Class: Radiopaque agent
- Injection, suspension, lipid-based up to 1.2 × 10 10 /mL (after activation)
- Injection, suspension, protein-based 0.22 ± 0.11 mg/mL
Provides contrast enhancement of the left ventricular chamber and aids delineation of the left ventricular endocardial borders during echocardiography.Perflutren, protein-based
Creates an echogenic contrast effect in the blood.
Protein binding expected to be minimal.
96% eliminated through the lungs; pulmonary elimination half-life is 1.3 min (lipid-based).
Special PopulationsRenal Function Impairment
No data available.Hepatic Function Impairment
The pharmacokinetics of perflutren have not been studied in subjects with hepatic disease.Elderly
The pharmacokinetics of perflutren in elderly patients have not been studied.
Indications and Usage
To opacify the left ventricular chamber and to improve delineation of the left ventricular endocardial borders in patients with suboptimal echocardiograms.
Known or suspected right-to-left, bidirectional, or transient right-to-left cardiac shunts; known or suspected hypersensitivity to perflutren or any component; intra-arterial injection; hypersensitivity to blood, blood products, or albumin (protein-based only).
Dosage and AdministrationPerflutren, lipid-based
IV bolus 10 mcL/kg of the activated product within 30 to 60 sec, followed by a 10 mL saline flush. May repeat 30 min after first injection, if needed.
IV infusion 1.3 mL of activated product added to 50 mL of preservative-free saline, initiated at a rate of 4 mL/min. Titrate as necessary to achieve optimal image enhancement, not to exceed 10 mL/min.Perflutren, protein-based
IV 0.5 mL injected into a peripheral vein. Additional doses of 0.5 mL, up to 5 mL cumulatively in a 10-min period, may be injected, up to a maximum total dose of 8.7 mL in any one patient study.
- Do not inject air into the vial when withdrawing a dose.
- Perflutren, lipid-based
- Administer only after activation in the Vialmix apparatus. Before injection, this product must be activated and prepared according to the manufacturer's instructions.
- Administer by IV bolus or infusion only. For IV bolus, administer over 30 to 60 sec and follow with a 10 mL saline flush. For IV infusion, administer at a rate of 4 to 10 mL/min.
- If the product is not used within 5 min of Vialmix activation, resuspend the microspheres by 10 sec of hand agitation by inverting the vial. The activated perflutren may be used for up to 12 h after Vialmix , but only after the microspheres are resuspended by hand agitation.
- Use the product immediately after withdrawing from the vial; do not allow to stand in the syringe.
- After baseline noncontrast echocardiography, the mechanical index for the ultrasound device should be set at 0.8 or below. Inject activated perflutren and begin ultrasound imaging immediately.
- Perflutren, protein-based
- Administer in a peripheral vein only, at a rate of no more than 1 mL/sec.
- Follow injection with a flush of dextrose 5% or sodium chloride 0.9%.
- Invert vial and gently rotate to resuspend microspheres.
- Do not use if the solution appears clear rather than milky white after resuspension.
- Vent vial with a sterile vent spike or a sterile 18-gauge needle before withdrawing product from the vial.
- If more than 1 min has passed after withdrawing contents of the vial into a syringe, resuspend the microspheres by gently rotating and inverting the syringe.
- Do not aspirate blood back into the syringe before administration; this may lead to formation of a blood clot within the syringe.
Store between 36° and 46°F. Do not freeze. Discard unused product properly.
Drug InteractionsDrugs that prolong the QT interval (eg, antiarrhythmic agents [eg, amiodarone, bretylium, disopyramide, dofetilide, procainamide, quinidine, sotalol], arsenic trioxide, chlorpromazine, cisapride, dolasetron, droperidol, mefloquine, mesoridazine, moxifloxacin, pentamidine, pimozide, tacrolimus, thioridazine, ziprasidone)
An additive effect of perflutren with other drugs that prolong the QT interval, increasing the risk of life-threatening cardiac arrhythmias (including torsades de pointes), cannot be excluded.
Chest pain, extracardiac vascular disorders (1%); cardiac arrest, hypertension, hypotension, shock, syncope, symptomatic arrhythmias (atrial fibrillation, tachycardia, bradycardia, supraventricular tachycardia, transient ischemic attack, ventricular fibrillation, ventricular tachycardia) (postmarketing).
Headache (5%); warm sensation/flushing (4%); dizziness (3%); malaise/weakness/fatigue (1%); agitation, coma, convulsions, fatigue, loss of consciousness, tremor (postmarketing).
Altered taste (2%); vision blurred (postmarketing).
Nausea and/or vomiting (4%).
Anaphylactic/anaphylactoid reaction, anaphylactic shock, angioedema, bronchospasm, edema (pharyngeal, palatal, mouth, peripheral, localized), erythema, facial hypoesthesia, flushing, hypersensitivity, pruritus, rash, swelling (face, lips, tongue, eye, upper airway), throat tightness, urticaria.
Erythema, injection-site discomfort/disorders (1%).
Dyspnea (1%); decreased oxygenation, hypoxia, respiratory arrest or distress, stridor, wheezing (postmarketing).
Back/renal pain, chills/fever, flu-like symptoms (1%).
Serious cardiopulmonary reactions, including fatalities, have occurred during or following perflutren administration. Assess all patients for conditions that preclude perflutren use. Monitor vital signs, ECG, and cutaneous oxygen saturation during and for at least 30 min after administration of perflutren in patients with pulmonary hypertension or unstable cardiopulmonary conditions. Ensure that resuscitation equipment and trained personnel are readily available.
Monitor vital sign measurements, electrocardiography, and cutaneous oxygen saturation in patients with pulmonary hypertension or unstable cardiopulmonary conditions during and for 30 min following perflutren administration. Closely observe all patients during and following perflutren administration. Monitor all patients for signs and symptoms of anaphylactoid reactions.
Category B (lipid-based); Category C (protein-based).
Safety and efficacy not established.
Reports of acute and/or serious anaphylactoid reactions (eg, angioedema, bronchospasm, edema [pharyngeal, palatal, mouth, peripheral, localized], facial hypoesthesia, flushing, erythema, hypersensitivity, loss of consciousness, pruritus, rash, shock, swelling [face, eye, lip, tongue, upper airway], throat tightness, urticaria) have occurred in patients with no prior exposure to perflutren.
Perflutren may bypass the pulmonary particle-filtering mechanism and directly enter the arterial circulation in patients with right-to-left, bidirectional, or transient right-to-left cardiac shunts, resulting in occlusion and ischemia.
Has occurred in patients receiving doses of lipid-based perflutren of up to 10 mcL/kg.
End-systolic triggering with high ultrasound mechanical indices may lead to ventricular arrhythmias.
Transmission of infectious agents
Perflutren protein-based contains albumin; there is a theoretical risk of transmission of Creutzfeldt-Jakob disease and viral diseases.
No data available.
- Advise patients to inform their health care provider if they may be pregnant or are breast-feeding an infant.
- Instruct patients to inform their health care provider if they have ever had an allergic or hypersensitivity reaction to blood, blood products, or albumin (perflutren protein-based only).
- Advise patients to inform their health care provider if they have a congenital heart defect or recent worsening of heart or lung conditions.
Copyright © 2009 Wolters Kluwer Health.