GE Healthcare Receives FDA Approval for Change in Contraindications in Prescribing Information for OptisonTM

MARLBOROUGH, Mass.–(BUSINESS WIRE)–GE Healthcare announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to remove hypersensitivity to ‘blood and blood products’ from the contraindications in its prescribing information for its product Optison^TM (Perflutren Protein-Type A Microspheres Injectable Suspension, USP).

Optison is an ultrasound enhancing agent (UEA) that can improve the visualization of the left ventricular border ─ an area of the heart that is critical to see in order to help assess heart conditions. It is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders.

As a result of the FDA decision, the contraindications on the prescribing information for Optison have now been changed from:

“Do not administer Optison to patients with known or suspected hypersensitivity to perflutren, blood, blood products or albumin”

To:

“Do not administer Optison to patients with known or suspected hypersensitivity to perflutren or albumin”

Marco Campione, General Manager Americas for GE Healthcare, said: “More than three million patients have received Optison since it was approved by the FDA in 1997. During that time, there have been no reported cases of blood or blood product hypersensitivity reactions. No other albumin products on the market have this contraindication. We are pleased, therefore, that the FDA has made this decision.”

Jonathan R. Lindner, MD, M. Lowell Edwards Professor of Medicine, Chief, ONPRC Division of Cardiometabolic Health, Oregon Health & Science University, said: “Ultrasound enhancing agents (UEAs) have been shown to improve patient care through improved diagnostic accuracy and greater confidence in interpretation of echocardiograms. Accordingly, the peeling away of precautions or contraindications for the use of UEAs that are not supported by science removes unnecessary hurdles to employing this valuable asset in cardiovascular imaging.”

Removing the need to screen for hypersensitivity to blood and blood products will help to improve workflow efficiency for clinicians. As the FDA has never classified Optison as a blood product – it has always been classified as a medical imaging drug product – there continues to be no related religious-based objection, and no additional patient consent is required.

Please see additional Important Safety Information About Optison on page 3, and Full Prescribing Information at tinyurl.com/OptisonPI2021.

GE Healthcare has a legacy of industry-defining innovations in ultrasound including having introduced the world’s first high resolution 4D fetal ultrasound system, the first handheld ultrasound and the world’s first ultrasound optimized for AI.

About GE Healthcare:

GE Healthcare is the $18 billion healthcare business of GE (NYSE: GE). As a leading global medical technology, pharmaceutical diagnostics and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 47,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world.

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About Optison:

Optison was the first ultrasound enhancing agent (UEA) introduced to the market over 20 years ago. It helps clinicians to better visualize the left ventricle in previously suboptimal echocardiograms. It can enhance image quality of the left ventricle and the endocardial borders compared to unenhanced images. It also helps workflow efficiency related to preparation, administration, portability and storage attributes. Optison is stable at room temperature for up to 24 hours and is quick to prepare, allowing for quick access to the UEA in hospital settings like the echo lab, intensive care unit or emergency room. It has a well-established safety profile, and is the only UEA in the US that does not contain polyethylene glycol (PEG). PEG containing UEAs are contraindicated for patients with hypersensitivity to PEG. Optison does not contain preservatives and is for single patient use only. Healthcare professionals should follow labelled instructions for product handling and use and discard unused product properly.

Optison is not for use in patients with known or suspected hypersensitivity to perflutren or albumin. As for all ultrasound enhancing agents, Optison has a Boxed Warning indicating that serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration. Healthcare professionals should assess all patients for the presence of any condition that precludes Optison administration and always have resuscitation equipment and trained personnel readily available.

More information about Optison is available here:

https://www.gehealthcare.com/products/contrast-media/optison

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INDICATION AND USAGE

OPTISON (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders.

IMPORTANT SAFETY INFORMATION

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

CONTRAINDICATION: Do not administer OPTISON to 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 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.

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.

This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral disease.

ADVERSE EVENTS: The most frequently reported adverse reactions in clinical trials were headache, nausea and/or vomiting, warm sensation or flushing and dizziness. 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.

Please see the full Prescribing Information at tinyurl.com/OptisonPI2021, 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 the FDA at 800 FDA 1088 or www.fda.gov/medwatch