TechneLite Technetium Tc99m Generator

 



 

HEU vs. LEU TechneLite®: Fact vs. Fiction

Technetium Tc 99m Generator

MYTH: LEU-sourced Mo-99 is not equivalent to HEU-sourced Mo-99.

FACT: LEU and HEU-sourced Mo-99 are equivalent in performance and use as recognized by FDA approval of LEU-produced Mo-99 generators. Lantheus’ TechneLite® generators, using a blend of HEU and LEU, were approved by the FDA for commercial use in 2010 and have been routinely used in the U.S. market since 2011. The only difference between the LEU TechneLite® generator and the standard TechneLite® generator is that LEU TechneLite® is produced using Mo-99 sourced from at least 95 percent LEU instead of HEU. Lantheus receives LEU-sourced Mo-99 from NTP Radioisotopes and the Australian Nuclear Science and Technology Organization (ANSTO).


MYTH: LEU generators are not the same as HEU generators.

FACT: Lantheus’ LEU and HEU generators are equivalent in terms of both elution process and performance. LEU and HEU generators use the exact same isotope – Mo-99 – and the package inserts for both are identical.


MYTH: Radiopharmacies will have to report to the U.S. Government how much LEU vs. HEU was used when providing Tc-99m based unit doses.

FACT: There is currently no requirement for a radiopharmacy to report LEU and HEU usage to the U.S. government. When a hospital files for the recently implemented incremental HOPPS add-on payment, it needs to show that it has met the conditions of the new service definition, as it does for any billed service. To facilitate ease of identification in a radiopharmacy, each LEU generator has a unique product number and a visual identifier on the generator can cover. Additionally, Lantheus provides customers with an LEU TechneLite® generator certification document.


MYTH: Switching to LEU will have a negative effect on the Mo-99 supply chain and will exacerbate global shortages.

FACT: U.S. government and the international community are committed to minimizing — and eventually eliminating — the use of HEU from all civil nuclear applications, at the same time preserving patient access to valuable medical procedures using medical isotopes. Historically, medical isotope production has been a significant consumer of HEU. The U.S. government has been working with reactors and governments outside of the U.S. to encourage the conversion of Mo-99 production from using HEU to LEU. In addition, the U.S. government is currently providing funding for domestic projects that plan to produce Mo-99 using non-HEU based technologies.


MYTH: There is not enough LEU capacity to meet the needs of the Medicare HOPPS population.

FACT: Under a five-year agreement through 2017, Lantheus will receive an increasing supply of LEU-sourced Mo-99 from NTP and ANSTO. Lantheus plans to increase its use of LEU-sourced Mo-99 with a goal of eventually eliminating HEU-sourced Mo-99 from its supply chain. Lantheus believes that it is well-positioned to meet the LEU dose volume needs of the Medicare HOPPS population.

 

On-demand webinar
Implementing Low Enriched Uranium:  Q&A videos
Practical Experiences from the Radiopharmacy and the Healthcare Provider

 

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On-demand webinar
Our Industry's Road to LEU Q&A videos

 

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INDICATIONS AND USAGE:

The TechneLite® generator is a source of sodium pertechnetate Tc-99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. 

Sodium Pertechnetate Tc-99m Injection is used IN ADULTS as an agent for:
Thyroid Imaging
Salivary Gland Imaging
Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux.
Nasolacrimal Drainage System Imaging
Sodium Pertechnetate Tc-99m Injection is used IN CHILDREN as an agent for:
Thyroid Imaging
Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux.

CONTRAINDICATIONS:

None Known

IMPORTANT SAFETY INFORMATION:

Allergic reactions including anaphylaxis have been reported infrequently following the administration of Sodium Pertechnetate Tc-99m Injection.

WARNINGS:

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.

PRECAUTIONS:

Since the eluate does not contain an antimicrobial agent, it should not be used after 12 hours from the time of TechneLite®, Technetium Tc-99m Generator, elution. After the termination of the nasolacrimal imaging procedure, blowing the nose and washing the eyes with sterile distilled water or an isotonic sodium chloride solution will further minimize the radiation dose. As in the use of any radioactive material, care should be taken to minimize radiation exposure to patients and occupational workers. Radiopharmaceuticals should be used only by physicians who are qualified by training and experience and who are licensed in the safe handling of radionuclides.

Please see full Prescribing Information

 

To place an order call 1-800-299-3431 or visit ecommerce.lantheus.com