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Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Hematology | Immunology | Oncology | Family Medicine | Infections and Infectious Diseases

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Leukine (sargramostim)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Immunex
Approval Status: Approved November 1996
Treatment Area: 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.