Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) is an ultrasound enhancing agent (UEA) indicated for use in patients with suboptimal echocardiograms

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At a Glance

Enhanced echocardiograms

Helps to better visualize the left ventricle in suboptimal echocardiograms1

Only PEG-free choice

Only ultrasound enhancing agent in the US without polyethylene glycol

20+ years of clinical use

Well-established safety profile in multiple care settings for patients 18 and up2-4

Improved efficiency

No machine required for administration & stable at room temperature for up to 24 hours5

A clear path forward™

Optison is used to opacify the left ventricle and improve delineation of the left ventricular endocardial borders. Manufactured in house by GE Healthcare and FDA approved in 1997, Optison has a safety profile established over decades. It can enhance left ventricle and endocardial border image quality, and help with efficiency related to preparation, administration, portability, and storage.
Features

Optison can improve both echocardiogram visualization and workflow efficiency for clinicians

Used in more than 800 medical sites throughout the US, Optison can enhance left ventricle image quality by creating an echogenic contrast effect in the blood.
STRUCTURE

Optison: The albumin-shelled microsphere

Optison was the first UEA using a gas other than air introduced to the US market in 1997. Optison contains perflutren, a stable gas, encapsulated by an albumin shell and does not contain synthetic lipids or polyethylene glycol (PEG).5-7
ALBUMIN-BASED

An abundant plasma protein manufactured in the liver

Optison is classified as a medical imaging drug product by the FDA; it is not a blood product, even though the microsphere shell is made from a naturally occurring blood protein, albumin.5 In 2021, the FDA removed the hypersensitivity to blood and blood products contraindication for Optison.
SAFETY

Well-established safety profile over decades of use

More than three million patients have received Optison since it was approved by the FDA in 1997. Optison has a well-established safety profile across multiple patient care settings in patients 18 years old and above.2-5 Unlike the potential with some other UEAs8,9, Optison has not been shown to cause moderate to severe pain or vaso-occlusive crisis in patients with sickle cell disease. In addition, Optison is the only UEA in the US that does not contain PEG, so it can be safely used by patients with a PEG hypersensitivity. Optison is manufactured, prepared and quality control checked in GE HealthCare's site in Olso, Norway.
FLEXIBLE

Multiple options for administration

Optison, like other UEAs, is administered in everyday clinical practice in a variety of ways including bolus and diluted bolus.10-15

Support your need to visualize with clarity

Optison can improve the delineation in suboptimal echocardiograms to help clinicians better assess heart conditions. Learn more about supporting resources available for Optison. 

Safety data for Optison

Available for over 20 years, Optison has a well-established and well-documented safety profile. 

Administering Optison

For bolus injection, Optison takes less than one minute to prepare from suspension to injection in three steps: prepare, check, and load syringe.

No extra screening and consent

In 2021, the FDA removed the hypersensitivity to blood and blood products contraindication for Optison.

Educational programs

From advanced information to recent guidelines and standards, our resources can help you understand how using a UEA can improve your echocardiography workflow.

Additional Resources
 

FAQ: Why is polyethylene glycol (PEG) adversely impacting echocardiography patients?

 

How echo labs can manage the risk of polyethylene glycol (PEG) hypersensitivity

 

Getting it bright: How ultrasound enhancing agents help inform and transform patient care

REFERENCES
  1. Cohen JL, Cheirif J, Segar DS, et al. Improved left ventricular endocardial border delineation and opacification with OPTISON (FS069), a new echocardiographic contrast agent. Results of a phase III Multicenter Trial. J Am Coll Cardiol. 1998;32(3):746-752.
  2. Wei K, Shah S, Jaber WA, DeMaria A. An observational study of the occurrence of serious adverse reactions among patients who receive optison in routine medical practice. J Am Soc Echocardiogr. 2014;27:1006-1010.
  3. Exuzides A, Main ML, Colby C, Grayburn PA, Feinstein SB, Goldman JH. A retrospective comparison of mortality in critically ill hospitalized patients undergoing echocardiography with and without an ultrasound contrast agent. JACC Cardiovasc Imaging. 2010;3:578-585.
  4. Main ML, Grayburn PA, Lang RM, et al. Effect of Optison on pulmonary artery systolic pressure and pulmonary vascular resistance. Am J Cardiol. 2013;112:1657-1661.
  5. Optison [prescribing information]. Marlborough, MA: GE Healthcare. 2021.
  6. Lindner J. A Practical Approach to Contrast Echocardiography, 2017. https://www.acc.org/latest-in-cardiology/articles/2017/07/10/09/17/a-practical-approach-to-contrast-echocardiography. Accessed January 27, 2022.
  7. Quinlan GJ, Greg S. Martin GS, Evans TW. Albumin: Biochemical Properties and Therapeutic Potential. Hepatology. 2005;41:1211-1219.
  8. Wu M, Fields JJ, Sachdev V, et al. Increased susceptibility for adverse reactions to ultrasound enhancing agents in sickle cell disease. J Am Soc Echocardiogr. 2023;36:208-15.
  9. Lindner JR, Belcik T, Widlansky M, et al. Contrast-enhanced ultrasound detects changes in microvascular blood flow in adults with sickle cell disease. PLoS ONE. 2019;14:e0218783.
  10. Porter TR, Abdelmoneim S, Todd Belcik JT. 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;27:797-810.
  11. Zhao H, O’Quinn R, Ambrose M, et al. Contrast-enhanced echocardiography has the greatest impact in patients with reduced ejection fractions. J Am Soc Echocardiogr. 2018;31:289-296.
  12. Doukky R, Donenberg MJ, Parker J, et al. Use of ultrasound enhancing agents in transesophageal echocardiography to improve interpretive confidence of left atrial appendage thrombus. Echocardiography. 2018; DOI: 10.1111/echo.14228.
  13. Karadogin I, Genovese D, Kruse E, et al. Contrast-enhanced echocardiographic measurement of longitudinal strain: accuracy and its relationship with image quality. J CV Imaging. 2020;36:431-439.
  14. Chong A, Haluska B, Wahi S. Clinical application and laboratory protocols for performing contrast echocardiography. Indian Heart Journal. 2013;65:337-346.
  15. Data on File. GE Healthcare; 2021.

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IMPORTANT SAFETY INFORMATION

INDICATIONS:

OPTISON is an ultrasound contrast agent indicated for use in adult and pediatric patients with suboptimal echocardiogram to opacify to the left ventricle to improve the delineation of the left ventricle endocardial borders.

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 OPTISON administration
• Always have resuscitation equipment and trained personnel readily available

 


CONTRAINDICATIONS:
OPTISON is contraindicated in patients with known or suspected hypersensitivity to perflutren or albumin.

 WARNINGS AND PRECAUTIONS:

  • Serious cardiopulmonary reactions including fatalities have occurred uncommonly during or shortly following perflutren-containing microsphere administration, typically within 30 minutes of administration. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias).
  • Serious anaphylactic reactions have been observed during or shortly following perflutren-containing microsphere administration, including shock, hypersensitivity, bronchospasm, throat tightness, angioedema, edema (pharyngeal, palatal, mouth, peripheral, localized), swelling (face, eye, lip, tongue, upper airway), facial hypoesthesia, rash, urticaria, pruritus, flushing, and erythema have occurred in patients with no prior exposure to perflutren-containing microsphere products.
  • When administering OPTISON to patients with a cardiac shunt, microspheres can bypass filtering of the lungs and enter the arterial circulation. Assess patients with shunts for embolic phenomena following OPTISON administration. OPTISON is only for intravenous administration; do not administer OPTISON by intra-arterial injection.
  • High ultrasound mechanical index values may cause microsphere rupture and lead to ventricular arrhythmias. Additionally, end-systolic triggering with high mechanical indices has been reported to cause ventricular arrhythmias. OPTISON is not recommended for use at mechanical indices greater than 0.8.

Adverse Reactions

Common adverse reactions (incidence > 0.5%) were: headache, nausea and/or vomiting, warm sensation or flushing, dizziness, dysgeusia, chills or fever, flu-like symptoms, malaise/weakness/fatigue, chest pain, dyspnea, injection site discomfort, and erythema. Cardiac arrests and other serious but nonfatal adverse reactions were uncommonly reported in post-approval use. Reports also identified neurologic reactions (loss of consciousness or convulsions) as well as anaphylactoid reactions.  Overall, the safety profile observed in pediatric patients from the clinical study was consistent with the safety profile in adult patients.

Use in Specific Populations

Pregnancy and Lactation

There are no data with OPTISON use in pregnant woman to inform any drug-associated risks. 

There are no data on the presence of perflutren protein-type A microspheres in human milk, the effects on the breastfed infant or the effects on milk production.

Pediatric Use

Safety and efficacy of OPTISON in pediatric patient is supported by evidence from adequate and well-controlled studies in adults and additional efficacy and safety data from a clinical study in 37 pediatric patients aged 9-17 years.

Geriatric Use

No overall differences in safety or effectiveness were observed in patients 65 years and over but a greater sensitivity to OPTISON in older individuals cannot be ruled out.

Please see the full Prescribing Information, including Boxed Warning for additional important safety information.

To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800 654 0118 (option 2 then option 1) or by email at GPV.drugsafety@gehealthcare.com  or FDA at 800 FDA 1088 or www.fda.gov/medwatch