Safety
Profile

DEFINITY® Has a Proven Safety Profile Across Broad Patient Populations and in Multiple Care Settings¹

DEFINITY® has a proven impact on reducing mortality risk in hospitalized and critically ill patients^2,3

Case-Based Review of Clinical Safety: Contrast Echocardiography in the Acute Critical Care Setting

Eyal Herzog, MD shows how the appropriate use of DEFINITY® assisted in achieving quality diagnostic imaging in critically ill patients with suboptimal echocardiograms

Reduction in Mortality Risk

DEFINITY® WAS ASSOCIATED WITH A

28%

lower mortality at 48 hours in critically ill patients²

DEFINITY® DEMONSTRATED A

24%

decreased risk of mortality at 24 hours in hospitalized patients³

DEFINITY® is demonstrated to be safe in patients with high prevalence of cardiopulmonary disease and pulmonary hypertension^4-6

References:

DEFINITY® [package insert]. N. Billerica, MA: Lantheus Medical Imaging, Inc.
Main ML, Ryan AC, Davis TE, Albano MP, Kusnetzky LL, Hibberd M. Acute mortality in hospitalized patients undergoing echocardiography with and without an ultrasound contrast agent (multicenter registry results in 4,300,966 consecutive patients). Am J Cardiol. 2008;102(12):1742-1746.
Main ML, Hibberd MG, Ryan A, Lowe TJ, Miller P, Bhat G. Acute mortality in critically ill patients undergoing echocardiography with or without an ultrasound contrast agent. JACC Cardiovasc Imaging. 2014;7(1):40-48.
Wei K, Main ML, Lang RM, et al. The effect of Definity on systemic and pulmonary hemodynamics in patients. J Am Soc Echocardiogr. 2012;25(5):584-588.
Wever-Pinzon O, Suma V, Ahuja A, et al. Safety of echocardiographic contrast in hospitalized patients with pulmonary hypertension: a multi-center study. Eur Heart J Cardiovasc Imaging. 2012;13(10):857-862.
Weiss RJ, Ahmad M, Villanueva F, et al. CaRES (Contrast Echocardiography Registry for Safety Surveillance): a prospective multicenter study to evaluate the safety of the ultrasound contrast agent definity in clinical practice. J Am Soc Echocardiogr. 2012;25(7):790-795.

DEFINITY® RT (Perflutren Lipid Microsphere) Injectable Suspension

INDICATIONS

Activated DEFINITY® and activated DEFINITY® RT (Perflutren Lipid Microsphere) Injectable Suspension are 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® and DEFINITY® RT to patients with known or suspected hypersensitivity to perflutren lipid microsphere or its components, such as polyethylene glycol (PEG).

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® and DEFINITY® RT administration [see Contraindications (4)].
Always have resuscitation equipment and trained personnel readily available.

In postmarketing use, rare but serious cardiopulmonary or hypersensitivity reactions have been reported during or shortly following perflutren and PEG-containing microsphere administration [see Adverse Reactions (6)]. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions and/or with pre-existing PEG hypersensitivity [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 conditions.

Patients with sickle cell disease may be at higher risk of painful crisis and DEFINITY® and DEFINITY® RT should be administered with caution.

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

Customer Service 1.800.299.3431

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Safety Profile

DEFINITY® Has a Proven Safety Profile Across Broad Patient Populations and in Multiple Care Settings1

Reduction in Mortality Risk

Safety
Profile

DEFINITY® Has a Proven Safety Profile Across Broad Patient Populations and in Multiple Care Settings¹