Summary

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• 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.