Sulfur Hexafluoride: Side Effects, Uses, Dosage, Interactions, Warnings (2024)

• Uses
  • What Is Sulfur Hexafluoride and How Does It Work?
• Dosage
  • What Are the Dosages of Sulfur Hexafluoride?
• Side Effects
  • What Are Side Effects Associated with Using Sulfur Hexafluoride?
• Drug Interactions
  • What Other Drugs Interact with Sulfur Hexafluoride?
• Warning and Precautions
  • What Are Warnings and Precautions for Sulfur Hexafluoride?

What Is Sulfur Hexafluoride and How Does It Work?

Sulfur hexafluoride 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 patients with suboptimal echocardiograms and ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients.

Sulfur hexafluoride is available under the following different brand names: Lumason.

What Are the Dosages of Sulfur Hexafluoride?

Dosages of Sulfur Hexafluoride

Adult and Pediatric Dosage Forms and Strengths

Injectable suspension

• 100 mg
• 200 mg
• 500 mg

Dosage Considerations – Should be Given as Follows:

Recommended Daily Intake

Kit contains:

1. 2-compartment vial containing 25mg of lipid-type A lyophilized powder and headspace fill of 60.7mg sulfur hexafluoride
2. A 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

Dosage Considerations – Should be Given as Follows:

Cardiac Imaging

• Indicated for adult patients with suboptimal echocardiograms to opacify the left ventricular chamber and improve the delineation of the left ventricular endocardial border
• After baseline non-contrast 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 intravenous (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
• Pediatric: Safety and efficacy not established

Liver Ultrasonography

• Indicated for liver ultrasonography for characterization of focal liver lesions in adult and pediatric patients
• Adult: 2.4 mL administered as an intravenous (IV) injection during ultrasonography of the liver
• During a single examination, the 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
• Pediatric: 0.03 mL/kg administered as an intravenous (IV) injection during ultrasonography of the liver; not to exceed 2.4mL/injection
• During a single examination, the 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, Pediatric

• 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 the second cycle of voiding and imaging, without the need for a second sulfur hexafluoride administration

What Are Side Effects Associated with Using Sulfur Hexafluoride?

Common side effects of sulfur_hexafluoride include:

• Headache
• Nausea
• Changes in taste
• Injection site pain or warmth
• Chest discomfort or pain
• Feeling hot
• Chest pain
• Dizziness

Postmarketing side effects of sulfur hexafluoride reported include:

• Serious reactions (typically within 30 minutes of administration) have been reported and include fatalities (symptoms suggestive of anaphylactoid/hypersensitivity), irregular heartbeats (arrhythmias), and high blood pressure (hypertensive) episodes
• The risk for serious cardiopulmonary reactions may increase with unstable cardiopulmonary conditions (heart attack/acute myocardial infarction [MI], acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias

This is not a complete list of side effects and other serious side effects may occur. Call your doctor for information and medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What Other Drugs Interact with Sulfur Hexafluoride?

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Sulfur hexafluoride has no known severe, serious, moderate, or mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

What Are Warnings and Precautions for Sulfur Hexafluoride?

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 the 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.
• The risk of cardiopulmonary reactions increased with unstable cardiopulmonary conditions (heart attack/acute myocardial infarction [MI], acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias).
• This medication contains sulfur hexafluoride.
• Do not take Lumason if you are allergic to sulfur hexafluoride or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity

Effects of Drug Abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Sulfur Hexafluoride?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Sulfur Hexafluoride?"

Cautions

• For intravenous or intravesicular use only; do not administer by intra-arterial injection.
• Serious cardiopulmonary reactions, including fatalities, were reported (see Warnings).
• Rare anaphylactoid reactions (e.g., skin redness, rash, hives, 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 intravenous (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.

Pregnancy and Lactation

• Sulfur hexafluoride may be acceptable for use during pregnancy. Either animal studies show no risk but human studies are not available or animal studies showed minor risks and human studies were done and showed no risk.
• It is unknown if sulfur hexafluoride is distributed in human breast milk. Because of the drug's rapid clearance, advise breastfeeding women to pump and discard breast milk once after the drug's administration.