Gadoterate meglumine

(Dotarem®)

Gadoterate meglumine

Drug updated on 7/25/2024

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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  • Gadoterate meglumine (Dotarem) is indicated for intravenous use with MRI in the brain, spine, and associated tissues to detect and visualize areas with disruption of the blood-brain barrier or abnormal vascularity.
  • The information was derived from two systematic reviews/meta-analyses studies.
  • Dotarem exhibits a lower prevalence of Symptoms Associated with Gadolinium Exposure (SAGE) compared to gadobenate dimeglumine and gadoteridol, indicating potentially better safety regarding SAGE-related adverse events.
  • In patients with stage 4 or 5 chronic kidney disease (CKD), no cases of Nephrogenic Systemic Fibrosis (NSF) were reported following administration of Dotarem; however, it has an upper bound risk estimate higher than gadobenate dimeglumine but lower than gadobutrol and gadoteridol.
  • For general populations as well as high-risk subgroups like those with advanced CKD, Dotarem shows a favorable safety profile based on the reviewed data concerning both SAGE prevalence and NSF incidence rates.
  • No direct conclusions about comparative imaging effectiveness can be drawn from these studies since they focus primarily on safety outcomes rather than imaging efficacy.