Perflutren lipid microsphere (Intravenous)

Perflutren lipid microsphere injection is used during an echocardiogram to assist in diagnosing or identifying issues with the heart.

Perflutren lipid microsphere is an ultrasound contrast agent. Ultrasound contrast agents are used to provide a clearer image during ultrasound. Ultrasound is a specific 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 machine 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 transformed into images on a television screen. Unlike x-rays, ultrasound does not use ionizing radiation. The lipid microspheres sonicated preparation contains very small gas-filled lipid microspheres that reflect the sound waves and help produce a better image.

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

It is very important that your doctor closely monitor your progress while you are receiving this medicine. This will help your doctor determine if the medicine is working correctly and decide if you should continue treatment.

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

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical help. 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.

In deciding to use a diagnostic test, any risks of the test must be weighed against the benefits. This is a decision you and your doctor will make together. Other factors may also affect 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 about any other allergies you have, including allergies to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how age affects the effects of perflutren lipid microsphere injection in children. Safety and effectiveness have not been established for this group.

Geriatric

Studies conducted so far have not shown specific problems in older adults that would limit the effectiveness of perflutren lipid microsphere injection in the elderly. However, older 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 while breastfeeding. Weigh the potential benefits against the potential risks before taking 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 other precautions may be necessary. Inform your healthcare professional about any other prescription or nonprescription (over-the-counter [OTC]) medicines you are taking.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this diagnostic test. Make sure to inform your doctor if you have any other medical issues, 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 (e.g., coronary artery syndrome) or
• Heart rhythm problems (e.g., ventricular arrhythmia) or
• Heart shunt or
• Lung disease—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:

Rare

• Black, tarry stools
• Blurred vision
• Chest pain
• Chills
• Difficulty with breathing
• Severe or continuing dizziness
• 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
• 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
• Tightness in the chest
• 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.

In the U.S.

• Definity
• Definity RT

Available Dosage Forms:

• Suspension

Therapeutic Class: Radiological Non-Ionic Contrast Media

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.