Gadobutrol: A Review in Contrast-Enhanced MRI and MRA
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Intravenous gadobutrol [Gadovist™ (EU); Gadavist® (USA)] is a second-generation, extracellular non-ionic macrocyclic gadolinium-based contrast agent (GBCA) that is approved for use in paediatric (including term neonates) and adult patients undergoing diagnostic contrast-enhanced (CE) MRI for visualization of pathological lesions in all body regions or for CE MRA to evaluate perfusion and flow-related abnormalities. Its unique physicochemical profile, including its high thermostability and proton relaxation times, means that gadobutrol is formulated at twice the gadolinium ion concentration of other GBCAs, resulting in a narrower bolus and consequently, improved dynamic image enhancement. Based on > 20 years of experience in the clinical trial and real-world settings (> 50 million doses) and its low risk for developing nephrogenic systemic fibrosis (NSF), gadobutrol represents an effective and safe diagnostic GBCA for use in CE MRI and MRA to visualize pathological lesions and vascular perfusion and flow-related abnormalities in all body regions in a broad spectrum of patients, including term neonates and other paediatric patients, young and elderly adult patients, and those with moderate or severe renal or hepatic impairment or cardiovascular (CV) disease.
Compliance with Ethical Standards
During the peer review process, the manufacturer of gadobutrol was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
The preparation of this review was not supported by any external funding.
Conflict of interest
Lesley Scott is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.
- 1.American College of Rheumatology. ACR manual on contrast media: version 10.3. 2017. https://www.acr.org. Accessed 29 Mar 2018.
- 3.European Medicines Agency. Gadolinium-containing contrast agents and nephrogenic systemic fibrosis: long-term consequences of retention in human skin and bone. 2010. http://www.ema.europa.eu/. Accessed 29 Mar 2018.
- 4.US FDA. New warnings for using gadolinium-based contrast agents in patients with kidney dysfunction. 2015. http://www.fda.gov. Accessed 29 Mar 2018.
- 11.Bayer HealthCare Pharmaceuticals Inc. Gadavist (gadobutrol) injection, for intravenous use: US prescribing information. 2016. http://labeling.bayerhealthcare.com. Accessed 1 Mar 2018.
- 12.Bayer plc. Summary of product characteristics, labelling and package leaflet: Gadovist 1.0 mmol/mL solution for injection. 2017. https://www.medicines.org.uk/emc/product/2876. Accessed 26 Jun 2018.
- 22.Anzalone N, Scarabino T, Venturi C, et al. Cerebral neoplastic enhancing lesions: multicenter, randomized, crossover intraindividual comparison between gadobutrol (1.0 M) and gadoterate meglumine (0.5 M) at 0.1 mmol Gd/kg body weight in a clinical setting. Eur J Radiol. 2013;82(1):139–45.CrossRefPubMedGoogle Scholar
- 24.Katakami N, Inaba Y, Sugata S, et al. Magnetic resonance evaluation of brain metastases from systemic malignances with two doses of gadobutrol 1.0 M compared with gadoteridol: a multicenter, phase II/III study in patients with known or suspected brain metastases. Invest Radiol. 2011;46(7):411–8.CrossRefPubMedGoogle Scholar
- 26.Maravilla KR, Smith MP, Vymazal J, et al. Are there differences between macrocyclic gadolinium contrast agents for brain tumor imaging? Results of a multicenter intraindividual crossover comparison of gadobutrol with gadoteridol (the TRUTH study). Am J Neuroradiol. 2015;36(1):14–23.CrossRefPubMedGoogle Scholar
- 29.Schaefer FKW, Schaefer PJ, Altjohann C, et al. A multicenter, site-independent, blinded study to compare the diagnostic accuracy of contrast-enhanced magnetic resonance angiography using 1.0 M gadobutrol (Gadovist™) to intraarterial digital subtraction angiography in body arteries. Eur J Radiol. 2007;61(2):315–23.CrossRefPubMedGoogle Scholar
- 32.Hammerstingl R, Adam G, Ayuso J-R, et al. Comparison of 1.0 M gadobutrol and 0.5 M gadopentetate dimeglumine-enhanced magnetic resonance imaging in five hundred seventy-two patients with known or suspected liver lesions: results of a multicenter, double-blind, interindividual, randomized clinical phase-III trial. Invest Radiol. 2009;44(3):168–76.CrossRefPubMedGoogle Scholar
- 33.Tombach B, Bohndorf K, Brodtrager W, et al. Comparison of 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine-enhanced MRI in 471 patients with known or suspected renal lesions: results of a multicenter, single-blind, interindividual, randomized clinical phase III trial. Eur Radiol. 2008;18(11):2610–9.CrossRefPubMedGoogle Scholar
- 38.Sardanelli F. Preoperative breast MRI: first results from the MIPA study [abstract]. Insights into Imaging. 2017;8(Suppl. 1):S491.Google Scholar
- 39.Trimboli RM, Di Leo G, Sacchetto D, et al. New insights into preoperative breast magnetic resonance imaging (MRI) from the multicentre individual patient analysis (MIPA) study [abstract]. Insights into Imaging. 2017;8(Suppl. 1):485.Google Scholar
- 41.Kuwatsuru R, Takahashi S, Umeoka S, et al. A multicenter, randomized, controlled, single-blind comparison phase III study to determine the efficacy and safety of gadobutrol 1.0 M versus gadopentetate dimeglumine following single injection in patients referred for contrast-enhanced MRI of the body regions or extremities. J Magn Reson Imaging. 2015;41(2):404–13.CrossRefPubMedGoogle Scholar
- 45.De Cobelli F, Esposito A, Perseghin G, et al. Intraindividual comparison of gadobutrol and gadopentetate dimeglumine for detection of myocardial late enhancement in cardiac MRI. AM J Radiol. 2012;198:809–16.Google Scholar
- 50.Data on file, Bayer AG., 2018.Google Scholar
- 55.Palkowitsch P, Voth M. Summary of the safety data for gadobutrol and gadofosveset. Eur Radiol. 2009;18(Suppl. 5):E47–54.Google Scholar
- 60.Granata V, Cascella M, Fusco R, et al. Immediate adverse reactions to gadolinium-based MR contrast media: a retrospective analysis on 10,608 examinations. BioMed Res Internat. 2016;10:3918292.Google Scholar
- 64.Bayer Pharmaceutical Co., Ltd. Gadovist IV injection: Japanese prescribing information. 2017. http://www.pmda.go.jp. Accessed 12 Feb 2018.
- 66.Fehlings MG, Martin AR, Tetreault LA, et al. A clinical practice guideline for the management of patients with acute spinal cord injury: recommendations on the role of baseline magnetic resonance imaging in clinical decision making and outcome prediction. Global Spine J. 2017;7(35):221S–30S.CrossRefPubMedPubMedCentralGoogle Scholar
- 69.European Society of Urogenital Radiology. ESUR guidelines on contrast media: version 8.1. 2017. http://www.esur.org/guidelines/. Accessed 23 Apr 2018.
- 86.European Medicines Agency. EMA’s final opinion confirms restrictions on use of linear gadolinium agents in body scans. 2017. http://www.ema.europa.eu/. Accessed 23 May 2018.
- 87.US FDA. FDA drug safety communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warning. 2018. http://www.fda.gov. Accessed 23 May 2018.