Indication and Important Risk Information about the RadioGenix® System and Sodium Pertechnetate Tc 99m Injection USP
The RadioGenix® System is a technetium Tc-99m generator used to produce Sodium Pertechnetate Tc 99m Injection, USP. Sodium Pertechnetate Tc 99m Injection is a radioactive diagnostic agent and can be used 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 Vesicoureteral Imaging (direct isotopic cystography) for detection of vesicoureteral reflux.
IMPORTANT RISK INFORMATION
- Allergic reactions (skin rash, hives, or itching) including anaphylaxis have been reported following the administration of Sodium Pertechnetate Tc 99m Injection. Monitor all patients for hypersensitivity reactions.
- 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. Use the lowest dose of Sodium Pertechnetate Tc 99m Injection necessary for imaging and ensure safe handling and preparation to protect the patient and health care worker from unintentional radiation exposure. Encourage patients to drink fluids and void as frequently as possible after intravenous or intravesicular administration. Advise patients to blow their nose and wash their eyes with water after ophthalmic administration.
- Radiation risks associated with the use of Sodium Pertechnetate Tc 99m Injection are greater in children than in adults and, in general, the younger the child, the greater the risk owing to greater absorbed radiation doses and longer life expectancy. These greater risks should be taken firmly into account in all benefit-risk assessments involving children. Long-term cumulative radiation exposure may be associated with an increased risk of cancer.
- Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for 12 to 24 hours after Sodium Pertechnetate Tc 99m Injection administration.
- Sodium Pertechnetate Tc 99m Injection should be given to pregnant women only if the expected benefits to be gained clearly outweigh the potential hazards.
- Only use potassium molybdate Mo-99, processing reagents, saline and other supplies, including kit/packs, provided by NorthStar Medical Radioisotopes. Do not administer Sodium Pertechnetate Tc 99m Injection after the 0.15 microCi of Mo-99/mCi of Tc-99m limit has been reached or when the 24 hour expiration time from elution is reached, whichever occurs earlier. Follow step-by-step instructions for use provided in the Operator’s Guide, RadioGenix System 1.2.
To report SUSPECTED ADVERSE REACTIONS, contact NorthStar® Medical Radioisotopes, LLC at 1-844-438-6659; or FDA at 1-800-332-1088 or www.fda.gov/medwatch.
For RadioGenix® System version 1.2 Full Prescribing Information, click here or visit https://www.northstarnm.com/wp-content/uploads/2021/05/RadioGenix-System-version-1.2-Package-Insert-Rev-04-April-2021.pdf.
NorthStar believes that approval of the RadioGenix® System and non-uranium based Mo-99 production technology marks 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 RadioGenix® System, for use in producing the widely used medical radioisotope technetium-99m (Tc-99m) from non-uranium produced molybdenum-99 (Mo-99). NorthStar’s RadioGenix® 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 RadioGenix® System uses 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”.