Fresenius Kabi Further Expands Radiology Portfolio with Launch of Gadobutrol Injection

2023-08-08

上市批准

FDA-approved generic for MRI procedures is fully substitutable for Gadavist® LAKE ZURICH, Ill.--(BUSINESS WIRE)-- Fresenius Kabi announced today it has launched Gadobutrol Injection, a generic substitute for the contrast agent Gadavist®, which is used in magnetic resonance imaging (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 growing 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," said John Ducker, president and CEO of Fresenius Kabi USA. Gadobutrol Injection is a gadolinium-based contrast agent indicated for use with MRI.1 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 magnetic resonance imaging (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 (CAD). WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF) See full prescribing information for complete boxed warning Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or Acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. IMPORTANT SAFETY INFORMATION Contraindications: History of severe hypersensitivity reaction to gadobutrol injection. Nephrogenic Systemic Fibrosis has occurred in patients with impaired elimination of GBCAs. Higher than recommended dosing or repeated dosing appears to increase the risk. Anaphylactic and other hypersensitivity reactions with cardiovascular, respiratory, or cutaneous manifestations, ranging from mild to severe, including death, have occurred. Monitor patients closely during and after administration of gadobutrol injection. Gadolinium is retained for months or years in brain, bone, and other organs. Adverse Events: Most common adverse reactions (incidence ≥ 0.5%) are headache, nausea, and dizziness. Pregnancy: Use only if imaging is essential during pregnancy and cannot be delayed. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or . This Important Safety Information does not include all the information needed to use Gadobutrol Injection safely and effectively. Please see full prescribing information, including BOXED WARNING, for Gadobutrol Injection at . About Fresenius Kabi Fresenius Kabi ( ) is a global health care company that specializes in medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used to help care for patients with critical and chronic conditions. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. To learn about U.S. career opportunities at Fresenius Kabi, visit us at and follow us on LinkedIn. References Gadobutrol Injection Package Insert, January 2023 *Gadavist® is a registered trademark of Bayer. *Dotarem® is a registered trademark of Guerbet. *Kinevac® is a registered trademark of Bracco Diagnostics Inc. *Visipaque® is a registered trademark of GE Healthcare.