Elucirem™ (gadopiclenol) and Vueway™ (gadopiclenol) are now available for use with magnetic resonance imaging (MRI) in patients 2 years of age and older to detect and visualize lesions with abnormal vascularity in the central nervous system (CNS; brain, spine and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).
Gadopiclenol is a highly stable macrocyclic gadolinium-based contrast agent (GBCA) designed to accelerate the relaxation rates of water protons resulting in an increase in signal intensity of tissues. Gadopiclenol only requires half of the gadolinium dose of conventional nonspecific GBCAs.
The Food and Drug Administration (FDA) approved gadopiclenol in September 2022 based on data from the phase 3 PICTURE (ClinicalTrials.gov Identifier: NCT03996447) and PROMISE (ClinicalTrials.gov Identifier: NCT03986138) studies. Both studies demonstrated that gadopiclenol-enhanced MRI was superior to unenhanced MRI and was noninferior to gadobutrol. The most common adverse reactions reported were injection site pain, headache, nausea, injection site warmth, injection site coldness, dizziness, and localized swelling.
“Having the ability to use a lower dose of gadolinium, while seeing the diagnostic value and good tolerance during the MRI would be a significant improvement for the practice of neuroradiology,” said principal investigator, Dr Laurie A. Loevner, Division Chief, Neuroradiology and Professor of Radiology at the Perelman School of Medicine at the University of Pennsylvania.
Gadopiclenol carries a Boxed Warning associated with an increased risk of nephrogenic systemic fibrosis among patients with impaired elimination of GBCAs. Use of GBCAs in these patients should be avoided unless the diagnostic information is essential and not available with noncontrasted MRI or other modalities.
Elucirem and Vueway are supplied in single-dose vials (3mL, 7.5mL, 10mL, 15mL), single-dose prefilled syringes (7.5mL, 10mL, 15mL) and pharmacy bulk packages (30mL, 50mL, 100mL) containing 0.5mmol/mL of gadopiclenol.
This article originally appeared on MPR
- Guerbet announces commercial launch and first patient dosing of Elucirem™ (gadopiclenol) injection, a novel new macrocyclic GBCA for use in contrast-enhanced magnetic resonance imaging (MRI). News release. Guerbet. Accessed February 14, 2023. https://www.prnewswire.com/news-releases/guerbet-announces-commercial-launch-and-first-patient-dosing-of-elucirem-gadopiclenol-injection-a-novel-new-macrocyclic-gbca-for-use-in-contrast-enhanced-magnetic-resonance-imaging-mri-301745569.html.
- Preeminent hospitals and medical practices nationwide lead in patient care with first use of Bracco’s Vueway™ (gadopiclenol) solution for injection for MRI. News release. Bracco Diagnostics Inc. Accessed February 14, 2023. https://www.prnewswire.com/news-releases/preeminent-hospitals-and-medical-practices-nationwide-lead-in-patient-care-with-first-use-of-braccos-vueway-gadopiclenol-solution-for-injection-for-mri-301746296.html.
- Elucirem. Package insert. Guerbet LLC; 2022. Accessed February 14, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216986s000lbl.pdf.
- Vueway. Package insert. Bracco Diagnostics Inc; 2022. Accessed February 14, 2023. https://www.bracco.com/sites/default/files/2022-11/us-en-spc-vueway.pdf.