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Elucirem™ (gadopiclenol) and Vueway™ (gadopiclenol) at the moment are out there to be used with magnetic resonance imaging (MRI) in sufferers 2 years of age and older to detect and visualize lesions with irregular vascularity within the central nervous system (CNS; mind, backbone and related tissues) and the physique (head and neck, thorax, stomach, pelvis, and musculoskeletal system).
Gadopiclenol is a extremely secure macrocyclic gadolinium-based distinction agent (GBCA) designed to speed up the relief charges of water protons leading to a rise in sign depth of tissues. Gadopiclenol solely requires half of the gadolinium dose of standard nonspecific GBCAs.
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Being able to make use of a decrease dose of gadolinium, whereas seeing the diagnostic worth and good tolerance throughout the MRI can be a major enchancment for the follow of neuroradiology.
The Meals and Drug Administration (FDA) accredited gadopiclenol in September 2022 primarily based on information from the section 3 PICTURE (ClinicalTrials.gov Identifier: NCT03996447) and PROMISE (ClinicalTrials.gov Identifier: NCT03986138) research. Each research demonstrated that gadopiclenol-enhanced MRI was superior to unenhanced MRI and was noninferior to gadobutrol. The commonest opposed reactions reported have been injection web site ache, headache, nausea, injection web site heat, injection web site coldness, dizziness, and localized swelling.
“Being able to make use of a decrease dose of gadolinium, whereas seeing the diagnostic worth and good tolerance throughout the MRI can be a major enchancment for the follow of neuroradiology,” mentioned principal investigator, Dr Laurie A. Loevner, Division Chief, Neuroradiology and Professor of Radiology on the Perelman Faculty of Drugs on the College of Pennsylvania.
Gadopiclenol carries a Boxed Warning related to an elevated danger of nephrogenic systemic fibrosis amongst sufferers with impaired elimination of GBCAs. Use of GBCAs in these sufferers needs to be averted until the diagnostic info is crucial and never out there with noncontrasted MRI or different modalities.
Elucirem and Vueway are provided in single-dose vials (3 mL, 7.5 mL, 10 mL, 15 mL), single-dose prefilled syringes (7.5 mL, 10 mL, 15 mL) and pharmacy bulk packages (30 mL, 50 mL, 100 mL) containing 0.5 mmol/mL of gadopiclenol.
This text initially appeared on MPR
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