Drug updated on 4/12/2024
| Dosage Form | Injection (intravenous; 0.5 mmol/mL containing 376.9 mg/mL gadoterate meglumine) |
| Drug Class | Gadolinium-based contrast agent |
| 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.
Summary
- Gadoterate meglumine (Dotarem) is indicated for intravenous use with magnetic resonance imaging in brain, spine, and associated tissues to detect and visualize areas with disruption of the blood-brain barrier or abnormal vascularity.
- Two systematic reviews/meta-analyses provided information on the safety and effectiveness of Gadoterate meglumine compared to other gadolinium-based contrast agents.
- The first study highlighted that symptoms associated with gadolinium exposure represent a notable percentage of adverse events reported. However, it was found that Gadoterate meglumine exhibited a substantially lower percentage of these symptoms compared to other drugs like gadobenate dimeglumine and gadoteridol, suggesting a better safety profile.
- The second study focused on the risk assessment among patients with stage 4 or 5 chronic kidney disease who received group II gadolinium-based contrast agents, including Gadoterate meglumine. It revealed negligible incidence rates for Nephrogenic Systemic Fibrosis (NSF), indicating a favorable safety profile, especially in patients with compromised renal function.
- In terms of population types and subgroup considerations, Gadoterate meglumine seems safer for general populations, including both adult and pediatric patients, due to its fewer associated symptoms and those suffering from chronic kidney disease due to a low NSF risk factor according to the analysis presented.
- The overall comparison suggests that while all Group II gadolinium-based contrast agents have similar profiles, Gadoterate meglumine stands out because it has been shown through studies that this drug presents fewer risks specifically towards the occurrence of severe adverse events alongside almost no cases leading towards NSF making it an ideal choice amongst high-risk patient groups such as those diagnosed with chronic kidney disease.
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 |