Drug updated on 9/4/2024
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).
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Summary
- Gadavist (gadobutrol) is indicated 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; and to assess myocardial perfusion (stress and rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- The reviewed studies do not provide direct evidence of gadobutrol's (Gadavist) effectiveness in clinical settings, as the focus was on administration protocols and safety concerns related to gadolinium-based contrast agents (GBCAs).
- The safety assessment involved 16 studies with 4931 patients with stage 4 or 5 chronic kidney disease (CKD). No cases of nephrogenic systemic fibrosis (NSF) were reported among patients receiving gadobutrol, resulting in a pooled incidence of 0% (upper bound of 95% CI, 1.11%).
- Gadobutrol showed a comparable safety profile to other group II GBCAs in patients with severe CKD, with no NSF cases reported across studies, indicating a very low risk in this high-risk population.
- In patients with stage 4 or 5 chronic kidney disease (eGFR < 30 mL/min/1.73 m²), including those with or without dialysis, the pooled incidence of nephrogenic systemic fibrosis (NSF) following gadobutrol administration was 0% (upper bound of 95% CI, 1.11%), indicating a very low risk of NSF in this high-risk subgroup and supporting the potential benefit-risk ratio favoring gadobutrol use in indicated examinations.
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 |