Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres. Most serious reactions occur within 30 minutes of administration. Assess all patients for the presence of any condition that precludes administration. Always have resuscitation equipment and trained personnel readily available.
Cardiovascular imaging: IV: 2 mL during echocardiography; may repeat once during procedure to prolong contrast enhancement.
Note: Adjust the mechanical index for the ultrasound device to 0.8 or lower after baseline non-contrast echocardiography is complete. Continue imaging following injection.
Hepatic ultrasonography: IV: 2.4 mL during ultrasonography; may repeat once during procedure.
Note: Adjust to low mechanical index (≤0.4) after identification of the target focal lesion on non-contrast ultrasound examination. Continue imaging following injection.
Diagnostic vessel assessment: SonoVue [Canadian product]: IV: 1.2 mL during Doppler ultrasound; may repeat once during procedure.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Sulfur hexafluoride lipid microspheres: Pediatric drug information")
Note: Route of administration varies with indication; use caution.
Echocardiography: Infants, Children, and Adolescents: IV: 0.03 mL/kg during echocardiography; may give 1 additional dose of 0.03 mL/kg during procedure if needed. Maximum dose: 2 mL/dose. Note: Adjust the mechanical index for the ultrasound device to ≤0.8 after baseline noncontrast echocardiography is complete. Continue imaging following injection.
Hepatic ultrasonography: Infants, Children, and Adolescents: IV: 0.03 mL/kg during ultrasonography; may give 1 additional dose of 0.03 mL/kg during procedure if needed. Maximum dose: 2.4 mL/dose. Note: Adjust to low mechanical index (≤0.4) after identification of the target focal lesion on noncontrast ultrasound examination. Continue imaging following injection.
Urinary ultrasonography: Infants, Children, and Adolescents: Intravesical: Instill 1 mL into the bladder via a 6 to 8 French urinary catheter during ultrasonography; bladder may be refilled with NS for a second cycle of voiding and imaging, without the need of a second dose of contrast agent. Note: Adjust to low mechanical index (≤0.4) after baseline noncontrast ultrasound examination. Perform continuous alternate ultrasound imaging of the bladder, ureters, and kidneys during filling and voiding of the bladder.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%: Nervous system: Headache (1%)
<1%:
Cardiovascular: Chest discomfort, chest pain
Gastrointestinal: Dysgeusia, nausea
Local: Pain at injection site, warm sensation at injection site
Nervous system: Dizziness, feeling hot
Frequency not defined:
Cardiovascular: Atrial fibrillation, bradycardia, cardiac arrhythmia, hypertension, hypotension, shock, supraventricular tachycardia, syncope, tachycardia, ventricular fibrillation, ventricular tachycardia
Nervous system: Loss of consciousness, seizure
Respiratory: Apnea, dyspnea, hypoxia, stridor, wheezing
Postmarketing:
Cardiovascular: Edema (including peripheral edema), flushing, hypertensive crisis
Dermatologic: Erythema of skin, skin rash, urticaria
Gastrointestinal: Palatal edema
Hypersensitivity: Anaphylactic shock, anaphylaxis, angioedema, hypersensitivity reaction (including severe hypersensitivity reaction), mouth edema, nonimmune anaphylaxis
Local: Localized edema
Nervous system: Facial hypoesthesia
Respiratory: Bronchospasm, pharyngeal edema
Miscellaneous: Swelling (facial swelling, swelling of eye, swelling of lips, swollen tongue, upper airway swelling)
Hypersensitivity to sulfur hexafluoride lipid-type A microspheres or any component of the formulation, including polyethylene glycol.
SonoVue [Canadian product]: Hypersensitivity to sulfur hexafluoride or any component of the formulation; known right-to-left cardiac shunts; severe pulmonary hypertension (pulmonary artery pressure >90 mm Hg); uncontrolled systemic hypertension; adult respiratory distress syndrome.
Concerns related to adverse events:
• Cardiopulmonary reactions: [US Boxed Warning]: Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or shortly following administration of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres. Most serious reactions occur within 30 minutes of administration. Assess all patients for the presence of any condition that precludes administration. Always have resuscitation equipment and trained personnel readily available. Risk is increased in patients with unstable cardiopulmonary conditions (acute MI, acute coronary artery syndromes, worsening or unstable CHF, serious ventricular arrhythmias). Monitor all patients for acute reactions.
• Hypersensitivity: Postmarketing reports of serious anaphylactoid reactions (eg, death, shock, bronchospasm, dyspnea, throat tightness, angioedema, edema [oropharyngeal, palatal, peripheral, and localized], swelling [face, eye, lip, tongue, upper airway], facial hypoesthesia, rash, urticaria, pruritus, flushing, erythema) have been reported in patients with no prior exposure. Assess patients for prior hypersensitivity reactions to products containing polyethylene glycol (eg, certain colonoscopy bowel preparations, laxatives); increased risk of serious reactions may occur. Monitor for signs and symptoms of hypersensitivity reactions. Equipment for resuscitation and trained personnel should be readily available.
Other warnings/precautions:
• Administration: For IV or intravesical use only; do not administer intra-arterially.
• High mechanical index values: Not recommended for use at mechanical indices >0.8. High mechanical index values may cause microsphere cavitation or rupture and lead to ventricular arrhythmias; end-systolic triggering with high mechanical indices has also been reported to cause ventricular arrhythmias.
• Systemic embolization: After administration to patients with cardiac shunts, some IV injected sulfur hexafluoride lipid-type A microspheres may bypass filtering by the lung and enter the arterial circulation. Assess patients with shunts for embolic phenomena following administration.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension Reconstituted, Injection:
Lumason: Lipid-type A 25 mg and sulfur hexafluoride 60.7 mg (1 ea) [contains polyethylene glycol (macrogol)]
No
Suspension (reconstituted) (Lumason Injection)
60.7-25 mg (per each): $170.52
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IV: Administer as an IV bolus; do not administer intra-arterially. Follow each injection with an intravenous flush of NS (5 mL in adults).
SonoVue [Canadian product]: Administer as an IV bolus; do not administer intra-arterially. The recommended rate of injection during Doppler ultrasound is 1.2 mL over a period of 1 second; however, a slower rate of injection over 2 to 3 seconds is recommended during transcranial Doppler to reduce blooming artifacts. Follow each injection with an intravenous flush of 5 mL NS.
Intravesical: Empty the bladder of urine, and then fill bladder with NS to ~33% to 50% of predicted total volume. Administer sulfur hexafluoride lipid microspheres as an intravesical bolus injection through a 6 to 8 french urinary catheter. Continue filling bladder with NS until patient has the urge to micturate or at first sign of back pressure. Immediately following the first voiding, the bladder may be refilled with NS only for a second cycle of voiding and imaging.
IV: Administer as an IV bolus; do not administer intra-arterially. Follow each injection with an intravenous flush of 5 mL NS.
Intravesical: Empty the bladder of urine, and then fill bladder with NS to ~33% to 50% of predicted total volume. Administer sulfur hexafluoride lipid microspheres as an intravesical bolus injection through an appropriate size urinary catheter (typically 6 to 8 French). Continue filling bladder with NS until patient has the urge to micturate or at first sign of back pressure. Immediately following the first voiding, the bladder may be refilled with NS only for a second cycle of voiding and imaging.
Cardiovascular imaging: 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.
Hepatic ultrasonography: To characterize focal liver lesions in adult and pediatric patients.
Urinary tract ultrasonography: Evaluation of suspected or known vesicoureteral reflux in pediatric patients.
SonoVue [Canadian product]:
Cardiovascular imaging: To improve the visualization of cardiac chambers and endocardial border delineation during echocardiography.
Diagnostic vessel assessment: To facilitate Doppler evaluation of cerebral and extracranial carotid and peripheral arteries; increases Doppler image quality and the duration of clinically useful signal enhancement in abdominal and renal arteries and in portal vein assessment.
Urinary tract ultrasonography: For use in ultrasonography of the urinary tract in pediatric patients for the evaluation of suspected or known vesicoureteral reflux.
Limitations of use: Use only in patients whose examinations without contrast enhancement are inconclusive.
None known.
There are no known significant interactions.
Adverse events have not been observed in animal reproduction studies.
It is not known if sulfur hexafluoride lipid-type A microspheres is excreted in breast milk. According to the manufacturer, the decision to continue or discontinue breast-feeding during therapy should take into account the risk of infant exposure, the benefits of breast-feeding to the infant, and benefits of treatment to the mother. Sulfur hexafluoride is rapidly cleared. Prior to breast-feeding, women should pump and discard breast milk one time after administration.
Cardiopulmonary reactions (rare); signs and symptoms of anaphylactoid reactions (rare). Monitor patient as appropriate based upon patient clinical disposition; specific monitoring parameters based upon sulfur hexafluoride microspheres administration are not necessary (Muskula 2017).
SonoVue [Canadian product]: ECG (during echocardiography and in high-risk patients); BP; monitor for 30 minutes after administration.
Ultrasound contrast agent for cardiovascular imaging and hepatic and urinary tract ultrasonography.
Duration: Cardiovascular imaging 1.7 to 3.1 minutes (useful contrast effect)
Distribution: Vdss: Sulfur hexafluoride (SF6): 341 L (0.03 mL/kg dose); 710 L (0.3 mL/kg dose)
Metabolism: Little or none
Half-life elimination: Terminal: SF6: ~10 minutes (0.3 mL/kg dose; half-life could not be estimated at the 0.03 mL/kg dose)
Time to peak, plasma: SF6: 1 to 2 minutes; up to 4 minutes in pulmonary impairment
Excretion: SF6: Lungs (88% unchanged)
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