The following information is obtained from various newswires,
published medical journal articles, and medical conference presentations.
Company: Immunex
Approval Status: Approved November 1996
Treatment for: replenishment of white blood cells, fungal infections
General Information
A new liquid, multiple-dose formulation of Leukine has been approved. Leukine, a yeast-expressed granulocyte-macrophage colony stimulating factor (GM-CSF), has been available in the United States since 1991.
Leukine helps older adult leukemia subjects’ white blood cells recover quickly, and it helps prevent life-threatening infections, including fungal infections, which often complicate their recovery and increase their risk of complications. A liquid formulation is designed for easier use in the hospital or clinic and will be simpler for subjects to administer at home.
Leukine Liquid will be available initially in a 500-mcg-vial size. Immunex will continue marketing the 250 mcg and 500 mcg lyophilized product.
GM-CSF is an immune modulator that stimulates production and function of white blood cells that are vital for preventing life-threatening infections, especially fungal infections. Leukine is used for bone marrow and peripheral blood progenitor cell transplantations, and the exclusive indication for the treatment of chemotherapy-induced neutropenia in older adult subjects with acute myelogenous leukemia.
