Drug updated on 9/4/2024
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
- 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.
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 |