Mallinckrodt Pharmaceuticals Expands Nuclear Medicine Offerings, Announces U.S. Availability of Xenon 133
ST. LOUIS (March 10, 2016) – Mallinckrodt (NYSE: MNK), a leading global specialty biopharmaceutical and nuclear imaging company, today announced its re-entry into the radiopharmaceutical Xenon Xe 133 Gas (Xenon 133) market, expanding the company’s offerings to meet the needs of U.S. nuclear medicine patients. Mallinckrodt is a global leader in the manufacture and supply of nuclear medicine diagnostic imaging agents.
Radiopharmaceuticals are products that can be used in conjunction with gamma cameras for nuclear medicine procedures to help physicians find and help diagnose certain diseases or study the function of the body's organs. Xenon 133, 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.
“We are pleased to provide our customers with a choice when selecting Xenon 133 to help diagnose patient disease for approved indications,” said Dan Brague, Mallinckrodt Vice President and General Manager, Nuclear Imaging. “As a global leader in nuclear medicine, Mallinckrodt’s commitment to the industry is evidenced by our ongoing investments in nuclear medicine, including making Xenon 133 available to clinicians across the U.S., with a focus on long-term supply.”
Orders for Xenon 133 from Mallinckrodt 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 AND 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.
Find Full U.S. Prescribing Information available online.
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical and biopharmaceutical products and therapies, as well as nuclear imaging products. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; analgesics and hemostasis products; and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing; and the Nuclear Imaging segment includes nuclear imaging agents. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
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