IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS CARDIOPULMONARY REACTIONS
• 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: TThe 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 https://www.fda.gov/medwatch