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Lumason Dosage

Generic name: SULFUR HEXAFLUORIDE 60.7mg in 1mg, DISTEAROYLPHOSPHATIDYLCHOLINE, DL- .19mg in 1mg, 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL), SODIUM SALT .19mg in 1mg;
Dosage form: injection, suspension

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

2.1  Important Administration Instructions

Do not administer Lumason by intra-arterial injection [see Warnings and Precautions (5.3)].

2.2  Recommended Dose

Echocardiography

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.

Ultrasonography of the Liver

Adults

The recommended dose of Lumason after reconstitution in adult patients is 2.4 mL administered as an intravenous injection during ultrasonography of the liver. During a single examination, a second injection of 2.4 mL may be administered, if needed. Follow Lumason injection with an intravenous flush using 5 mL of 0.9% Sodium Chloride Injection.

Pediatric Patients

The recommended dose of Lumason after reconstitution in pediatric patients is 0.03 mL per kg administered as an intravenous injection during ultrasonography of the liver. During a single examination, a second injection of 0.03 mL per kg may be administered, if needed. Do not exceed 2.4 mL per injection. Follow Lumason injection with an intravenous flush of 0.9% Sodium Chloride Injection.

2.3  Administration

Contents of Lumason Kit

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.
glass-vial-spike-syringe-and-rod

Lumason Reconstitution Steps:

  • Inspect the Lumason 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.
  • Under aseptic conditions, reconstitute Lumason 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).

figure-1

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

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).

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).

figure-4

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

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.

figure-6

7. For preparation of doses greater than or equal to 1 mL, invert the system and slowly withdraw the intended volume of suspension into the syringe (see Figure 7). For preparation of doses less than 1 mL, withdraw 2 mL of the reconstituted suspension into the 5 mL syringe and measure the volume of Lumason to inject by using the 0.2 mL graduations between the 1 mL and 2 mL marks.

figure-7

8. Unscrew the syringe from the Mini-Spike (see Figure 8). Peel and remove the diluent label to display the reconstituted product label. Immediately connect the syringe to the dose administration line (20 G) and administer as directed under Lumason Administration section below.

figure-8

Lumason Administration:

  • Administer Lumason as an intravenous bolus injection.
  • Use immediately after reconstitution. If the suspension is not used immediately after reconstitution, resuspend the microspheres for a few seconds by hand agitation before the suspension is drawn into the syringe. Reconstituted suspension within a vial may be used for up to 3 hours from the time of its reconstitution. Maintain the vial containing the reconstituted suspension at room temperature.
  • Lumason is for single use only. Discard unused portions of the reconstituted suspension 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.

2.4  Imaging Guidelines

Echocardiography

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.

Ultrasonography of the Liver

After identification of the target focal lesion on non-contrast ultrasound examination, hold transducer still while switching scanner to low mechanical index (≤ 0.4) contrast-specific imaging. Ultrasound imaging is then continued following Lumason injection.

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