Fresenius Kabi announces 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.
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
INDICATIONS AND USAGE
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.
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.
Pregnancy: Use only if imaging is essential during pregnancy and cannot be delayed.
- 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.