Preeminent Hospitals and Medical Practices Nationwide Lead in Patient Care with First Use of Bracco's VUEWAY™ (gadopiclenol) solution for injection for MRI

Requiring half the gadolinium dosage compared to other macrocyclic gadolinium-based contrast agents (GBCAs) in approved indications in the U.S., gadopiclenol also has the highest relaxivity compared to approved GBCAs^1-7

MONROE TOWNSHIP, N.J., Feb. 14, 2023 /PRNewswire/ -- 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 Wellstar Health System is among the first establishments in the nation to trial VUEWAY™ (gadopiclenol) injection, a recently FDA-approved macrocyclic gadolinium-based contrast agent (GBCA) for use in magnetic resonance imaging (MRI). Gadopiclenol needs only half the dose compared to other GBCAs in approved indications in the U.S. to accomplish the same image clarity due to the fact that it has the highest relaxivity of all GBCAs compared to approved GBCAs.^1-7

"We are honored to stand alongside these prestigious leaders of the medical community for the first VUEWAY injections, after FDA approval," said Fulvio Renoldi Bracco, Vice-Chairman & CEO of Bracco Imaging. "We're particularly excited about our innovations in contrast imaging because of the wide-reaching impact across disease categories with 30 million MRI scans conducted annually, globally.⁸ That these institutions have prioritized offering VUEWAY injection, a novel next-generation MRI contrast agent, reinforces the potential value VUEWAY injection will provide in patient care and diagnostics."

VUEWAY (gadopiclenol) injection received FDA approval on Sept. 21, 2022, for use with MRI in adults and pediatric patients aged two years and older to detect and visualize lesions in the central nervous system (brain, spine, and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).⁷

Two recent Phase III trials sharing similar methodologies and endpoints demonstrate the efficacy and safety of gadopiclenol in MRI of the CNS (the PICTURE trial) and of the body (the PROMISE trial). Combining study populations, over 500 individuals had MRI scans compared when done with gadopiclenol at half the dose of a conventional agent, gadobutrol, at full dose. Even with the lower dosage, blinded readers rated gadopiclenol scans as having comparable image quality.^9-11

VUEWAY injection is manufactured in the U.S. by Liebel-Flarsheim Company LLC in Raleigh, NC. 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).⁷ 

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

About Bracco Imaging
Bracco Imaging S.p.A. ("Bracco Imaging"), part of the Bracco Group, is an innovative world leader delivering end-to-end products and solutions through its comprehensive portfolio across diagnostic imaging modalities. Headquartered in Milan, Italy, Bracco Imaging's purpose is to improve people's lives by shaping the future of prevention and precision diagnostic imaging. The Bracco Imaging portfolio includes products and solutions for all key diagnostic imaging modalities: X-ray imaging, magnetic resonance imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents. Bracco Imaging has approximately 3,600 employees and operates in more than 100 markets globally. Bracco Imaging has a well-skilled and innovative Research and Development (R&D) organization with an efficient process-oriented approach and track record in the diagnostic imaging industry. R&D activities are located in four centers based in Italy, Switzerland, the United Kingdom and the United States. Bracco Group global revenues were 1.4 billion Euros in 2020. To learn more about Bracco Imaging, visit www.bracco.com.  

Bracco Diagnostics Inc. Media Relations (USA)
Kimberly Gerweck
Senior Manager, Marketing Communications
[email protected]
D: +1 609-524-2777

¹ Robic C, Port M, Rousseaux O, et al. Physicochemical and Pharmacokinetic Profiles of Gadopiclenol: A New Macrocyclic Gadolinium Chelate with High T1 Relaxivity. Invest Radiol 2019; 54: 475-484.
² GADAVIST^® (gadobutrol) Injection. Full Prescribing Information.  Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ; April 2022.
³ DOTAREM^® (gadoterate meglumine) Injection. Full Prescribing Information. Guerbet LLC. Princeton, NJ. April 2022.
⁴ CLARISCAN™ (gadoterate meglumine) injection for intravenous use. Full Prescribing Information. GE Healthcare. Chicago, IL; February 2020.
⁵ ProHance^® (Gadoteridol) Injection. Full Prescribing Information and Patient Medication Guide. Monroe Twp., NJ: Bracco Diagnostics Inc.; June 2022.
⁶ MultiHance^® (gadobenate dimeglumine) Injection. Full Prescribing Information and Patient Medication Guide. Monroe Twp., NJ: Bracco Diagnostics Inc.; August 2018.
⁷ Vueway™ (gadopiclenol) Injection Full Prescribing Information. Monroe Twp., NJ: Bracco Diagnostics Inc.; September 2022.
⁸ Lohrke J, et al. 25 Years of Contrast-Enhanced MRI: Developments, Current Challenges and Future Perspectives. Adv Ther. 2016 Jan;33(1):1-28.
⁹ Loevner L, Kolumban B, Hutoczki G, et al. Efficacy and Safety of Gadopiclenol for Contrast-Enhanced MRI of the Central Nervous System. The PICTURE Randomized Clinical Trial. Invest Radiol. 2022 Dec.
¹⁰ Clinical Study Report of Study GDX-44-010. Data on file.
¹¹ Clinical Study Report of Study GDX-44-011. Data on file.

US-VW-2300006 02/23

SOURCE Bracco Diagnostics Inc.