Worldwide clinical safety assessment of gadoteridol injection: an update

Abstract

Gadoteridol injection is a low molecular weight chelate complex of gadolinium (III) which is useful as a contrast agent for magnetic resonance imaging. A total of 2481 adult and pediatric subjects were studied with gadoteridol at doses from 0.025 to 0.3 mmol/kg in phase I-IIIb clinical trials in Europe and the United States. The study population had a mean age of 49 years, and included 119 patients under 18 years of age and 747 patients over 60 years of age. After 2656 administered injections of gadoteridol a total of 233 adverse events were recorded in 176 exposures, an incidence rate of 6.6 % irrespective of relationship to drug administration. The most frequently reported adverse events were nausea (1.5 %), taste perversion (0.9 %), and headache (0.6 %). All other adverse events occurred with an incidence of 0.5 % or less. This report confirms the excellent safety profile of gadoteridol in healthy subjects and patients with a variety of known or suspected pathologies.

MR contrast agents: Physical and pharmacologic basics

“…Comparable results have been extracted from the ProHance database of phase I-III clinical trials, which included 119 pediatric patients out of a total of 2656 injections. There was no correlation between age and the adverse event rate of 6.6% for doses ranging from 0.1 to 0.3 mmol/kg (95,96). In a meta-analysis of data from seven Omniscan studies with 353 pediatric patients ranging in age from neonate to 18 years, 0.1 mmol/kg of Omniscan resulted in a 4% overall adverse event rate (97).…”

Safety of the Gadolinium-Based Contrast Agents for Magnetic Resonance Imaging, Focusing in Part on Their Accumulation in the Brain and Especially the Dentate Nucleus

“…Anecdotal information has often been alleged to differentiate the agents on the basis of adverse reactions, although all studies performed for agency approval report similar values, as do well controlled large prospective trials, irrespective of the class of the agent (macrocyclic or linear, ionic, or nonionic). 15,16 …”

Gadolinium concentration analysis in brain phantom by X-ray fluorescence

“…If T increases, the count rate increases, reaching an upper value limit. As the volume increases, the fraction of radiation that reaches the deeper layers will be small, according to equation (8). Similarly, the emitted radiation from the deeper layers undergoes attenuation on its way to the detector.…”