Sulfur Hexafluoride

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.

• 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.

• 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 )] .contraindicated

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

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 ) 5.1 Serious 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.

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 6.1 Clinical 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.

8.1 Pregnancy 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.

Metabolism

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.

• Oct 10, 2014NDANDA203684Bracco

1. 1Dyspnoea29117%
2. 2Nausea23613%
3. 3Anaphylactic Reaction22613%
4. 4Hyperhidrosis19711%
5. 5Flushing1629.2%
6. 6Hypotension1518.6%
7. 7Dizziness1418.0%
8. 8Feeling Hot1237.0%
9. 9Hypersensitivity1226.9%
10. 10Erythema1156.5%
11. 11Unresponsive To Stimuli1136.4%
12. 12Blood Pressure Decreased1116.3%
13. 13Paraesthesia1096.2%
14. 14Cardiac Arrest1056.0%
15. 15Chest Pain1015.7%

Recent PubMed references pinned to Sulfur Hexafluoride as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Computationally tailoring the adsorption behavior of ZrSe(2) for SF(6) decomposition species in GIS: Mechanistic insights into Cu(2)O/Ag(2)O functionalization.
  Environmental research · 2026 · Zhou L, Yang F, Gui Y, et al.
  PMID 42097386DOI 10.1016/j.envres.2026.124625
• Nonlinear Response of Phospholipid-Shelled Ultrasound Contrast Agents: Ambient Conditions Affect Temporal Evolution.
  Ultrasound in medicine & biology · 2026 · K S M, Menon SJ, Kaushik A, et al.
  PMID 41934081DOI 10.1016/j.ultrasmedbio.2026.02.024
• Dual-modality sonovue microbubbles integrating targeting-fluorescence and contrast-enhanced ultrasound for early tumor diagnosis.
  Colloids and surfaces. B, Biointerfaces · 2026 · Ying B, Wu X, Pan C, et al.
  PMID 41864109DOI 10.1016/j.colsurfb.2026.115626
• Long-term Anatomical and Visual Success of Pneumatic Retinopexy in Sequential Bilateral Giant Retinal Tears: A 20-Year Follow-up Case Report.
  Ophthalmic surgery, lasers & imaging retina · 2026 · Ercan ZE, Azizagaoglu B, Akkoyun I, et al.
  PMID 41818450DOI 10.3928/23258160-20260123-01
• Electroretinography (ERG) alterations following positional changes in gas-filled eyes after a vitrectomy.
  Documenta ophthalmologica. Advances in ophthalmology · 2026 · Ichinohe H, Yamabe Y, Fujibayashi S, et al.
  PMID 41627599DOI 10.1007/s10633-025-10075-6
• Intraocular gases and climate change: a call for sustainable vitreoretinal surgery.
  Frontiers in public health · 2025 · Silva JPY, Salongcay RP
  PMID 41409696DOI 10.3389/fpubh.2025.1706042
• [Sulphur hexafluoride (SF(6)) and climate impact: is the medical use still justified?].
  Die Ophthalmologie · 2026 · Krohne TU, Birtel J, Charbel Issa P, et al.
  PMID 41313376DOI 10.1007/s00347-025-02356-x
• Efficacy of sulfur hexafluoride (SF(6)) versus perfluoropropane (C(3)F(8)) tamponade in large macular hole.
  Romanian journal of ophthalmology · 2025 · Kumar A, Mishra SK, Rana V, et al.
  PMID 41189796DOI 10.22336/rjo.2025.56

The 10 most recently updated of 197 ClinicalTrials.gov registrations naming Sulfur Hexafluoride as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Y-90 Treatment Response Using Transarterial Radioembolization
  Recruiting · Phase 2 · Interventional · 30 enrolled · Thomas Jefferson University
  NCT07145801updated 2026-06-10
• Comparison Between Outcomes of Closure of Idiopathic Macular Hole Using Autologus Tenon Capsule Graft and Internal Limiting Membrane Flap Techniques (Pilot Study)
  Recruiting · Interventional · 20 enrolled · Ain Shams University
  NCT07633457updated 2026-06-08
• Pilot Study on the Clinical Efficacy of Focused Ultrasound-Mediated Targeted Drug Delivery System Combined With Neoadjuvant Therapy for HER2-Positive Breast Cancer
  Recruiting · Interventional · 20 enrolled · Second Affiliated Hospital, School of Medicine, Zhejiang University
  NCT07616440updated 2026-06-04
• Dynamic Contrast Enhanced Ultrasound for Predict and Assess Rectal Cancer Response After Neo-adjuvant Chemoradiation - RECT
  Completed · Interventional · 2 enrolled · University Hospital, Bordeaux
  NCT03068403updated 2026-05-22
• Comparative Study of Decellularized Human Amniotic Membrane Hydrogel and Inverted Internal Limiting Membrane Flap in Idiopathic Large Macular Holes
  Recruiting · Interventional · 26 enrolled · Walailak University
  NCT06433284updated 2026-05-19
• Vitrectomy, Subretinal Tissue Plasminogen Activator (TPA) and Intravitreal Gas for Submacular Haemorrhage Secondary to Exudative (Wet) Age-related Macular Degeneration (TIGER).
  Recruiting · Phase 3 · Interventional · 210 enrolled · King's College Hospital NHS Trust
  NCT04663750updated 2026-05-15
• Factors Influencing Volumetric MR-HIFU Ablation of Uterine Fibroids
  Completed · Interventional · 40 enrolled · University Hospital, Bordeaux
  NCT02386137updated 2026-05-14
• Efficacy of Auricular Acupressure Combined With Antihistamines in Patients With Wind-Heat Type Urticaria.
  Not yet recruiting · Interventional · 66 enrolled · University of Medicine and Pharmacy at Ho Chi Minh City
  NCT07575464updated 2026-05-08
• Ablation With Systemic Therapy vs Liver Resection With Systemic Therapy for Colorectal Liver Metastasis
  Completed · Observational · 151 enrolled · The First Hospital of Jilin University
  NCT07559851updated 2026-04-30
• Contrast Enhanced 3D Echocardiographic Quantification of Right Ventricular Volumes in Repaired CHD
  Completed · Phase 1 · Phase 2 · Interventional · 25 enrolled · Nemours Children's Clinic
  NCT05186415updated 2026-04-27

Frequently asked questions

How does Sulfur Hexafluoride work?

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.

What is Sulfur Hexafluoride used for?

According to FDA labeling, Sulfur Hexafluoride carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Sulfur Hexafluoride?

Sulfur Hexafluoride is classified as Contrast Agent for Ultrasound Imaging, Ultrasound Contrast Activity, Unknown Physiological Effect.

What are the contraindications for Sulfur Hexafluoride?

Sulfur Hexafluoride labeling lists contraindications including: 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 )] .. Always consult the full prescribing information and a clinician.