Bayer establishes US special access program for Leukine® while replacing current liquid information
1/23/2008
Leverkusen, January 23, 2008 – Bayer HealthCare announced today, following consultation with the United States Food and Drug Administration (FDA), that it will withdraw the current liquid formulation of Leukine marketed in the US. This decision was made in light of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with the liquid Leukine 500 mcg vial which currently contains EDTA (edetate disodium).
While Bayer works to increase supplies of lyophilized Leukine and reformulate the liquid Leukine (to eliminate EDTA), Bayer will establish a special access program for the currently marketed lyophilized Leukine 250 mcg vial which does not contain EDTA. The upward trend in adverse event reporting rates is only associated with the Leukine liquid 500 mcg vial containing EDTA. Bayer has not observed an upward trend in reporting rates of these adverse events in the marketed Leukine 250 mcg lyophilized vial which does not contain EDTA. These adverse reactions are listed in the Leukine prescribing information.
The special access program is designed to prioritize the supply of the lyophilized Leukine for patients with Acute Myelogenous Leukemia (AML) and those who are experiencing bone marrow transplantation graft failure or engraftment delay. Leukine is the only myeloid growth factor approved to reduce the incidence of infections resulting in early death following induction chemotherapy in older adults with AML and to prolong survival of patients with bone marrow graft failure or engraftment delay, as compared to historical experience. The special access program also will be used to provide continued Leukine therapy to patients currently participating in ongoing clinical studies.
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.
