Lantheus Medical Imaging Announces FDA Approval of DEFINITY® Label Update
Label Revision Removes Cardiac Shunt Contraindication
A cardiac shunt is a pattern of blood flow in the heart that deviates from the normal path of the circulatory system, which may present in 10 to 35 percent of patients.2 These patients were previously excluded from receiving a valuable echo contrast study of the left ventricle. The FDA's decision to remove the contraindication concerning known or suspected cardiac shunts was based on Lantheus' submission referencing several publications and data supporting the safety of echocardiography contrast products in patients with cardiac shunts. Information concerning administration in patients with a cardiac shunt appears in the Warnings section of the DEFINITY Prescribing Information.
"The label change implemented by
Dr. Weissman continued, "This is an important step toward broader acceptance and appropriate use of echo contrast agents, which can safely and cost effectively provide critical information to help clinicians accurately diagnose and manage patients to achieve better outcomes."
About Suboptimal Echocardiograms
Up to 20 percent of all resting echocardiography studies and up to 30 percent of those conducted in critical care patients can result in suboptimal echocardiograms.3-6 A suboptimal image is one in which two or more contiguous left ventricular segments in any of the three apical views cannot be visualized.3,4,7 The use of contrast in suboptimal echocardiograms may help with clinical evaluation of the patient.4,8
DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension is an ultrasound contrast agent for use in patients with suboptimal echocardiograms (see Indications and Important Safety Information below and find full Prescribing Information at www.definityimaging.com).1 DEFINITY is engineered to produce small and consistently sized durable microbubbles to fully evaluate the left ventricle.1 DEFINITY has extensive safety experience and a consistent safety profile.9 Since its launch in 2001, more than seven million echo studies have been performed with DEFINITY and it is the most prescribed contrast agent in the U.S.10
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 of the left ventricular endocardial border.
Do not administer DEFINITY® to patients with known or suspected hypersensitivity to perflutren.
IMPORTANT SAFETY INFORMATION
WARNING: Serious Cardiopulmonary Reactions
Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or
In post marketing use, rare but serious cardiopulmonary or hypersensitivity 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 Adverse Reactions (6.2)]. It is not always possible to reliably establish a causal relationship to drug exposure due to the presence of underlying cardiopulmonary disease.
Please see full Prescribing Information, including boxed WARNING regarding serious cardiopulmonary reactions, on www.definityimaging.com.
Safe Harbor for Forward-Looking and Cautionary Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks and uncertainties that may be described from time to time in
1 DEFINITY® (Package Insert),
2 Parker JM, et al, Safety of ultrasound contrast agents in patients with known or suspected cardiac shunts. Am J Cardiol. 2013; 112:1039-1045.
3 Waggoner AD, et al, Guidelines for the cardiac sonographer in the performance of contrast echocardiography. J Am Soc Echocardiogr. 2001: 417-420.
4 Mulvagh S et al. J Am Soc Echocardiogr. 2008;21(11):1179-1201
5 Edited by Scott d. Solomon, MD, Essential Echocardiography, A Practical handbook with DVD.
6 Kurt M, Shaikh, et al. Impact of contrast echocardiography on evaluation of ventricular function and clinical management in a large prospective cohort. J Am Coll Cardiol. 2009;53(9):802-810.
7 IAC Standards and Guidelines for Adult Echocardiography Accreditation http://www.intersocietal.org/echo/standards/IACAdultEchocardiographyStandards2014.pdf
8 Kitzman DW et al. Efficacy and safety of the novel ultrasound contrast agent perflutren (Definity) in patients with suboptimal baseline left ventricular echocardiographic images. Am J Cardiol. 2000; 86: 669-674
9 Data on file,
Lantheus Medical Imaging, Inc.
Meara Murphy, 978-671-8508
Director, Investor Relations & Corporate Communications
Gary Santo, 978-671-8960
Head of Capital Markets & Investor Relations