Dosing & Uses
Dosage Forms & Strengths
injectable suspension kit
- 2-compartment vial containing 25mg of lipid-type A lyophilized powder and headspace fill of 60.7mg sulfur hexafluoride
- Prefilled syringe containing 5mL NaCl 0.9%
- Mini-spike
- Following reconstitution with 5mL diluent, suspension contains 1.5-5.6 x108 lipid microspheres/mL with 45mcg/mL of sulfur hexafluoride
Cardiac Imaging
Indicated for patients with suboptimal echocardiograms to opacify the left ventricular chamber and improve the delineation of the left ventricular endocardial border
After baseline noncontrast echocardiography is complete, the mechanical index for the ultrasound device should be adjusted to 0.8 or lower; ultrasound imaging is then continued following sulfur hexafluoride administration
2 mL reconstituted solution IV bolus injection during echocardiography; flush IV line with 5 mL 0.9% NaCl
During a single examination, a second injection may be administered to prolong contrast enhancement
Also see Administration
Liver Ultrasonography
Indicated for liver ultrasonography for characterization of focal liver lesions in adult and pediatric patients
2.4 mL administered as an IV injection during ultrasonography of the liver
During a single examination, a second injection of 2.4 mL may be administered, if needed
Follow sodium hexafluoride injection with IV flush using 5 mL of 0.9% NaCl
Also see Administration
Dosage Forms & Strengths
injectable suspension kit
- 2-compartment vial containing 25mg of lipid-type A lyophilized powder and headspace fill of 60.7mg sulfur hexafluoride
- Prefilled syringe containing 5mL NaCl 0.9%
- Mini-spike
- Following reconstitution with 5mL diluent, suspension contains 1.5-5.6 x108 lipid microspheres/mL with 45mcg/mL of sulfur hexafluoride
Cardiac Imaging
Indicated for patients with suboptimal echocardiograms to opacify the left ventricular chamber and improve the delineation of the left ventricular endocardial border
After baseline noncontrast echocardiography is complete, the mechanical index for the ultrasound device should be adjusted to 0.8 or lower; ultrasound imaging is then continued following sulfur hexafluoride administration
0.03 mL/kg administered as an IV injection during echocardiography; not to exceed 2 mL/injection
During a single examination, a second injection of 0.03 mL/kg may be administered, if needed
Follow sodium hexafluoride injection with IV flush using 5 mL of 0.9% NaCl
Liver Ultrasonography
Indicated for use in liver ultrasonography for characterization of focal liver lesions in adult and pediatric patients
0.03 mL/kg administered as an IV injection during ultrasonography of the liver; not to exceed 2.4mL/injection
During a single examination, a second injection of 0.03 mL/kg may be administered, if needed
Follow sodium hexafluoride injection with IV flush using 5 mL of 0.9% NaCl
Urinary Tract Ultrasonography
Indicated for ultrasonography of the urinary tract in pediatric patients to evaluate suspected or known vesicoureteral reflux
1 mL intravesical bolus injection through a 6-8 French urinary catheter
The bladder may be refilled with 0.9% NaCl for a second cycle of voiding and imaging, without the need of a second sulfur hexafluoride administration
Adverse Effects
<1%
Headache (0.9%)
Nausea (0.6%)
Dysgeusia (0.3%)
Injection site pain (0.3%)
Chest discomfort (0.3%)
Feeling hot (0.3%)
Chest pain (0.2%)
Injection site warmth (0.2%)
Postmarketing Reports
Serious reactions (typically within 30 minutes of administration) have been reported and include fatalities (symptoms suggestive of anaphylactoid/hypersensitivity), arrhythmias, and hypertensive episodes
Risk for serious cardiopulmonary reactions may increase with unstable cardiopulmonary conditions (acute MI, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias)
Warnings
Black Box Warnings
Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following administration of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres
Most serious reactions occur within 30 minutes of administration
Assess all patients for presence of any condition that precludes administration (see Contraindications)
Always have cardiopulmonary resuscitation personnel and equipment readily available before administering contrast media, and monitor all patients during and following for adverse reactions
Risk of cardiopulmonary reactions increased with unstable cardiopulmonary conditions (acute MI, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias)
Contraindications
Hypersensitivity to product or components, including polyethylene glycol (PEG)
Cautions
For intravenous or intravesicular use only; do not administer by intra-arterial injection
Serious cardiopulmonary reactions, including fatalities, reported (see Black Box Warnings)
Rare anaphylactoid reactions (eg, skin erythema, rash, urticaria, flushing, throat tightness, dyspnea, anaphylactic shock) observed; may occur in patients with no history of prior exposure (see Contraindications)
Risk of systemic embolization; in patients with right-to-left, bidirectional, or transient right-to-left cardiac shunts, some IV sulfur hexafluoride lipid-containing microspheres may bypass filtering by the lung and directly enter the arterial circulation; occlusion of microcirculation by these microspheres may result in tissue ischemia; assess for embolic phenomena following administration
High ultrasound mechanical index values may cause microsphere cavitation or rupture and lead to ventricular arrhythmias; end-systolic triggering with high mechanical indices has been reported to cause ventricular arrhythmias
Hypersensitivity reactions
- In postmarketing use, serious hypersensitivity reactions were observed during or shortly following sulfur hexafluoride lipid-containing microsphere administration
- The reactions may include 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
- Product contains PEG; there may be increased risk of serious reactions including death in patients with prior hypersensitivity reaction(s) to PEG
- 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 product administration and monitor all patients for hypersensitivity reactions
Pregnancy & Lactation
Pregnancy
There are no data on 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
Lactation
There are no data on presence in human milk, effects on breastfed infant, or effects on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Within the blood, acoustic impedance of the sulfur hexafluoride microspheres is lower than that of the surrounding nonaqueous tissue
This allows reflection of an ultrasound beam from the interface between the microspheres and the surrounding tissue, thus enabling a visual image between the blood and the surrounding tissues
Absorption
Peak blood concentration: 1-2 minutes
Distribution
Vd: 341 L (mostly within lung)
Metabolism
Undergoes little or no biotransformation; 88% recovered unchanged in expired air
Elimination
Half-life, terminal: 10 minutes
82% eliminated via the lungs within 20 minutes
Undergoes first pass elimination within the pulmonary circulation; ~40-50% eliminated in the expired air during the first minute following injection
Administration
IV Preparation
Using aseptic techniques, reconstitute vial using mini-spike with prefilled syringe contents (ie, 5 mL NaCl 0.9%)
Do not remove syringe and mini-spike from vial
Shake vigorously for 20 seconds, mixing all contents in the vial
Resulting suspension should appear as a homogenous, white, milky liquid; this indicates formation of sulfur hexafluoride lipid microspheres
Following reconstitution, resulting suspension contains 1.5-5.6 x108 lipid microspheres/mL with 45 mcg/mL of sulfur hexafluoride
Invert vial and syringe and slowly withdraw 2 mL of the reconstituted suspension into the syringe
Unscrew syringe from mini-spike and immediately connect the syringe to the dosage administration line (20 G)
Kit contains
- 2-compartment vial containing 25 mg of lipid-type A lyophilized powder and headspace fill of 60.7 mg sulfur hexafluoride
- Prefilled syringe containing 5 mL NaCl 0.9%
- Mini-spike
IV Administration
Administer suspension as IV bolus injection immediately after reconstitution
Provides useful echocardiographic signal intensity for 2 minutes following the injection
If not used immediately after reconstitution, the microspheres should be resuspended by a few seconds of hand agitation before the suspension is withdrawn into the syringe
Intravesical (Urinary Instillation) Preparation
Doses ≥1 mL: Invert the system and slowly withdraw the intended volume of suspension into the syringe
Doses <1 mL: Withdraw 2 mL of the reconstituted suspension into the 5 mL syringe and measure the volume of sulfur hexafluoride to inject by using the 0.2 mL graduations between the 1-2 mL marks
Intravesical (Urinary Instillation) Administration
Insert a sterile 6-8 french urinary catheter into the bladder under sterile conditions
Empty the bladder of urine, and then fill the bladder with 0.9% NaCl to ~33-50% of its predicted total volume
The total bladder volume in children is calculated as: [(age in years + 2) x 30] mL
Administer as an intravesical bolus injection through the urinary catheter
Continue filling the bladder with saline until the patient has the urge to micturate or at the first sign of back pressure to the infusion
Immediately following the first voiding, the bladder may be refilled with normal saline for a second cycle of voiding and imaging, without the need of a second administration
Storage
Unreconstituted kit: Store at room temperature 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF)
Reconstituted suspension: May store at room temperature for up to 3 hr; does not contain antimicrobial preservative
Images
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.