FDA-approved generic for MRI procedures is fully substitutable for Dotarem®
LAKE ZURICH, Ill., October 04, 2022--(BUSINESS WIRE)--Fresenius Kabi announced today it has launched Gadoterate Meglumine Injection, USP, a bioequivalent and therapeutic equivalent substitute for the contrast agent Dotarem®. This is the second contrast agent introduced by Fresenius Kabi in the United States this year. Fresenius Kabi introduced Iodixanol Injection, USP in July during a nationwide shortage.
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Fresenius Kabi Gadoterate Meglumine Injection, USP is an FDA-approved generic for MRI procedures that is fully substitutable for Dotarem®. (Photo: Business Wire)
Contrast agents are used by radiologists to enhance the visibility of internal structures in imaging procedures such as MRI or CT scans. Contrast agents are a new category of health care products for Fresenius Kabi.
"Fresenius Kabi is pleased to expand our contrast agent portfolio and our support for the radiology community with the launch of Gadoterate Meglumine Injection, USP," said John Ducker, president and CEO of Fresenius Kabi USA. "Contrast agents are vital to patient diagnosis, and the addition of Fresenius Kabi Gadoterate Meglumine will provide hospitals and clinics across the U.S. with more high-quality choices to support patient care."
Gadoterate Meglumine Injection is a gadolinium-based contrast agent (GBCA) indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.1 In the United States, GBCAs are used in 30-45 percent of the approximately 40 million MRI procedures performed each year.2
As a macrocyclic ionic GBCA, Gadoterate Meglumine offers the strongest bond between the gadolinium atom and the chelate compared to other GBCAs. This greater stability means that the gadolinium has a higher likelihood to be excreted from the body as opposed to separating from the chelate and being retained in the body.3,4
Fresenius Kabi Gadoterate Meglumine Injection, USP is preservative-free, and the container closure is not made with natural rubber latex. It is currently available in four presentations:
Gadoterate Meglumine Injection, USP 5 mL Single Dose Vial
Gadoterate Meglumine Injection, USP 10 mL Single Dose Vial
Gadoterate Meglumine Injection, USP 15 mL Single Dose Vial
Gadoterate Meglumine Injection, USP 20 mL Single Dose Vial
Gadoterate Meglumine Injection is a gadolinium-based contrast agent indicated: for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.
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 less than 30 mL/min/1.73 m2), or
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 more than 60 years, hypertension, or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
Gadoterate Meglumine Injection is contraindicated in clinically important hypersensitivity reactions to Gadoterate Meglumine Injection.
Nephrogenic Systemic Fibrosis has occurred in patients with impaired elimination of GBCAs. Higher than recommended dosing or repeat dosing appear to increase the risk.
Hypersensitivity: Anaphylactoid/anaphylactic reactions with cardiovascular, respiratory, or cutaneous manifestations, ranging from mild to severe, including death, have uncommonly occurred. Monitor patients closely for need of emergency cardiorespiratory support.
Gadolinium is retained for months or years in brain, bone, and other organs.
Adverse Events: The most frequent (≥ 0.2%) adverse reactions in clinical studies were nausea, headache, injection site pain, injection site coldness, and rash.
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 www.fda.gov/medwatch.
Pregnancy: Use only if imaging is essential during pregnancy and cannot be delayed.
This Important Safety Information does not include all the information needed to use Gadoterate Meglumine Injection, USP safely and effectively. Please see full prescribing information, including BOXED WARNING, for Gadoterate Meglumine Injection, USP at www.fresenius-kabi.com/us.
Fresenius Kabi (www.fresenius-kabi.com/us) 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 critically and chronically ill patients. 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 http://www.fresenius-kabi.com/us/join-us and follow us on LinkedIn.
Gadoterate Meglumine Injection Package Insert, April 2022
Cheong BYC, Wilson JM, Preventza OA, Muthupillai R. Gadolinium-based contrast agents: updates and answers to typical questions regarding gadolinium use. Tex Heart Inst J 2022; 49(3): e217680. doi: 10.14503/THIJ-21- 7680
NCHR Report: The Health Risks of MRIs with Gadolinium-Based Contrast Agents. Stephanie Fox-Rawlings, PhD and Diana Zuckerman, PhD. National Center for Health Research. 2019.
Extracellular Gadolinium Contrast Agents: Differences in Stability. S.K. Morcos. European Journal of Radiology. 66 (2008) 175-179.
*Dotarem® is a registered trademark of Guerbet.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221004005162/en/
Joanie Clougherty (614) 717-5741 joan.clougherty@fresenius-kabi.com
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