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INDICATIONS AND USAGE | IMPORTANT SAFETY INFORMATION

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

Indications

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

IMPORTANT SAFETY INFORMATION

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. Most serious reactions occur within 30 minutes of administration.

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

Contraindications

LUMASON (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use is contraindicated in patients with known or suspected hypersensitivity to sulfur hexafluoride lipid microsphere or its components, such as polyethylene glycol (PEG).

Warnings

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or shortly following administration of ultrasound contrast agents, including LUMASON. Always have cardiopulmonary resuscitation personnel and equipment readily available prior to LUMASON administration and monitor all patients for acute reactions.

Post-marketing hypersensitivity reactions, including serious hypersensitivity reactions, have been observed during use or shortly following LUMASON administration. These reactions may occur in patients with no history of prior exposure to sulfur hexafluoride lipid-containing microspheres. LUMASON contains PEG. There may be increased risk of serious reactions including death in patients with prior hypersensitivity reaction(s) to PEG.

Systemic embolization may occur in patients with cardiac shunts. Assess patients with cardiac shunts for embolic phenomena following LUMASON administration.

There is a risk of ventricular arrhythmia related to high mechanical index in patients administered LUMASON. LUMASON is not recommended for use at mechanical indices greater than 0.8.

The most common adverse reactions (incidence ≥ 0.5%) are headache (1%) and nausea (0.5%).

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.

Please click here for full Prescribing Information for LUMASON ultrasound contrast agent, including BOXED WARNING on Serious Cardiopulmonary Reactions.

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 and SONOVUE are registered trademarks of Bracco Diagnostics Inc. and its affiliated entities.

All other trademarks and registered trademarks are the property of their respective owners.