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As a radioisotope central to diagnostic imaging tests, technetium-99m (Tc-99m) is in high demand worldwide. NorthStar innovation makes a reliable domestic supply of Tc-99m possible for the 40,0001 patients in the U.S. every single day who rely on it for crucial healthcare decisions.

The RadioGenix System is the first of its kind – an innovative, high tech radioisotope separation platform that is used to produce Tc-99m from non-uranium produced molybdenum-99 (Mo-99).

PRODUCING Mo-99
REQUIRES SOLUTIONS
THAT ARE

RELIABLE AND
DOMESTIC

Reliable production of non-uranium based Mo-99/Tc-99m meets patients’ health care needs and is re-shaping the Mo-99 supply chain, previously 100% dependent on foreign supply.

This year, we launched concentrated Mo-99 (cMo-99) to provide radiopharmacists with even greater benefits. Our cMo-99 source vessels are now available in higher activity levels (7.5, 12, 15 and 19 Ci) with a 21-day expiration (from date of production), and Tc-99m generated by RadioGenix Systems now has a beyond use date (BUD) of 24 hours.

MAKING A DIFFERENCE
FOR PATIENTS

Over 40,0001 every day rely on imaging test results using Tc-99m. NorthStar’s Mo-99 and the RadioGenix System help to fulfill the demand.

1DOE/NNSA, “NNSA’s Molybdenum-99 Program: Establishing a Reliable Supply of Mo-99 Produced Without Highly Enriched Uranium”, 2017

PRODUCING Mo-99 REQUIRES
SOLUTIONS THAT ARE

ECO FRIENDLY

NorthStar continues to invest in modern, non-uranium-based production methods, which produce benign and recyclable waste streams free of toxic and radioactive waste, unlike those that continue to use enriched uranium-based fission methods.

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. Read More »

Indication and Important Risk Information about the RadioGenix® System and Sodium Pertechnetate Tc 99m Injection USP

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.
  • 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.