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Lumason

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Uses

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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History

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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:

  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:

chem-struct1

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:

chem-struct2

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
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    Lumason | Bracco Diagnostics Inc

    Lumason | Bracco Diagnostics Inc
    2.1  Recommended Dose

    The recommended dose of Lumason after reconstitution is 2 mL administered as an intravenous bolus injection during echocardiography. During a single examination, a second injection of 2 mL may be administered to prolong contrast enhancement. Follow each Lumason injection with an intravenous flush using 5 mL of 0.9% Sodium Chloride Injection.

    2.2  LumaSon Reconstitution

    Lumason is supplied within a kit containing the following:

    a clear glass vial labeled as Lumason (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, 25 mg lipid-type A /60.7 mg powder and headspace filled with sulfur hexafluoride, a prefilled syringe with 5 mL Sodium Chloride 0.9% Injection, USP, (Diluent), a Mini-Spike.

    Reconstitution steps:

    Prior to Lumason reconstitution, inspect the kit and its components for signs of damage. Do not use the kit if the protective caps on the vial and prefilled syringe are not intact or if the kit shows other signs of damage. Perform all Lumason reconstitution steps under aseptic conditions. The Lumason vial and the prefilled syringe do not contain a bacteriostatic preservative. Lumason is reconstituted by injecting the prefilled syringe contents (5 mL Sodium Chloride 0.9% Injection, USP) into the Lumason vial using the following illustrated steps.

    1. Connect the plunger rod to the prefilled syringe barrel by screwing it clockwise into the syringe (see Figure 1).



    2. Open the Mini-Spike blister and remove the syringe tip cap (see Figure 2).



    3. Open the Mini-Spike green cap and connect the syringe to the Mini-Spike by screwing it in clockwise (see Figure 3).



    4. Remove the flip cap plastic protective cap from the vial, remove the Mini-Spike spike protection and position the spike in the center of the rubber stopper of the vial. Press firmly inward until the spike is fully inserted in the stopper (see Figure 4).



    5. Empty the content of the syringe into the vial by pushing on the plunger rod (see Figure 5).



    6. Shake vigorously for 20 seconds, mixing all the contents in the vial (see Figure 6). A homogeneous white milky liquid indicates formation of sulfur hexafluoride lipid microspheres.



    7. Invert the system and slowly withdraw 2 mL of suspension into the syringe (see Figure 7).



    8. Unscrew the syringe from the Mini-Spike (see Figure 8). Immediately connect the syringe to the dose administration line (20 G) and administer as directed under Administration section below.



    Administration:

    Administer Lumason as an intravenous bolus injection. The milky white Lumason suspension should be used immediately after reconstitution. If the suspension is 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. Reconstituted suspension within a vial may be used for up to 3 hours from the time of its reconstitution, after the microspheres have been resuspended by hand agitation prior to withdrawal of the suspension into the syringe. Maintain the vial containing the reconstituted suspension at room temperature. Lumason is for single use only. Unused portions of the reconstituted suspension must be discarded after one use in accordance with regulations dealing with the disposal of such materials. Syringe and other materials used should also be properly disposed of after single use. 2.3  Imaging Guidelines

    After baseline non-contrast echocardiography is complete, the mechanical index for the ultrasound device should be adjusted to 0.8 or lower. Ultrasound imaging is then continued following Lumason injection.

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