DEFINITY

Why Use DEFINITY®?


DEFINITY® makes a clear difference in the clinical setting*

  • Imaging agents are particularly useful when examining technically difficult patients, who often have suboptimal images. Some populations such as those: *1,2
Clinical Value of
Contrast Echocardiography
Presented by:
Miguel A. Quiñones, MD, FACC
Professor of Medicine
Weill Cornell Medical College
New York, New York
Methodist DeBakey Cardiology Associates
Houston, Texas

View Archived Webcast Presentation
DEFINITY populations
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Contrast Echocardiography:
My Clinical Experience
Presented by:
Howard Leong-Poi, MD, FRCPC
St. Michael's Hospital
University of Toronto

Audio Presentation


It should be noted that Lantheus Medical Imaging has not done specific clinical trials on these patient types.

 

1. Mulvagh SL et al. Contrast Echocardiography: Current and future applications. J Am Soc Echocardiogr 2000; 13: 331-42.
2. Burgess P et al. Performing an Echocardiographic Examination with a Contrast Agent: A Series on Contrast Echocardiography, Article 2. JASE 2000; 13: 629-636.
3. Shaw LJ et al. Clinical and economic outcomes assessment with myocardial contrast echocardiography Heart 1999; 82: 16-21.
4. Waggoner AD et al. Guidelines for the cardiac sonographer in the performance of contrast echocardiography:
recommendations of the American Society of Echocardiography Council on Cardiac Sonography. J Am Soc Echocardiogr 2001;14: 417-420.
5. 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.
6. Source: AMR/Arlington Medical Resources, Inc. [Echocardiography Monthly Monitor]
7. Data on file, Lantheus Medical Imaging, Inc.

 


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 of 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 of administration.

  • Assess all patients for the presence of any condition that precludes DEFINITY® administration [See CONTRAINDICATIONS (4)].

  • Always have resuscitation equipment and trained personnel readily available.


In post marketing 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 of underlying cardiopulmonary disease.

Please see full Prescribing Information, including boxed WARNING regarding serious cardiopulmonary reactions.

 

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