Distearoylphosphatidylcholine, dl-, Sodium 1,2-dipalmitoyl-sn-glycero-3-phospho-(1'-rac-glycerol) and Sulfur hexafluoride

Echocardiography Lumason is indicated 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. Ultrasonography of the Liver Lumason is indicated for use with ultrasound of the liver in adult and pediatric patients to characterize focal liver lesions. Ultrasonography of the Urinary Tract Lumason is indicated for use in ultrasonography of the urinary tract in pediatric patients for the evaluation of suspected or known vesicoureteral reflux.

Within the blood, the acoustic impedance of Lumason microspheres is lower than that of the surrounding non-aqueous tissue. Therefore, an ultrasound beam is reflected from the interface between the microspheres and the surrounding tissue. The reflected ultrasound signal provides a visual image that shows a contrast between the blood and the surrounding tissues. For ultrasonography of the urinary tract in pediatric patients, the intravesically administered Lumason microspheres increase signal intensity of fluids within the urethra, bladder, ureters, and renal pelvis.

Avoid intra-arterial injection. See Full Prescribing Information for reconstitution instructions. For intravenous injection: Echocardiography in adults: After reconstitution, administer 2 mL as an intravenous injection. Echocardiography in pediatric patients: After reconstitution, administer 0.03 mL per kg as an intravenous injection up to a maximum of 2 mL per injection. Ultrasonography of the liver in adults: After reconstitution, administer 2.4 mL as an intravenous injection. Ultrasonography of the liver in pediatric patients: After reconstitution, administer 0.03 mL per kg as an intravenous injection, up to a maximum of 2.4 mL per injection. May repeat dose one time during a single examination. Follow each injection with an intravenous flush of 0.9% Sodium Chloride Injection, USP.

Lumason is contraindicated in patients with known or suspected: Hypersensitivity to sulfur hexafluoride lipid microsphere or its components, such as polyethylene glycol (PEG). Hypersensitivity to sulfur hexafluoride lipid microspheres or its components, such as polyethylene glycol (PEG)

Boxed 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. Cardiopulmonary reactions, including fatalities. Always have resuscitation equipment and trained personnel readily available. Hypersensitivity reactions. Serious acute hypersensitivity reactions have occurred in patients with no prior exposure to sulfur hexafluoride lipid-containing microsphere products, including patients with prior hypersensitivity reaction(s) to PEG

The following serious adverse reactions are discussed elsewhere in the labeling: Cardiopulmonary reactions Hypersensitivity reactions Most common adverse reactions (incidence ≥ 0.5%) are headache and nausea.

Store the kit at 25°C (77°F), excursions permitted to 15-30°C (59-86°F).