Lumason (sulfur hexafluoride lipid-type A microspheres)

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.

Common side effects of Lumason include:

• headache
• nausea
• changes in taste
• injection site pain or warmth
• feeling hot
• chest discomfort or pain,
• or dizziness

Important Administration Instructions

Do not administer Lumason by intra-arterial injection.

Recommended Dosage

Echocardiography

Adults

• The recommended dose of Lumason after reconstitution is 2 mL administered as an intravenous bolus injection during echocardiography.
• During a single examination, a second injection of 2 mL may be administered to prolong contrast enhancement.
• Follow each Lumason injection with an intravenous flush using 5 mL of 0.9% Sodium Chloride Injection, USP.

Pediatric Patients

• The recommended dose of Lumason after reconstitution in pediatric patients is 0.03 mL per kg administered as an intravenous injection during echocardiography.
• During a single examination, a second injection of 0.03 mL per kg may be administered, if needed.
• Do not exceed 2 mL per injection. Follow Lumason injection with an intravenous flush using 5 mL of 0.9% Sodium Chloride Injection, USP.

Ultrasonography Of The Liver

Adults

• The recommended dose of Lumason after reconstitution in adult patients is 2.4 mL administered as an intravenous injection during ultrasonography of the liver.
• During a single examination, a second injection of 2.4 mL may be administered, if needed.
• Follow Lumason injection with an intravenous flush using 5 mL of 0.9% Sodium Chloride Injection, USP.

Pediatric Patients

• The recommended dose of Lumason after reconstitution in pediatric patients is 0.03 mL per kg administered as an intravenous injection during ultrasonography of the liver.
• During a single examination, a second injection of 0.03 mL per kg may be administered, if needed.
• Do not exceed 2.4 mL per injection.
• Follow Lumason injection with an intravenous flush of 0.9% Sodium Chloride Injection, USP.

Ultrasonography Of The Urinary Tract

Pediatric Patients

• The recommended dose of Lumason after reconstitution is 1 mL.
• 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.

• There are no data with Lumason use in pregnant women to inform any drug-associated risks.
• There are no data on the presence of Lumason in human milk, the effects on the breastfed infant, or the effects on milk production.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Lumason and any potential adverse effects on the breastfed infant from Lumason or from the underlying maternal condition.