Xenon Xe 133 Gas

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.
• Transfer the appropriate Xenon Xe 133 Gas dose from the Xenon Xe 133 Gas unit dose vial(s) to a breathing device or spirometer utilizing the Xenotron™ I Xenon Gas Dispenser. Follow the directions for use that are provided with the Xenotron I Xenon Gas Dispenser.

Adverse reactions

• 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.