Only LUMASON® ultrasound enhancing agent has multiple indications for adult and pediatric patients.
In ultrasonography of the liver, LUMASON® provides dynamic patterns of lesion-liver enhancement during all 3 phases
Thirty-six-year-old female. A. 4.0 cm hypoechoic lesion B-mode sonography. B. LUMASON showed a peripheral enhancement with nodular contrast accumulations in the arterial phase. C. Slow progression of the enhancement from the periphery toward the center of the lesion, with a broader peripheral enhancement zone seen in the portal phase. D. During the late phase, the lesion is completely filled with contrast and appears hyperenhanced compared to the surrounding normal liver tissue. The enhancement pattern is typical for a hemangioma.
Ultrasound image is reprinted with permission from World Journal of Gastroenterology.3 Individual results may vary.
LUMASON contrast-enhanced ultrasound showed improvement in characterization of focal liver lesions when compared with unenhanced ultrasound1
Study A
| Sensitivity (patients with malignant lesions) N=119 |
Specificity (patients with benign lesions) N=140 |
|||||
|---|---|---|---|---|---|---|
| Reader 1 | Reader 2 | Reader 3 | Reader 1 | Reader 2 | Reader 3 | |
| LUMASON % | 87* | 76* | 92* | 71 | 83* | 73* |
| Non-contrast % | 49 | 35 | 16 | 63 | 54 | 22 |
| Difference (95% CI) |
38 (30, 54) |
41 (29, 52) |
76 (67, 84) |
8 (-4, 21) |
29 (21, 44) |
51 (40, 61) |
Study B
| Sensitivity (patients with malignant lesions) N=124 |
Specificity (patients with benign lesions) N=116 |
|||||
|---|---|---|---|---|---|---|
| Reader 4 | Reader 5 | Reader 6 | Reader 4 | Reader 5 | Reader 6 | |
| LUMASON % | 65 | 61* | 47 | 72* | 67* | 88* |
| Non-contrast % | 53 | 41 | 66 | 24 | 7 | 59 |
| Difference (95% CI) |
12 (-1, 23) |
20 (7, 32) |
-19 (-31, -7) |
48 (35, 58) |
60 (50, 70) |
29 (18, 40) |
*Statistically significant improvement from non-contrast (p<0.05 based on McNemar’s test)
The individual who appears is for illustrative purposes. The person depicted is a model and not a real healthcare professional.
INDICATIONS AND USAGE | 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.
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., Princeton, 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.
IMPORTANT SAFETY INFORMATION | INDICATION AND USAGE
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.
References:
1. LUMASON® (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use full Prescribing Information. Princeton, NJ: Bracco Diagnostics Inc.; August 2021.
2. 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.