This is a discussion on Leukine Supply within the Managed Care Issues for Injectable Drugs forum, part of the Managed Care Drug Coverage category; What is going on with Leukine? Any supply/distribution issues after it came back on the market?...
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The liquid formulation of Leukine was withdrawn in January 2008 in an effort to reformulate the product, without EDTA (edetate disodium). From January 2006 through January 2008, Bayer reported an increase in adverse event rates, including syncope, that corresponded with the addition of EDTA. At that time, the lyophilized version, which did not contain EDTA, was reserved in a special access program for patients with the greatest medical need. In May 2008, Bayer relaunched liquid Leukine (without EDTA) and closed the access program for lyophilized Leukine.
Upon our inquiry, Bayer responded that there were no supply issues w/ Leukine, which was also confirmed by one of the large Blues plans. Link to manufacturer letter: • Bayer Dear Healthcare Provider letter 5/08 |
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