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Perflutren lipid microsphere (Intravenous route)

Pronunciation:

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

Brand Names:

  • Definity

Dosage Forms:

  • Suspension

Classifications:

Therapeutic—

Radiological Non-Ionic Contrast Media

Uses of This Medicine:

Perflutren lipid microsphere preparation 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, like for example, the heart. 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 perflutren lipid microspheres preparation contains very small gas-filled lipid microspheres that reflect the sound waves and help create a better picture. The lipid microsphere preparation is given by injection into a vein before ultrasound to help diagnose problems of the heart.

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 have not been performed on the relationship of age to the effects of perflutren lipid microsphere injection in the pediatric population. Safety and efficacy have not 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.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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:

  • Congestive heart failure, unstable or
  • Heart attack, acute or
  • Heart disease (eg, coronary artery syndrome) or
  • Heart rhythm problems (eg, ventricular arrhythmia) or
  • Respiratory distress syndrome—May increase risk for more serious side effects.
  • Heart rhythm problems (eg, QT prolongation)—Use with caution. May make this condition worse.

Proper Use of This Medicine:

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

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis 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.

Tell your doctor right away if you have a chest pain, fast, slow, pounding, or irregular heartbeat, lightheadedness, dizziness, or fainting, or troubled breathing. These may be symptoms of heart or lung problems.

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
Cough
difficulty with swallowing
dizziness
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
tightness in the chest
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.


Last Updated: 9/4/2017
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