TechneLite Technetium Tc99m Generator

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About the LEU TechneLite® Generator

Technetium Tc99m Generator Cut-out

LEU TechneLite® (Technetium Tc-99m Generator) is a technetium-99m (Tc-99m) generator that provides the essential medical isotope used by hospitals and radiopharmacies to radiolabel a variety of radiopharmaceuticals requiring Tc-99m, which are used in critical diagnostic imaging tests. Lantheus received FDA approval for the commercial use of LEU in 2010 and has used a blend of Highly Enriched Uranium (HEU) and LEU molybdenum-99 (Mo-99) in its TechneLite® generators in the U.S. market since 2011. In January 2013, TechneLite® became the first Tc-99m generator in the United States that contains at least 95 percent non-HEU-sourced Mo-99 that meets the Centers for Medicare and Medicaid Services (CMS) criteria for the incremental add-on Hospital Outpatient Prospective Payment System (HOPPS) payment. With greater access to LEU Mo-99 through its supply chain diversification strategy, Lantheus can now move closer to its goal of eventually eliminating HEU-sourced Mo-99 from its supply chain.

 

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Implementing Low Enriched Uranium:
Practical Experiences from the Radiopharmacy and the Healthcare Provider


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Our Industry's Road to LEU


Why the LEU TechneLite® Generator?

Aligns with U.S. Government’s Global Nuclear Safety Mandate to Eliminate Use of HEU in Medical Isotope Production


With the introduction of the LEU TechneLite® generator for use in connection with nuclear imaging procedures, Lantheus fully supports the United States government’s global nuclear security strategy to encourage reliable supplies of medical radioisotopes produced from non-HEU sources. On January 2, 2013, President Obama signed into law the American Medical Isotopes Production Act of 2011 (AMIPA) as part of the 2013 National Defense Authorization Act. The AMIPA encourages the domestic production of LEU Mo-99 and provides for the eventual prohibition of the export of HEU from the United States.

The company’s LEU and HEU-produced TechneLite® generators are equivalent in performance and use as recognized by FDA approval of LEU-produced Mo-99 generators. 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.

Meets Centers for Medicare and Medicaid Services (CMS) Reimbursement Guidelines

CMS stipulated in the Medicare payment rules, for Medicare Hospital Outpatients, that CMS will provide an incremental add-on payment for every Tc-99m diagnostic dose produced from non-HEU-sourced Mo-99, such as LEU. Lantheus’ LEU TechneLite® generator satisfies the CMS add-on payment requirements.

Leverages Strong Heritage of Manufacturing Excellence and Focus on Customer Service

The LEU TechneLite® generator has its own product item number as well as a visual identifier on the generator can cover, which indicates that it is an LEU TechneLite® generator. In order to meet customer needs, the LEU TechneLite® generator has a dedicated manufacturing run.

Demonstrates Lantheus’ Ongoing Commitment to Ensuring Reliable Access to Technetium-99m

As a leader in the radiopharmaceutical business, Lantheus has developed a world class, globally diversified and balanced Mo-99 supply chain for the procurement of Mo-99. The company receives Mo-99 from four of the five major processors and seven of the eight associated reactors. As the industry moves toward LEU-based Mo-99 supply, Lantheus’ introduction of the LEU TechneLite® generator and gradual conversion to 100 percent LEU-derived Mo-99 ensures that our customers will have access to Tc-99m, now and in the future.


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