Title

ABLAVAR® (gadofosveset trisodium) is the first and only gadolinium-based contrast agent FDA-approved for MRA in the United States.1,2 ABLAVAR® is for use with MRA to evaluate aortoiliac occlusive disease in adults with known or suspected peripheral vascular disease.1

ABLAVAR®: unique chemistry at work

ABLAVAR® is a unique contrast agent specifically designed to overcome the limitations of MRA imaging with extracellular contrast agents.3

The ABLAVAR® difference is its reversible binding to the blood protein albumin.This binding allows ABLAVAR® to remain in the circulation (the “blood pool”) for up to 1 hour.1,3 As a result, high-resolution, finely detailed MRA images can be obtained in order to visualize the extent and severity of vascular pathology -- all with a single, low-dose injection.1,3,4

Only ABLAVAR® provides high-resolution, first-pass and steady-state images that, together, provide diagnostic accuracy comparable to XRA, with fewer uninterpretable images than both XRA and noncontrast-enhanced MRA.5,6

Efficacy
  • ABLAVAR® provides both bright, first-pass images and high-resolution, steady-state images for evaluating the location, extent, and severity of disease for appropriate intervention3,5,6
  • ABLAVAR®-enhanced MRA provides information that can impact diagnosis and patient management15,16
  • Phase 3 clinical trials prove that ABLAVAR®-enhanced MRA provides:
    • Diagnostic accuracy comparable to the reference standard XRA5,6
    • Fewer uninterpretable images than either XRA or noncontrast MRA5,6
Safety
  • Contains the lowest dose of gadolinium (70% less) of all of the gadolinium-based contrast agents used in MRA*1,7-11
  • No reported cases of nephrogenic systemic fibrosis in over 90,000 patients12
  • Documented safety and tolerability1,5,6
  • Side effects are mild and transient5,6
  • No exposure to ionizing radiation and iodinated contrast media as with XRA and CTA13,14
Cost-effectiveness
  • Fewer uninterpretable images than XRA and noncontrast MRA5,6
  • Less costly than diagnostic XRA17,18
  • 40% lower contrast volume (in mL/kg) than other gadolinium-based contrast agents used in MRA*1,7-11
  • Avoids the need for repeat dosing and/or repeat studies if:
    • The first-pass image is missed3,16
    • Patient movement interferes with imaging 3,16
    • Additional high-resolution images are needed to evaluate diseased vasculature19,20
  • Both 10-mL and 15-mL packaging help reduce contrast waste
Convenience
  • Single, low-dose injection1,4
  • Imaging can be performed for up to 1 hour if necessary1
  • Can be administered manually or by power injection1
  • Available directly from Lantheus or through most major wholesale distributors

*Of these agents, only ABLAVAR® is indicated for MRA.

References

1. ABLAVAR® [package insert]. North Billerica, MA: Lantheus Medical Imaging, Inc.; 2011. 2. US Food and Drug Administration Web site. http://www.fda.gov/drugs. Accessed July 12, 2010. 3. Goyen M. Gadofosveset-enhanced magnetic resonance angiography. Vas Health Risk Manag. 2008;4(1):1-9. 4. Bremerich J, Bilecen D, Reimer P. MR angiography with blood pool contrast agents. Eur Radiol. 2007;17(12):3017-3024. 5. Goyen M, Edelman M, Perreault P, et al. MR angiography of aortoiliac occlusive disease: a phase III study of the safety and effectiveness of the blood-pool contrast agent MS-325. Radiology. 2005;236(3):825-833. 6. Rapp JH, Wolff SD, Quinn SF, et al. Aortoiliac occlusive disease in patients with known or suspected peripheral vascular disease: safety and efficacy of gadofosveset-enhanced MR angiography—multicenter comparative phase III study. Radiology. 2005;236(1):71-78.7. Magnevist® [package insert]. Wayne, NJ: Bayer HealthCare Pharmaceuticals, Inc.; 2010. 8. Omniscan™ [package insert]. Princeton, NJ: GE Healthcare, Inc.; 2010. 9. MultiHance® [package insert]. Princeton, NJ: Bracco Diagnostics, Inc.; 2010. 10. ProHance® [package insert]. Princeton, NJ: Bracco Diagnostics, Inc.; 2010. 11. Optimark™ [package insert]. St. Louis, MO: Mallinckrodt, Inc.; 2010. 12. Data on file, Lantheus Medical Imaging, Inc. 13. Norgren L, Hiatt WR, Dormandy JA, et al. Inter-society consensus for the management of peripheral arterial disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33(suppl 1):S1-S75. 14. Prince MR, Meaney JF. Expanding role of MR angiography in clinical practice. Eur Radiol. 2006;16(suppl 2):B3-B8. 15. Huppertz A, Kroll H, Klessen C, et al. Biphasic blood pool contrast agent-enhanced whole-body MR angiography for treatment planning in patients with significant arterial stenosis. Invest Radiol. 2009;44(7):422-432. 16. Willinek W, Hadizadeh D. Patient management and referrals: impact of high-resolution steady state MRA with Vasovist. In: Leiner T, Goyen M, Rohrer M, Schönberg S, eds. Clinical Blood Pool MR Imaging. Heidelberg, Germany: Springer Medizin Verlag; 2008. 17. Hay JW, Lawler E, Yucel K, et al. Cost impact of diagnostic imaging for lower extremity peripheral vascular occlusive disease. Value Health. 2009;12(2):262-266. 18. Carr S, Turnipseed W, Grist T. Role of magnetic resonance angiography in peripheral vascular disease. In: AbuRahma AF, Bergan JJ, eds. Noninvasive Vascular Diagnosis: A Practical Guide to Therapy. 2nd ed., London, UK: Springer-Verlag; 2007. 19. Schwenke C, Kienbaum S, Bergmann K. Health economic benefits of Vasovist. In: Leiner T, Goyen M, Rohrer M, Schönberg S, eds. Clinical Blood Pool MR Imaging. Heidelberg, Germany: Springer Medizin Verlag; 2008. 20. Hadizadeh DR, Gieseke J, Lohmaier SH, et al. Peripheral MR angiography with blood pool contrast agent: prospective intraindividual comparative study of high-spatial-resolution steady-state MR angiography versus standard-resolution first-pass MR angiography and DSA. Radiology. 2008;249(2):701-711.