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news.Bayer HealthCare Pharmaceuticals has reported that following consultation with the FDA, it will withdraw the current liquid formulation of Leukine marketed in the US.
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The 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 500mcg vial that currently contains EDTA (edetate disodium).
While Bayer works to increase supplies of lyophilized Leukine and reformulate the liquid Leukine (to eliminate EDTA), it will also establish a special access program for the currently marketed lyophilized Leukine 250mcg 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 250mcg lyophilized vial which does not contain EDTA.
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 engraftment failure or delay. The special access program will also be used to provide continued Leukine therapy to patients currently participating in ongoing clinical studies.