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LumaSon SULFUR HEXAFLUORIDE 60.7 mg/mg; .19 mg/mg; 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL) .19 mg/mg Injection, Powder, Lyophilized, For Suspension — NDC 00270-7097-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

LumaSon SULFUR HEXAFLUORIDE 60.7 mg/mg; .19 mg/mg; 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL) .19 mg/mg Injection, Powder, Lyophilized, For Suspension — NDC 0270-7097-08 (Billing 00270-7097-08)

by BRACCO DIAGNOSTICS INC · 20 VIAL in 1 BOX / 25 mg in 1 VIAL

This is a package of LumaSon SULFUR HEXAFLUORIDE 60.7 mg/mg; .19 mg/mg; 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL) .19 mg/mg Injection, Powder, Lyophilized, For Suspension from BRACCO DIAGNOSTICS INC, marketed since Apr 2021 and currently FDA-listed.

NDC 00270-7097-08
🏷️ FDA NDC (as labeled) 0270-7097-08 billing pads the labeler segment with a zero
This package
Contains25 mg in 1 vial Pack sizes2 compare ↓
Product page 00270-7097-07 Also comes in: 20 vials 0270-7097-07
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0270-7097-08
Product NDC 0270-7097
11-digit billing NDC 00270709708
NCPDP billing unit EA — each (per item)
UNII WS7LR3I1D6, EAG959U971, 841B886EJ7
Application # NDA203684
SPL Set ID 69822a55-226c-f133-e3b8-2b5826667c5b
Established class (EPC) Contrast Agent for Ultrasound Imaging
Mechanism of action Ultrasound Contrast Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-04-01
Route INTRAVENOUS, INTRAVESICAL
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Substance SULFUR HEXAFLUORIDE; DISTEAROYLPHOSPHATIDYLCHOLINE, DL-; SODIUM 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 059242
GCN 24815
HICL code 032972
Ingredient (HICL) Sulfur Hexafluoride Microsphr
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z9
Therapeutic class — intermediate (HIC2) Unclassified Drugs
HIC3 code Z9D
Therapeutic class — specific (HIC3) Diagnostic Preparations,Miscellaneous
AHFS code 36:68.00.00
AHFS class Roentgenography And Other Imaging Agents
FDB label name LUMASON 25 MG VIAL
FDB brand name Lumason
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 059242
  • GCN: 24815
  • HICL (First Databank): 032972
  • AHFS class code: 36:68.00.00
Why two NDCs? The FDA registers this code as 0270-7097-08 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00270-7097-08. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name LUMASON 25 MG VIAL Ingredient Sulfur Hexafluoride Microsphr

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer mLPer 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 —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)0270-7097-08
11-digit billing NDC00270-7097-08
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeQ9950
DescriptorInjection, sulfur hexafluoride lipid microspheres, per ml
Billing units / pkg100 units
How the units are derivedThis package is 5; the HCPCS unit is 1 ML, so one package = 100 billing units.
Medicare Part B spend (2026 (Q1))$67,999 · 846 claims · $80.38 per claim (all NDCs under Q9950)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00270-7097-08 You're viewing this 20 VIAL in 1 BOX / 25 mg in 1 VIAL 2021-04-01 — Active
00270-7097-07 0270-7097-07 Main listing 20 VIAL in 1 BOX / 25 mg in 1 VIAL 2021-04-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 20 vial in 1 box / 25 mg in 1 vial.
What NDC number is used to bill for this package of LumaSon SULFUR HEXAFLUORIDE 60.7 mg/mg; .19 mg/mg; 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL) .19 mg/mg Injection, Powder, Lyophilized, For Suspension?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
LumaSon 60.7 mg/mg; .19 mg/mg; 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL) .19 mg/mgthis 00270-7097-08 BRACCO 20 vials — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2014
First FDA approval
Oct 2014
📍
2026
Currently FDA-listed
12 years listed
🛡️
2039
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

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.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through May 2039. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 15, 2014 RLD RS ⏳ ~12.6 yr to latest listed protection

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.

Patents & exclusivity — FDA Orange Book
US 11723869 — method of use (U-3666)
US 11723869 — method of use (U-3667)
US 11723869 — method of use (U-3668)
US 10232061 — drug product
US 10335502 — drug product
2014 2016 2018 2020 2022 2024 2026 2028 2030 2032 2034 2036 2038
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 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.

Listed patents (5)
PatentTypeUse codeExpires
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
Common questions
Is there a generic version of LUMASON 25 MG VIAL?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for LUMASON 25 MG VIAL. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until May 2039 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • .04 mg / 1 mg UNII 2V16EO95H1
    Palmitic acid is a saturated fatty acid derived from plant and animal sources. It serves as an emulsifier and lubricant in medicines, helping ingredients mix smoothly and preventing sticking during manufacturing.
  • 24.56 mg / 1 mg UNII 4R4HFI6D95
    Polyethylene glycol 4000 is a synthetic polymer derived from petroleum. It serves as a binder, filler, and lubricant in solid dosage forms, and helps control how quickly the medicine dissolves.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerBRACCO DIAGNOSTICS INC
Application holderBRACCO DIAGNOSTICS INC
FDA applicationNDA203684 (NDA)
Labeler code00270
First marketedApr 2021
Product typeHuman Prescription Drug
Portfolio30 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 162 words ▾

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 166 words ▾

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 ~3 min read ▾

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… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 153 words ▾

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 55 words ▾

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 ~2 min read ▾

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 ~2 min read ▾

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 ~3 min read ▾

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 204 words ▾

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 ~1 min read ▾

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 70 words ▾

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 ~3 min read ▾

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 84 words ▾

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 140 words ▾

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 ~2 min read ▾

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 117 words ▾

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

🧬 Pharmacokinetics ~1 min read ▾

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.

🧬 Pharmacodynamics 157 words ▾

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.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Echocardiography Adults A total of 191 patients with suspected cardiac disease and suboptimal non-contrast echocardiography received Lumason in three multi-center controlled clinical trials (76 patients in Study A, 62 patients in Study B, and 53 patients in Study C). Among these patients, there were 127 men and 64 women. The mean age was 59 years (range 22 to 96 years).

The racial and ethnic representations were 79% White, 16% Black, 4% Hispanic, < 1% Asian, and < 1% other racial or ethnic groups. The mean weight was 204 lbs (range 92 to 405 lbs). Approximately 20% of the patients had a chronic pulmonary disorder and 30% had a history of heart failure.

Of the 106 patients for whom a New York Heart Association (NYHA) classification of heart failure was assigned, 49% were Class I, 33% were Class II, and 18% were Class III. Patients with NYHA Class IV heart failure were not included in these studies. In Studies A and B, each patient received four intravenous bolus injections of Lumason (0.5, 1, 2, and 4 mL), in randomized order.

In Study C, each patient received two doses of Lumason (1 mL and 2 mL) in randomized order. All three studies assessed endocardial border delineation and left ventricular opacification. For each patient in each study, echocardiography with Lumason was compared to non-contrast (baseline) echocardiography.

A recording of 2D echocardiography was obtained from 30 seconds prior to each injection to at least 15 minutes after dosing or until the disappearance of the contrast effect, whichever was longer. Contrast and non-contrast echocardiographic images for each patient were evaluated by two independent reviewers, who were blinded to clinical information and the Lumason dose. Evaluation of left ventricular endocardial border consisted of segment based assessment involving six endocardial segments and using two apical views (2- and 4-chamber views).

Endocardial Border Delineation and Duration of Useful Contrast Effect In all three studies, administration of Lumason improved left ventricular endocardial border delineation. The majority of the patients who received a 2.0 mL dose of Lumason had improvement in endocardial border delineation manifested as visualization of at least two additional endocardial border segments. Table 3 demonstrates the improvement in endocardial border delineation following Lumason administration as a reduction in percentage of patients with inadequate border delineation in at least one pair of adjacent segments (combined 2-chamber and 4-chamber view).

The results are shown by reader. Table 3. Reduction in Percentage of Patients with Inadequate Border Delineation Reader Study A N = 76 Study B N = 62 Study C N = 53 Non- contrast Lumason Non- contrast Lumason Non- contrast Lumason A 60 (79%) 22 (33%) 31 (50%) 12 (19%) 12 (23%) 10 (19%) B 62 (82%) 29 (37%) 54 (87%) 6 (10%) 45 (85%) 20 (38%) Following the first appearance of contrast within the left ventricle the mean duration of useful contrast effect ranged from 1.7 to 3.1 minutes.

Left Ventricular Opacification In all three studies, complete left ventricular opacification was observed in 52% to 80% of the patients following administration of a 2.0 mL dose of Lumason. The studies did not sufficiently assess the effect of Lumason upon measures of left ventricular ejection fraction and wall motion. Pediatric patients: Twelve pediatric patients 9 to 17 years of age with suspected cardiac disease and suboptimal non-contrast echocardiography received Lumason in one prospective multicenter clinical trial.

Patients received Lumason at a dose of 0.03 mL/kg (mean 1.83 mL). There were 7 female, 10 white, and 2 black patients. For both the non-contrast and contrast-enhanced images, standard apical 4-, 2-, and 3- chamber views with harmonic imaging were acquired.

Contrast and non-contrast images for each patient were evaluated by three independent reviewers, who were blinded to clinical information. Endocardial Border Delineat… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 82 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies were performed to evaluate the carcinogenic potential of Lumason. No evidence of genotoxicity was found in the following studies conducted with Lumason: 1) a bacterial mutagenesis (Ames) assay, 2) an in vitro human lymphocyte chromosome aberration assay, and 3) an in vivo mouse micronucleus assay. No impairment of fertility was observed in rats receiving Lumason at doses up to 8 times the human dose based on body surface area.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 79 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies were performed to evaluate the carcinogenic potential of Lumason. No evidence of genotoxicity was found in the following studies conducted with Lumason: 1) a bacterial mutagenesis (Ames) assay, 2) an in vitro human lymphocyte chromosome aberration assay, and 3) an in vivo mouse micronucleus assay. No impairment of fertility was observed in rats receiving Lumason at doses up to 8 times the human dose based on body surface area.

📄 Recent Major Changes 14 words ▾

Contraindications ( 4 ) 4/2021 Warnings and Precautions, Hypersensitivity Reactions ( 5.2 ) 4/2021

📄 Package Label / Principal Display Panel 78 words ▾

Lumason - KIT Box Label NDC: 0270-7099-73 Lumason - NovaPLus - Kit - Box Label-CF1084-06

Lumason - Box of 5 Kits NDC: 0270-7099-73 Lumason - NovaPlus - Box of 5 Kits - CE1085-05

Lumason Vial Label NDC: 0270-7099-73 Lumason - NovaPlus - Kit Vial Label - CI1083-05

Lumason 20x Carton NDC: 0270-7097-08 Lumason - NovaPlus - MP - 20x25 MG - BOX COVER - CF116D-05

Lumason Vial Label NDC: 0270-7097-08 Lumason - NovaPlus - MP - Vial Label-CI116C-03

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for LumaSon (this brand).

Top reported reactions

Dyspnoea312
Nausea255
Anaphylactic Reaction243
Hyperhidrosis217
Flushing175
Hypotension161
Dizziness154

Age at onset

Neonate1
Infant1
Adult30
Elderly17

Reporter sex

1,865 reports

Serious outcomes

Life-threatening496
Hospitalization459
Death91
Disabling16
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 448 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
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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) ✓ Available
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Orange Book / therapeutic-equivalence data ✓ Available
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Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by BRACCO DIAGNOSTICS INC. Listing status can change — the directory data on this page refreshes weekly.
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Yes — the FDA directory lists 1 other package presentation of this same product, including 20 vials (00270-7097-07). Each has its own NDC and its own page — see the package list near the top of this page.
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← 00270-7035-44 · BRACCO 00270-7099-73 · BRACCO →
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