ABLAVAR™ Product and Prescribing Information
Beyond first-pass imaging: ABLAVAR™ (gadofosveset trisodium)
ABLAVAR™ is the first and only FDA-approved contrast agent for use in magnetic resonance angiography (MRA) to evaluate aortoilac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease (PVD).1,2
ABLAVAR™ Prescribing Information
Download the full ABLAVAR™ Prescribing Information, including boxed WARNING regarding Nephrogenic Systemic Fibrosis (NSF).
Download Prescribing Information
ABLAVAR™ Material Safety Data Sheet (MSDS)
Download the complete ABLAVAR™ MSDS.
ABLAVAR™ Formulary Kit
Download the complete ABLAVAR™ Formulary Kit PDF file, which includes helpful information about ABLAVAR™, blood-pool imaging, ordering and contact information, clinical abstracts from pivotal Phase 2 and 3 trials, dosing guidelines, and full Prescribing Information, including boxed WARNING regarding Nephrogenic Systemic Fibrosis (NSF).
References
1. ABLAVAR™ [package insert]. North Billerica, MA: Lantheus Medical Imaging, Inc.; 2009. 2. U.S. Food and Drug Administration Web Site. http://www.fda.gov/drugs. Accessed September 28, 2009.
INDICATIONS:
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.
CONTRAINDICATIONS:
History of a prior allergic reaction to a gadolinium-based contrast agent.
IMPORTANT SAFETY INFORMATION:
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
Gadolinium-based contrast agents increase the risk of nephrogenic systemic fibrosis (NSF) in patients with:
- acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2), or
- acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
In these patients, avoid use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. 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 from the body prior to any re-administration.
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 paramagnetic 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. 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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