Perflutren Lipid Microspheres

• It is used before a heart imaging test.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, change in eyesight.
• Chest pain or pressure.
• A heartbeat that does not feel normal.
• Shortness of breath.
• Fast or slow heartbeat.
• Seizures.
• Numbness or tingling of the face.
• Flushing.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine (perflutren lipid microspheres), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine (perflutren lipid microspheres). It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine (perflutren lipid microspheres).

Review Date: October 4, 2017

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injection, solution [preservative free]: OFP 6.52 mg/mL and lipid blend 0.75 mg/mL (2 mL) [following activation, forms a suspension containing perflutren lipid microspheres 1.2 x 1010/mL and OFP 1.1 mg/mL]

• Definity

Cardiovascular imaging: Dose should be given following baseline noncontrast echocardiography. Imaging should begin immediately following dose and compared to noncontrast image. Mechanical index for the ultrasound device should be set at ≤0.8.

IV bolus: 10 microliters (mcL)/kg of activated product, followed by 10 mL saline flush; may repeat in 30 minutes (followed by 10 mL saline flush) if needed (maximum dose per imaging study: 2 bolus doses)

IV infusion: Initial: 4 mL/minute (or 240 mL/hour) of prepared infusion; titrate to achieve optimal image (maximum dose per imaging study: 1 IV infusion)

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

There are no known significant interactions.

Cardiopulmonary reactions; cardiac rhythm monitoring; signs and symptoms of anaphylactoid reactions; heart rate, respiratory rate, and pulse oximetry (during and for 30 minutes following infusion)