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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

0.6-2 minutes

Use: Labeled Indications

Opacification of left ventricular chamber and improvement of delineation of the left ventricular endocardial border in patients with suboptimal echocardiograms

Contraindications

Hypersensitivity to perflutren or any component of the formulation, blood, blood products, or albumin; right-to-left, bidirectional, or transient right-to-left cardiac shunt; administration by intra-arterial injection

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

No dosage adjustment provided in manufacturer’s labeling.

Dosing: Hepatic Impairment

No dosage adjustment provided in manufacturer’s labeling (has not been studied).

Administration

While allowing the vial to come to room temperature, invert and gently rotate to resuspend the microspheres; solution should appear 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 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/fever (1%), malaise/weakness/fatigue (1%)

Gastrointestinal: Nausea/vomiting (4%), altered taste (2%)

Local: Injection site discomfort (1%)

Respiratory: Dyspnea (1%)

Miscellaneous: Flu-like syndrome (1%)

<1% (Limited to important or life-threatening): Anaphylactoid reaction, angioedema, arthralgia, atrial fibrillation, back pain, body or muscle aches, bradycardia, bronchospasm, burning sensation in the eyes, cardiac arrest, cardiopulmonary reaction, cough, discoloration at the injection site, edema (pharyngeal, palatal, mouth, peripheral, localized), eosinophilia, erythema, eye irritation, hypersensitivity, hypertension, hypoesthesia, hypotension, hypoxia, induration, irritability, loss of consciousness, oxygen desaturation (due to coughing), palpitation, paresthesia, photophobia, premature ventricular contraction, pruritus, rash, respiratory arrest, respiratory distress, seizure, shock, stridor, supraventricular fibrillation, supraventricular tachycardia, swelling (face, eye, lip, tongue, upper airway), syncope, tachycardia, tinnitus, tremor, urticaria, ventricular fibrillation, ventricular tachycardia, visual blurring, 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

Boxed warning:

• Serious cardiopulmonary reactions: See “Concerns related to adverse effects” below

Concerns related to adverse effects:

• Anaphylactoid reactions: Postmarketing reports of 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. Immediate treatment (including epinephrine 1 mg/mL) should be available.

• Serious cardiopulmonary reactions: [U.S. Boxed Warning]: Serious cardiopulmonary reactions (some fatal) have occurred uncommonly during or within 30 minutes following administration. Ensure patient does not have any contraindications for use. 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 syndromes, worsening or unstable HF, serious ventricular arrhythmias).

• 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. Safety of perflutren protein-type A microspheres with mechanical indices >0.8 or end-systolic triggering has not been established.

Disease-related concerns:

• Cardiac shunts: Patients with right-to-left, bidirectional, or transient right-to-left cardiac shunts should not receive perflutren protein-type A microspheres. Use of phospholipid encapsulated microspheres will result in microvascular occlusion and ischemia since the pulmonary particle-filtering mechanism will be bypassed resulting in a direct transfer from venous to arterial circulation.

• Congenital heart defects: Extreme caution should be used in patients with congenital heart defects. Safety and efficacy have not been established in this population.

Dosage form specific issues:

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

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)

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events were 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, arrhythmia, tachycardia, bradycardia, shortness of breath, dizziness, severe headache, wheezing, 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 healthcare 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.

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