ABLAVAR^® is a gadolinium-based contrast agent (GBCA) that contains the lowest amount of gadolinium per patient dose of all contrast agents used in MRA.* With ABLAVAR^®, gadolinium content is 70% less than with all other agents^1-6 and allows for 40% less contrast volume to be administered compared with other agents that have historically been used in MRA^1-6 -- without compromising image quality necessary to confidently interpret MRA test results.

ABLAVAR^® was specifically designed for MRA imaging and designed to overcome the limitations of MRA imaging with extracellular contrast agents.⁷

What makes ABLAVAR^® different from other agents is its degree of binding to serum albumin (~85%).¹

The benefits of reversible albumin binding include:

• extended intravascular retention⁸
• high thermodynamic stability and kinetic inertness⁹
• a reduction of the molecular tumbling rate which results in substantially increase relaxivity (T1-lowering potency)¹⁰

ABLAVAR^®'s relaxivity has been shown to be equal to 19L·mmol^–1·s^–1 at 1.5T@37°C¹¹

Because of the smaller volume of extravascular distribution (lowest of all other available MR contrast agents*) and its significantly increased relaxivity (highest of all other available MR contrast agents), ABLAVAR^® allows radiologists to acquire high-resolution, submillimetric data sets with greater accuracy/agreement with reference standards for determining stenosis grade and the ability to analyze small vessels and those vessels with slow or complex flow^12,13

On-label Dosing for ABLAVAR^® and Other Gadolinium Contrast Agents^1-6*
*Of these agents, only ABLAVAR^® is approved for steady-state imaging.

• Avoidance of the need for repeat dosing and or repeat studies if the initial contrast bolus is missed or patient movement interferes with first-pass imaging⁸
• The potential to alter diagnosis and/or modification of treatment approaches by improving diagnostic accuracy, and it may translate into improved distinction between those patients appropriate for surgery or endovascular treatment^8,13

Use of gadolinium-based contrast agents in MRI/MRA imaging carries a rare, yet very serious risk of nephrogenic systemic fibrosis (NSF), particulary in patients with compromised renal function.¹

Recently, the American College of Radiology, addressing the issue of NSF, revised its recommendation on the use of gadolinium-based agents.

The 2010 ACR Manual on Contrast Agents, notes the following:¹⁴

• “NSF is believed to occur more commonly in patients who have received high doses of GBCM [gadolinium-based contrast media] as well as in patients who have received higher cumulative doses of the agents.”
• Use “the lowest possible dose of GBCM required to obtain the needed clinical information, avoiding double- or triple-dose studies and avoiding the use of those GBCM that have been most frequently associated with NSF.”
• Although studies suggest that renal failure patients are at the highest risk for NSF when they are exposed to high doses or multiple doses of GBCM, the ACR advises, “Use of the lowest dose needed to obtain a diagnostic study is suggested, and is recommended as appropriate for all patients regardless of renal status.”

The following was noted in the December 8, 2009 Joint Meeting of the Cardiovascular and Renal Drugs and Drug Safety and Risk Presentation:

“Almost half of the patients with biopsy-proven NSF in the International Center for NSF research (ICNSFR) data registry contracted the disease following a single administration, one-third having had magnetic resonance angiography (MRA)”¹⁴

The FDA has recommended:¹⁵

• “When administering a gadolinium-based contrast agent, do not exceed the recommended dose, and allow a sufficient period of time for elimination of the agent prior to any readministration.”
• “Do not repeat administration of any GBCA during a single imaging session"

*Of these agents, only ABLAVAR^® is approved for steady-state imaging.

References

1. ABLAVAR^® [package insert]. North Billerica, MA: Lantheus Medical Imaging, Inc., 2011. 2. Magnevist® [package insert]. Wayne, NJ: Bayer HealthCare Pharmaceuticals, Inc.; 2010. 3. Omniscan™ [package insert]. Princeton, NJ: GE Healthcare, Inc.; 2010. 4. MultiHance® [package insert]. Princeton, NJ: Bracco Diagnostics, Inc.; 2010. 5. ProHance® [package insert]. Princeton, NJ: Bracco Diagnostics, Inc.; 2010. 6. Optimark™ [package insert]. St. Louis, MO: Mallinckrodt, Inc.; 2010. 7. Bremerich J, Bilecen D, Reimer P. MR angiography with blood pool contrast agents. Eur Radiol. 2007;17(12):3017-3024.8. Leiner T, Goyen M, Rohrer M, Schönberg S, eds. Clinical Blood Pool MR Imaging. Heidelberg, Germany: Springer Medizin Verlag; 2008. 9. Caravan P, Comuzzi C, Crooks W, McMurry TJ, Choppin GR, Woulfe SR. Thermodynamic stability and kinetic inertness of MS-325, a new blood pool agent for magnetic resonance imaging. Inorg Chem. 2001;40(9):2170-2176. 10. Lauffer RB, Parmelee DJ, Dunham SU, et al. MS-325: albumin-targeted contrast agent for MR angiography. Radiology. 1998;207(5):529-538. 11. Rohrer M, Bauer H, Mintorovitch J, et al. Comparison of magnetic properties of MRI contrast media solutions at different magnetic field strengths. Invest Radiol 2005; 40:715–724. 12. Chiribiri A, Morton G, Nagel E. Gadofosveset injection for magnetic resonance angiography. Imaging Medicine. 2010;2(4):383-393. 13. 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. 14. ACR Manual on Contrast Media v7. American College of Radiology Web site. http://www.acr.org/secondarymainmenucategories/quality_safety/contrast_manual.aspx. Accessed July 29, 2010. 15. FDA drug safety communication: new warnings for using gadolinium-based contrast agents in patients with kidney dysfunction. US Food and Drug Administration Web site. http://www.fda.gov/Drugs/DrugSafety/ucm223966.htm. Accessed October 18, 2010.