Safety, Efficacy and Pharmacokinetics of Anidulafungin in Patients 1 Month to <2 Years of Age With Invasive Candidiasis, Including Candidemia

Abstract

Nineteen patients 1 month to <2 years of age with (n = 16) or at high risk of (n = 3) invasive candidiasis received anidulafungin for 5-35 days (3 mg/kg day 1, 1.5 mg/kg daily thereafter) followed by optional fluconazole (NCT00761267). Most treatment-emergent adverse events were mild/moderate, and no treatment-related deaths occurred. End of intravenous therapy global response success rate was 68.8%. Pharmacokinetics were similar to adult patients.

Review on Current Status of Echinocandins Use

“…The safety and the efficacy of anidulafungin in children and patients under 18 years have not been established. However, the first prospective study of safety and efficacy of anidulafungin in pediatric patients aged 1 month to 2 years has been recently published [13]. According to this research, no deaths were reported due to anidulafungin usage, moreover the results were comparable to the reported pharmacokinetic parameters in adults.…”

Clinical and epidemiological aspects of Candidemia in eight medical centers in the state of Parana, Brazil: Parana Candidemia Network

“… 21 , 46 Besides adults, the efficacy, safety and tolerability of echinocandins have also been confirmed in children, initially for micafungin 47 and more recently for anidulafungin. 48 , 49 …”

Population Analysis of Anidulafungin in Infants to Older Adults With Confirmed or Suspected Invasive Candidiasis

“…dosing regimen of a 3.0 mg/kg LD followed by 1.5 mg/kg MD q.d., capped at the adult approved doses of 200 mg LD/100 mg MD q.d., is proposed for children from 1 month of age to match adults. The estimated systemic anidulafungin exposures achieved with this regimen in pediatric patients aged 1 month to < 18 years old with IC (study 1) 21 were comparable to exposures demonstrated to be efficacious in adults with IC at the recommended adult dosing regimen (200 mg LD/100 mg MD q.d.). The optimal anidulafungin dosing for neonatal treatment is so far unknown and animal studies suggest that higher doses are required to achieve central nervous system coverage for the treatment of HCME in premature infants and neonates.…”

“…19 The PKs, safety, and efficacy of anidulafungin were evaluated in a recently completed phase IIIb, prospective, open-label, noncomparative study in children aged 1 month to < 18 years of age with confirmed or at high risk of IC (study 1, NCT00761267). 20,21 Here, we describe the PKs of anidulafungin in a pooled population analysis in the first analysis of this type across a full range of ages, from neonates to older adults, in patients with confirmed, suspected, or at high risk of IC. Exposure-response analyses in patients aged from 1 month to older adults with confirmed IC are also reported.…”