ABLAVAR®-enhanced MRA is an innovative approach to evaluating aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease1,2
A single dose of ABLAVAR® contains the lowest dose of gadolinium of all contrast agents used in MRA*1,3-7 and provides
*Of these agents, only ABLAVAR® is approved for steady-state imaging.
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 24, 2010. 3. Magnevist® [package insert]. Wayne, NJ: Bayer HealthCare Pharmaceuticals, Inc.; 2010. 4. Omniscan™ [package insert]. Princeton, NJ: GE Healthcare, Inc.; 2010. 5. MultiHance® [package insert]. Princeton, NJ: Bracco Diagnostics, Inc.; 2010. 6. ProHance® [package insert]. Princeton, NJ: Bracco Diagnostics, Inc.; 2010. 7. Optimark™ [package insert]. St. Louis, MO: Mallinckrodt, Inc.; 2010. 8. Goyen M. Gadofosveset-enhanced magnetic resonance angiography. Vasc Health Risk Manag. 2008;4(1):1-9. 9. 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. 10. 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. 11. 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; 2008:253. 12. 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.
ABLAVAR® is indicated for use as a contrast agent in magnetic resonance angiography (MRA) to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease.
History of a prior allergic reaction to a gadolinium-based contrast agent.
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.
ABLAVAR® Injection: As with other contrast media, the possibility of serious or life-threatening anaphylactic or anaphylactoid reactions, including cardiovascular, respiratory and/or cutaneous manifestations, should always be considered. As with other gadolinium based contrast agents, caution should be exercised in patients with renal insufficiency due to the possibility of further deterioration in renal function.
In clinical trials, a small increase (2.8 msec) in the average change from baseline in QTc was observed at 45 minutes following ABLAVAR® administration. These QTc prolongations were not associated with arrhythmias or symptoms. Caution should be used in patients at high risk for arrhythmias due to baseline QTc prolongation.
Have emergency resuscitative equipment available prior to and during ABLAVAR® administration.
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