Visipaque™ (iodixanol) Injection

The first FDA-approved contrast media for intravascular use that is iso-osmolar to blood and isotonic at all concentrations in the US
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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 pressure2,3

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 stay4,5

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
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 trials25-28
• Meta-analyses of intra-arterial studies29-31
• 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.

REFERENCES
  1. 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.
  2. Visipaque Prescribing Information. Marlborough, MA: GE HealthCare; 2023.
  3. Swanson DP, Chilton HM, Thrall JH. In: Pharmaceuticals in Medical Imaging. Collier MacMillan Publishers, London 1990
  4. Aluko P, et al. Value in Health. 25(7): S386-387. July 2022.
  5. Keuffel E et al. J Med Econ. 2018;21:356-364.
  6. 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.
  7. 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.
  8. 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.
  9. Mehran R, Dangas GD, Weisbord SD. Contrast-Associated Acute Kidney Injury. N Engl J Med. 2019;380(22):2146-2155.
  10. Christiansen C. X-ray contrast media-an overview. Toxicology. 2005; 209(2): 185-7.
  11. Widmark JM. Imaging-related medications: a class overview. Proc (Bayl Univ Med Cent). 2007; 20(4): 408-17.
  12. Almén T. Visipaque – a step forward a historical review Acta Radiol. 1995; 36(Suppl.399): 2-18.
  13. Rosenberg C et al. J Invasive Cardiology 2017; 29(1): 9-15.
  14. 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.
  15. Marshall G. Radiography. 2008;14:128-134.
  16. Marshall G. Sharps injuries among radiographers: Dangers associated with opening bottles of contrast agent. Radiography. 2008;14:128-134.
  17. 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.
  18. 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.
  19. 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.
  20. Kerneis M, Nafee T, et al. Most promising therapies in interventional cardiology. Curr Cardiol Rep. 2019; 21(4): 26.
  21. Bonow RO, Braunwald E. The evidence supporting cardiovascular guidelines – Is there evidence of progress in the last decade? JAMA. 2019; 321(11): 1053-4.
  22. 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.
  23. 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.
  24. 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.
  25. 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.
  26. 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.
  27. 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.
  28. 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.
  29. 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.
  30. 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.
  31. 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.
  32. Iacovelli F et al. Int J Cardiol 2021; 329: 56-62.
  33. 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.
  34. 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.
  35. RCR. Clinical radiology. UK workforce census 2018 report. London: RCR, April 2019.
  36. 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.
  37. ACR Manual on Contrast Media. Version 2024.

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IMPORTANT SAFETY INFORMATION FOR VISIPAQUE (iodixanol) INJECTION

 WARNING: NOT FOR INTRATHECAL USE
Inadvertent intrathecal administration may cause death, convulsions/seizures,
cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest,
rhabdomyolysis, hyperthermia, and brain edema.

CONTRAINDICATION: Visipaque injection is contraindicated for intrathecal use.

WARNINGS AND PRECAUTIONS:
• Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Most severe reactions develop shortly after the start of the injection, but reactions can occur up to hours later. Always have emergency equipment and trained personnel available.
• Contrast Induced Acute Kidney Injury: Acute injury including renal failure can occur. Minimize dose and maintain adequate hydration to minimize risk.
• Cardiovascular Reactions: Life-threatening or fatal cardiovascular reactions, including hypotension, shock, and cardiac arrest have occurred with the use of Visipaque. Most deaths occur during injection or five to ten minutes later, with cardiovascular disease as the main aggravating factor. Use the lowest necessary dose of Visipaque in patients with congestive heart failure.
• Thromboembolic Events: Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke can occur during angiocardiography procedures with both ionic and nonionic contrast agents.
• Extravasation and Injection Site Reactions: Extravasation of Visipaque injection may cause tissue necrosis and/or compartment syndrome, particularly in patients with severe arterial or venous disease. Ensure intravascular placement of catheters prior to injection.
• Thyroid Storm in Patients With Hyperthyroidism: Thyroid storm has occurred after the intravascular use of iodinated contrast agents in patients with hyperthyroidism, or with an autonomously functioning thyroid nodule.
• Hypertensive Crisis in Patients With Pheochromocytoma: Hypertensive crisis has occurred after the use of iodinated contrast agents in patients with pheochromocytoma. Inject the minimum amount of contrast necessary, assess the blood pressure throughout the procedure, and have measures for treatment of a hypertensive crisis readily available.
• Sickle Cell Crisis in Patients With Sickle Cell Disease: Iodinated contrast agents when administered intravascularly may promote sickling in individuals who are homozygous for sickle cell disease.
• Severe Cutaneous Adverse Reactions: Severe cutaneous adverse reactions (SCARs) may develop from one hour to several weeks after intravascular contrast agent administration. These reactions include Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS). Avoid administering Visipaque to patients with a history of a SCAR to Visipaque.
• Pediatric Use: Pediatric patients at high risk of adverse reactions during and after administration of contrast agents include those with asthma, hypersensitivity to other medication and/or allergens, cyanotic and acyanotic heart disease, chronic heart failure, or a serum creatinine >1.5 mg/dL. Patients with immature renal function or dehydration may be at increased risk due to prolonged elimination of iodinated contrast agents. Thyroid dysfunction in pediatric patients 0 to 3 Years of Age: Monitor these patients for thyroid function abnormalities and treat as clinically needed.
• Geriatric Use: While no overall differences in safety or effectiveness were observed in patients >65 years, greater sensitivity regarding some older individuals cannot be ruled out.

ADVERSE REACTIONS:
• Serious, life-threatening, and fatal reactions, mostly of cardiovascular origin, have been associated with the administration of iodine-containing contrast agents, including Visipaque Injection. 
• Most common adverse reactions (incidence greater than 0.5%) in adult patients after Visipaque injection: Discomfort, warmth, pain; Cardiovascular: angina. Gastrointestinal: diarrhea, nausea, vomiting. Nervous System: agitation, anxiety, insomnia, nervousness, dizziness, headache, migraine, unusual skin sensations, sensory disturbance, fainting, sensation of spinning. Skin: itchy rash, severe itching, hives. Special Senses: Smell, taste, and vision alteration. Pediatric patients experienced similar adverse reactions.

Please see the full Prescribing Information, including Boxed Warning for additional important safety information.
 
To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 800 654 0118 (option 2, then option 1), or the FDA at 800 FDA 1088 or www.fda.gov/medwatch.

 

Product Indications

Intra-Arterial Procedures
Adult and pediatric patients 12 years of age and older: Intra-arterial digital subtraction angiography (270 and 320 mg iodine/mL); angiocardiography (left ventriculography and selective coronary arteriography), peripheral arteriography, visceral arteriography, and cerebral arteriography (320 mg iodine/mL). Pediatric patients less than 12 years of age: Angiocardiography, cerebral arteriography, and visceral arteriography (320 mg iodine/mL)

Intravenous Procedures
Adult and pediatric patients 12 years of age and older: Computed tomography (CT) imaging of the head and body (270 and 320 mg iodine/mL); excretory urography (270 and 320 mg iodine/mL); peripheral venography (270 mg iodine/mL); coronary computed tomography angiography (CCTA) to assist in the diagnostic evaluation of patients with suspected  artery disease (320 mg iodine/mL). Pediatric patients less than 12 years of age: CT imaging of the head and body (270 mg iodine/mL); excretory urography (270 mgiodine/mL)

Please see full Prescribing Information for Visipaque and full Prescribing Information for Visipaque Bulk Package.

JB07513US December 2024