You are undoubtedly keenly aware of the continued Mo-99 supply shortages and the impact that they have had on radiopharmacy operations, Tc-99m availability and your ability to meet patient needs.
ROI is proud to lead the way once again in implementing new technologies that will help our customers and continue our innovative solutions mindset. This includes the ability to reliably provide critically important isotope supply. We are very pleased to announce that we are utilizing the latest in Tc-99m production technology with the addition of a NorthStar Medical Radioisotopes’ RadioGenix® System – the first in the region. The FDA-approved RadioGenix System is an innovative, high tech radioisotope separation platform that uses domestically sourced, non-uranium-based Mo-99 and an environmentally friendly production process to produce USP-equivalent Sodium Pertechnetate Tc 99m injection for patient use. Our customers now have stable, reliable access to domestically produced Mo-99 to produce Tc-99m which in turn will enable reliable scheduling of procedures to meet your patients’ healthcare needs in a timely manner.
Having ready access to USP-equivalent Tc-99m that is independent of the fragile, foreign Mo-99 supply chain will help us serve you and your patients with Tc-99m on time and when you need it.
Sincerely,
Brian Hardesty, RPh, MBA
Radiopharmacy of Indianapolis
Indication and Important Risk Information About the RadioGenix® System and Sodium Pertechnetate Tc-99m Injection USP
INDICATION
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.
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 kits, 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 12 hour expiration time from elution is reached, whichever occurs earlier.
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.
Full RadioGenix™ System Prescribing Information.