November 3, 2011 – Lantheus Medical Imaging announced important changes to the U.S. product label for Definity Vial for (perflutren lipid microsphere) Injectable Suspension. The contrast agent is 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.
After a review of Lantheus’ 2010 application for proposed label changes submitted to the U.S. Food and Drug Administration (FDA), the following revisions have been made to the prescribing information for Definity:
· Removal of the statement from the boxed warning: “In patients with pulmonary hypertension or unstable cardiopulmonary conditions, monitor vital sign measurements, electrocardiography and cutaneous oxygen saturation during and for at least 30 minutes after Definity administration.” Similar language was also removed from the warning section of the label.
· Addition of the statement to the boxed warning: “Most serious reactions occur within 30 minutes of administration,” which is consistent with the current information in the warning section.
· Removal of the statement from the product indications and usage section of the label: “The safety and efficacy of Definity with exercise stress or pharmacologic stress testing have not been established.”
· Addition of the further qualifier in the statement in the warning section: “Serious cardiopulmonary reactions, including fatalities, have occurred ‘uncommonly’ during or following perflutren-containing microsphere administration.”
· Inclusion of summary data from post-approval CaRES (Contrast echocardiography Registry for Safety Surveillance) safety registry in the post-marketing experience section and from post-approval pulmonary hypertension study in the clinical trials experience section.
For more information: www.definityimaging.com