lumason - Medication Listings

Lumason (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous or intravesical use is used to prepare the ultrasound contrast agent. Lumason is supplied in two presentations (single patient use kit or 20-vial pack): The single patient use kit contains the following three items: one clear glass 10 mL vial containing 25 mg of white 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 0.9% Sodium Chloride Injection, USP (Diluent) Each prefilled syringe with 5 mL of diluent 0.9% Sodium Chloride Injection, USP is sterile, nonpyrogenic, and additive-free containing 9 mg sodium chloride per mL. one Mini-Spike The 20-vial pack is comprised of: twenty Lumason clear vials, each containing 25 mg of lipid-type A sterile white lyophilized powder with headspace filled with 60.7 mg of sulfur hexafluoride gas twenty Mini-Spikes twenty peel-off syringe labels 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, SF 6 , or 60.7 mg per vial. 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. The sulfur hexafluoride lipid microspheres are composed of SF 6 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-Di s tearoyl- sn- glycero-3-phosphocholine (DSPC), with empirical formula C 44 H 88 NO 8 P, 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 C 38 H 74 NaO 10 P, has a molecular weight of 745 and the following chemical structure: Each milliliter of reconstituted Lumason suspension contains 1.5 to 5.6 x10 8 microspheres, 68 mcg SF 6 (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 sulfur-hexafluoride-chemical-structure empirical-formula-790-6 empirical-formula-745

Lumason (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous or intravesical use is used to prepare the ultrasound contrast agent. Lumason is supplied in two presentations (single patient use kit or 20-vial pack): The single patient use kit contains the following three items: one clear glass 10 mL vial containing 25 mg of white 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 0.9% Sodium Chloride Injection, USP (Diluent) Each prefilled syringe with 5 mL of diluent 0.9% Sodium Chloride Injection, USP is sterile, nonpyrogenic, and additive-free containing 9 mg sodium chloride per mL. one Mini-Spike The 20-vial pack is comprised of: twenty Lumason clear vials, each containing 25 mg of lipid-type A sterile white lyophilized powder with headspace filled with 60.7 mg of sulfur hexafluoride gas twenty Mini-Spikes twenty peel-off syringe labels 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, SF 6 , or 60.7 mg per vial. 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. The sulfur hexafluoride lipid microspheres are composed of SF 6 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-Di s tearoyl- sn- glycero-3-phosphocholine (DSPC), with empirical formula C 44 H 88 NO 8 P, 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 C 38 H 74 NaO 10 P, has a molecular weight of 745 and the following chemical structure: Each milliliter of reconstituted Lumason suspension contains 1.5 to 5.6 x10 8 microspheres, 68 mcg SF 6 (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 sulfur-hexafluoride-chemical-structure empirical-formula-790-6 empirical-formula-745