About DEFINITY®
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 atwww.definityimaging.com).1DEFINITY 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.2 Since its launch in 2001, more than 11 million echo studies have been performed with DEFINITY® and it is the most prescribed contrast agent in the U.S.3
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 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 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, onwww.definityimaging.com.
About Lantheus Holdings, Inc. and Lantheus Medical Imaging, Inc.
Lantheus Holdings, Inc. is the parent company of LMI, a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products. LMI provides a broad portfolio of products, including the echocardiography contrast agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension and TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures. The Company is headquartered in North Billerica, Massachusetts with offices in Puerto Rico and Canada. For more information, visitwww.lantheus.com.
1 | DEFINITY® (Package Insert), North Billerica, MA, Lantheus Medical Imaging, Inc., 2017. |
2 | Data on file, Lantheus Medical Imaging, Inc. |
3 | ©2019 DR/Decision Resources, LLC. All rights reserved. Reproduction, distribution, transmission or publication is prohibited. Reprinted with permission. |
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