The new formulation does not contain EDTA (edetate disodium), which was in the product’s liquid 500 mcg vial manufactured from January 2006 to January 2008.
With the approval and relaunch of liquid Leukine (Sargramostim) in a non-EDTA formulation, Bayer is closing a special access program that reserved priority access to lyophilized Leukine 250mcg vials, which do not contain EDTA, for patients with the greatest medical need. Sufficient supply of the new, non-EDTA liquid and lyophilized formulations of Leukine is now available to meet cancer care market demand.
Paul MacCarthy, vice president and head of US Medical Affairs for Bayer HealthCare Pharmaceuticals, said: “Bayer is pleased to bring back to US oncologists and hematologists an EDTA-free formulation of liquid Leukine for the care of their patients.”