Oseltamivir pharmacokinetics, dosing, and resistance among children aged <2 years with influenza

Academic Article


  • Background. Children <2 years of age are at high risk of influenza-related mortality and morbidity. However, the appropriate dose of oseltamivir for children <2 years of age is unknown.Methods. The National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group evaluated oseltamivir in infants aged <2 years in an age-de-escalation, adaptive design with a targeted systemic exposure.Results. From 2006 to 2010, 87 subjects enrolled. An oseltamivir dose of 3.0 mg/kg produced drug exposures within the target range in subjects 0-8 months of age, although there was a greater degree of variability in infants <3 months of age. In subjects 9-11 months of age, a dose of 3.5 mg/kg produced drug exposures within the target range. Six of 10 subjects aged 12-23 months receiving the Food and Drug Administration-approved unit dose for this age group (ie, 30 mg) had oseltamivir carboxylate exposures below the target range. Virus from 3 subjects developed oseltamivir resistance during antiviral treatment.Conclusions. The appropriate twice-daily oral oseltamivir dose for infants ≤8 months of age is 3.0 mg/kg, while the dose for infants 9-11 months old is 3.5 mg/kg.Clinical Trials Registration. NCT00391768. © 2012 The Author 2012. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved.
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    Author List

  • Kimberlin DW; Acosta EP; Prichard MN; Sánchez PJ; Ampofo K; Lang D; Ashouri N; Vanchiere JA; Abzug MJ; Abughali N
  • Start Page

  • 709
  • End Page

  • 720
  • Volume

  • 207
  • Issue

  • 5