ACR Classifies Gadopiclenol as a Group II Agent

Vueway

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

 

Monroe Township, NJ, May 10, 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 today 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

 

VUEWAY injection is now available to order from Bracco Diagnostics Inc. Visit VUEWAY.com for more information, including its full Prescribing Information and Important Safety Information.

 

VUEWAY® (gadopiclenol) solution for injection

 

Indications

VUEWAY injection is indicated in adults and children aged 2 years and older for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in:

  • the central nervous system (brain, spine and surrounding tissues),
  • the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).

 

IMPORTANT SAFETY INFORMATION

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.

  • The risk for NSF appears highest among patients with:
    • Chronic, severe kidney disease (GFR < 30 mL/min/1.73 m2), or
    • Acute kidney injury.
  • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
  • For patients at highest risk for NSF, do not exceed the recommended VUEWAY dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.

 

Contraindications

VUEWAY injection is contraindicated in patients with history of hypersensitivity reactions to VUEWAY.

 

Warnings

Risk of nephrogenic systemic fibrosis is increased in patients using GBCA agents that have impaired elimination of the drugs, with the highest risk in patients with chronic, severe kidney disease as well as patients with acute kidney injury. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities.

 

Hypersensitivity reactions, including serious hypersensitivity reactions, could occur during use or shortly following VUEWAY administration. Assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders, administer VUEWAY only in situations where trained personnel and therapies are promptly available for the treatment of hypersensitivity reactions, and observe patients for signs and symptoms of hypersensitivity reactions after administration.

 

Gadolinium retention can be for months or years in several organs after administration. The highest concentrations (nanomoles per gram of tissue) have been identified in the bone, followed by other organs (brain, skin, kidney, liver and spleen). Minimize repetitive GBCA imaging studies, particularly closely spaced studies, when possible.

 

Acute kidney injury requiring dialysis has occurred with the use of GBCAs in patients with chronically reduced renal function. The risk of acute kidney injury may increase with increasing dose of the contrast agent.

 

Ensure catheter and venous patency before injecting as extravasation may occur, and cause tissue irritation.

 

VUEWAY may impair the visualization of lesions seen on non-contrast MRI. Therefore, caution should be exercised when VUEWAY MRI scans are interpreted without a companion non-contrast MRI scan.

 

The most common adverse reactions (incidence ≥ 0.5%) are injection site pain (0.7%), and headache (0.7%).

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

 

Please click here for full Prescribing Information for VUEWAY, including BOXED WARNING on Nephrogenic Systemic Fibrosis.

 

Manufactured for Bracco Diagnostics Inc. by Liebel-Flarsheim Company LLC - Raleigh, NC, USA 27616.

 

VUEWAY is a trademark of Bracco Imaging S.p.A.

 

All other trademarks and registered trademarks are the property of their respective owners.

 

Bracco Diagnostics Inc.

259 Prospect Plains Road, Building H Monroe Township, NJ 08831 USA

Phone: 609-514-2200

Toll-Free: 1-877-272-2269 (U.S. only)

Fax: 609-514-2446

 

© 2023 Bracco Diagnostics Inc. All Rights Reserved.

 

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.

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