News | Contrast Media | May 16, 2023

American College of Radiology Classifies VUEWAY as a Group II Agent Relative to NSF

VUEWAY (gadopiclenol) solution for injection and VUEWAY (gadopiclenol) Pharmacy Bulk Package are available for use in the U.S. following the market launch in February 2023¹

May 16, 2023 — Bracco Imaging, an innovative world leader delivering end-to-end products and solutions through a comprehensive portfolio inclusive of precision diagnostic imaging modalities, announced that the American College of Radiology (ACR) has classified VUEWAY (gadopiclenol) as a Group II agent within its classification of gadolinium-based contrast agents relative to the risk of development of nephrogenic systemic fibrosis (NSF).²

The ACR Committee on Drugs and Contrast Media states that, "Gadopiclenol demonstrates kinetic stability and a long dissociation half-life that is comparable to other Group II macrocyclic agents," and therefore considers that, "the risk of NSF among patients exposed to standard or lower than standard doses of gadopiclenol is sufficiently low or possibly nonexistent such that it has been classified as a Group II agent."²

"We are pleased that the ACR Committee on Drugs and Contrast Media classified gadopiclenol as a Group II agent, in view of its very high stability, and made healthcare professionals aware of the low risk of NSF with this agent," said Alberto Spinazzi, MD, Chief Medical and Regulatory Officer at Bracco. "We are encouraged by the steady stream of medical institutions who have added VUEWAY injection to their formulary in view of the high stability and high relaxivity of this agent, and the benefit it provides to patients. We look forward to its continued adoption across the U.S. and globally, as we work towards regulatory approvals in other countries."

VUEWAY injection is approved for use in adult and pediatric patients aged 2 years and older with magnetic resonance imaging (MRI) of the CNS (brain, spine, and surrounding tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) at the dose of 0.05 mmol/kg.¹

For more information: www.vueway.com

References:

¹ Vueway (gadopiclenol) solution for injection Full Prescribing Information and Patient Medication Guide. Monroe Twp., NJ: Bracco Diagnostics Inc.; September 2022.

² American College of Radiology. ACR Manual on Contrast Media. 2023.