Overview

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Web ordering Full prescribing information

Overview

Details

Resources

Support

Web ordering Full prescribing information

Visipaque™ (Iodixanol) Injection

Visipaque™ (iodixanol) injection - the only contrast media for intravascular use that is iso-osmolar to blood and isotonic at all concentrations in the US

At a glance

25+ years of clinical use

May help mitigate risk of MARCE in comorbid patients¹

Iso-osmolar and isotonic

Reducing vascular fluid shift and impact of differences in osmotic pressure^2,3

Enhance your CCTA scans

The first FDA-approved contrast medium for Coronary CTA

May help reduce costs

Lower hospitalization costs due to shortened length of stay^4,5

Consider Visipaque for patients at risk for adverse outcomes

More than 1 in 7 adults in the US are estimated to have CKD, and most don't know it.⁶ 34.2 million Americans - just over 1 in 10 - have diabetes.⁷ By 2060, 1 in 4 people in the US will be aged 65+, with the number over 85 years expected to nearly triple.⁸

Appropriate selection of contrast media for necessary diagnostic or interventional procedure imaging in at risk patients should be considered to help mitigate the risk of adverse events.⁹ Visipaque is an iodinated iso-osmolar, isotonic contrast agent indicated for multiple intra-arterial and intravenous procedures in adults and pediatric patients.

Features

Your choice of iodinated contrast media could help mitigate post-procedural adverse events in at risk patients

Interventional, structural, or endovascular procedures (e.g. Transcatheter Aortic Valve Implantation (TAVI), interventions for Chronic Total Occlusion (CTO), Percutaneous Coronary Intervention (PCI)) may need to use higher volumes of iodinated contrast media, potentially leading to greater incidence of acute kidney injury (AKI). Reducing the frequency of adverse reactions such as AKI, major adverse renal cardiovascular event (MARCE), and acute AEs has therefore been a driving force in the development of these diagnostic agents since their initial introduction.^9,10

Safety

Formulated for at risk patient populations

Visipaque is an isotonic, third-generation agent with a dimeric molecular structure developed to further improve the safety profile of iodinated contrast agents.^11,12 It is iso-osmolar to blood with the aim of counteracting major fluid shifts across membranes and limiting discomfort.^12-14 It is also formulated with balanced electrolytes to help minimize effects on cardiac contractile force/fibrillatory
propensity.^12-14 While 'low' osmolar agents form the mainstay in the general population of patients undergoing endovascular diagnostic or interventional procedures, Visipaque may be selected for more complex procedures in patients considered at risk for cardiovascular or renal adverse outcomes.^1,11

visipaque-iodixanol-injection-safety-ph-en

Packaging

Get your job done easier and faster with improved packaging

Introducing the flip top cap on our +PLUSPAK™ polymer bottles. This packaging facilitates opening the cap and is an improvement on the ring pull design, with a reduced risk of injury¹⁵. This new design also helps reduce costs and environmental impact with less storage space needed and lower disposal costs.^16-18 It helps to streamline processes and traceability through color coding, triple-tracking stickers, a 2D DataMatrix, and an integrated hanger with a label easy to read even when inverted.

Value

Can help reduce cost by reducing adverse events to at risk patients

When compared to total interventional procedure cost, contrast media is inexpensive but contrast-associated acute kidney injury (CA-AKI) and contrast media-related adverse events may increase the use of health care resources and cost of care.¹⁹ Given the growth of vulnerable patient populations, it is important to identify clinical practices that reduce the incidence and associated costs of MARCE.⁵

According to a study conducted to determine the net economic impact of switching from low-osmolar contrast media (LOCM) to iso-osmolar contrast media (IOCM; iodixanol) in patients undergoing inpatient coronary or peripheral angioplasty in the US, moving on to an IOCM-only strategy may yield potential cost savings associated with MARCE to US hospitals where coronary and peripheral procedures are performed.⁵

Evidence-based

Data to support clinical decision making

Randomized controlled trials often do not address all the clinical scenarios that confront physicians.^20,21 Specifically in interventional cardiology, patients with multiple risk factors are often routinely excluded from revascularization randomized controlled trials (RCTs).^22,23 Real-world evidence complement traditional clinical trials, with broader populations and health care delivery that reflects actual clinical practice.²⁴

In the interventional cardiology setting, use of iso-osmolar Visipaque is supported by:
• Robust randomized controlled trials^25-28
• Meta-analyses of intra-arterial studies^29-31
• Registry and real-world data analysis outcomes^{1, 32-34}

Reduce patient discomfort

Increased patient comfort can help improve throughput

Enhancing patient comfort during peripheral endovascular procedures is important for both patients and efficiency, as movement during scanning may necessitate studies being repeated or prolonged. ^{13, 35-36}

A benefit of iso-osmolar Visipaque when compared with pooled LOCMs is the reduction in discomfort associated in arteriography.¹² According to the ACR, iso-osmolar CM “...are associated with the least amount of vasospasm and the least peripheral discomfort for peripheral angiograms”.³⁷

Support you need for your procedures

Learn more about supporting resources available for Visipaque.

Educational programs

Contrast-associated acute kidney injury (CA-AKI) is a challenge that may be encountered in the cardiac catheterization lab.

Learn more

Educational programs

Webinar: Acute Kidney Injury - Complications in the Cardiac Cath Lab
Contrast-associated acute kidney injury (CA-AKI) is a challenge that may be encountered in the cardiac catheterization lab. In this on-demand webinar, Dr. Arnold Seto, Cardiac Cath Lab Director, Long Beach VA, and Director of Interventional Cardiology Research at University of California, Irvine, discusses the increasing incidence with comorbidities and complex procedures. He talks about the implications of AKI as well as mitigation strategies. Dr. Seto also shares emerging data on AKI in COVID-19 patients.

Watch now

References

McCullough P et al. Major Adverse Renal and Cardiovascular Events following Intra-Arterial Contrast Media Administration in Hospitalized Patients with Comorbid Conditions. Cardiorenal Med 2021; 11(4): 193–9.
Visipaque Prescribing Information. Marlborough, MA: GE HealthCare; 2023.
Swanson DP, Chilton HM, Thrall JH. In: Pharmaceuticals in Medical Imaging. Collier MacMillan Publishers, London 1990
Aluko P, et al. Value in Health. 25(7): S386-387. July 2022.
Keuffel E et al. J Med Econ. 2018;21:356-364.
Centers for Disease Control and Prevention. Chronic Kidney Disease in the United States, 2021. Atlanta, GA: US Department of Health and Human Services, Centers for Disease Control and Prevention; 2021.
Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2020. Atlanta, GA: Centers for Disease Control and Prevention, U.S. Dept of Health and Human Services; 2020.
Vespa, Jonathan, Lauren Medina, and David M. Armstrong, “Demographic Turning Points for the United States: Population Projections for 2020 to 2060,” Current Population Reports, P25-1144, U.S. Census Bureau, Washington, DC, 2020.
Mehran R, Dangas GD, Weisbord SD. Contrast-Associated Acute Kidney Injury. N Engl J Med. 2019;380(22):2146-2155.
Christiansen C. X-ray contrast media-an overview. Toxicology. 2005; 209(2): 185-7.
Widmark JM. Imaging-related medications: a class overview. Proc (Bayl Univ Med Cent). 2007; 20(4): 408-17.
Almén T. Visipaque – a step forward a historical review Acta Radiol. 1995; 36(Suppl.399): 2-18.
Rosenberg C et al. J Invasive Cardiology 2017; 29(1): 9-15.
Fountaine H, Harnish P, Andrew E, Grynne B. Safety, tolerance, and pharmacokinetics of iodixanol injection, a nonionic, isosmolar, hexa-iodinated contrast agent. Acad Radiol. 1996; 3 Suppl 3:S475-84.
Marshall G. Radiography. 2008;14:128-134.
Marshall G. Sharps injuries among radiographers: Dangers associated with opening bottles of contrast agent. Radiography. 2008;14:128-134.
Gricar J, Deutsch S, Blackburn J, Zyczynski T. The economic and safety impact of glass versus polymer containers in a radiology department. Radiol Manage. 2007;Sep/Oct:34-42.
Dhaliwal H, Browne M, Flanagan W, Laurin L, Hamilton M. A life cycle assessment of packaging options for contrast media delivery: comparing polymer bottle vs. glass bottle. Int J Life Cycle Assess. 2014;19:1965-1973.
Amin AP et al. Incremental Cost of Acute Kidney Injury after Percutaneous Coronary Intervention in the United States. Am J Cardiol. 2020 Jan 1;125(1):29-33.
Kerneis M, Nafee T, et al. Most promising therapies in interventional cardiology. Curr Cardiol Rep. 2019; 21(4): 26.
Bonow RO, Braunwald E. The evidence supporting cardiovascular guidelines – Is there evidence of progress in the last decade? JAMA. 2019; 321(11): 1053-4.
De Marzo V, D’Amario D, Galli M, Vergallo R, Porto I. High-risk percutaneous coronary intervention: how to define it today? Minerva Cardioangiol. 2018; 66(5): 576-93.
Kinnaird T, Gallagher S, et al. Complex high-risk and indicated percutaneous coronary intervention for stable angina: Does operator volume influence patient outcome? Am Heart J. 2020; 222: 15-25.
Sherman RE, Anderson SA, et al. Real-world evidence – What is it and what can it tell us? N Engl J Med. 2016; 375: 2293-7.
Aspelin P, Aubry P, Fransson S-G, Strasser R, Willenbrock R, Berg KJ. Nephrotoxic effects in high-risk patients undergoing angiography. N Engl J Med. 2003;348(6): 491-9.
Harrison JK, Hermiller JB, et al. A randomized study of 1276 patients undergoing PCI using iodixanol (Visipaque) vs iopamidol (Isovue); comparison of in-hospital and 30 day major adverse cardiac event. The results of the VICC trial. Am Heart J. 2004; 147(4): 612-14.
Davidson CJ, Laskey WK, et al. Randomized trial of contrast media utilization in high-risk PTCA. The COURT trial. Circulation. 2000; 101(18): 2172-7.
Nie B, Cheng W-J, et al. A prospective, double-blind, randomized, controlled trial on the efficacy and cardiorenal safety of iodixanol vs. iopromide in patients with chronic kidney disease undergoing coronary angiography with or without percutaneous coronary intervention. Catheter Cardiovasc Interv. 2008; 72(7):958-65.
McCullough PA, Brown JR. Effects of intra-arterial and intravenous iso-osmolar contrast medium (iodixanol) on the risk of contrast-induced acute kidney injury: a meta-analysis. Cardiorenal Med. 2011; 1(4): 220-24.
Dong M, Jiao Z, Liu T, Guo F, Li G. Effect of administration route on the renal safety of contrast agents: a meta-analysis of randomized controlled trials. J Nephrol. 2012; 25(3): 290-301.
Zhao F, Lei R, et al. Comparative effect of iso-osmolar versus low-osmolar contrast media on the incidence of contrast-induced acute kidney injury in diabetic patients: a systematic review and meta-analysis. Cancer Imaging. 2019; 19(1): 38.
Iacovelli F et al. Int J Cardiol 2021; 329: 56-62.
Prasad A et al. Use of iso-osmolar contrast media during endovascular revascularization is associated with a lower incidence of major adverse renal, cardiac, or limb events. Catheter Cardiovasc Interv 2021; 2022; 99(4): 1335-42.
Amin AP et al. Association of Iso-Osmolar vs Low-Osmolar Contrast Media With Major Adverse Renal or Cardiovascular Events in Patients at High Risk for Acute Kidney Injury Undergoing Endovascular Abdominal Aortic Aneurysm Repair. J Invasive Cardiol 2021; 33(8): E640-6.
RCR. Clinical radiology. UK workforce census 2018 report. London: RCR, April 2019.
Ortiz-Lopez C, Prasad A. Iso-osmolar contrast (iodixanol) reduces patient and operator pain during peripheral angiography. Catheter Cardiovasc Interv. 2014; 84(6): 1026-7.
ACR Manual on Contrast Media. Version 2024.

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JB07513US July 2025

Visipaque™ (Iodixanol) Injection

25+ years of clinical use

Iso-osmolar and isotonic

Enhance your CCTA scans

May help reduce costs

Consider Visipaque for patients at risk for adverse outcomes

Support you need for your procedures

Educational programs

References

Have a question? We would love to hear from you.

Contact us We’re ready to support you in your moments that matter. For service assistance, call us.

Contact us

We’re ready to support you in your moments that matter.
For service assistance, call us.