Gadopiclenol
MRI contrast agent
From Wikipedia, the free encyclopedia
Gadopiclenol, sold under the brand name Elucirem or Vueway among others, is a contrast agent used with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system and in the body.[1][6] Gadopiclenol is a paramagnetic macrocyclic non-ionic complex of gadolinium.[1]
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| Trade names | Vueway, Elucirem |
| AHFS/Drugs.com | Micromedex Detailed Consumer Information |
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| Routes of administration | Intravenous |
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| Metabolism | None[1] |
| Excretion | Kidneys[1] |
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| Formula | C35H54GdN7O15 |
| Molar mass | 970.10 g·mol−1 |
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Gadopiclenol was approved for medical use in the United States in September 2022,[1][7][8] and in the European Union in December 2023.[2][3][4][5] Developed initially by Guerbet with intellectual property contributions from Bracco Imaging, gadopiclenol was commercialized following a strategic collaboration between the companies for manufacturing, research, and distribution.[9]
Pharmacology
Gadopiclenol has a higher relaxivity compared with standard gadolinium-based contrast agents (GBCAs). The higher relaxivity allows for a lower dose of gadopiclenol, reducing the total amount of gadolinium administered to the patient while preserving imaging quality. Gadopiclenol was approved by the FDA with a recommended dose of 0.05 mmol/kg for adults and pediatric patients aged 2 years and older. This is half the dose of standard macrocyclic GBCAs, which have a recommended dose of 0.1 mmol/kg.[1][10][11]
Safety
Gadopiclenol carries a warning, like all GBCAs, which warns against intrathecal use, and mandates patient screening for kidney problems, that the recommended dose not be exceeded, and that sufficient time elapse for elimination before re-administration.[1][12]
Society and culture
European Union
Gadopiclenol was approved for medical use in the United States in September 2022 by the Food and Drug Administration.[1][13]
In October 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Elucirem, intended for contrast-enhanced magnetic resonance imaging (MRI) to improve detection and, visualization of pathologies when diagnostic information is essential and not available with unenhanced MRI.[2] The applicant for this medicinal product is Guerbet.[2] In October and December 2023, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal products Elucirem and Vueway, intended for contrast-enhanced magnetic resonance imaging (MRI) to improve detection and, visualization of pathologies when diagnostic information is essential and not available with unenhanced MRI. Gadopiclenol was approved for medical use in the European Union in December 2023.[2][3][4][5]
Brand names
Gadopiclenol is the international nonproprietary name.[14]
Gadopiclenol is sold under the brand names Vueway and Elucirem.[2][3][4][5]
