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Echocardiography images are courtesy of Dr. Linda Gillam, Atlantic Health System, Morristown, NJ. Individual results may vary.

LUMASON® (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use
INDICATIONS AND USAGE2

LUMASON® is an ultrasound contrast agent indicated for use:

  • in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult and pediatric patients with suboptimal echocardiograms
  • in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients
  • in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patients
CONTRAINDICATIONS2

LUMASON® is contraindicated in patients with:

  • history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in LUMASON
IMPORTANT SAFETY INFORMATION2
WARNING: SERIOUS CARDIOPULMONARY REACTIONS

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres [see Warnings and Precautions (5.1)]. Most serious reactions occur within 30 minutes of administration [see Warnings and Precautions (5.1)].

  • Assess all patients for the presence of any condition that precludes administration [see Contraindications (4)].
  • Always have resuscitation equipment and trained personnel readily available [see Warnings and Precautions (5.1)].

The risk for serious cardiopulmonary 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) [see Warnings and Precautions (5.1)]. Hypersensitivity reactions have uncommonly been observed following the injection of LUMASON [see Warnings and Precautions (5.2)]. The most common adverse reactions are headache and nausea [see Adverse Reactions (6.1)].2

Please see full Prescribing Information for LUMASON ultrasound contrast agent including boxed WARNING at https://www.braccoimaging.com/us-en/products/contrast-enhanced-ultrasound/lumason

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

LUMASON is manufactured for Bracco Diagnostics Inc., Monroe Township, NJ 08831 by Bracco Suisse S.A., Plan-les-Ouates Geneve, Switzerland (LUMASON lyophilized powder vial-25 mg lipid-type A/60.7 sulfur hexafluoride gas); Vetter Pharma-Fertigung GmbH & Co. KG, 88212 Ravensburg, Germany (Sodium Chloride 0.9% Injection, USP); B. Braun Melsungen AG, 34212 Melsungen, Germany (Mini-Spike).

LUMASON is a registered trademark of Bracco Diagnostics Inc.

  1. 1. © 2020 Millennium Research Group, Inc. All rights reserved. Reproduction, distribution, transmission or publication is prohibited. Reprinted with permission.
  2. 2. LUMASON® (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use full Prescribing Information. Monroe Twp., NJ: Bracco Diagnostics Inc.; November 2019.
Bracco Diagnostics Inc.
259 Prospect Plains Road, Building H
Monroe Township, NJ 08831 USA
Phone: 609-514-2200
Toll Free: 1-877-272-2269 (U.S. only)
Fax: 609-514-2446

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