Update on Lantheus Commitment During Molybdenum-99 Shortage
March 4, 2010
We would like to take this opportunity to thank you for your continued support of Lantheus Medical Imaging. Together, we have made a positive impact in maintaining patient access to critical medical isotopes.
The planned shutdown of the High-Flux Reactor (HFR) in the Netherlands began on February 19, 20101 and the National Research Universal (NRU) reactor in Canada is not expected to be back on line until the end of April 2010.2 Although this additional delay in the start up of the NRU reactor is disappointing, we are confident that it will come back to service.
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Current Global State of Mo-99 Production
Molybdenum-99 Supply Statement from Lantheus Medical Imaging
As a Technetium-99m (Tc-99m) generator manufacturer, we are one part of a very complex supply chain. We are working with our suppliers to obtain Molybdenum-99 (Mo-99) during this current shortage. The amount of Mo-99 we receive over the course of this outage will vary day by day. We are communicating with our radiopharmacy partners and customers on a daily basis about the TechneLite® generators we will be able to provide based on the actual Mo-99 we receive on any given day. We are doing all we can to allocate our TechneLite® generators as equitably as possible. The radiopharmacies who use our Tc-99m generators to make unit-dose radiopharmaceuticals for patient use are in contact with their customers – the healthcare professional – to let them know the supply of patient-ready product they can expect to receive so that they, in turn, can triage patient imaging procedures accordingly.
In addition, we are one of two Tc-99m generator manufacturers in North America. Estimating the percentage of the market that can be served on any given day depends not only on the Tc-99m we are able to supply but also on the amount the other manufacturer is able to supply and the success of the communication chain that is outlined above. We are therefore, regrettably, not in a position to provide ongoing supply estimates.
Important Safety Information for TechneLite®:
Allergic reactions including anaphylaxis have been reported infrequently.
Please See Full Prescribing Information
Important Safety Information for Cardiolite®:
Indications and Usage:
Cardiolite®, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Cardiolite® evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (eg, exercise or pharmacologic stress in accordance with the pharmacologic stress agent's labeling).
It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia.
Important Safety Information:
Exercise and pharmacologic stress testing should be performed only under the supervision of a qualified physician. Cardiolite® has been rarely associated with acute severe allergic events of angioedema and urticaria. The most frequently reported adverse events include headache, chest pain/angina, ST segment changes on ECG, nausea, and abnormal taste and smell.
Please See Full Prescribing Information
Important Safety Information for Thallium 201:
Adverse patient reaction to Tl 201 is extremely rare. Rashes and/or temporary low blood pressure have occurred, which have been treated with no further reported complications.
Please See Full Prescribing Information
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