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Gadoterate meglumine

(Dotarem®)

Dotarem®

Drug updated on 11/1/2024

Dosage FormInjection (intravenous; 0.5 mmol/mL containing 376.9 mg/mL gadoterate meglumine)
Drug ClassGadolinium-based contrast imaging agents
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • 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.

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Summary
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  • This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
  • Gadolinium-based contrast agents (GBCAs) with higher T1 relaxivity values demonstrate superior diagnostic efficacy, with a difference of at least 40% in relaxivity resulting in either enhanced performance at the same gadolinium dose or comparable outcomes at a lower dose.
  • The pooled incidence of nephrogenic systemic fibrosis (NSF) in patients with stage 4 or 5 chronic kidney disease (CKD) receiving gadoterate meglumine was 0 out of 1204, indicating a very low risk of NSF in this population, with a 95% confidence interval upper bound of 0.31%.
  • Hypersensitivity reactions, including both immediate and delayed responses, were documented in the review, with cross-reactivity noted among macrocyclic GBCAs, underscoring the need for caution in patients with known sensitivities.
  • Hypersensitivity reactions to gadolinium-based contrast agents (GBCAs), including gadoterate meglumine, were documented, with immediate reactions noted in 17 studies and non-immediate reactions in 6 studies, indicating cross-reactivity among macrocyclic agents.
  • The systematic review specifically evaluated the risk of nephrogenic systemic fibrosis (NSF) in patients with stage 4 or 5 chronic kidney disease (CKD), finding an extremely low incidence of NSF (0 out of 1204), suggesting that gadoterate meglumine is relatively safe for use in this high-risk population, and also studied hypersensitivity reactions, noting cross-reactivity among macrocyclic agents, indicating the need for careful selection of alternatives in patients with known sensitivities.