Drug updated on 4/16/2024
| Dosage Form | Injection (intravenous; 604.72 mg/mL [1 mmol/mL]) |
| Drug Class | Gadolinium-based contrast imaging agents |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients, including term neonates.
- To assess the presence and extent of malignant breast disease in adult patients.
- To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients, including term neonates.
- To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).
Summary
- Gadobutrol (Gadavist) is used for detecting and visualizing areas with disrupted blood-brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients, including term neonates. It also assesses the presence and extent of malignant breast disease in adults, evaluates known or suspected supra-aortic or renal artery disease in both adults and children, as well as assessing myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease.
- Two systematic reviews/meta-analyses focused on different clinical applications of Gadavist compared to other gadolinium-based contrast agents regarding safety and effectiveness.
- The first study indicates a wide variation in technical parameters for using various contrast agents like Gadavist, which was utilized 37% of the time among all studies included. However, it did not directly compare its safety or effectiveness across different contrast agents but highlighted heterogeneity within their clinical application settings.
- Regarding the population types considered by these studies: the first study included a diverse range of patients undergoing cardiothoracic MR angiography without specific mentions about high-risk subgroups; whereas the second study specifically focused on the stage 4/5 chronic kidney disease (CKD) patient subgroup who are at increased risk for Nephrogenic Systemic Fibrosis (NSF).
- According to the findings from the second study's meta-analysis involving CKD stage 4/5 patients exposed to group II GBCAs including Gadavist - no incidents of NSF were found. Although the upper bound risk assumption for NSF when using this drug was slightly higher than some other GBCAs like gadobenate dimeglumine & gadoterate meglumine, indicating a very low but non-zero risk assumption while treating high-risk CKD patients.
- Despite having a slightly higher upper bound risk value compared to some other Group II GBCA drugs, overall negligible risks for NSF in patients with severe CKD were found, thereby emphasizing its safety. Further standardization in clinical application and dosing could enhance patient outcomes.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Gadavist (gadobutrol) Prescribing Information. | 2024 | Bayer HealthCare Pharmaceuticals Inc., Wayne, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| ACR Manual on Contrast Media. | 2023 | Canadian Journal of Cardiology |
| Use of Intravenous Gadolinium-based Contrast Media in Patients with Kidney Disease: Consensus Statements from the American College of Radiology and the National Kidney Foundation. | 2021 | 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 |
| Updated clinical practice guideline on use of gadolinium-based contrast agents in kidney disease issued by the Canadian Association of Radiologists. | 2019 | Canadian Association of Radiologists |