Perflutren protein type A: Drug information

(For additional information see "Perflutren protein type A: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)

ALERT: US 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.

Brand Names: US

Optison

Pharmacologic Category

Diagnostic Agent

Dosing: Adult

Opacification of left ventricle

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: Kidney Impairment: Adult

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

Dosing: Hepatic Impairment: Adult

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

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

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)

Contraindications

Hypersensitivity to perflutren, albumin, or any component of the formulation.

Warnings/Precautions

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.

Dosage Forms: US

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]

Generic Equivalent Available: US

Administration: Adult

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.

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

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies.

Breastfeeding Considerations

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

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).

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 (Adult Data Unless Noted)

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

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AT) Austria: Optison;
(GB) United Kingdom: Optison

Dolan MS, Gala SS, Dodla S, et al. Safety and efficacy of commercially available ultrasound contrast agents for rest and stress echocardiography a multicenter experience. J Am Coll Cardiol. 2009;53(1):32-38. doi: 10.1016/j.jacc.2008.08.066. [PubMed 19118722]
Kalra A, Shroff GR, Erlien D, et al. Perflutren-based echocardiographic contrast in patients with right-to-left intracardiac shunts. JACC Cardiovasc Imaging. 2014;7(2):206-207. doi: 10.1016/j.jcmg.2013.11.003. [PubMed 24524748]
Kurt M, Shaikh KA, Peterson L, et al. Impact of contrast echocardiography on evaluation of ventricular function and clinical management in a large prospective cohort. J Am Coll Cardiol. 2009;53(9):802-810. doi: 10.1016/j.jacc.2009.01.005. [PubMed 19245974]
Kusnetzky LL, Khalid A, Khumri TM, et al. Acute mortality in hospitalized patients undergoing echocardiography with and without an ultrasound contrast agent: results in 18,671 consecutive studies. J Am Coll Cardiol. 2008;51(17):1704-1706. doi: 10.1016/j.jacc.2008.03.006. [PubMed 18436124]
Main ML, Ryan AC, Davis TE, et al. Acute mortality in hospitalized patients undergoing echocardiography with and without an ultrasound contrast agent (multicenter registry results in 4,300,966 consecutive patients). Am J Cardiol. 2008;102(12):1742-1746. doi: 10.1016/j.amjcard.2008.08.019. [PubMed 19064035]
Main ML, Hibberd MG, Ryan A, et al. Acute mortality in critically ill patients undergoing echocardiography with or without an ultrasound contrast agent. JACC Cardiovasc Imaging. 2014;7(1):40-48. doi: 10.1016/j.jcmg.2013.08.012. [PubMed 24290568]
Muskula PR, Main ML. Safety with echocardiographic contrast agents. Circ Cardiovascular Imaging. 2017;10(4). pii: e005459. doi: 10.1161/CIRCIMAGING.116.005459. [PubMed 28377467]
Nucifora G, Marsan NA, Siebelink HM, et al. Safety of contrast-enhanced echocardiography within 24 h after acute myocardial infarction. Eur J Echocardiogr. 2008;9(6):816-818. doi: 10.1093/ejechocard/jen167. [PubMed 18635517]
Optison (perflutren protein type A microspheres) [prescribing information]. Marlborough, MA: GE Healthcare Inc; September 2021.
Parker JM, Weller MW, Feinstein LM, et al. Safety of ultrasound contrast agents in patients with known or suspected cardiac shunts. Am J Cardiol. 2013;112(7):1039-1045. doi: 10.1016/j.amjcard.2013.05.042. [PubMed 23816393]
Porter TR, Abdelmoneim S, Belcik JT, et al. Guidelines for the cardiac sonographer in the performance of contrast echocardiography: a focused update from the American Society of Echocardiography. J Am Soc Echocardiogr. 2014;27(8):797-810. doi: 10.1016/j.echo.2014.05.011. [PubMed 25085408]
Wei K, Mulvagh SL, Carson L, et al. The safety of deFinity and Optison for ultrasound image enhancement: a retrospective analysis of 78,383 administered contrast doses. J Am Soc Echocardiogr. 2008;21(11):1202-1206. doi: 10.1016/j.echo.2008.07.019. [PubMed 18848430]
Wei K, Main ML, Lang RM, et al. The effect of Definity on systemic and pulmonary hemodynamics in patients. J Am Soc Echocardiogr. 2012;25(5):584-588. doi: 10.1016/j.echo.2012.01.019. [PubMed 22365709]
Weiss RJ, Ahmad M, Villanueva F, et al. CaRES (Contrast Echocardiography Registry for Safety Surveillance): a prospective multicenter study to evaluate the safety of the ultrasound contrast agent definity in clinical practice. J Am Soc Echocardiogr. 2012;25(7):790-795. doi: 10.1016/j.echo.2012.04.002. [PubMed 22560734]
Wever-Pinzon O, Suma V, Ahuja A, et al. Safety of echocardiographic contrast in hospitalized patients with pulmonary hypertension: a multi-center study. Eur Heart J Cardiovasc Imaging. 2012;13(10):857-862. doi: 10.1093/ehjci/jes057. [PubMed 22427401]

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Perflutren protein type A: Drug information