TechneLite^® (Technetium Tc 99m Generator)

Proven Quality and Reliability¹

• 100% Assay and Mo-99 breakthrough testing¹

• 100% Terminal Sterilization¹

• 0% Sterility Assurance failure¹

• 99% on-time delivery¹

• Predictable elution results and consistent yields¹

TechneLite^® 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, such as NEUROLITE^®, (Kit for the Preparation of Technetium Tc99m Bicisate for Injection), and radiopharmaceuticals requiring Tc-99m used in other critical diagnostic imaging tests.

Sodium Pertechnetate Tc-99m Injection, eluted from the TechneLite^® generator, is also used in a number of diagnostic imaging procedures in adults including thyroid imaging, salivary gland imaging, urinary bladder imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux, and nasolacrimal drainage system imaging. Sodium Pertechnetate Tc-99m Injection, eluted from the TechneLite^® generator, is used in children for thyroid imaging and urinary bladder imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux.

Lantheus received FDA approval for the commercial use of Low Enriched Uranium (LEU) in 2010. In January 2013, TechneLite® became the first Tc-99m generator in the United States that contains at least 95 percent non-Highly Enriched Uranium (HEU)-sourced Mo-99 which 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 is moving closer to its goal of eliminating HEU-sourced Mo-99 from its supply chain.

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 three of the four major processors and five of the six 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.

 

 

References: 1. Data on File, Lantheus.