LumaSon SULFUR HEXAFLUORIDE Kit
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🩺 Clinical
Patient education
Supplement & herbal interactions
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · Q9950 | $18.126 / Q9950 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| LumaSonthis 00270-7099-73 | BRACCO | 5 kits | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 11723869 ↗ | Method of use | U-3666 | May 15, 2039 |
| US 11723869 ↗ | Method of use | U-3667 | May 15, 2039 |
| US 11723869 ↗ | Method of use | U-3668 | May 15, 2039 |
| US 10232061 ↗ | Drug product | — | Jul 6, 2038 |
| US 10335502 ↗ | Drug product | — | Jul 6, 2038 |
Is there a generic version of LUMASON 25 MG VIAL?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00270-7099-73 You're viewing this | 5 KIT in 1 BOX (0270-7099-73) / 1 KIT in 1 KIT * 25 mg in 1 VIAL * 5 mL in 1 SYRINGE | 2020-01-15 | Active |
| 00270-7099-16 | 5 KIT in 1 BOX (0270-7099-16) / 1 KIT in 1 KIT * 25 mg in 1 VIAL * 5 mL in 1 SYRINGE | 2015-01-15 | Active |
Pack size FAQ
What quantity is in NDC 00270-7099-73?
What NDC number is used to bill for this package of LumaSon SULFUR HEXAFLUORIDE Kit?
🧭 About this NDC listing & data coverage
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: SERIOUS CARDIOPULMONARY REACTIONS Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres [see Warnings and Precautions ( 5.1 )] . Most serious reactions occur within 30 minutes of administration [see Warnings and Precautions ( 5.1 )] . Assess all patients for the presence of any condition that precludes administration [see Contraindications ( 4 )] .
Always have resuscitation equipment and trained personnel readily available [see Warnings and Precautions ( 5.1 )] . WARNING: SERIOUS CARDIOPULMONARY REACTIONS See full prescribing information for complete boxed warning Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres ( 5.1 ). Most serious reactions occur within 30 minutes of administration ( 5.1 ).
Assess all patients for the presence of any condition that precludes administration ( 4 ). Always have resuscitation equipment and trained personnel readily available ( 5.1 ).
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Echocardiography Lumason is indicated for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. Ultrasonography of the Liver Lumason is indicated for use with ultrasound of the liver in adult and pediatric patients to characterize focal liver lesions. Ultrasonography of the Urinary Tract Lumason is indicated for use in ultrasonography of the urinary tract in pediatric patients for the evaluation of suspected or known vesicoureteral reflux.
Lumason is an ultrasound contrast agent indicated for use in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult and pediatric patients with suboptimal echocardiograms ( 1 ) in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients ( 1 ) in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patients ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Avoid intra-arterial injection ( 2.1 , 5.3 ) See Full Prescribing Information for reconstitution instructions ( 2.3 ) For intravenous injection : Echocardiography in adults: After reconstitution, administer 2 mL as an intravenous injection ( 2.2 , 2.4 ) Echocardiography in pediatric patients: After reconstitution, administer 0.03 mL per kg as an intravenous injection up to a maximum of 2 mL per injection ( 2.2 , 2.4 ) Ultrasonography of the liver in adults: After reconstitution, administer 2.4 mL as an intravenous injection ( 2.2 , 2.4 ) Ultrasonography of the liver in pediatric patients: After reconstitution, administer 0.03 mL per kg as an intravenous injection, up to a maximum of 2.4 mL per injection ( 2.2 , 2.4 ) May repeat dose one time during a single examination ( 2.2 , 2.4 ) Follow each injection with an intravenous flush of 0.9% Sodium Chloride Injection, USP ( 2.2 , 2.4 ) For intravesical administration in pediatric patients : Ultrasonography of the urinary tract: After reconstitution, administer 1 mL via sterile 6 to 8F urinary catheter.
Bladder should be first emptied and then partially filled with 0.9% Sodium Chloride Injection, USP before injection of Lumason ( 2.2 , 2.4 ) After Lumason administration, continue filling the bladder with 0.9% Sodium Chloride Injection, USP until the patient has the urge to micturate or at the first sign of back pressure to the infusion ( 2.4 )
2.1Important Administration Instructions Do not administer Lumason by intra-arterial injection [see Warnings and Precautions ( 5.3 )] .
2.2Recommended Dosage Echocardiography Adults 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, USP.
Pediatric Patients The recommended dose of Lumason after reconstitution in pediatric patients is 0.03 mL per kg administered as an intravenous injection during echocardiography. During a single examination, a second injection of 0.03 mL per kg may be administered, if needed. Do not exceed 2 mL per injection.
Follow Lumason injection with an intravenous flush using 5 mL of 0.9% Sodium Chloride Injection, USP. 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, USP. 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, USP. Ultrasonography of the Urinary Tract Pediatric Patients The recommended dose of Lumason after reconstitution is 1 mL.
The bladder may be refilled with 0.9% Sodium Chloride Injection, USP for a second cycle of voiding and imaging, without the need of a second Lumason administration.
2.3Reconstitution Instructions Refer to Section 2.3.1 for instructions for using the single patient use kit with diluent provided Refer to Section 2.3.2 for instructions for using the 20-vial pack without diluent provided 2.3.1 Lumason Kit (single patient use kit) Contents of Lumason Kit Inspect the Lumason kit and its components for signs of damage. Do not use the kit if the protective caps on the Lumason vial and prefilled syringe with 5 mL 0.9% Sodium Chloride Injection, USP are not intact or if the kit shows other signs…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS For injectable suspension: Lumason is supplied in two presentations (single patient use kit or 20-vial pack): 3-part single patient use kit comprised of: one Lumason clear vial containing 25 mg of lipid-type A sterile white lyophilized powder with headspace filled with 60.7 mg of sulfur hexafluoride gas one prefilled syringe containing 5 mL of 0.9% Sodium Chloride Injection, USP (Diluent) one Mini-Spike 20-vial pack 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 Following reconstitution, Lumason is a homogeneous, milky white suspension containing 1.5 to 5.6 x 10 8 microspheres/mL with 45 mcg/mL of sulfur hexafluoride.
For injectable suspension: 25 mg of lipid-type A lyophilized powder with headspace fill of 60.7 mg sulfur hexafluoride in a single-patient use vial for reconstitution ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Lumason is contraindicated in patients with known or suspected: Hypersensitivity to sulfur hexafluoride lipid microsphere or its components, such as polyethylene glycol (PEG) [see Warnings and Precautions ( 5.2 ) and Description ( 11 )] . Hypersensitivity to sulfur hexafluoride lipid microspheres or its components, such as polyethylene glycol (PEG) ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Cardiopulmonary reactions, including fatalities. Always have resuscitation equipment and trained personnel readily available ( 5.1 ) Hypersensitivity reactions. Serious acute hypersensitivity reactions have occurred in patients with no prior exposure to sulfur hexafluoride lipid-containing microsphere products, including patients with prior hypersensitivity reaction(s) to PEG ( 5.2 , 6 )
5.1Serious Cardiopulmonary Reactions Serious cardiopulmonary reactions, including fatalities have occurred uncommonly during or shortly following administration of ultrasound contrast agents, including Lumason. These reactions typically occurred within 30 minutes of administration. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias).
Always have cardiopulmonary resuscitation personnel and equipment readily available prior to Lumason administration and monitor all patients for acute reactions. The reported reactions that may follow the administration of ultrasound contrast agents include: fatal cardiac or respiratory arrest, shock, syncope, symptomatic arrhythmias (atrial fibrillation, tachycardia, bradycardia, supraventricular tachycardia, ventricular fibrillation, and ventricular tachycardia), hypertension, hypotension, dyspnea, hypoxia, chest pain, respiratory distress, stridor, wheezing, loss of consciousness, and convulsions.
5.2Hypersensitivity Reactions In postmarketing use, serious hypersensitivity reactions were observed during or shortly following sulfur hexafluoride lipid-containing microsphere administration including: Anaphylaxis, with manifestations that may include death, shock, bronchospasm, dyspnea, throat tightness, angioedema, edema (pharyngeal, palatal, mouth, peripheral, localized), swelling (face, eye, lip, tongue, upper airway), facial hypoesthesia, rash, urticaria, pruritus, flushing, and erythema. These reactions may occur in patients with no history of prior exposure to sulfur hexafluoride lipid-containing microspheres.
Lumason contains PEG. There may be increased risk of serious reactions including death in patients with prior hypersensitivity reaction(s) to PEG [see Adverse Reactions ( 6.2 )] . Clinically assess patients for prior hypersensitivity reactions to products containing PEG, such as certain colonoscopy bowel preparations and laxatives.
Always have cardiopulmonary resuscitation personnel and equipment readily available prior to Lumason administration and monitor all patients for hypersensitivity reactions.
5.3Systemic Embolization When administering Lumason to patients with cardiac shunt, microspheres can bypass filtering by the lung and enter the arterial circulation. Assess patients with shunts for embolic phenomena following Lumason administration. Lumason is only for intravenous and/or intravesical administration; do not administer Lumason by intra-arterial injection [see Dosage and Administration ( 2.1 )].
5.4Ventricular Arrhythmia Related to High Mechanical Index High ultrasound mechanical index values may cause microsphere cavitation or rupture and lead to ventricular arrhythmias. Additionally, end-systolic triggering with high mechanical indices has been reported to cause ventricular arrhythmias. Lumason is not recommended for use at mechanical indices greater than 0.8.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Cardiopulmonary reactions [see Warnings and Precautions ( 5.1 )] Hypersensitivity reactions [see Warnings and Precautions ( 5.2 )] Most common adverse reactions (incidence ≥ 0.5%) are headache and nausea ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adults In completed clinical trials, a total of 6984 adult subjects (128 healthy volunteers and 6856 patients) received Lumason at cumulative doses ranging from 0.2 to 161 mL (mean 9.8 mL). Lumason was administered mainly as single or multiple injections; however, some subjects received infusion dosing.
The majority (75%) of subjects received Lumason at cumulative doses of 10 mL or less. There were 64% men and 36% women, with an average age of 59 years (range 17 to 99 years). A total of 79% subjects were White; 4% were Black; 16% were Asian; <1% were Hispanic; and <1% were in other racial groups or race was not reported.
In the clinical trials, serious adverse reactions were observed in 2 subjects; one who experienced a hypersensitivity-type rash and presyncope and another who experienced anaphylactic shock shortly following Lumason administration. The most commonly reported adverse reactions among patients (occurring among at least 0.2% of patients) are listed below (Table 1). Most adverse reactions were mild to moderate in intensity and resolved spontaneously. *occurring in at least 0.2% of patients Table 1.
Adverse Reactions in Adult Patients* n = 6856 Number (%) of Patients with Adverse Reactions 340 (5%) Headache 65 (1%) Nausea 37 (0.5%) Dysgeusia 29 (0.4%) Injection site pain 23 (0.3%) Feeling Hot 18 (0.3%) Chest discomfort 17 (0.2%) Chest pain 12 (0.2%) Dizziness 11 (0.2%) Injection Site Warmth 11 (0.2%) Pediatric Patients: In completed clinical trials for echocardiography, a total of 12 pediatric patients received Lumason at a dose of 0.03 mL/kg. No adverse reactions were identified in pediatric patients [see Clinical Studies ( 14.1 )] .
6.2Postmarketing Experience In the international postmarketing clinical experience and clinical trials, serious adverse reactions have uncommonly been reported following administration of Lumason. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The serious adverse reactions include fatalities, especially in a pattern of symptoms suggestive of anaphylactoid/hypersensitivity reactions.
Other serious reactions included arrhythmias and hypertensive episodes. These reactions typically occurred within 30 minutes of Lumason administration. These serious reactions may be increased among patients with pre-existing PEG hypersensitivity and/or unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) [see Warnings and Precautions ( 5.1 , 5.2 )] .
Hypersensitivity Anaphylaxis, with manifestations that may include death, shock, bronchospasm, dyspnea, throat tightness, angioedema, edema (pharyngeal, palatal, mouth, peripheral, localized), swelling (face, eye, lip, tongue, upper airway), facial hypoesthesia, rash, urticaria, pruritus, flushing, and erythema.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no data with Lumason use in pregnant women to inform any drug-associated risks. No adverse developmental outcomes were observed in animal reproduction studies with administration of sulfur hexafluoride lipid-type A microspheres in pregnant rats and rabbits during organogenesis at doses up to at least 10 and 20 times, respectively, the maximum human dose of 4.8 mL based on body surface area ( see Data ). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Data Animal Data Lumason was administered intravenously to rats at doses of 0.2, 1, and 5 mL/kg (approximately 0.4, 2, and 10 times the recommended maximum human dose of 4.8 mL, respectively, based on body surface area); Lumason doses were administered daily for about 30 consecutive days, from two weeks before pairing until the end of organogenesis. Lumason was administered intravenously to rabbits at doses of 0.2, 1, and 5 mL/kg (approximately 0.8, 4, and 20 times the recommended maximum human dose, respectively, based on body surface area); Lumason doses were administered daily from gestation day 6 to day 19 inclusive.
No significant findings on the fetus were observed.
8.2Lactation Risk Summary There are no data on the presence of Lumason in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Lumason and any potential adverse effects on the breastfed infant from Lumason or from the underlying maternal condition.
8.4Pediatric Use Echocardiography Safety and effectiveness have been established for use in pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve delineation of the left endocardial border. Safety and effectiveness in pediatric patients are based on adequate and well-controlled studies in adults and are supported by a clinical study in 12 pediatric patients (mean age: 13.8 years) with extrapolation of efficacy to younger pediatric patients. No new adverse reactions were reported in the pediatric study [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14.1 )] .
Safety of intravenous use of Lumason was based on evaluation of published literature involving the use of Lumason in over 1400 pediatric patients (0 to 17 years). Ultrasonography of the Liver Safety and effectiveness in pediatric patients has been established for use in ultrasonography of the liver for characterization of focal liver lesions from adequate and well controlled trials in adult patients and a clinical study of 44 pediatric patients [see Clinical Studies ( 14 )] . Safety of intravenous use of Lumason was based on evaluation of published literature involving use of Lumason in over 1400 pediatric patients.
Non-fatal anaphylaxis was reported in one pediatric patient. Ultrasonography of the Urinary Tract Safety and effectiveness in pediatric patients has been established for use in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux from two published studies comprising a total of 411 pediatric patients [see Clinical Studies ( 14 )] . Safety of intravesical use of Lumason was based on evaluation of published literature involving use of Lumason in over 6000 pediatric patients.
No adverse reactions were reported.
8.5Geriatric Use Of the total number of 6856 adult patients in clinical studies of Lumason, 39% were 65 and over, while 11% were 75 and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly or younger patients, but greater sensitivity of some older individuals cannot be ruled out.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no data with Lumason use in pregnant women to inform any drug-associated risks. No adverse developmental outcomes were observed in animal reproduction studies with administration of sulfur hexafluoride lipid-type A microspheres in pregnant rats and rabbits during organogenesis at doses up to at least 10 and 20 times, respectively, the maximum human dose of 4.8 mL based on body surface area ( see Data ). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Data Animal Data Lumason was administered intravenously to rats at doses of 0.2, 1, and 5 mL/kg (approximately 0.4, 2, and 10 times the recommended maximum human dose of 4.8 mL, respectively, based on body surface area); Lumason doses were administered daily for about 30 consecutive days, from two weeks before pairing until the end of organogenesis. Lumason was administered intravenously to rabbits at doses of 0.2, 1, and 5 mL/kg (approximately 0.8, 4, and 20 times the recommended maximum human dose, respectively, based on body surface area); Lumason doses were administered daily from gestation day 6 to day 19 inclusive.
No significant findings on the fetus were observed.
🧒 Pediatric Use ▾
8.4Pediatric Use Echocardiography Safety and effectiveness have been established for use in pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve delineation of the left endocardial border. Safety and effectiveness in pediatric patients are based on adequate and well-controlled studies in adults and are supported by a clinical study in 12 pediatric patients (mean age: 13.8 years) with extrapolation of efficacy to younger pediatric patients. No new adverse reactions were reported in the pediatric study [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14.1 )] .
Safety of intravenous use of Lumason was based on evaluation of published literature involving the use of Lumason in over 1400 pediatric patients (0 to 17 years). Ultrasonography of the Liver Safety and effectiveness in pediatric patients has been established for use in ultrasonography of the liver for characterization of focal liver lesions from adequate and well controlled trials in adult patients and a clinical study of 44 pediatric patients [see Clinical Studies ( 14 )] . Safety of intravenous use of Lumason was based on evaluation of published literature involving use of Lumason in over 1400 pediatric patients.
Non-fatal anaphylaxis was reported in one pediatric patient. Ultrasonography of the Urinary Tract Safety and effectiveness in pediatric patients has been established for use in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux from two published studies comprising a total of 411 pediatric patients [see Clinical Studies ( 14 )] . Safety of intravesical use of Lumason was based on evaluation of published literature involving use of Lumason in over 6000 pediatric patients.
No adverse reactions were reported.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the total number of 6856 adult patients in clinical studies of Lumason, 39% were 65 and over, while 11% were 75 and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly or younger patients, but greater sensitivity of some older individuals cannot be ruled out.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Within the blood, the acoustic impedance of Lumason microspheres is lower than that of the surrounding non-aqueous tissue. Therefore, an ultrasound beam is reflected from the interface between the microspheres and the surrounding tissue. The reflected ultrasound signal provides a visual image that shows a contrast between the blood and the surrounding tissues.
For ultrasonography of the urinary tract in pediatric patients, the intravesically administered Lumason microspheres increase signal intensity of fluids within the urethra, bladder, ureters, and renal pelvis.
12.2Pharmacodynamics Lumason provides useful echocardiographic signal intensity for two minutes after intravenous injection. Lumason microspheres are destroyed and contrast enhancement decreases as the mechanical index increases (values of 0.8 or less are recommended). For ultrasonography of the liver, Lumason provides dynamic patterns of differential signal intensity enhancement between focal liver lesions and liver parenchyma during the arterial, portal venous, and late phase of signal intensity enhancement of the microvasculature.
In ultrasonography of the urinary tract, Lumason facilitates the detection of reflux of fluid from the bladder into the ureters. Pulmonary Hemodynamic Effects The effect of Lumason on pulmonary hemodynamics was studied in a prospective, open-label study of 36 patients scheduled for right heart catheterization, including 18 with mean pulmonary arterial pressure (MPAP) > 25 mmHg and 18 with MPAP ≤ 25 mmHg. No clinically important pulmonary hemodynamic changes were observed.
This study did not assess the effect of Lumason on visualization of cardiac or pulmonary structures.
12.3Pharmacokinetics The pharmacokinetic of the SF 6 gas component of Lumason was evaluated in 12 healthy adult subjects. After intravenous bolus injections of 0.03 mL/kg and 0.3 mL/kg of Lumason, corresponding to approximately 1 and 10 times the recommended doses, concentrations of SF 6 in blood peaked within 1 to 2 minutes for both doses. The terminal half-life of SF 6 in blood was approximately 10 minutes for the 0.3 mL/kg dose.
The area-under-the-curve of SF 6 was dose-proportional over the dose range studied. Distribution In a study of healthy subjects, the mean values for the apparent steady-state volume of distribution of SF 6 following intravenous administration, were 341 mcL and 710 mcL for Lumason doses of 0.03 mL/kg and 0.3 mL/kg, respectively. Preferential distribution to the lung is likely responsible for these values.
Elimination Following intravenous administration, the SF 6 component of Lumason is eliminated via the lungs. In a clinical study that examined SF 6 elimination twenty minutes following Lumason injection, the mean cumulative recovery of SF 6 in expired air was 82 ± 20% (SD) at the 0.03 mL/kg dose and 88 ± 26% (SD) at the 0.3 mL/kg dose. SF 6 undergoes first pass elimination within the pulmonary circulation; approximately 40% to 50% of the SF 6 content was eliminated in the expired air during the first minute following Lumason injection.
Metabolism SF 6 undergoes little or no biotransformation; following intravenous administration, 88% of an administered dose is recovered unchanged in expired air. Pharmacokinetics in Specific Populations Pulmonary Impairment: In a study of patients with pulmonary impairment, blood concentrations of SF 6 peaked at 1 to 4 minutes following intravenous Lumason administration. The cumulative recovery of SF 6 in expired air was 102 ± 18% (mean ± standard deviation), and the terminal half-life of SF 6 in blood was similar to that measured in healthy subjects.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Within the blood, the acoustic impedance of Lumason microspheres is lower than that of the surrounding non-aqueous tissue. Therefore, an ultrasound beam is reflected from the interface between the microspheres and the surrounding tissue. The reflected ultrasound signal provides a visual image that shows a contrast between the blood and the surrounding tissues.
For ultrasonography of the urinary tract in pediatric patients, the intravesically administered Lumason microspheres increase signal intensity of fluids within the urethra, bladder, ureters, and renal pelvis.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Lumason (sulfur hexafluoride lipid-type A microspheres) for injectable suspension is supplied as a single patient use kit and as a 20-vial pack as follows: 5 single patient use kits (NDC 0270-7099-73) with each kit containing: One Lumason vial of 25 mg lipid-type A white lyophilized powder with headspace fill of 60.7 mg of sulfur hexafluoride One prefilled syringe containing 5mL of 0.9% Sodium Chloride Injection, USP (Diluent) One Mini-Spike Each kit is packaged in a clear plastic container. 20-vial pack (NDC 0270-7097-08) containing: Twenty (20) Lumason vials of 25 mg lipid-type A white lyophilized powder with headspace fill of 60.7 mg of sulfur hexafluoride Twenty (20) Mini-Spikes Twenty (20) peel-off syringe labels
16.2Storage and Handling Store the kit at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION 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
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise patients to inform their healthcare provider if they develop any symptoms of hypersensitivity after LUMASON administration including rash, wheezing, or shortness of breath. Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08540 by BRACCO Suisse SA Plan-les-Ouates Geneve, Switzerland (Lumason lyophilized powder vial-25 mg lipid- type A/60.7 mg sulfur hexafluoride gas) Vetter Pharma-Fertigung GmbH & Co.
KG 88212 Ravensburg, Germany (0.9% Sodium Chloride Injection, USP) or Bracco Imaging S.p.A. Via Ribes, 5, 10010 Colleretto Giacosa (TO), Italy (0.9% Sodium Chloride Injection, USP) B. Braun Melsungen AG 34212 Melsungen, Germany (Mini-Spike) This product is covered by US Patent No.
5,686,060 Novaplus is a registered trademark of Vizient, Inc. CL1082-08 Revised: July 2024 novaplus logo