Pronunciation:

SUL-fur hex-a-FLOOR-ide LIP-id type A MYE-kroe-sfeerz

Brand Names:

• Lumason

Dosage Forms:

• Powder for Suspension

Warnings:

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid type A microspheres. Most serious reactions occur within 30 minutes of administration. Assess all patients for the presence of any condition that precludes administration and always have resuscitation equipment and trained personnel readily available .

Classifications:

Therapeutic—

Diagnostic Agent

Uses of This Medicine:

Sulfur hexafluoride lipid type A microspheres injection is used during an echocardiogram to help diagnose or find problems in the heart. It is also used to help diagnose or find problems in the liver or urinary tract.

Sulfur hexafluoride lipid type A microspheres is an ultrasound contrast agent. Ultrasound contrast agents are used to help provide a clear picture during ultrasound. Ultrasound is a special kind of diagnostic procedure. It uses high-frequency sound waves to create images or “pictures” of certain areas inside the body. The sound waves produced by the ultrasound equipment can be reflected (bounced off) by different parts of the body, such as the heart or liver. As the sound waves return they are electronically converted into images on a television screen. Unlike x-rays, ultrasound does not involve ionizing radiation. The lipid microspheres sonicated preparation contains very small gas-filled lipid microspheres that reflect the sound waves and help create a better picture.

This medicine is to be given only by or under the direct supervision of a doctor with specialized training in ultrasound procedures.

Before Using This Medicine:

In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of sulfur hexafluoride lipid type A microsphere injection for echocardiogram, liver and urinary tract ultrasound in children. Safety and efficacy have been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sulfur hexafluoride lipid type A microsphere injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to polyethylene glycol—Should not be used in patients with this condition.

• Congestive heart failure, unstable or
• Heart attack, acute or
• Heart disease (eg, coronary artery syndrome), acute or
• Heart rhythm problems (eg, ventricular arrhythmia) or
• Heart shunt or
• Lung disease—May increase risk for more serious side effects.

Proper Use of This Medicine:

A doctor or other trained health professional will give you or your child this medicine. This medicine is given through a needle placed in one of your veins or into your bladder before the ultrasound.

Your doctor may have special instructions for you in preparation for your test. If you do not understand the instructions you receive or if you have not received such instructions, check with your doctor in advance.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress very closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

Serious heart or lung problems may occur while you are receiving this medicine. Tell your doctor right away if you or your child have a chest pain, fast, slow, pounding, or irregular heartbeat, lightheadedness, dizziness, or fainting, or trouble breathing.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known

Blurred vision

cold, clammy skin

confusion

cough

difficulty with breathing or swallowing

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fainting

fast, pounding, or irregular heartbeat or pulse

fast, weak pulse

flushing, redness of the skin

headache

hives or welts

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

lightheadedness

nervousness

no blood pressure or pulse

no breathing

noisy breathing

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

seizures

skin itching, rash, or redness

stopping of heart

sweating

swelling of the face, throat, or tongue

swelling of the hands, ankles, feet, or lower legs

tightness in the chest

unconsciousness

unusual tiredness or weakness

unusually warm skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare

Change in taste

loss of taste

nausea

pain or warmth at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.