Fresenius Kabi, the German healthcare company with U.S. headquarters in Illinois, has launched a new generic substitute for Gadavist, the gadolinium-based contrast agent from Bayer commonly used during MRI exams.
The contrast agent, simply called Gadobutrol Injection, has been approved by the U.S. Food and Drug Administration and is available now in the United States. This is the fourth addition to Fresenius Kabi’s radiology portfolio, joining generic versions of Dotarem, Kinevac and Visipaque.
According to a prepared statement from Fresenius Kabi, Gadobutrol Injection is indicated to help detect and visualize areas with a disrupted blood brain barrier, assess the presence of malignant breast disease, evaluate suspected supra-aortic or renal artery disease and assess myocardial perfusion and late gadolinium enhancement in coronary artery disease patients.
Gadobutrol Injection is available in single-dose vials containing 2 mL, 7.5 mL, 10 mL and 15 mL.
The company did note that the most common adverse reactions to its newest contrast agent are headaches, nausea and dizziness. In addition, like all GBCAs, Gadobutrol Injection may increase a patient’s risk of nephrogenic systemic fibrosis.
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