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.
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).
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
1% to 10%:
Cardiovascular: Chest pain (1%), flushing (4%)
Gastrointestinal: Dysgeusia (2%), nausea (≤4%), vomiting (≤4%)
Local: Discomfort at injection site (1%)
Nervous system: Chills (≤1%), dizziness (3%), fatigue (≤1%), headache (5%), malaise (≤1%)
Neuromuscular & skeletal: Asthenia (≤1%)
Respiratory: Dyspnea (1%), flu-like symptoms (1%)
Miscellaneous: Fever (≤1%)
<1%:
Cardiovascular: Palpitations, ventricular premature contractions
Dermatologic: Erythema of skin, pruritus, skin discoloration at injection site, skin rash, skin sclerosis, urticaria
Gastrointestinal: Xerostomia
Hematologic & oncologic: Oxygen desaturation (due to coughing)
Hypersensitivity: Hypersensitivity reaction
Nervous system: Body pain, irritability, paresthesia
Neuromuscular & skeletal: Arthralgia, back pain, myalgia, tremor
Ophthalmic: Blurred vision, burning sensation of eyes, photophobia
Otic: Tinnitus
Respiratory: Wheezing
Postmarketing:
Cardiovascular: Atrial fibrillation, bradycardia, edema, hypertension, hypotension, peripheral edema, shock, supraventricular cardiac arrhythmia, supraventricular tachycardia, syncope, tachycardia, ventricular fibrillation, ventricular tachycardia
Gastrointestinal: Palatal edema
Hypersensitivity: Anaphylaxis, angioedema, mouth edema, nonimmune anaphylaxis
Local: Localized edema
Nervous system: Facial hypoesthesia, loss of consciousness, seizure
Respiratory: Bronchospasm, hypoxia, pharyngeal edema, respiratory distress, stridor
Miscellaneous: Swelling (facial swelling, swelling of eye, swelling of lips, swollen tongue, upper airway swelling)
Hypersensitivity to perflutren, albumin, or any component of the formulation.
Concerns related to adverse effects:
• Hypersensitivity 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: 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.
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]
No
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.
Opacification of left ventricle: Opacification of left ventricle and improvement of delineation of the left ventricular endocardial borders in patients with suboptimal echocardiograms
None known.
There are no known significant interactions.
Adverse events have not been observed in animal reproduction studies.
It is not known if perflutren protein type A is excreted in breast milk. According to the manufacturer, the decision to continue or discontinue breast-feeding during therapy should take into account the risk of infant exposure, the benefits of breast-feeding to the infant, and benefits of treatment to the mother
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).
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.
Duration: Contrast enhancement: Dose dependent: 1 minute (0.2 mL) to 5 minutes (5 mL)
Metabolism: Perflutren: Not metabolized
Half-life elimination: 1.3 ± 0.69 minutes
Excretion: Perflutren: Lungs
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