Description
Perflutren protein type A microsphere injection is used during an echocardiogram to help diagnose or find problems in the heart.
Perflutren protein type A 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. 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 albumin microspheres sonicated preparation contains very small gas-filled albumin 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.
This product is available in the following dosage forms:
- Suspension
Before Using
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of perflutren protein type A microsphere injection in the pediatric population. Safety and efficacy have not been established. .
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of perflutren protein type A microsphere injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.
Breastfeeding
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.
Drug Interactions
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 albumin—Should not be given to patients with this condition.
- Congestive heart failure or
- Heart attack or
- Heart disease (eg, coronary artery syndrome) or
- Heart rhythm problems (eg, ventricular arrhythmia) or
- Heart shunt or
- Lung disease—Use with caution. May increase risk for more serious side effects.
Proper Use
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 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
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 have a chest pain, fast, slow, pounding, or irregular heartbeat, lightheadedness, dizziness, or fainting, or trouble breathing.
This medicine may cause a serious type of 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.
This medicine contains albumin, which is made from human blood. All donated blood is tested for certain viruses. Although your risk for getting a virus from the medicine is very low, talk with your doctor if you have concerns.
Side Effects
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:
Less common
- Chest pain
- feeling of warmth
- fever or chills
- redness of the face, neck, arms, and occasionally, upper chest
- trouble breathing
Rare
- Hives or welts, itching, or skin rash
- fast, irregular, pounding, or racing heartbeat or pulse
- redness of the skin
Incidence not known
- Blurred vision
- chest discomfort or tightness
- cold, clammy skin
- confusion
- 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
- feeling of warmth
- headache
- hoarseness
- irritation
- joint pain, stiffness, or swelling
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lightheadedness, dizziness, or fainting
- nervousness
- no blood pressure or pulse
- noisy breathing
- pounding in the ears
- redness of the face, neck, arms, and occasionally, upper chest
- seizures
- stopping of heart
- sweating
- trouble swallowing
- unconsciousness
- 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
- Bad, unusual, or unpleasant (after) taste
- change in taste
- cough
- discomfort at the injection site
- nausea or vomiting
- sore throat
- stuffy or runny nose
Rare
- Back pain
- body or muscle aches
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in color vision
- continuing ringing or buzzing or other unexplained noise in the ears
- difficulty with moving
- difficulty seeing at night
- discoloration of the skin at the injection site
- dry mouth
- hearing loss
- increased sensitivity of the eyes to sunlight
- muscle pain or stiffness
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.
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