The FDA removes the contraindication for use of Bracco Diagnostics Inc.'s LUMASON® (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use, in patients with cardiac shunts.
Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., one of the world's leading companies in the diagnostic imaging business, announced that the U.S. FDA has removed the contraindication for use of LUMASON in patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts.
In view of a potential safety hazard deriving from the use of LUMASON in this patient population, i.e., some of the intravenously injected microspheres bypassing the filtering by the lung and entering the arterial circulation, a specific warning has been maintained in the approved labeling of the agent (WARNINGS AND PRECAUTIONS section, 5.3: Systemic Embolization). Also, LUMASON must not be administered by intra-arterial injection.
"The removal of this contraindication implies that the FDA has determined that the benefits from the diagnostic information that could be obtained through the use of LUMASON in patients with cardiac shunts may outweigh the risk for systemic embolization," stated Alberto Spinazzi, MD, Head, Global Medical and Regulatory Affairs, Bracco Group. "FDA review is critical to ensuring the quality, safety and efficacy of contrast agents like LUMASON, and, in general, of medicinal products."
LUMASON, known globally as SonoVue®, which has been marketed since 2001 and now in more than 30 countries, was initially approved in October 2014 by the FDA for use in adults with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. LUMASON then gained FDA approval in March 2016 for use in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients, and in December 2016, for use for the evaluation of suspected or known vesicoureteral reflux in pediatric patients.
With a proven safety profile, LUMASON is an ultrasound contrast agent made up of gas-filled microspheres that reflect the sound waves to enhance the echogenicity of the blood or urine, which results in an improvement in the diagnostic quality of the ultrasound images. The agent is packaged in a convenient three-part portable kit that does not require refrigeration or mechanical agitation. Each kit contains a LUMASON vial containing 25 mg of lipid-type A lyophilized powder and 60.7 mg sulfur hexafluoride headspace, a prefilled syringe containing 5 mL of Sodium Chloride 0.9% Injection, USP (Diluent), and a Mini-Spike.1
In late 2015, the Centers for Medicare and Medicaid Services (CMS) granted "pass-through" status for LUMASON reimbursement, under the Hospital Outpatient Prospective Payment System (HOPPS). Contrast material is not separately paid by Medicare for outpatient hospitals under HOPPS unless the product has "pass-through" status. This additional payment is unique to LUMASON due to its new technology status. Effective October 1, 2016, CMS approved the request for coverage and coding for liver and/or abdominal ultrasound with contrast under the HOPPS indicating that Healthcare Common Procedure Coding System (HCPCS) code C9744 can be assigned for these procedures when performed in the hospital outpatient setting.
INDICATIONS AND USAGE1
LUMASON is an ultrasound contrast agent indicated for use:
- in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with suboptimal echocardiograms
- in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients
- in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patients
LUMASON is contraindicated in patients with:
- history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in LUMASON
- LUMASON (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use full Prescribing Information. Monroe Twp., NJ: Bracco Diagnostics Inc.; December 2016.
(Source: PR Newswire)