DEFINITY® News and Updates

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DEFINITY® News and Updates

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Safety 
Profile

Young patient in a hospital bed under observation, illustrating the safety profile of DEFINITY® Young patient in a hospital bed under observation, illustrating the safety profile of DEFINITY®

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

  • 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 MICU2

DEFINITY® has a safety profile established over 25 years1

In premarket clinical trials of 1716 patients, 1.1% experienced serious cardiopulmonary adverse reactions, and 0.9% discontinued use of DEFINITY® as a result of adverse reactions such as urticaria, pruritus, dizziness, chest pain, dyspnea, and back pain.1

Table showing adverse reactions
Table showing Adverse reactions occurring in ≥0.5% of all DEFINITY®-treated adult subjects

In a prospective, multicenter, observational study of 1053 patients who received DEFINITY® in routine clinical practice, no deaths or serious adverse reactions were reported. Adverse reactions from spontaneous postmarketing reports over 25 years include cardiopulmonary reactions (including fatal cardiac or respiratory arrest), anaphylaxis and other immune system reactions, a variety of neurologic reactions, and acute pain episodes (including vaso-occlusive crisis in patients with sickle cell disease).1

DEFINITY® has a demonstrated safety profile in patients with a high prevalence of cardiopulmonary disease and pulmonary hypertension3-5

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

ICU=intensive care unit; MICU=medical intensive care unit; SICU=surgical intensive care unit.

References:

  1. DEFINITY® [package insert]. N. Billerica, MA: Lantheus Medical Imaging, Inc.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

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.


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 the accompanying full Prescribing Information and important safety information, including BOXED WARNING for serious cardiopulmonary reactions. 

PM-US-DE-0832 11/25

References:

  1. DEFINITY®. Prescribing Information. Lantheus.
  2. 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
  3. 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
  4. 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
  5. 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

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