The only FDA approved ultrasound enhancing agent not containing PEG GE Healthcare

Optison is the only FDA-approved ultrasound enhancing agent (UEA) in the United States that does not contain polyethylene glycol (PEG).

Recently PEG has been in the spotlight and we wanted to help answer some questions you may have.

The Food and Drug Administration (FDA) has notified healthcare professionals that three of the currently four available UEAs contain PEG and should not be administered to patients with known or suspected allergies to PEG. The companies that manufacture these PEG-containing UEAs have been required to add a contraindication and update the hypersensitivity reactions section of their UEA Prescribing Information.¹ The FDA is aware of immediate hypersensitivity reactions, including 11 cases of anaphylaxis and two deaths, which appear related to the administration of PEG-containing UEAs among patients with a reported history of PEG allergy.¹

The PEG contraindication is not a class effect for all UEAs. Optison is the only UEA in the United States that does not contain PEG.

Please see to the right Important Safety Information about Optison, including Boxed Warning. For further information about Optison, please see the Full Prescribing Information here.

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Reference:
1. American College of Radiology (ACR). h‌ttps://www.acr.‌org/Advocacy-andEconomics/Advocacy-News/Advocacy-News-Issues/In-the-April-24-2021-Issue/FDA-Warns-Against-Some-Ultrasound-Contrast-Agents

© 2021 General Electric Company.
GE, the GE Monogram, and Optison are trademarks of General Electric Company.
Any third-party trademarks are the property of their respective owners.

May 2021 JB05244US
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

PRODUCT INDICATION: Optison 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.
CONTRAINDICATION: Do not administer Optison to patients with known or suspected hypersensitivity to perflutren, blood, blood products, 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.
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.
Please read the full Prescribing Information here, for additional important safety information.


                                         
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