sulfur hexafluoride (Rx)

Brand and Other Names:Lumason
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable suspension

  • Kit contains:
  • 1. 2-compartment vial containing 25mg of lipid-type A lyophilized powder and headspace fill of 60.7mg sulfur hexafluoride
  • 2. Prefilled syringe containing 5mL NaCl 0.9%
  • 3. Mini-spike
  • Following reconstitution with 5mL diluent, suspension contains 1.5-5.6 x10^8 lipid microspheres/mL with 45mcg/mL of sulfur hexafluoride
more...

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 contains:
  • 1. 2-compartment vial containing 25mg of lipid-type A lyophilized powder and headspace fill of 60.7mg sulfur hexafluoride
  • 2. Prefilled syringe containing 5mL NaCl 0.9%
  • 3. Mini-spike
  • Following reconstitution with 5mL diluent, suspension contains 1.5-5.6 x10^8 lipid microspheres/mL with 45mcg/mL of sulfur hexafluoride
more...

Cardiac Imaging

Safety and efficacy not established

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

Also see Administration

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

Also see Administration

Next:

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)

Previous
Next:

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

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

Previous
Next:

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.

more...
Previous
Next:

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

Previous
Next:

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 x10^8 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 25°C (77°F); excursions permitted to 15-30°C (59-86°F)

Reconstituted suspension: May store at room temperature for up to 3 hr; does not contain antimicrobial preservative

Previous
Next:

Images

Previous
Next:

Formulary

FormularyPatient Discounts

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.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
Additional Offers
Email to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Email Forms to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Previous
Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.