Skip to Content

Perflutren Protein Type A

Pronunciation

(per FLOO tren PRO teen typ aye)

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]

Brand Names: U.S.

  • Optison™

Pharmacologic Category

  • Diagnostic Agent

Pharmacology

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.

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

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.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment

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

Administration

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% (Limited to important or life-threatening): 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

ALERT: U.S. Boxed Warning

Serious cardiopulmonary reactions:

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration. Assess all patients for the presence of any condition that precludes administration. Always have resuscitation equipment and trained personnel readily available.

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 should be readily available. Reported reactions include fatal cardiac or respiratory arrest, shock, syncope, symptomatic arrhythmias (atrial fibrillation, tachycardia, bradycardia, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia), hypertension, hypotension, dyspnea, hypoxia, chest pain, respiratory distress, stridor, wheezing, loss of consciousness, and convulsions. 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). Monitor all patients for acute reactions.

• QTc prolongation: Transient QTc prolongation (>30 msec) has been observed with another microbubble contrast agent (perflutren lipid microsphere), some with associated cardiac rhythm changes; malignant symptomatology was not observed in clinical trials. Clinical trials evaluating the effects of perflutren protein-type A microspheres on the QT interval have not been conducted; however, effects on the QT interval are expected to be similar. Monitor patients at high risk of arrhythmias due to QTc prolongation.

• 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.

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

Monitor for cardiopulmonary reactions in all patients; in high-risk patients (ie, unstable cardiopulmonary conditions), closely monitor blood pressure, heart rate, oxygen saturation, cardiac rhythm (during and for 30 minutes following infusion); signs and symptoms of anaphylactoid reactions.

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber angina, abnormal heartbeat, tachycardia, bradycardia, shortness of breath, dizziness, severe headache, wheezing, numbness or tingling feeling of face, seizures, nausea, flushing, or passing out (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Hide