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

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Abstract
Rational 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 P < 0.05) age-related trends in the mean elimination half-life (t½) of gadolinium with the older group having a slightly longer t½ (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.