTIVE: To 
      evaluate the safety and pharmacokinetics of once-daily 3 mg/kg and 4.5 mg/kg 
      micafungin in children with proven, probable or suspected invasive candidiasis. 
      METHODS: Micafungin safety and pharmacokinetics were assessed in 2 phase I, 
      open-label, repeat-dose trials. In Study 2101, children aged 2-16 years were 
      grouped by weight to receive 3 mg/kg (>/=25 kg) or 4.5 mg/kg (<25 kg) intravenous 
      micafungin for 10-14 days. In Study 2102, children aged 4 months to <2 years 
      received 4.5 mg/kg micafungin. Study protocols were otherwise identical. RESULTS: 
      Safety was analyzed in 78 and 9 children in Studies 2101 and 2102, respectively. 
      Although adverse events (AEs) were experienced by most children (2101: n=62; 
      2102: n=9), micafungin-related AEs were less common (2101: n=28; 2102: n=1), and 
      the number of patients discontinuing due to AEs was low (2101: n=4; 2102: n=1). 
      The most common micafungin-related AEs were infusion-associated symptoms, pyrexia 
      and hypomagnesemia (Study 2101), and liver function abnormalities (Study 2102). 
      The micafungin pharmacokinetic profile was similar to that seen in other studies 
      conducted in children, but different than that observed in adults. CONCLUSIONS: 
      In this small cohort of children, once-daily doses of 3 mg/kg and 4.5 mg/kg 
      micafungin were well tolerated. Pharmacokinetic data will be combined in a 
      population pharmacokinetic analysis to support US dosing recommendations in 
      children.
FAU - Benjamin, Daniel K Jr
AU  - Benjamin DK Jr
AD  - From the *Duke Clinical Research Institute, Duke University, Durham, NC; 
      daggerUniversity of California, Los Angeles, CA; double daggerAstellas Scientific and Medical 
      Affairs, Inc.;  section signAstellas Pharma Global Development, Inc., Northbrook, IL; and 
       paragraph signChildren's Hospital of Orange County, Orange, CA.
FAU - Deville, Jaime G
AU  - Deville JG
FAU - Azie, Nkechi
AU  - Azie N
FAU - Kovanda, Laura
AU  - Kovanda L
FAU - Roy, Mike
AU  - Roy M
FAU - Wu, Chunzhang
AU  - Wu C
FAU - Arrieta, Antonio
AU  - Arrieta A
LA  - eng
GR  - K24 HD058735/HD/NICHD NIH HHS/United States
GR  - R01 HD057956/HD/NICHD NIH HHS/United States
GR  - 1R01FD003519-04/FD/FDA HHS/United States
GR  - HHSN275201000003I/HD/NICHD NIH HHS/United States
GR  - U10 HD045962/HD/NICHD NIH HHS/United States
GR  - 1K24HD058735-05/HD/NICHD NIH HHS/United States
GR  - HHSN275201000003C/AA/NIAAA NIH HHS/United States
GR  - 1R01HD057956-05/HD/NICHD NIH HHS/United States
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Pediatr Infect Dis J
JT  - The Pediatric infectious disease journal
JID - 8701858
RN  - 0 (Antifungal Agents)
RN  - 0 (Echinocandins)
RN  - 0 (Lipopeptides)
RN  - R10H71BSWG (Micafungin)
SB  - IM
MH  - Adolescent
MH  - Antifungal Agents/administration & dosage/*adverse effects/*pharmacokinetics
MH  - Body Weight
MH  - Candidiasis, Invasive/*drug therapy/*metabolism
MH  - Child
MH  - Child, Preschool
MH  - Drug Administration Schedule
MH  - Echinocandins/administration & dosage/*adverse effects/*pharmacokinetics
MH  - Female
MH  - Humans
MH  - Infant
MH  - Kidney Function Tests
MH  - Lipopeptides/administration & dosage/*adverse effects/*pharmacokinetics
MH  - Liver Function Tests
MH  - Male
MH  - Micafungin
PMC - PMC3818701
MID - NIHMS502867
EDAT- 2013/08/21 06:00
MHDA- 2014/06/15 06:00
PMCR- 2014/11/01
CRDT- 2013/08/21 06:00
PHST- 2013/08/21 06:00 [entrez]
PHST- 2013/08/21 06:00 [pubmed]
PHST- 2014/06/15 06:00 [medline]
PHST- 2014/11/01 00:00 [pmc-release]
AID - 10.1097/INF.0b013e31829efd14 [doi]
PST - ppublish
SO  - Pediatr Infect Dis J. 2013 Nov;32(11):e419-25. doi: 10.1097/INF.0b013e31829efd14.