Pronunciation:

per-FLOO-tren LIP-id MYE-kroe-sfeer

Brand Names:

• Definity
• Definity RT

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Radiological Non-Ionic Contrast Media

Uses of This Medicine:

Perflutren lipid microsphere injection is used during an echocardiogram to help diagnose or find problems in the heart.

Perflutren lipid microsphere 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 perflutren lipid microsphere injection in the pediatric population. 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 perflutren lipid microsphere injection in the elderly.

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) or
• Heart rhythm problems (eg, ventricular arrhythmia) or
• Heart shunt or
• Lung disease or
• Sickle cell disease—May increase risk for more serious side effects.

Proper Use of This Medicine:

A doctor or other trained health professional will give you this medicine. This medicine is given through an IV catheter that is placed in one of your veins 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 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 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 require 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:

Rare

Black, tarry stools

blurred vision

chest pain

chills

difficulty with breathing

dizziness, severe or continuing

fast, pounding, or irregular heartbeat or pulse

hives, itching, or skin rash

lightheadedness when getting up from a lying or sitting position

slow or irregular heartbeat

swollen glands

unusual bleeding or bruising

Incidence not known

Anxiety

change in consciousness

chest tightness

confusion

cough

difficulty with swallowing

dizziness

dry mouth

fainting

irritability

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

loss of consciousness

nervousness

noisy breathing

numbness or tingling in the face, arms, or legs

pounding in the ears

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

restlessness

seizures

shaking

sweating

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

trouble breathing

trouble sleeping

trouble speaking, thinking, or walking

unusual tiredness or weakness

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:

Less common

Back pain

feeling of warmth on the skin

headache

nausea

redness of the face, neck, arms, and occasionally, upper chest

Rare

Acid or sour stomach

bruising

diarrhea

difficulty with moving

dizziness

dryness of the mouth

feeling of constant movement of self or surroundings

fever

heartburn

indigestion

leg cramps

muscle stiffness or tension

pain at the injection site

pain or swelling in the joints

prickly or tingling sensation

sneezing or runny nose

stomach upset or pain

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.