FDA Revises Label for DEFINITY Agent
May 13, 2008 – The FDA approved changes to the U.S. product label for DEFINITY Vial For (Perflutren Lipid Microsphere) Injectable Suspension to reflect monitoring in only patients with pulmonary hypertension or unstable cardiopulmonary conditions.
The DEFINITY label changes the FDA just approved supercede the FDA-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 the following: “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 warninigs sections have been revised to reflect monitoring in only patients with pulmonary hypertension or unstable cardiopulmonary conditions as compared to the previous label which included language regarding monitoring in all patients.
For full prescribing information: www.lantheus.com
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