LEUKINE (sargramostim) injection and LEUKINE (sargramostim)

LEUKINE (sargramostim) injection and LEUKINE (sargramostim) for injection for subcutaneous or intravenous use are recombinant human granulocyte-macrophage colony stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in a yeast (S. cerevisiae) expression system. LEUKINE is a glycoprotein of 127 amino acids characterized by three 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. LEUKINE differs from human GM-CSF by one amino acid at position 23, where leucine is substituted for arginine.

LEUKINE (sargramostim) injection is a sterile, clear, colorless solution preserved with 1.1% benzyl alcohol in a multiple-dose vial. Each 1 mL vial contains 500 mcg sargramostim and has a pH range of 6.7 – 7.7. LEUKINE (sargramostim) for injection is supplied as a sterile, preservative-free, white lyophilized powder in a single-dose vial. Each single-dose vial delivers 250 mcg sargramostim. Inactive ingredients are mannitol (40 mg), sucrose (10 mg), and tromethamine (1.2 mg). Reconstitution with 1 mL of the appropriate diluent (sterile water for injection or bacteriostatic water for injection) yields a solution containing 250 mcg/mL sargramostim at a pH range of 7.1 – 7.7 with a deliverable volume of 1 mL (250 mcg).