The most utilized ultrasound enhancing agent is approved for use in pediatric patients
Data on file, Lantheus.
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 patients2,3
- Prescribing information includes data from multiple well-controlled clinical studies
- Demonstrated a consistent safety profile when studied across gender and race in adults, including those age 65 and older
- Published patient management data in ICU setting, including SICU and MICU*4
*ICU, intensive care unit; MICU, medical intensive care unit; SICU, surgical intensive care unit.
Reduction in Mortality Risk
In a retrospective evaluation of short-term (1-day) mortality in >4 million hospitalized patients who underwent echocardiography with DEFINITY® compared to those without contrast:
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
In a retrospective study of all-cause mortality in >1 million critically ill patients who underwent echocardiography with DEFINITY® compared to those without contrast:
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 hypertension4-6
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
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.
INDICATIONS
DEFINITY® is indicated, after activation, for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS CARDIOPULMONARY REACTIONS
Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. 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 [see Warnings and Precautions (5.1)].
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.
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