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Lumason is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
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Lumason (sulfur hexafluoride lipid-type A microspheres) for injectable suspension is used to prepare the ultrasound contrast agent. The single use kit contains the following three items:
- one clear glass 10 mL vial containing 25 mg of lyophilized powder lipid-type A, 60.7 mg of sulfur hexafluoride gas and capped with a blue flip-cap
- one prefilled syringe containing 5 mL Sodium Chloride 0.9% Injection, USP (Diluent)
- one Mini-Spike
Each vial is formulated as a 25 mg sterile, pyrogen-free lyophilized powder containing 24.56 mg of polyethylene glycol 4000, 0.19 mg of distearoylphosphatidyl-choline (DSPC), 0.19 mg of dipalmitoylphosphatidylglycerol sodium (DPPG-Na) and 0.04 mg of palmitic acid. The headspace of each vial contains 6.07 mg/mL (± 2 %) sulfur hexafluoride, SF6, or 60.7 mg per vial.
Each prefilled syringe with 5 mL of diluent 0.9% Sodium Chloride Injection is sterile, nonpyrogenic, preservative free containing 9 mg sodium chloride per mL.
Upon reconstitution with 5mL diluent, Lumason is a milky white, homogeneous suspension containing sulfur hexafluoride lipid-type A microspheres. The suspension is isotonic and has a pH of 4.5 to 7.5; it is only for intravenous administration.
The sulfur hexafluoride lipid microspheres are composed of SF6 gas in the core surrounded by an outer shell monolayer of phospholipids consisting DSPC and DPPG-Na with palmitic acid as a stabilizer.
Sulfur hexafluoride has a molecular weight of 145.9 and the following chemical structure:
1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC), with empirical formula C44H88NO8P, has a molecular weight of 790.6 and the following chemical structure:
1,2-Dipalmitoyl-sn-glycero-3-phospho-rac-glycerol sodium (DPPG-Na), with empirical formula C38H74 NaO10P, has a molecular weight of 745 and the following chemical structure:
Each milliliter of reconstituted Lumason suspension contains 1.5 to 5.6 x108 microspheres, 68 mcg SF6 (12 mcL), 0.038 mg DSPC, 0.038 mg DPPG-Na, 4.91 mg polyethylene glycol 4000 and 0.008 mg palmitic acid. The sulphur hexafluoride associated with the microspheres suspension is 45 mcg/mL. Fifteen to twenty three percent of the total lipids in the suspension are associated with the microspheres.
The sulfur hexafluoride lipid microsphere characteristics are listed in Table 2:
|Table 2. Microsphere Characteristics|
|Mean diameter range||1.5 – 2.5 µm|
|Percent of microspheres ≤ 10 µm||≥ 99%|
|Upper size limit||100.0% ≤ 20 µm|