Visipaque™ (iodixanol) Injection

The first Health Canada approved contrast media for intravascular use that is iso-osmolar to blood and isotonic at all concentrations
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AT A GLANCE

25+ years of clinical use

Visipaque has been used in 184 million procedures worldwide1

Iso-osmolar and isotonic

The only iso-osmolar product in Canada

Safe & inclusive

Gluten-free and latex-free & Halal certified2

Global adoption & research backing

Used in more than 100 countries and mentioned in over 1,550 publications3

Consider Visipaque for patients at risk for adverse outcomes

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.4 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.4,5
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.6,7 It is iso-osmolar to blood with the aim of counteracting major fluid shifts across membranes and limiting discomfort.7-9 It is also formulated with balanced electrolytes to help minimize effects on cardiac contractile force/fibrillatory
propensity.7-9 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.6,10
PACKAGING

Get your job done easier and faster with improved packaging

Introducing the flip top cap on our polymer bottle packaging. This packaging facilitates opening the cap and is an improvement on the ring pull design, with a reduced risk of injury11. This new design also helps reduce costs and environmental impact with less storage space needed and lower disposal costs.12-14 It helps to streamline processes and traceability through color coding, triple-tracking stickers, a 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.15 Given the growth of vulnerable patient populations, it is important to identify clinical practices that reduce the incidence and associated costs of MARCE.16

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.16
EVIDENCE-BASED

Data to support clinical decision making

Randomized controlled trials often do not address all the clinical scenarios that confront physicians.17,18 Specifically in interventional cardiology, patients with multiple risk factors are often routinely excluded from revascularization randomized controlled trials (RCTs).19,20 Real-world evidence complement traditional clinical trials, with broader populations and health care delivery that reflects actual clinical practice.21

In the interventional cardiology setting, use of iso-osmolar Visipaque is supported by:
• Robust randomized controlled trials22-25
• Meta-analyses of intra-arterial studies26-28
• Registry and real-world data analysis outcomes 10, 29-31
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. 8,32,33

A benefit of iso-osmolar Visipaque when compared with pooled LOCMs is the reduction in discomfort associated in arteriography.7 According to the ACR, iso-osmolar CM “...are associated with the least amount of vasospasm and the least peripheral discomfort for peripheral angiograms”.34
REFERENCES
  1. Data on file. GE Healthcare Contrast Media Demand; 2020
  2. Data on file, Halal Certification; GE Healthcare
  3. PubMed.gov search results for Visipaque. https://pubmed.ncbi.nlm.nih.gov/?term=visipaque.
  4. Mehran R, Dangas GD, Weisbord SD. Contrast-Associated Acute Kidney Injury. N Engl J Med. 2019;380(22):2146-2155.
  5. Christiansen C. X-ray contrast media-an overview. Toxicology. 2005; 209(2): 185-7.
  6. Widmark JM. Imaging-related medications: a class overview. Proc (Bayl Univ Med Cent). 2007; 20(4): 408-17.
  7. Almén T. Visipaque – a step forward a historical review Acta Radiol. 1995; 36(Suppl.399): 2-18.
  8. Rosenberg C et al. J Invasive Cardiology 2017; 29(1): 9-15.
  9. 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.
  10. 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.
  11. Marshall G. Radiography. 2008;14:128-134
  12. Marshall G. Sharps injuries among radiographers: Dangers associated with opening bottles of contrast agent. Radiography. 2008;14:128-134.
  13. 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.
  14. 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..
  15. 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.
  16. . Keuffel E et al. J Med Econ. 2018;21:356-364.
  17. Kerneis M, Nafee T, et al. Most promising therapies in interventional cardiology. Curr Cardiol Rep. 2019; 21(4): 26.
  18. Bonow RO, Braunwald E. The evidence supporting cardiovascular guidelines – Is there evidence of progress in the last decade? JAMA. 2019; 321(11): 1053-4.
  19. 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.
  20. 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.
  21. 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.
  22. 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.
  23. 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.
  24. 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.
  25. 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.
  26. 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.
  27. 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.
  28. 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.
  29. Iacovelli F et al. Int J Cardiol 2021; 329: 56-62.
  30. 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.
  31. 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.
  32. RCR. Clinical radiology. UK workforce census 2018 report. London: RCR, April 2019.
  33. 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.
  34. ACR Manual on Contrast Media. Version 2025.

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PRODUCT INDICATIONS AND USE – VISIPAQUE (IODIXANOL INJECTION USP)

• VISIPAQUE (iodixanol) 320 mg I/mL is indicated for use in angiocardiography (left ventriculography, aortic root injections and selective coronary arteriography) and can be used in the diagnosis of coronary artery disease as well as evaluation of the function of the chambers of the heart and heart valves.
• VISIPAQUE 320 mg I/mL is indicated for visualization of the aorta and its branches and for selective peripheral and visceral arteriography and in diagnosing arterial occlusive diseases, aneurysms, arteriovenous malformations and tumors. It may be used for both conventional radiography and digital subtraction angiography (DSA).
• VISIPAQUE 270 mg I/mL is also indicated for visualization of the aorta and its branches and for selective visceral arteriography and in diagnosing arterial occlusive diseases and tumors.
• VISIPAQUE 320 mg I/mL or 270 mg I/mL administered intravenously is indicated in refining diagnostic precision in areas of the brain that may not otherwise be satisfactorily visualized.
• VISIPAQUE 320 mg I/mL or 270 mg I/mL administered intravenously is indicated for enhancement of computed tomographic images for detection and evaluation of lesions in the liver, pancreas, kidney, aorta, mediastinum, pelvis, abdominal cavity, thoracic space, and retroperitoneal space.
• VISIPAQUE 320 mg I/mL or 270 mg I/mL administered intravenously is indicated in excretory urography to provide diagnostic contrast of the urinary tract and in the diagnosis of prostate enlargement, renal calculi, obstructive uropathy, urinary tract anomalies, neurogenic bladder, and urinary tract malignancies.
• VISIPAQUE 270 mg I/mL administered intravenously is indicated for venography and is useful in the diagnosis of thrombosis, phlebitis, or obstructed venous system.
Important safety information about Visipaque
CONTRAINDICATIONS: Visipaque (iodixanol) should not be administered to patients with known or suspected hypersensitivity to iodixanol.
MOST SERIOUS WARNINGS AND PRECAUTIONS
Concentration Used: Use the recommended Visipaque concentration for the particular procedure to be undertaken.
Fatal Reactions: Serious or fatal reactions have been associated with the administration of water soluble contrast media. It is of utmost importance that a course of action be carefully planned in advance for immediate treatment of serious reactions, and that adequate facilities and appropriate personnel be readily available in case a severe reaction should occur.
Other serious warnings and precautions:
• Hypersensitivity including serious, life-threatening, fatal anaphylactic/anaphylactoid reactions. Patients should be observed for at least 30 minutes after administration.
• Contrast media-induced nephrotoxicity, presenting as transient impairment of renal function, may occur after intravascular Visipaque administration.
• Patients with pre-existing renal impairment, diabetes mellitus, sepsis, hypotension, dehydration, cardiovascular disease, elderly patients, and patients with multiple myeloma, hypertension, patients on medications which alter renal function and patients with hyperuricemia, are at increased risk of this condition. Patients with both renal impairment and diabetes are at the highest risk for contrast media-induced
• Pheochromocytoma
• Sickle cell
• Multiple myeloma
• Coagulation with serious, rarely fatal thromboembolic events
• Use with vasopressors, general anesthesia, metformin, cholecystographic agents, adrenergic beta-blockers, or inotropic agents
• Ensure patients are well hydrated prior to administration
• Patients with a history of allergy, bronchial asthma or other allergic manifestations, combined renal and hepatic disease, the elderly, debilitated or severely ill patients, those with homocystinuria, endotoxemia, elevated body temperature, severe hypertension or congestive heart failure and other cardiovascular diseases, Buergerʼs disease, severe ischemia, suspected thrombosis, ischemic disease, local infection, significantly obstructed vascular system, chronic obstructive pulmonary disease, ventricular failure, pulmonary hypertension, stenotic pulmonary vascular beds, hyperthyroidism and recent renal transplant recipients, as well as patients sensitive to iodine, present an additional risk and call for careful benefit/risk ratio assessment.
• Increased intracranial pressure, cerebral thrombosis or embolism, primary or metastatic cerebral lesions, subarachnoid hemorrhage, arterial spasm, transient ischemic attacks, and in any condition when the blood brain barrier is breached or the transit time of the contrast material through the cerebral vasculature is prolonged.
      • Ensure proper catheter placement
     • Aortic administration
     • Monitor vital signs and ECG through the procedure
     • Myelography and CT scan of the head
     • Breastfeeding
     • Safety and efficacy not established in children
     • Radioactive iodine uptake studies and Multistix® measurements
Prior to administration, please read the Product Monograph for Visipaque and the Important Safety Information About Iodinated Contrast Media, which is available by calling 1 800 654 0118 (option 2, then option 3) or through an email request to canadainfo@ge.com.
To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 1 800 654 0118 (option 2, then option 1), or email canadainfo@ge.com to request an adverse events form, or fax a request for a form to 905 847 5849. Adverse reactions can also be reported to Health Canada as follows:
• Online at MedEffect.com
• By calling 1 866 234 2345 (toll-free)
• By completing a Canada Vigilance Reporting Form and sending it by:
     • Fax to 1 866 678 6789 (toll-free)
     • Mail to Canada Vigilance Program, Health Canada, Postal Locator 0701E Ottawa, ON K1A 0K9
     • Postage-paid labels and the Canada Vigilance Reporting Form are available at MedEffect.com

JB01513CA January 2026