Drug updated on 7/25/2024
Dosage Form | Injection (intravenous; 0.5 mmol/mL containing 376.9 mg/mL gadoterate meglumine) |
Drug Class | Gadolinium-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
- 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.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Dotarem (gadoterate meglumine) Prescribing Information. | 2024 | Guerbet LLC, Princeton, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
ACR manual on contrast media. | 2021 | American College of Radiology |
2021 Update on Safety of Magnetic Resonance Imaging: Joint Statement From Canadian Cardiovascular Society/ Canadian Society for Cardiovascular Magnetic Resonance/ Canadian Heart Rhythm Society. | 2021 | Canadian Journal of Cardiology |
Contrast-enhanced MRI: History and Current Recommendations. | 2021 | Applied Radiology |