Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2013 Mar 1;207(5):709-20.
doi: 10.1093/infdis/jis765. Epub 2012 Dec 10.

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

David W Kimberlin  1 , Edward P Acosta, Mark N Prichard, Pablo J Sánchez, Krow Ampofo, David Lang, Negar Ashouri, John A Vanchiere, Mark J Abzug, Nazha Abughali, Mary T Caserta, Janet A Englund, Sunil K Sood, Michael G Spigarelli, John S Bradley, Judy Lew, Marian G Michaels, Wen Wan, Gretchen Cloud, Penelope Jester, Fred D Lakeman, Richard J Whitley; National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group
Collaborators, Affiliations

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

David W Kimberlin et al. J Infect Dis. .

Abstract

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.

Trial registration: ClinicalTrials.gov NCT00391768.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Screening, enrollment, and follow-up during the course of the study.
Figure 2.
Figure 2.
Oseltamivir carboxylate geometric mean 12-hour area under the concentration curve (AUC12), by age and dosage cohort, with target and range.
Figure 3.
Figure 3.
Decline in nasopharyngeal influenza virus load over time, by age and dosage cohort.
See this image and copyright information in PMC

Comment in

References

    1. Bhat N, Wright JG, Broder KR, et al. Influenza-associated deaths among children in the United States, 2003—2004. N. Engl. J. Med. 2005;353:2559–67. - PubMed
    1. Izurieta HS, Thompson WW, Kramarz P, et al. Influenza and the rates of hospitalization for respiratory disease among infants and young children. N. Engl. J. Med. 2000;342:232–9. - PubMed
    1. Neuzil KM, Mellen BG, Wright PF, Mitchel EF, Jr, Griffin MR. The effect of influenza on hospitalizations, outpatient visits, and courses of antibiotics in children. N. Engl. J. Med. 2000;342:225–31. - PubMed
    1. Iwane MK, Edwards KM, Szilagyi PG, et al. Population-based surveillance for hospitalizations associated with respiratory syncytial virus, influenza virus, and parainfluenza viruses among young children. Pediatrics. 2004;113:1758–64. - PubMed
    1. O'Brien MA, Uyeki TM, Shay DK, et al. Incidence of outpatient visits and hospitalizations related to influenza in infants and young children. Pediatrics. 2004;113:585–93. - PubMed

Publication types

Associated data