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

Abstract	In a pooled population analysis, we investigated the pharmacokinetics of i.v. anidulafungin in four studies across a full range of adult and pediatric ages in patients with confirmed, suspected, or at high risk of invasive candidiasis (IC). Relationships between anidulafungin exposure and key efficacy end points (global response of success and all-cause mortality) and safety end points (all-cause hepatic or gastrointestinal adverse events) in all patients and separately in pediatric patients and the appropriate dosing regimen for IC treatment in pediatric patients were evaluated. Pediatric patients received a 3.0 mg/kg (maximum 200 mg) i.v. loading dose and 1.5 mg/kg (maximum 100 mg) daily thereafter. Adults received a 200 mg i.v. loading dose and 100 mg daily thereafter. Estimated systemic anidulafungin exposures were similar across age groups (neonates to adults) at the weight-based doses studied in pediatric patients. No clear associations were identified between anidulafungin exposure and efficacy or safety end points.
Authors	Rujia Xie, Lynn McFadyen, Susan Raber, Robert Swanson, Margaret Tawadrous, Heidi Leister-Tebbe, Michael Cohen-Wolkowiez, Daniel K Benjamin Jr, Ping Liu
Journal	Clinical pharmacology and therapeutics (Clin Pharmacol Ther) Vol. 108 Issue 2 Pg. 316-325 (08 2020) ISSN: 1532-6535 [Electronic] United States
PMID	32189334 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
Copyright	© 2020 Pfizer Pte Ltd. Clinical Pharmacology & Therapeutics Published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.
Chemical References	Antifungal Agents Anidulafungin
Topics	Administration, Intravenous Adolescent Adult Age Factors Aged Aged, 80 and over Anidulafungin (administration & dosage, adverse effects, pharmacokinetics) Antifungal Agents (administration & dosage, adverse effects, pharmacokinetics) Candidiasis, Invasive (diagnosis, drug therapy, microbiology) Child Child, Preschool Clinical Trials as Topic Dose-Response Relationship, Drug Drug Dosage Calculations Drug Monitoring Humans Infant Infant, Newborn Male Middle Aged Models, Biological Treatment Outcome Young Adult

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