Sulfur Hexafluoride
FDA Drug Information • Also known as: Lumason
- Brand Names
- Lumason
- Drug Class
- Contrast Agent for Ultrasound Imaging [EPC]
- Route
- INTRAVENOUS, INTRAVESICAL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
- Product Type
- HUMAN PRESCRIPTION DRUG
⚠ Boxed Warning (Black Box)
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 ).
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...
What Is Sulfur Hexafluoride Used For?
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 ) 2.1 Important Administration Instructions Do not administer Lumason by intra-arterial injection [see Warnings and Precautions ( 5.3 )] . 2.2 Recommended 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...
Side Effects (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 6.1 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. 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 )] . 6.2 Postmarketing 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.
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 )
Pregnancy and Breastfeeding
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.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How 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 0270-7099-16) 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 0270-7097-07) 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 16.2 Storage and Handling Store the kit at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.