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Pharmacokinetics and Safety of the MRI Contrast Agent Gadoversetamide Injection (OptiMARK) in Healthy Pediatric Subjects

James F Baker, Linda C Kratz, Gary R Stevens, James H Wible Jr

Invest Radiol. 2004 Jun;39(6):334-9.

PMID: 15167099

Abstract:

Rationale and objective:
This clinical trial examined the pharmacokinetics of gadoversetamide, a magnetic resonance imaging contrast agent, in normal pediatric subjects.
Materials and methods:
Seventeen healthy pediatric subjects received a single intravenous injection of gadoversetamide (0.1 mmol/kg, 0.2 mL/kg). Sixteen subjects that were evaluable for pharmacokinetic analysis fell into 2 stratified age groups: 2 years to <5 years and 5 years to <18 years of age. Serum samples were analyzed for total gadolinium as a measure of gadoversetamide concentration.
Results:
Statistical analysis demonstrated significant (P < 0.05) age-related trends in the mean elimination half-life (t 1/2) of gadolinium with the older group having a slightly longer t 1/2 (1.39 hours) than the younger group (1.19 hours). No age-related changes occurred in volume of distribution or total body clearance, when normalized to body weight or body surface area.
Conclusions:
Based on this preliminary pharmacokinetic assessment, no adjustment from the approved adult gadoversetamide dose of 0.1 mmol/kg should be necessary for children aged 2 or older.

Chemicals Related in the Paper:

Catalog Number Product Name Structure CAS Number Price
CS31041718 Gadoversetamide Related Compound A Gadoversetamide Related Compound A Price
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