Drug updated on 12/11/2024
| 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
- 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
- Indicated to assess the presence and extent of malignant breast disease in adult patients
- Indicated to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients, including term neonates
- Indicated to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).
Latest News
Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Effectiveness of Gadobutrol in Cardiothoracic Applications: In a systematic review of 16 studies with 506 patients, gadobutrol (Gadavist) was used as a contrast agent in 37% of cases, with other agents including gadopentetate dimeglumine (31%) and gadobenate dimeglumine (13%). Studies varied in contrast doses (0.02-0.2 mmol/kg) and injection rates (1-5 ml/s), with sequences such as TWIST (81%), TRICKS (13%), and CENTRA (6%) used for imaging.
- Comparative Data Limitations: No direct effectiveness comparison between gadobutrol and other contrast agents was possible from the studies, as specific outcome measures for cross-agent efficacy were not provided.
- Field Strength and Population: Most studies (81%) used a magnetic field strength of 1.5 T; the remaining 19% utilized 3 T. No evidence of differential effectiveness was found among varying population types or subgroups within the patient cohort.
- In a meta-analysis of 16 studies involving 4931 patients with stage 4 or 5 chronic kidney disease (CKD) who received group II gadolinium-based contrast agents (GBCAs), including gadobenate dimeglumine, gadobutrol, gadoterate meglumine, and gadoteridol, the pooled incidence of nephrogenic systemic fibrosis (NSF) was 0% (upper bound of 95% confidence interval (CI), 0.07%).
- No cases of NSF were reported across individual GBCAs: gadobenate dimeglumine (0 of 3167, 95% CI upper bound 0.12%), gadoterate meglumine (0 of 1204, 95% CI upper bound 0.31%), gadobutrol (0 of 330, 95% CI upper bound 1.11%), and gadoteridol (0 of 230, 95% CI upper bound 1.59%).
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Gadavist (gadobutrol) Prescribing Information. | 2024 | Bayer HealthCare Pharmaceuticals Inc., Whippany, 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. | 2019 | 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 |