DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension
DEFINITY® RT (Perflutren Lipid Microsphere) Injectable Suspension
Activated DEFINITY® and activated DEFINITY® RT (Perflutren Lipid Microsphere) Injectable Suspension are indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
Do not administer DEFINITY® and DEFINITY® RT to patients with known or suspected hypersensitivity to perflutren lipid microsphere or its components.
IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS CARDIOPULMONARY REACTIONS
Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration [see Warnings and Precautions (5.1)]. Most serious reactions occur within 30 minutes of administration.
- Assess all patients for the presence of any condition that precludes DEFINITY®® administration and DEFINITY® RT administration [see Contraindications (4)].
- Always have resuscitation equipment and trained personnel readily available.
In postmarketing use, rare but serious cardiopulmonary or hypersensitivity reactions have been reported during or shortly following perflutren-containing microsphere administration [see Adverse Reactions (6)]. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions [see Adverse Reactions (6.2)]. It is not always possible to reliably establish a causal relationship to drug exposure due to the presence of underlying cardiopulmonary disease.