Fresenius Kabi has launched Gadobutrol Injection, a generic substitute for the contrast agent Gadavist®, which is used in MRI procedures. Fresenius Kabi Gadobutrol Injection, a high-relaxivity macrocyclic agent, is available immediately in the United States. It is the second MRI offering in the company’s radiology portfolio, which also includes: Gadoterate Meglumine Injection, USP, a generic equivalent of Dotarem; Sincalide for Injection, an authorized generic of Kinevac; and Iodixanol Injection, USP, a generic for Visipaque.
“Fresenius Kabi is pleased to introduce Gadobutrol Injection as the newest addition to our U.S. radiology portfolio, expanding the range of cost-effective contrast agent options available to hospitals and clinics,” says John Ducker, president and CEO of Fresenius Kabi USA.
Gadobutrol Injection is a gadolinium-based contrast agent indicated for use with MRI.It is the fourth product offering in the Fresenius Kabi radiology portfolio, which first launched in July 2022 with the introduction of Iodixanol Injection, USP during a nationwide shortage.
Gadobutrol Injection is available to order direct from the company and through wholesalers and distributors. It is currently available in 2 mL, 7.5 mL, 10 mL, and 15 mL Single Dose Vials. Fresenius Kabi Gadobutrol Injection is preservative-free, and the container closure is not made with natural rubber latex.
Indications and Usage
Gadobutrol injection is a gadolinium-based contrast agent indicated for use with MRI:
- 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.
