INDICATIONS AND USAGE1
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 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
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 INFORMATION1
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)].1
Please see full Prescribing Information including boxed WARNING at http://www.braccoimaging.com/us-en/products-and-solutions/contrast-enhanced-ultrasound/lumason/prescribing-information
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.
SonoVue is a registered trademark of Bracco Suisse S.A.
Bracco Diagnostics Inc.
259 Prospect Plains Road, Building H
Monroe Township, NJ 08831 USA
Toll Free: 1-877-272-2269 (U.S. only)
References: 1. 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.; December 2016. 2. Papadopoulou F, Ntoulia A, Siomou E, Darge K. Contrast-enhanced voiding urosonography with intravesical administration of a second-generation ultrasound contrast agent for diagnosis of vesicoureteral reflux: prospective evaluation of contrast safety in 1,010 children. Pediatr Radiol. 2014;44(6):719-728. 3. Trillaud H, Bruel JM, Valette PJ, et al. Characterization of focal liver lesions with SonoVue-enhanced sonography: International multicenter-study in comparison to CT and MRI. World J Gastroenterol. 2009;15(30):3748-3756. 4. Schneider M. Characteristics of SonoVue™. Echocardiography. 1999;16(7, pt 2):743-746. 5. Schneider M, Arditi M, Barrau MB, et al. BR1: a new ultrasound contrast agent based on sulfur hexafluoride-filled microbubbles. Invest Radiol. 1995;30(8):451-457. 6. Data on file. Bracco Diagnostics Inc.