Safety
Profile

DEFINITY® Has a Proven Safety Profile Across Broad Patient Populations and in Multiple Care Settings^1,2

Prescribing information includes data from multiple well-controlled clinical studies¹
Demonstrated a consistent safety profile when studied across gender and race in adults, including those aged 65 years and older¹
Published patient management data in ICU setting, including SICU and MICU^2-4

DEFINITY® is demonstrated to be safe in patients with a high prevalence of cardiopulmonary disease and pulmonary hypertension^5-7

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.⁴

INDICATION

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

BOXED 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.
Always have resuscitation equipment and trained personnel readily available.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

IMPORTANT SAFETY INFORMATION

BOXED WARNING: SERIOUS CARDIOPULMONARY REACTIONS

Assess all patients for the presence of any condition that precludes DEFINITY® administration.
Always have resuscitation equipment and trained personnel readily available.

CONTRAINDICATIONS:

Contraindicated in patients with known or suspected hypersensitivity to perflutren lipid microsphere or its components, such as polyethylene glycol (PEG).

WARNINGS AND PRECAUTIONS:

Serious Cardiopulmonary Reactions have occurred during or following administration. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias).

Serious Hypersensitivity Reactions have been observed during or shortly following administration including anaphylaxis, with manifestations that may include death. DEFINITY® contains PEG and may increase risk of serious reactions including death in patients with prior hypersensitivity reaction(s) to PEG. Clinically assess patients for prior hypersensitivity reactions to products containing PEG. Monitor all patients for hypersensitivity reactions.

Systemic Embolization may occur in patients with a cardiac shunt. Assess patients with shunts for embolic phenomena following administration. DEFINITY® is only for intravenous administration and must not be administered by intra-arterial injection.

There is a risk of Ventricular Arrhythmia Related to High Mechanical Index. Additionally, end-systolic triggering with high mechanical indices has been reported to cause ventricular arrhythmias. The maximum recommended mechanical index for use with DEFINITY® is 0.8 in adult patients and 0.3 in pediatric patients.

Acute Pain Episodes in Patients with Sickle Cell Disease (SCD) shortly following administration have been reported. Discontinue DEFINITY® in SCD patients experiencing new or worsening pain.

ADVERSE REACTIONS:

The most common adverse reactions (≥0.5%) are headache, back/renal pain, flushing, nausea, chest pain, injection site reactions, and dizziness.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.

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

References:

DEFINITY®. Prescribing Information. Lantheus.
Kurt M, Shaikh KA, Peterson L, 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. doi:10.1016/j.jacc.2009.01.005
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. doi:10.1016/j.jcmg.2013.08.012
Main ML, Fu JW, Gundrum J, LaPointe NA, Gillam LD, Mulvagh SL. Impact of contrast echocardiography on outcomes in critically ill patients. Am J Cardiol. 2021;150:117-122. doi:10.1016/j.amjcard.2021.03.039
Weiss RJ, Ahmad M, Villanueva F, et al; CaRES Investigators. 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. doi:10.1016/j.echo.2012.04.002
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. doi:10.1093/ehjci/jes057
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. doi:10.1016/j.echo.2012.01.019

DEFINITY® Customer Service 1.800.299.3431

BACK TO
TOP

Safety Profile

DEFINITY® Has a Proven Safety Profile Across Broad Patient Populations and in Multiple Care Settings1,2

DEFINITY® is demonstrated to be safe in patients with a high prevalence of cardiopulmonary disease and pulmonary hypertension5-7

INDICATION

IMPORTANT SAFETY INFORMATION

BOXED WARNING: SERIOUS CARDIOPULMONARY REACTIONS

DEFINITY® Customer Service 1.800.299.3431

DEFINITY® Customer Service 1.800.299.3431

Safety
Profile

DEFINITY® Has a Proven Safety Profile Across Broad Patient Populations and in Multiple Care Settings^1,2

DEFINITY® is demonstrated to be safe in patients with a high prevalence of cardiopulmonary disease and pulmonary hypertension^5-7

DEFINITY® Customer Service
1.800.299.3431