Across a variety <strong>of</strong> patient types with suboptimal echoes and multiple clinical settings... People and image depicted are for illustrative purposes only. To place an order, call 1-800-299-3431 or visit www.definityimaging.com DEFINITY and corporate logo display are registered trademarks <strong>of</strong> Lantheus Medical Imaging, Inc. © 2012 Lantheus Medical Imaging, Inc. All rights reserved. Printed in U.S.A. DEF MAR JA March 2012
A DEFINITY ® Echo— Giving You a Diagnostic Advantage in Suboptimal Echoes for Improved Patient Management 1,2 In a study by Kurt et al... • Significantly increases the percentage <strong>of</strong> evaluable segments, indicating a consistent diagnostic advantage 1 • Enhances the quality <strong>of</strong> suboptimal echoes, which may result in more accurate and efficient diagnosis 1 • Results in important alterations in medical management and avoidance <strong>of</strong> additional diagnostic procedures 1 DEFINITY ® has a proven safety pr<strong>of</strong>ile 2-4 and has been used in more than 3.5 million patients. 5 Lantheus Medical Imaging, Inc., is pleased to share the FDA changes to the US Prescribing Information for DEFINITY ® • These changes are specific to DEFINITY ® and follow the FDA review <strong>of</strong> Lantheus’ labeling supplement submission dated September 2010, and subsequent to the FDA Safety Advisory Committee meeting held in May 2011 • Please contact Lantheus Medical Imaging, Inc., at 1-800-343-7851 or go to definityimaging.com for further information Please see accompanying brief summary, including boxed WARNING regarding serious cardiopulmonary reactions. Please Visit Booth 507 References: 1. Kurt M, Shaikh KA, Peterson L, et al. Impact <strong>of</strong> contrast echocardiography on evaluation <strong>of</strong> ventricular function and clinical management in a large prospective cohort. J Am Coll Cardiol. 2009;53(9):802-810. 2. Kitzman DW, Goldman ME, Gillam LD, Cohen JL, Aurigemma GP, Gottdiener JS. Efficacy and safety <strong>of</strong> the novel ultrasound contrast agent perflutren (Definity) in patients with suboptimal baseline left ventricular echocardiographic images. Am J Cardiol. 2000;86(6):669- 674. 3. Data on file, Lantheus Medical Imaging, Inc. 4. Nucifora G, Marsan NA, Siebelink H-M J, et al. Safety <strong>of</strong> contrast-enhanced echocardiography within 24 h after acute myocardial infarction. Eur J Echocardiogr. 2008;9(6):816-818. 5. ©2001-2011 AMR/Arlington Medical Resources, LLC all rights reserved. Reproduction, distribution, transmission or publication is prohibited. Reprinted with permission. INDIcATIoNS Activated DEFINITY ® (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation <strong>of</strong> the left ventricular endocardial border. coNTRAINDIcATIoNS Do not administer DEFINITY ® to patients with known or suspected right-to-left, bi-directional or transient right-to-left cardiac shunts, by intra-arterial injection, or to patients with known hypersensitivity to perflutren. IMPoRTANT SAFETY INFoRMATIoN WARNING: Serious cardiopulmonary Reactions Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration [See WARNINGS AND PRECAUTIONS (5.1)]. Most serious reactions occur within 30 minutes <strong>of</strong> administration. • Assess all patients for the presence <strong>of</strong> any condition that precludes DEFINITY ® administration [See CONTRAINDICATIONS (4)]. • Always have resuscitation equipment and trained personnel readily available. In postmarketing use, rare but serious cardiopulmonary or anaphylactoid reactions have been reported during or shortly following perflutren-containing microsphere administration [See ADVERSE REACTIONS (6)]. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions [See Postmarketing Experience (6.2)]. It is not always possible to reliably establish a causal relationship to drug exposure due to the presence <strong>of</strong> underlying cardiopulmonary disease.
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