Perflutren Protein Type A

Dosage Forms

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

Injection, suspension [preservative free]:

Optison: Perflutren 0.11-0.33 mg and protein-type A microspheres 5-8 x 10⁸ per mL (3 mL) [contains human albumin 10 mg/mL]

Pharmacology

Mechanism of Action

Perflutren is a stable gas that provides an echogenic contrast effect in the blood and allows for improved delineation of the left ventricular endocardial border.

Pharmacokinetics/Pharmacodynamics

Metabolism

Perflutren: Not metabolized

Excretion

Perflutren: Lungs

Duration of Action

Contrast enhancement: Dose dependent: 1 minute (0.2 mL) to 5 minutes (5 mL)

Half-Life Elimination

1.3 ± 0.69 minutes

Use: Labeled Indications

Opacification of left ventricle: Opacification of left ventricle and improvement of delineation of the left ventricular endocardial borders in patients with suboptimal echocardiograms

Contraindications

Hypersensitivity to perflutren or any component of the formulation, blood, blood products, or albumin

Dosage and Administration

Dosing: Adult

Opacification of left ventricle: IV: 0.5 mL via peripheral vein; flush with D₅W or NS following dose; may repeat in increments of 0.5 mL up to 5 mL cumulatively in 10 minutes (maximum total dose: 8.7 mL in any one patient study).

Dosing: Geriatric

Refer to adult dosing.

Administration

IV: For IV use only; do not administer intra-arterially. While allowing the vial to come to room temperature, invert and gently rotate to resuspend the microspheres; solution should appear opaque and milky-white. Do not use if solution is clear. Vent vial with a sterile vent spike or 18-gauge needle. Do not inject air into vial. Within 1 minute of resuspension, remove dose from the vial and inject using a ≥20-gauge angiocatheter into a peripheral vein at a rate ≤1 mL/second. Flush line with D₅W or NS immediately after injection. Repeat resuspension prior to injection if more than 1 minute elapses.

Storage

Store under refrigeration at 2°C to 8°C (36°F to 46°F); do not freeze. Discard unused portion.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

1% to 10%:

Cardiovascular: Flushing (4%), chest pain (1%)

Central nervous system: Headache (5%), dizziness (3%), chills (≤1%), fatigue (≤1%), malaise (≤1%)

Gastrointestinal: Nausea (≤4%), vomiting (≤4%), dysgeusia (2%)

Local: Discomfort at injection site (1%)

Neuromuscular & skeletal: Weakness (≤1%)

Respiratory: Dyspnea (1%), flu-like symptoms (1%)

Miscellaneous: Fever (≤1%)

<1%, postmarketing, and/or case reports: Anaphylactoid reaction, angioedema, arthralgia, atrial fibrillation, back pain, blurred vision, body pain, bradycardia, bronchospasm, burning sensation of eyes, cough, edema (localized edema, mouth edema, palatal edema, peripheral edema, pharyngeal edema), eosinophilia, erythema, eye irritation, hypersensitivity reaction, hypertension, hypoesthesia, hypotension, hypoxia, irritability, local discoloration (at injection site), loss of consciousness, myalgia, oxygen desaturation (due to coughing), palpitations, paresthesia, photophobia, pruritus, respiratory distress, seizure, shock, skin rash, skin sclerosis, stridor, supraventricular cardiac arrhythmia, supraventricular tachycardia, swelling (facial swelling, swelling of eye, swelling of lips, swollen tongue, upper airway swelling), syncope, tachycardia, tinnitus, tremor, urticaria, ventricular fibrillation, ventricular premature contractions, ventricular tachycardia, wheezing, xerostomia

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid reactions: Serious anaphylactoid reactions (eg, shock, hypersensitivity, bronchospasm, throat tightness, angioedema, edema [oropharyngeal, peripheral, and localized], swelling [face, eye, lip, tongue, upper airway], facial hypoesthesia, rash, urticaria, pruritus, flushing, and erythema) have been reported in patients with no prior exposure. Monitor for signs and symptoms of anaphylactoid reactions. Equipment for resuscitation and trained personnel should be readily available.
• Serious cardiopulmonary reactions: [US Boxed Warning]: Serious cardiopulmonary reactions (some fatal) have occurred uncommonly during or within 30 minutes following administration. Assess all patients for the presence of any condition that precludes administration. Equipment for resuscitation and trained personnel experienced in handling medical emergencies should always be immediately available. Risk may be increased in patients with unstable cardiopulmonary conditions (eg, acute MI, acute coronary artery syndromes, worsening or unstable heart failure, serious ventricular arrhythmias). However, multiple retrospective and prospective studies involving the use of perflutren-based ultrasound contrast agents have suggested they may be safely used in patients with significant cardiopulmonary disease (ie, acute coronary syndromes, heart failure, COPD, pulmonary hypertension) or critical illness (Dolan 2009; Kurt 2009; Kusnetzky 2008; Main 2008; Main 2014; Nucifora 2008; Wei 2008; Wei 2012; Weiss 2012; Wever-Pinzon 2012).
• Ventricular arrhythmias: High ultrasound mechanical indices with or without end-systolic triggering may cause ventricular arrhythmias. Use is not recommended at mechanical indices >0.8.

Disease-related concerns:

• Cardiac shunts: Assess patients for embolic phenomena following administration; microspheres can bypass filtering of the lung and enter the arterial circulation in patients with a cardiac shunt. Patients with small degrees of right-to-left shunting through patent foramen ovales (those that result in transient appearance of saline contrast in the left atrium or ventricle and do not fill the left atrial or LV cavity) are not considered at an increased risk for microvascular occlusion with perflutren-based ultrasound contrast agents (ASE [Porter 2014]; Kalra 2014; Muskula 2017; Parker 2013).

Dosage form specific issues:

• Albumin: Product contains albumin; may carry a remote risk of virus transmission or hypersensitivity reaction.

Other warnings/precautions:

• Appropriate use: For IV administration; do not administer by intra-arterial injection.

Monitoring Parameters

Cardiopulmonary reactions (rare); signs and symptoms of anaphylactoid reactions (rare). Monitor patient as appropriate based upon patient clinical disposition; specific monitoring parameters based upon perflutren lipid microspheres administration are not necessary (Muskula 2017).

Pregnancy

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies.

Patient Education

What is this drug used for?

• It is used before a heart imaging test.

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Chest pain
• Abnormal heartbeat
• Fast heartbeat
• Slow heartbeat
• Shortness of breath
• Dizziness
• Severe headache
• Vision changes
• Numbness or tingling feeling of face
• Seizures
• Nausea
• Vomiting
• Flushing
• Passing out
• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: 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. 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.