RadioGenix™ System is a technetium Tc-99m generator used to produce sterile, non-pyrogenic Sodium Pertechnetate Tc 99m Injection. Sodium Pertechnetate Tc-99m Injection is indicated for use in the preparation of FDA approved diagnostic radiopharmaceuticals.
Sodium Pertechnetate Tc-99m Injection is also indicated in
- Adults for: Salivary Gland Imaging and Nasolacrimal Drainage System Imaging (dacryoscintigraphy).
- Adults and pediatric patients for: Thyroid Imaging and Urinary Bladder Imaging (direct isotopic cystography) for detection of vesicoureteral reflux.
IMPORTANT SAFETY INFORMATION
- Radiation Exposure Risk: Sodium Pertechnetate Tc-99m injection contributes to a patient’s long-term cumulative radiation exposure. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure.
- Unintended Mo-99 Exposure: Only use potassium molybdate Mo-99, processing reagents, saline and other supplies, including kits, provided by NorthStar Medical Radioisotopes. Do not administer Sodium Pertechnetate Tc-99m Injection after the 0.15microCi of Mo-99/mCi of Tc-99m limit has been reached and discard the Sodium Pertechnetate Tc-99m Injection when the 12 hour expiration time is reached; whichever occurs earlier.
- Hypersensitivity Reactions: Monitor all patients for hypersensitivity reactions.
- Adverse Reactions: Allergic reactions, including anaphylaxis, have been reported infrequently following the administration of Sodium Pertechnetate Tc 99m Injection.
For Full RadioGenix™ System Prescribing Information, click here
NorthStar believes that approval of the RadioGenixTM System and NorthStar’s Mo-99 production technology can mark a new era in nuclear medicine technology by providing a stable, domestically produced and environmentally friendly Mo-99/Tc-99m supply for the United States.
NorthStar’s first product is an innovative, high tech isotope separation platform, the RadioGenixTM System, for use in producing the widely used medical radioisotope technetium-99m (Tc-99m) from non-uranium produced molybdenum-99 (Mo-99). NorthStar’s RadioGenixTM System is the first and only non-uranium based process for production of technetium-99m (Tc-99m) in the United States in more than 25 years.
The RadioGenixTM System uses NorthStar’s non-uranium based Mo-99 to separate Tc-99m designed to meet all USP standards and requirements. It is designed with quality and safety as the highest priority and includes “by design” engineering features to ensure operator safety and lot accuracy. The system also incorporates built-in quality features such as a proprietary ozone sterilization system to ensure that the final product is sterile and free of contaminants.
Tc-99m patient doses from NorthStar’s RadioGenix System are not derived from uranium source material and are therefore eligible for the Medicare Hospital Outpatient Prospective Payment System $10 add on payment for HCPCS “Q9969 Tc-99m from non-highly enriched uranium source, full cost recovery add-on, per study dose”.