NorthStar Medical Radioisotopes Statement on Novel Coronavirus and Reliable U.S. Mo-99 Supply
March 19, 2020
Statement Attributable to: Stephen Merrick, President and CEO, NorthStar Medical Radioisotopes
NorthStar Medical Radioisotopes supplies a medically critical isotope pair, Mo-99 and Tc-99m, which is used in more than 40,000 U.S. diagnostic imaging procedures daily. Information provided by these scans informs the care and treatment of patients with heart disease and cancer, critical conditions that challenge patients despite the novel coronavirus (COVID-19) outbreak. Given its global incidence and the reliance of other Mo-99 suppliers on fragile overseas Mo-99 supply, the COVID-19 outbreak has raised uncertainties about reliable Mo-99 supply for the United States.
As the only domestic supplier of Mo-99, NorthStar is committed to ensuring that we will continue to supply our customers and thus the U.S. healthcare system, with these important radioisotopes. We have taken the following actions:
- We have reviewed our entire supply chain and concluded that we have adequate inventories and confirmed supply of all critical product components.
- We are working closely with our manufacturing partners at the University of Missouri Research Reactor (MURR®), with whom we jointly produce Mo-99 in Columbia, Mo., to help ensure that they can continue to meet their production commitments.
- We have increased the number of RadioGenix® Systems (technetium 99m generator) available for deployment and stand ready to support an increase in demand over the coming weeks and months.
- We are taking appropriate precautions to support the health and safety of our employees, to enable us to continue to supply this medically critical product.
- We continue to progress our domestic Mo-99 expansion projects, with an eye to further increase domestic Mo-99 production capacity in the future.
NorthStar is committed to providing the United States with reliable and environmentally friendly radioisotope supply solutions to meet the needs of patients and to advance clinical research. We continue to monitor the COVID-19 outbreak closely and will provide any updates as needed.
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.
- 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.
- Discard the first eluate from every new Potassium Molybdate Mo 99 Source Vessel to minimize the risk of unintended radiation exposure from Rhenium Re-186.
- 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 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.
For Full RadioGenix® System Prescribing Information, click here or visit https://www.northstarnm.com/wp-content/uploads/2019/08/radiogenix-system-pi-july2019.pdf.
About NorthStar Medical Radioisotopes, LLC (NorthStar)
NorthStar Medical Radioisotopes is a nuclear medicine technology company committed to providing the United States with reliable and environmentally friendly radioisotope supply solutions to meet the needs of patients and to advance clinical research. The Company’s first product is the RadioGenix® System (technetium Tc 99m generator), an innovative and flexible platform technology initially approved by the U.S. Food and Drug Administration in February 2018 for the processing of nonuranium/non-highly enriched uranium based molybdenum-99 (Mo-99), the parent isotope of technetium-99m (Tc-99m), which is currently the most widely used diagnostic radioisotope for medical purposes. NorthStar’s proprietary and patented technologies include non-uranium based molybdenum-99 domestic production methods, patented separation chemistry systems, patented sterilization systems and a technology platform that potentially allows expanded product offerings to provide solutions in both the diagnostic and therapeutic markets. Founded in 2006 and based in Beloit, Wis., NorthStar Medical Radioisotopes, LLC is a wholly-owned subsidiary of NorthStar Medical Technologies, LLC. For more information, visit: www.northstarnm.com.
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