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(St. Louis – May 10, 2018) — Curium, a leading nuclear medicine solutions provider, announced today its re-entry into the radiopharmaceutical Xenon Xe 133 Gas market, expanding the company’s offerings to meet the needs of U.S. nuclear medicine patients. The bulk Xenon Xe 133 used in production is sourced from Curium’s Petten manufacturing facility, using Low Enriched Uranium (LEU) targets. Curium’s multi-year project to transition its molybdenum-99 (Mo-99) processing facility from Highly Enriched Uranium (HEU) to LEU was completed in late-2017. By sourcing the bulk Xenon Xe 133 material from LEU targets used in the Petten facility, Curium has created a vertically integrated supply chain that provides additional control over the manufacturing process and ensures product availability.
“We are pleased to provide our customers with a choice when selecting Xenon Xe 133 Gas to help diagnose patient disease for approved indications,” said Curium North American CEO, Dan Brague, “As a global leader in nuclear medicine, Curium’s commitment to the industry is evidenced by our ongoing investments in our product portfolio, including making Xenon Xe 133 Gas available to clinicians across the U.S., with a focus on reliable, long-term supply.”
Radiopharmaceuticals are products that can be used in conjunction with gamma cameras for nuclear medicine procedures to help physicians find and diagnose certain diseases or study the function of the body’s organs. Xenon Xe 133 Gas, approved by the U.S. Food and Drug Administration, has been shown to be valuable for diagnostic inhalation studies for the evaluation of pulmonary function, for imaging the lungs and may also be applied to assessment of cerebral blood flow.
Orders for Xenon Xe 133 Gas from Curium may be placed effective immediately.
INDICATIONS AND USAGE
Xenon Xe 133 Gas has been shown to be valuable for diagnostic inhalation studies for the evaluation of pulmonary function, for imaging the lungs and may also be applied to assessment of cerebral blood flow.
IMPORTANT RISK INFORMATION
WARNINGS & PRECAUTIONS
Xenon Xe 133 Gas delivery systems, i.e., respirators or spirometers, and associated tubing assemblies must be leakproof to avoid loss of radioactivity into the laboratory environs not specifically protected by exhaust systems.
Xenon Xe 133 Gas adheres to some plastics and rubber and should not be allowed to stand in tubing or respirator containers. Loss of radioactivity due to such adherence may render the study nondiagnostic.
Xenon Xe 133 Gas as well as other radioactive drugs, must be handled with care and appropriate safety measures should be used to minimize radiation exposure to clinical personnel. Also, care should be taken to minimize radiation exposure to the patients consistent with proper patient management.
Exhaled Xenon Xe 133 Gas should be controlled in a manner that is in compliance with the appropriate regulations of the government agency authorized to license the use of radionuclides.
Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides.
Adverse reactions specifically attributable to Xenon Xe 133 Gas have not been reported.
USE IN SPECIFIC POPULATIONS
Pregnancy Category C. Xenon Xe 133 Gas should be given to a pregnant woman only if clearly needed.
Breastfeeding: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Xenon Xe 133 Gas is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Please visit the Curium website for full Prescribing Information for Xenon Xe 133 Gas.
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Curium is a world-class nuclear medicine solutions provider with more than a century of industry experience. Formed by the union of IBA Molecular and Mallinckrodt Nuclear Medicine LLC, Curium is the largest vertically integrated radiopharmaceutical product manufacturer in the industry.
With manufacturing facilities across Europe and the United States, Curium supports over 14 million patients around the word with SPECT, PET, and therapeutic radiopharmaceuticals to provide potentially life-saving diagnostic solutions. The Curium brand name is inspired by the work of radiation researchers Marie and Pierre Curie and emphasizes a focus on nuclear medicine. To learn more, visit curiumpharma.com.
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