Summary

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• Dotarem (gadoterate meglumine) is indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine, and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood-brain barrier (BBB) and/or abnormal vascularity.
• This summary is based on the review of two systematic review(s)/meta-analysis(es). ^[1-2]
• No direct effectiveness outcomes for gadoterate meglumine or other gadolinium-based contrast agents (GBCAs) were reported.
• The European Pharmacovigilance Database (EV) and the FDA Adverse Event Reporting System (FAERS) reported a lower incidence of Symptoms Associated with Gadolinium Exposure (SAGE) for gadoterate meglumine (EV: 8.66%, FAERS: 12.99%) compared to gadobenate dimeglumine (EV: 25.83%, FAERS: 32.24%) and gadoteridol (EV: 15.51%, FAERS: 21.13%), but gadoterate meglumine was similar to gadobutrol (EV: 7.75%, FAERS: 13.31%).
• The pooled incidence of Nephrogenic Systemic Fibrosis (NSF) in patients with stage 4 or 5 chronic kidney disease (CKD) receiving group II GBCAs was 0% (0 of 4931, upper bound of 95% CI: 0.07%). Specifically, gadoterate meglumine showed no cases of NSF (0 of 1204 patients, upper bound of 95% CI: 0.31%), with a slightly higher upper bound compared to gadobenate dimeglumine but lower than gadobutrol and gadoteridol.
• There is no population types or subgroups information available in the reviewed studies.