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. 2025 Jun 1;60(6):423-427.
doi: 10.1097/RLI.0000000000001144. Epub 2024 Nov 21.

Safety of Gadopiclenol After Its First Year of Clinical Use

Alberto Spinazzi  1 , Eric Lancelot, Letizia Vitali, Christophe Cot, Gianpaolo Pirovano, Alvin Joseph, Miles A Kirchin, Elisabeth Darmon-Kern, Philippe Bourrinet
Affiliations

Safety of Gadopiclenol After Its First Year of Clinical Use

Alberto Spinazzi et al. Invest Radiol. .

Abstract

Gadopiclenol is a novel, macrocyclic high-relaxivity gadolinium-based contrast agent recently approved for use in magnetic resonance imaging of the central nervous system and body organs at a dose of 0.05 mmol/kg body weight. Postmarketing surveillance of its first year of clinical use in the United States of America showed no serious adverse events (AEs) following over 882,550 administrations and a very low rate of nonserious AEs (1 case every 27,580 exposures). The types of observed AEs were similar to those reported for other gadolinium-based contrast agents in clinical use. Safety data from postmarketing surveillance of gadopiclenol further confirm its positive benefit-risk profile demonstrated in preapproval clinical studies.

Keywords: Elucirem; Vueway; gadolinium-based contrast agents; gadopiclenol; pharmacovigilance; postmarketing surveillance; safety.

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Conflict of interest statement

Conflicts of interest and sources of funding: none declared.

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