Sulfur hexafluoride

Sulfur hexafluoride is an ultrasound contrast agent that is used to improve the quality of an echocardiogram (ultrasound of the heart). Sulfur hexafluoride works by changing the way ultrasound waves travel within your heart. This helps the ultrasound portray a sharper image of your heart.

Sulfur hexafluoride is used to allow certain segments of the heart to be seen more clearly on an echocardiogram.

Sulfur hexafluoride may also be used for purposes not listed in this medication guide.

You should not be treated with sulfur hexafluoride if you have a genetic heart condition called "cardiac shunt."

In rare cases, serious or fatal reactions may occur during the injection or shortly afterward. Tell your caregiver right away if you feel dizzy, nauseated, light-headed or short of breath, or if you have a severe headache, pounding in your ears, chest pain, fast or slow heartbeats, wheezing, or shallow breathing.

You may be more likely to have a serious reaction if you have severe or uncontrolled heart problems (congestive heart failure, a recent heart attack, serious heart rhythm disorder).

You should not be treated with sulfur hexafluoride if you are allergic to it, or if you have:

• a genetic heart condition called "cardiac shunt"; or
• if you are allergic to blood products or to a medicine that contains albumin.

To make sure sulfur hexafluoride is safe for you, tell your doctor if you have:

• a congenital heart defect;
• heart disease; or
• a lung condition that has recently become worse.

It is not known whether sulfur hexafluoride can harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether sulfur hexafluoride passes into breast milk or if it could harm a nursing baby. However, if you are breast-feeding a baby, use a breast pump to empty your milk supply one time after you are treated with sulfur hexafluoride. Throw out the milk you collect during this time and do not feed it to your baby.

Get emergency medical help if you have any of these signs of an allergic reaction: hives, skin redness, rash; warmth, numbness, or tingly feeling; trouble breathing, tight feeling in your throat; swelling of your face, lips, tongue, or throat.

In rare cases, serious or fatal reactions may occur during the injection or shortly afterward. Tell your caregivers right away if you have:

• a light-headed feeling, like you might pass out;
• severe dizziness, or a cold sweat;
• chest pain, wheezing, trouble breathing;
• fast or slow heartbeats;
• severe headache, blurred vision, pounding in your neck or ears, anxiety, confusion; or
• slow heart rate, weak pulse, fainting, weak or shallow breathing.

You may be more likely to have a serious reaction if you have severe or uncontrolled heart problems (congestive heart failure, a recent heart attack, serious heart rhythm disorder).

Common side effects may include:

• nausea;
• headache;
• altered sense of taste;
• feeling hot; or
• pain or warmth where the medicine was injected.

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

Sulfur hexafluoride is injected into a vein through an IV. A healthcare provider will give you this injection just before the start of your echocardiogram.

Your heart rate, breathing, blood pressure, oxygen levels, and other vital signs will be watched closely for at least 30 minutes after you receive sulfur hexafluoride. This is to make sure you do not have an allergic reaction to the medicine.

Get emergency medical help if you have any of these signs of an allergic reaction: hives, skin redness, rash; warmth, numbness, or tingly feeling; trouble breathing, tight feeling in your throat; swelling of your face, lips, tongue, or throat.

In rare cases, serious or fatal reactions may occur during the injection or shortly afterward. Tell your caregivers right away if you have:

• a light-headed feeling, like you might pass out;

• severe dizziness, or a cold sweat;

• chest pain, wheezing, trouble breathing;

• fast or slow heartbeats;

• severe headache, blurred vision, pounding in your neck or ears, anxiety, confusion; or

• slow heart rate, weak pulse, fainting, weak or shallow breathing.

You may be more likely to have a serious reaction if you have severe or uncontrolled heart problems (congestive heart failure, a recent heart attack, serious heart rhythm disorder).

Common side effects may include:

• nausea;

• headache;

• altered sense of taste;

• feeling hot; or

• pain or warmth where the medicine was injected.

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

Other drugs may interact with sulfur hexafluoride, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Applies to sulfur hexafluoride: intravenous powder for injection

General

The most common side effects are headache and nausea.[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Flushing
Rare (less than 0.1%): Hypotension
Postmarketing reports: Arrhythmia, hypertensive episode, severe cardiopulmonary reactions[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity, anaphylactic reaction, anaphylactoid reaction[Ref]

Nervous system

Uncommon (0.1% to 1%): Headache, paresthesia, dizziness, dysgeusia
Rare (less than 0.1%): Sinus headache
Frequency not reported: Loss of consciousness, vasovagal reaction[Ref]

Gastrointestinal

Uncommon (0.1% to 1%): Nausea
Rare (less than 0.1%): Abdominal pain[Ref]

Dermatologic

Uncommon (0.1% to 1%): Pruritus, rash[Ref]

Local

Uncommon (0.1% to 1%): Injection site reaction, injection site pain, injection site warmth[Ref]

Metabolic

Uncommon (0.1% to 1%): Blood glucose increased[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Back pain[Ref]

Other

Uncommon (0.1% to 1%): Chest pain, chest discomfort, pain, fatigue, feeling hot[Ref]

Respiratory

Uncommon (0.1% to 1%): Pharyngitis[Ref]

Ocular

Rare (less than 0.1%): Blurred vision[Ref]

Psychiatric

Rare (less than 0.1%): Insomnia[Ref]

Some side effects of sulfur hexafluoride may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

2 mL IV bolus during echocardiography

Comments:
-Reconstitute prior to administration; consult manufacturer product information.
-Follow each injection with a 5 mL IV flush of 0.9% sodium chloride.
-A second 2 mL IV bolus of drug may be given during a single examination to prolong contrast enhancement.

Use: To opacify the left ventricular chamber and improve the delineation of the left ventricular endocardial border in patients with suboptimal echocardiograms

Data not available

Data not available