Lantheus Medical Imaging of North Billerica, MA, has announced changes to the U.S. product label for Definity Vial For (perflutren lipid microsphere) Injectable Suspension to modify Definity's benefit/risk assessment.
The Definity label changes the U.S. Food and Drug Administration (FDA) approved supersede the agency-mandated label changes that Lantheus announced in October 2007 and include revisions to the boxed warning, warnings, and contraindications sections of the prescribing information. Similar label updates have been approved by the FDA for all perflutren-containing microsphere contrast agents.
The label's contraindications have been revised to read: "Do not administer Definity to patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts, hypersensitivity to perflutren. Do not administer Definity by intra-arterial injection."
All other contraindications have been removed from the contraindications section of the label. The boxed warning and warnings sections have been revised to reflect monitoring only in patients with pulmonary hypertension or unstable cardiopulmonary conditions, compared to the previous label, which included language regarding monitoring in all patients.
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