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Sulfur hexafluoride lipid microspheres: Drug information

Sulfur hexafluoride lipid microspheres: Drug information
(For additional information see "Sulfur hexafluoride lipid microspheres: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed 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. 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.

Brand Names: US
  • Lumason
Pharmacologic Category
  • Diagnostic Agent
Dosing: Adult
Cardiovascular imaging

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

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

Diagnostic vessel assessment: SonoVue [Canadian product]: IV: 1.2 mL during Doppler ultrasound; may repeat once during procedure.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Sulfur hexafluoride lipid microspheres: Pediatric drug information")

Note: Route of administration varies with indication; use caution.

Echocardiography

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

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

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.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

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)

Contraindications

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.

Warnings/Precautions

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.

Dosage Forms: US

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)]

Generic Equivalent Available: US

No

Pricing: US

Suspension (reconstituted) (Lumason Injection)

60.7-25 mg (per each): $170.52

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

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.

Administration: Pediatric

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.

Use: Labeled Indications

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.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies.

Breastfeeding Considerations

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.

Monitoring Parameters

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.

Mechanism of Action

Ultrasound contrast agent for cardiovascular imaging and hepatic and urinary tract ultrasonography.

Pharmacokinetics (Adult Data Unless Noted)

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)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AT) Austria: Sonovue;
  • (BE) Belgium: Sonovue;
  • (BG) Bulgaria: Sonovue;
  • (BR) Brazil: Sonovue;
  • (CN) China: Sonovue | Sulphur hexafluoride;
  • (CZ) Czech Republic: Sonovue;
  • (DE) Germany: Sonovue;
  • (FI) Finland: Sonovue;
  • (FR) France: Sonovue;
  • (GB) United Kingdom: Sonovue;
  • (GR) Greece: Sono vue;
  • (HK) Hong Kong: Sonovue;
  • (HR) Croatia: Sonovue;
  • (IE) Ireland: Sonovue;
  • (IT) Italy: Sonovue;
  • (KR) Korea, Republic of: Sonovue;
  • (LT) Lithuania: Sonovue;
  • (LV) Latvia: Sonovue;
  • (MY) Malaysia: Sonovue;
  • (NO) Norway: Sonovue;
  • (PL) Poland: Sonovue;
  • (PR) Puerto Rico: Lumason;
  • (PT) Portugal: Sonovue;
  • (RU) Russian Federation: Sonovue;
  • (SE) Sweden: Sonovue;
  • (SG) Singapore: Sonovue;
  • (SI) Slovenia: Sonovue
  1. Lumason (sulfur hexafluoride lipid-type A microspheres) [prescribing information]. Monroe Township, NJ: Bracco Diagnostics Inc; August 2021.
  2. Muskula PR, Main ML. Safety with echocardiographic contrast agents. Circ Cardiovascular Imaging. 2017;10(4). pii: e005459. doi: 10.1161/CIRCIMAGING.116.005459 [PubMed 28377467]
  3. SonoVue (sulfur hexafluoride) [product monograph]. Montreal, Quebec, Canada: Bracco Imaging Canada; December 2021.
Topic 97563 Version 76.0

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