Perflutren protein type a microsphere (Intravenous)

Perflutren protein type A microsphere injection is used during an echocardiogram to help diagnose or identify problems in the heart.

Perflutren protein type A microsphere is an ultrasound contrast agent. Ultrasound contrast agents help provide a clear image during an ultrasound. Ultrasound is a special type of diagnostic procedure that 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 changed 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 clearer picture.

This medicine must be given only by or under the direct supervision of a doctor who has specialized training in ultrasound procedures.

It is very important for your doctor to monitor your progress closely while you are receiving this medicine. This will help your doctor determine if the medicine is working properly and if you should continue to receive it.

Serious heart or lung problems may happen while you are receiving this medicine. Tell your doctor immediately if you experience chest pain, a fast, slow, pounding, or irregular heartbeat, lightheadedness, dizziness, fainting, or trouble breathing.

This medicine may cause a serious allergic reaction, including anaphylaxis, which can be life-threatening and needs immediate medical attention. Tell your doctor right away if you develop 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 comes from human blood. All donated blood is tested for certain viruses. Although your risk of getting a virus from the medicine is very low, discuss any concerns you have with your doctor.

In deciding to use a diagnostic test, any risks of the test must be weighed against the benefits it may provide. This is a decision you and your doctor will make together. Additionally, other factors may influence test results. For this test, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not been conducted to determine how age affects the effects of perflutren protein type A microsphere injection in children. Safety and effectiveness have not been established.

Geriatric

Studies conducted so far have not shown any specific problems in elderly patients that would limit the usefulness of perflutren protein type A microsphere injection. However, elderly patients may be more sensitive to the effects of this medicine than younger adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional whether you can use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this diagnostic test. Be sure to inform your doctor if you have any other medical issues, especially:

• Allergy to albumin—Should not be given to patients with this condition.

• Congestive heart failure or
• Heart attack or
• Heart disease (e.g., coronary artery syndrome) or
• Heart rhythm problems (e.g., ventricular arrhythmia) or
• Heart shunt or
• Lung disease—Use with caution. May increase the risk for more serious 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.

In the U.S.

• Optison

Available Dosage Forms:

• Suspension

Therapeutic Class: Diagnostic Agent, Cardiac Function

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.