Bracco Diagnostics announced that the Food and Drug Administration (FDA) has lifted the contraindication for use of Lumason (sulfur hexafluoride lipid-type A microspheres) in patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts.
A new warning has been added highlighting a potential safety hazard from the use of Lumason in this patient population. The updated labeling states that microspheres can bypass filtering by the lung and enter the arterial circulation when administered to patients with cardiac shunt. Patients should be assessed for embolic phenomena following administration.
Lumason is intended only for intravenous and/or intravesical administration. It must not be administered by intra-arterial administration.
Lumason was first approved in October 2014 for use in adults with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left endocardial border. Later, Lumason was approved for use in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients, and for the evaluation of suspected or known vesicoureteral reflux in pediatric patients.
Lumason is available as a 3-part portable kit that contains a 25mg vial, a prefilled syringe containing 5mL diluent, and a Mini-Spike.
For more information call (800) 257-5181 or visit Lumason.com.