TechneLite Technetium Tc99m Generator


Mo-99 and Tc-99m: Critical to Nuclear Medicine

Molybdenum-99 (Mo-99) is the parent isotope of technetium-99m (Tc-99m), which is the radioisotope most widely utilized for nuclear medicine diagnostic imaging tests.

What is TechneLite®?

TechneLite® is a technetium-99m (Tc-99m) generator that provides the essential medical isotope used by hospitals and radiopharmacies to radiolabel Cardiolite® (Kit for the Preparation of Technetium Tc-99m Sestamibi for Injection) and other radiopharmaceuticals requiring Tc-99m used in nuclear medicine imaging procedures.

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LANTHEUS' LOW-ENRICHED URANIUM (LEU)
TechneLite® GENERATOR


Innovative LEU TechneLite® Generator Meets CMS Criteria for Non-HEU Tc-99m Add-on Payment

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, LEU 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.

 

Lantheus Circles the Globe to Bring TechneLite® to YouLantheus Circles the Globe to Bring TechneLite to You


As a leader in the radiopharmaceutical business, Lantheus has developed a world class, globally diversified and balanced Molybdenum-99 (Mo-99) supply chain for the procurement of Mo-99. The company presently receives Mo-99 from three of the four major Mo-99 processors and five of the six associated producing reactors. As the industry moves toward Low-Enriched Uranium (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 Technetium Tc-99m, now and in the future.



TechneLite Production Process Map

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References: 1. National Nuclear Security Administration - U.S. Department of Energy, 2010. First LEU-Produced Molybdenum-99 Approved for Patient Use Arrives in U.S. [press release], 6 December 2010, Available at: <http://www.nnsa.energy.gov/mediaroom/pressreleases/leumoly120610> [Accessed 30 July 2012]
2. Lantheus Medical Imaging, 2010. Lantheus Medical Imaging Announces First Commercial Production of TechneLite® Generators from Low-Enriched Uranium-Produced Molybdenum-99. [press release], 6 December 2012, Available at: <http://www.lantheus.com/News-Press-2010-1206.html> [Accessed 30 July 2012]

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


Lantheus Medical Imaging


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