Leukine®(sargramostim) is a recombinant human granulocyte-macrophage colony stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in a yeast (S. cerevisiae) expression system. GM-CSF is a hematopoietic growth factor which stimulates proliferation and differentiation of hematopoietic progenitor cells. Leukine is a glycoprotein of 127 amino acids characterized by 3 primary molecular species having molecular masses of 19,500, 16,800 and 15,500 daltons. The amino acid sequence of Leukine differs from the natural human GM-CSF by a substitution of leucine at position 23, and the carbohydrate moiety may be different from the native protein. Sargramostim has been selected as the proper name for yeast-derived rhu GM-CSF.

The Leukine Liquid presentation is formulated as a sterile, preserved (1.1% benzyl alcohol) injectable solution (500 mcg/mL) in a vial. Lyophilized Leukine is a sterile, white, preservative-free, powder (250 mcg) that requires reconstitution with 1 mL Sterile Water for Injection, USP or 1 mL Bacteriostatic Water for Injection, USP.

Leukine Liquid and reconstituted lyophilized Leukine are clear colorless liquids suitable for subcutaneous injection or intravenous infusion. Leukine Liquid contains 500 mcg (2.8 x 10⁶ IU/mL) sargramostim and 1.1% benzyl alcohol in a 1 mL solution. The vial of lyophilized Leukine contains 250 mcg (1.4 x 10⁶ IU/vial) sargramostim. The Leukine liquid vial and reconstituted lyophilized Leukine vial also contain 40 mg/mL mannitol, USP; 10 mg/mL sucrose, NF; and 1.2 mg/mL tromethamine, USP as excipients. Biological potency is expressed in International Units (IU) as tested against the WHO First International Reference Standard. The specific activity of Leukine is approximately 5.6 x 10⁶ IU/mg.

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