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Pharmacokinetics of gadoversetamide injection, a gadolinium-based contrast agent, in pediatric patients

James H Wible1, Prasad N V Tata, Alicia M Napoli

  • 1Covidien Imaging Solutions, 675 McDonnell Blvd., Hazelwood, MO 63042, USA. james.wible@covidien.com

Magnetic Resonance Imaging
|September 26, 2008
PubMed

Insights

Gadoversetamide pharmacokinetics in pediatric patients (2-18 years) showed no significant differences based on age or sex. Adjustments for body size explained observed variations in distribution and clearance, ensuring consistent drug behavior across pediatric groups.

Area of Science:

  • Pharmacology
  • Pediatric Medicine
  • Radiology

Background:

  • Contrast-enhanced MRI is crucial for CNS imaging in pediatric patients.
  • Understanding the pharmacokinetics of contrast agents like gadoversetamide is essential for safe and effective use in children.

Purpose of the Study:

  • To evaluate the pharmacokinetics of gadoversetamide in pediatric patients aged 2-18 years.
  • To determine if age or sex significantly influences gadoversetamide's pharmacokinetic profile.

Main Methods:

  • Intravenous administration of gadoversetamide (0.1 mmol/kg) for contrast-enhanced MRI.
  • Serial blood and urine sample collection for pharmacokinetic analysis.
  • Comparison of pharmacokinetic parameters between pediatric age groups (2-11 and 12-18 years) and sexes.

Main Results:

  • No significant differences in terminal half-life, initial concentration, or AUC were observed between age groups or sexes.
  • While significant age-related differences in volume of distribution and clearance were noted, they became non-significant after correction for body mass or surface area.
  • No sex-related differences in volume of distribution or clearance were found.

Conclusions:

  • Gadoversetamide exhibits consistent pharmacokinetic behavior in pediatric patients aged 2-18 years, irrespective of age or sex.
  • Observed variations in volume of distribution and clearance are primarily attributed to body size rather than chronological age.
  • The findings support the reliable use of gadoversetamide in the specified pediatric population.
Abstract

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