Dosing and uses of Lumason (sulfur hexafluoride)
Adult dosage forms and strengths
injectable suspension
- Kit contains:
- 1. 2-compartment vial containing 25mg of lipid-type A lyophilized powder and headspace fill of 60.7mg sulfur hexafluoride
- 2. Prefilled syringe containing 5mL NaCl 0.9%
- 3. Mini-spike
- Following reconstitution with 5mL diluent, suspension contains 1.5-5.6 x10^8 lipid microspheres/mL with 45mcg/mL of sulfur hexafluoride
Cardiac Imaging
Indicated for patients with suboptimal echocardiograms to opacify the left ventricular chamber and improve the delineation of the left ventricular endocardial border
After baseline noncontrast echocardiography is complete, the mechanical index for the ultrasound device should be adjusted to 0.8 or lower; ultrasound imaging is then continued following sulfur hexafluoride administration
2 mL reconstituted solution IV bolus injection during echocardiography; flush IV line with 5 mL 0.9% NaCL
During a single examination, a second injection may be administered to prolong contrast enhancement
Liver Ultrasonography
Indicated for use in liver ultrasonography for characterization of focal liver lesions in adult and pediatric patients
2.4 mL administered as an IV injection during ultrasonography of the liver
During a single examination, a second injection of 2.4 mL may be administered, if needed
Follow sodium hexafluoride injection with IV flush using 5 mL of 0.9% NaCL
Pediatric dosage forms and strengths
injectable suspension
- Kit contains:
- 1. 2-compartment vial containing 25mg of lipid-type A lyophilized powder and headspace fill of 60.7mg sulfur hexafluoride
- 2. Prefilled syringe containing 5mL NaCl 0.9%
- 3. Mini-spike
- Following reconstitution with 5mL diluent, suspension contains 1.5-5.6 x10^8 lipid microspheres/mL with 45mcg/mL of sulfur hexafluoride
Liver Ultrasonography
Indicated for use in liver ultrasonography for characterization of focal liver lesions in adult and pediatric patients
0.03 mL/kg administered as an IV injection during ultrasonography of the liver
During a single examination, a second injection of 0.03 mL/kg may be administered, if needed
Do not exceed 2.4 mL/injection
Follow sodium hexafluoride injection with IV flush using 5 mL of 0.9% NaCL
Lumason (sulfur hexafluoride) adverse (side) effects
<1%
Headache (0.9%)
Nausea (0.6%)
Dysgeusia (0.3%)
Injection site pain (0.3%)
Chest discomfort (0.3%)
Feeling hot (0.3%)
Chest pain (0.2%)
Injection site warmth (0.2%)
Postmarketing Reports
Serious reactions (typically within 30 minutes of administration) have been reported and include fatalities (symptoms suggestive of anaphylactoid/hypersensitivity), arrhythmias, and hypertensive episodes
Risk for serious cardiopulmonary reactions may increase with unstable cardiopulmonary conditions (acute MI, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias)
Warnings
Black box warnings
Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following administration of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres
Most serious reactions occur within 30 minutes of administration
Assess all patients for presence of any condition that precludes administration (see Contraindications)
Always have cardiopulmonary resuscitation personnel and equipment readily available before administering contrast media, and monitor all patients during and following for adverse reactions
Risk of cardiopulmonary reactions increased with unstable cardiopulmonary conditions (acute MI, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias)
Contraindications
Known or suspected right-to-left, bidirectional, or transient right-to-left cardiac shunts
Hypersensitivity
Intra-arterial injection
Cautions
For intravenous use only; do not administer by intra-arterial injection (see Contraindications)
Serious cardiopulmonary reactions, including fatalities, reported (see Black box warnings)
Rare anaphylactoid reactions (eg, skin erythema, rash, urticaria, flushing, throat tightness, dyspnea, anaphylactic shock) observed; may occur in patients with no history of prior exposure (see Contraindications)
Risk of systemic embolization; in patients with right-to-left, bidirectional, or transient right-to-left cardiac shunts, some IV sulfur hexafluoride lipid-containing microspheres may bypass filtering by the lung and directly enter the arterial circulation; occlusion of microcirculation by these microspheres may result in tissue ischemia (see Contraindications)
High ultrasound mechanical index values may cause microsphere cavitation or rupture and lead to ventricular arrhythmias; end-systolic triggering with high mechanical indices has been reported to cause ventricular arrhythmias
Pregnancy and lactation
Pregnancy category: B
Lactation: Unknown if distributed in human breast milk; because of the drug’s rapid clearance, advise breastfeeding women to pump and discard breast milk once after the drug’s administration
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Lumason (sulfur hexafluoride)
Mechanism of action
Within the blood, acoustic impedance of the sulfur hexafluoride microspheres is lower than that of the surrounding nonaqueous tissue
This allows reflection of an ultrasound beam from the interface between the microspheres and the surrounding tissue, thus enabling a visual image between the blood and the surrounding tissues
Absorption
Peak blood concentration: 1-2 minutes
Distribution
Vd: 341 L (mostly within lung)
Metabolism
Undergoes little or no biotransformation; 88% recovered unchanged in expired air
Elimination
Half-life, terminal: 10 minutes
82% eliminated via the lungs within 20 minutes
Undergoes first pass elimination within the pulmonary circulation; ~40-50% eliminated in the expired air during the first minute following injection
Administration
IV Preparation
Using aseptic techniques, reconstitute vial using mini-spike with prefilled syringe contents (ie, 5 mL NaCl 0.9%)
Do not remove syringe and mini-spike from viaL
Shake vigorously for 20 seconds, mixing all contents in the viaL
Resulting suspension should appear as a homogenous, white, milky liquid; this indicates formation of sulfur hexafluoride lipid microspheres
Following reconstitution, resulting suspension contains 1.5-5.6 x10^8 lipid microspheres/mL with 45 mcg/mL of sulfur hexafluoride
Invert vial and syringe and slowly withdraw 2 mL of the reconstituted suspension into the syringe
Unscrew syringe from mini-spike and immediately connect the syringe to the dosage administration line (20 G)
Kit contains
- 2-compartment vial containing 25 mg of lipid-type A lyophilized powder and headspace fill of 60.7 mg sulfur hexafluoride
- Prefilled syringe containing 5 mL NaCl 0.9%
- Mini-spike
IV Administration
Administer suspension as IV bolus injection immediately after reconstitution
Provides useful echocardiographic signal intensity for 2 minutes following the injection
If not used immediately after reconstitution, the microspheres should be resuspended by a few seconds of hand agitation before the suspension is withdrawn into the syringe
Storage
Store unreconstituted kit at room temperature 25°C (77°F); excursions permitted to 15-30°C (59-86°F)
Reconstituted suspension: May store at room temperature for up to 3 hr; does not contain antimicrobial preservative
