Sulfur hexafluoride

What is Sulfur hexafluoride?

• Sulfur hexafluoride (Lumason) is an ultrasound contrast agent.
• Lumason is a contrast agent made up of gas-filled microbubbles (or microspheres) that reflect the sound waves to enhance the image. Lumason helps a physician see a patient's heart more clearly, allowing for clearer imaging of the left ventricle chamber and the smooth edge on the inside of the chambers of the heart, known as the endocardium.

What are the uses of this medicine?

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
• in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients
• in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patients

How does this medicine 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. The reflected ultrasound signal provides a visual image that shows a contrast between the blood and the surrounding tissues.
• For ultrasonography of the urinary tract in pediatric patients, the intravesically administered Lumason microspheres increase signal intensity of fluids within the urethra, bladder, ureters, and renal pelvis.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Hypersensitivity to sulfur hexafluoride lipid microsphere or its components, such as polyethylene glycol (PEG)

What drug interactions can this medicine cause?

• No formal drug interaction studies where conducted with Lumason.

Is this medicine FDA approved?

• This medicine is approved in the year 2014.

How should this medicine be used?

Recommended Dosage:

• Echocardiography in adults: After reconstitution, administer 2 mL as an intravenous injection
• 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
• Ultrasonography of the liver in adults: After reconstitution, administer 2.4 mL as an intravenous injection
• 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
• May repeat dose one time during a single examination
• Follow each injection with an intravenous flush of 0.9% Sodium Chloride Injection, USP

Administration

• Inspect visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
• The reconstituted suspension is milky-white, and does not contain visible particulate matter.
• Do not use the single-patient-use vial for more than one patient.

Intravenous Administration

• Administer Lumason as an intravenous bolus injection.

Intravesical Administration in Pediatric Patients

• Insert a sterile 6 French to 8 French urinary catheter into the bladder under sterile conditions;
• Empty the bladder of urine, and then fill the bladder with sterile 0.9% Sodium Chloride Injection, USP to approximately one third or half of its predicted total volume. The total bladder volume in children is calculated as [(age in years + 2) x 30] mL;
• Administer Lumason as an intravesical bolus injection through the urinary catheter;
• Continue filling the bladder wIith 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.
• Immediately following the first voiding, the bladder may be refilled with 0.9% Sodium Chloride Injection, USP for a second cycle of voiding and imaging, without the need of a second Lumason administration.

Imaging Guidelines Echocardiography

• After baseline non-contrast echocardiography is complete, adjust the mechanical index for the ultrasound device to 0.8 or lower. Continue ultrasound imaging following Lumason injection.

Ultrasonography of the Liver

• After identification of the target focal lesion on non-contrast ultrasound examination, hold transducer still while switching scanner to low mechanical index (≤ 0.4) contrast-specific imaging. Continue ultrasound imaging following Lumason injection.

Ultrasonography of the Urinary Tract

• After baseline non-contrast ultrasound examination of the kidney and bladder, switch the scanner to low mechanical index (≤0.4) contrast specific imaging. Perform continuous alternate ultrasound imaging of the bladder, ureters, and kidneys during filling and voiding of the bladder.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injectable suspension: 25 mg of lipid-type A lyophilized powder with headspace fill of 60.7 mg sulfur hexafluoride in a single-patient use vial for reconstitution

This medicine is available in fallowing brand namesː

• Lumason

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• nausea

What special precautions should I follow?

• Serious cardiopulmonary reactions, including fatalities have occurred uncommonly during or shortly following administration of ultrasound contrast agents, including Lumason. Always have resuscitation equipment and trained personnel readily available.
• 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.
• Lumason is only for intravenous and/or intravesical administration; do not administer Lumason by intra-arterial injection.
• When administering Lumason to patients with cardiac shunt, microspheres can bypass filtering by the lung and enter the arterial circulation. Assess patients with shunts for embolic phenomena following Lumason administration.
• Lumason is not recommended for use at mechanical indices greater than 0.8.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no data with Lumason use in pregnant women to inform any drug-associated risks.

Can this medicine be used in children?

Echocardiography

• Safety and effectiveness have been established for use in pediatric patients with suboptimal echocardiograms.

Ultrasonography of the Liver

• Safety and effectiveness in pediatric patients has been established for use in ultrasonography of the liver.

Ultrasonography of the Urinary Tract

• Safety and effectiveness in pediatric patients has been established for use in ultrasonography of the urinary tract

What are the active and inactive ingredients in this medicine?

Active ingredients:

• SULFUR HEXAFLUORIDE
• DISTEAROYLPHOSPHATIDYLCHOLINE, DL
• SODIUM 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL)

Inactive ingredients:

• POLYETHYLENE GLYCOL 4000
• PALMITIC ACID

Who manufactures and distributes this medicine?

• Packager: BRACCO DIAGNOSTICS INC

What should I know about storage and disposal of this medication?

• Store the kit at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)

• Dailymed label info on Sulfur hexafluoride
• FDA Sulfur hexafluoride