Safety and pharmacokinetics of multiple-dose anidulafungin in infants and neonates

M. Cohen-Wolkowiez; D. K. Benjamin; L. Piper; I. M. Cheifetz; C. Moran; P. Liu; J. Aram; A. D M Kashuba; E. Capparelli; T. J. Walsh; W. W. Hope; P. B. Smith

doi:10.1038/clpt.2011.26

Safety and pharmacokinetics of multiple-dose anidulafungin in infants and neonates

M. Cohen-Wolkowiez, D. K. Benjamin, L. Piper, I. M. Cheifetz, C. Moran, P. Liu, J. Aram, A. D M Kashuba, E. Capparelli, T. J. Walsh, W. W. Hope, P. B. Smith

Research output: Contribution to journal › Article › peer-review

Abstract

Candida infections are common and often fatal in infants and neonates. Anidulafungin has excellent activity against Candida species, but the pharmacokinetics (PK) and safety of the drug in infants and neonates are unknown. The object of our study was to determine the PK and safety of anidulafungin in infants and neonates at risk for invasive candidiasis. Intravenous anidulafungin (1.5mg/kg/day maintenance dose) was administered to 15 infants and neonates over 3 to 5 days. Plasma samples were collected after the first dose and again after the third to fifth doses. The pharmacokinetic parameters of the drug were determined by noncompartmental analysis. Safety was assessed using National Cancer Institute common toxicity criteria. The study showed that drug exposure levels were similar between neonates and infants; the median areas under the concentration-time curve (range) was 75 (30-109) μġh/ml and 98 (55-278) μġh/ml (P = 0.12) for neonates and infants, respectively. No drug-related serious adverse events were observed. The study results indicate that neonates and infants receiving 1.5mg/kg/day have anidulafungin exposure levels similar to those in children receiving similar weight-based dosing and in adult patients receiving 100mg/day. © 2011 american Society for Clinical Pharmacology and Therapeutics.

Original language	English
Pages (from-to)	702-707
Number of pages	5
Journal	Clinical Pharmacology and Therapeutics
Volume	89
Issue number	5
DOIs	https://doi.org/10.1038/clpt.2011.26
Publication status	Published - May 2011

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@article{176257de70114a73a55bec6ef6ac5f8a,

title = "Safety and pharmacokinetics of multiple-dose anidulafungin in infants and neonates",

abstract = "Candida infections are common and often fatal in infants and neonates. Anidulafungin has excellent activity against Candida species, but the pharmacokinetics (PK) and safety of the drug in infants and neonates are unknown. The object of our study was to determine the PK and safety of anidulafungin in infants and neonates at risk for invasive candidiasis. Intravenous anidulafungin (1.5mg/kg/day maintenance dose) was administered to 15 infants and neonates over 3 to 5 days. Plasma samples were collected after the first dose and again after the third to fifth doses. The pharmacokinetic parameters of the drug were determined by noncompartmental analysis. Safety was assessed using National Cancer Institute common toxicity criteria. The study showed that drug exposure levels were similar between neonates and infants; the median areas under the concentration-time curve (range) was 75 (30-109) μġh/ml and 98 (55-278) μġh/ml (P = 0.12) for neonates and infants, respectively. No drug-related serious adverse events were observed. The study results indicate that neonates and infants receiving 1.5mg/kg/day have anidulafungin exposure levels similar to those in children receiving similar weight-based dosing and in adult patients receiving 100mg/day. {\textcopyright} 2011 american Society for Clinical Pharmacology and Therapeutics.",

author = "M. Cohen-Wolkowiez and Benjamin, {D. K.} and L. Piper and Cheifetz, {I. M.} and C. Moran and P. Liu and J. Aram and Kashuba, {A. D M} and E. Capparelli and Walsh, {T. J.} and Hope, {W. W.} and Smith, {P. B.}",

year = "2011",

month = may,

doi = "10.1038/clpt.2011.26",

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pages = "702--707",

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issn = "0009-9236",

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AU - Cohen-Wolkowiez, M.

AU - Benjamin, D. K.

AU - Piper, L.

AU - Cheifetz, I. M.

AU - Moran, C.

AU - Liu, P.

AU - Aram, J.

AU - Kashuba, A. D M

AU - Capparelli, E.

AU - Walsh, T. J.

AU - Hope, W. W.

AU - Smith, P. B.

PY - 2011/5

Y1 - 2011/5

N2 - Candida infections are common and often fatal in infants and neonates. Anidulafungin has excellent activity against Candida species, but the pharmacokinetics (PK) and safety of the drug in infants and neonates are unknown. The object of our study was to determine the PK and safety of anidulafungin in infants and neonates at risk for invasive candidiasis. Intravenous anidulafungin (1.5mg/kg/day maintenance dose) was administered to 15 infants and neonates over 3 to 5 days. Plasma samples were collected after the first dose and again after the third to fifth doses. The pharmacokinetic parameters of the drug were determined by noncompartmental analysis. Safety was assessed using National Cancer Institute common toxicity criteria. The study showed that drug exposure levels were similar between neonates and infants; the median areas under the concentration-time curve (range) was 75 (30-109) μġh/ml and 98 (55-278) μġh/ml (P = 0.12) for neonates and infants, respectively. No drug-related serious adverse events were observed. The study results indicate that neonates and infants receiving 1.5mg/kg/day have anidulafungin exposure levels similar to those in children receiving similar weight-based dosing and in adult patients receiving 100mg/day. © 2011 american Society for Clinical Pharmacology and Therapeutics.

AB - Candida infections are common and often fatal in infants and neonates. Anidulafungin has excellent activity against Candida species, but the pharmacokinetics (PK) and safety of the drug in infants and neonates are unknown. The object of our study was to determine the PK and safety of anidulafungin in infants and neonates at risk for invasive candidiasis. Intravenous anidulafungin (1.5mg/kg/day maintenance dose) was administered to 15 infants and neonates over 3 to 5 days. Plasma samples were collected after the first dose and again after the third to fifth doses. The pharmacokinetic parameters of the drug were determined by noncompartmental analysis. Safety was assessed using National Cancer Institute common toxicity criteria. The study showed that drug exposure levels were similar between neonates and infants; the median areas under the concentration-time curve (range) was 75 (30-109) μġh/ml and 98 (55-278) μġh/ml (P = 0.12) for neonates and infants, respectively. No drug-related serious adverse events were observed. The study results indicate that neonates and infants receiving 1.5mg/kg/day have anidulafungin exposure levels similar to those in children receiving similar weight-based dosing and in adult patients receiving 100mg/day. © 2011 american Society for Clinical Pharmacology and Therapeutics.

U2 - 10.1038/clpt.2011.26

DO - 10.1038/clpt.2011.26

M3 - Article

SN - 0009-9236

VL - 89

SP - 702

EP - 707

JO - Clinical Pharmacology and Therapeutics

JF - Clinical Pharmacology and Therapeutics

IS - 5

ER -

Safety and pharmacokinetics of multiple-dose anidulafungin in infants and neonates

Abstract

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