Lumason Recall

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Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


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.


There is currently no drug history available for this drug.

Other Information

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:

  1. 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
  2. one prefilled syringe containing 5 mL Sodium Chloride 0.9% Injection, USP (Diluent)
  3. 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:

Sonvue 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

Lumason Manufacturers

  • Bracco Diagnostics Inc
    Lumason (Sulfur Hexafluoride) Kit [Bracco Diagnostics Inc]

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