Bayer Establishes US Special Access Program for Leukine(R) While Replacing Current Liquid F...(mpared tohistorical experience. The spec...),Health

Bayer informed the FDA of an increase in reporting rates of syncope, with or without documented hypotension; these adverse reactions are listed in the Leukine prescribing information. The timing of increased reporting of these adverse events coincides with a change in the formulation of liquid Leukine to include EDTA.

Bayer has posted a Dear Health Care Provider letter, along with its enclosures, on its websites today at http://www.pharma.bayer.com, http://www.bayeroncology.com and http://www.leukine.com and will be mailing it to U.S. oncologists and hematologists who prescribe and use Leukine for their patients.

In the coming days, Bayer will provide hematologists and oncologists who prescribe and use Leukine for their patients with instructions for accessing priority supplies of lyophilized Leukine 250 mcg vial. Bayer will work to increase supplies of lyophilized Leukine and reformulate the liquid Leukine (to eliminate EDTA) as quickly as possible.

As of today Bayer is withdrawing current stock and no longer accepting new orders for the current liquid Leukine formulation, and no existing orders will be shipped from our distribution centers. Bayer asks that all US wholesalers, hospitals, clinics and physician offices having current supplies of Leukine liquid 500 mcg vial containing EDTA return those to Bayer. Bayer will follow up with customers to work through the details of the return and file the appropriate paperwork to initiate reimbursement. If customers have questions regarding the return process they may call Bayer HealthCare Pharmaceuticals toll free at 1-888-84Bayer (1-888-842-2937).

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