SPL Set ID: 74e1ec6e-1630-4654-895c-2bd355f939e7

Filgrastim-ayow, a leukocyte growth factor, is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. Filgrastim-ayow is produced by Escherichia coli ( E coli ) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. Filgrastim-ayow has a molecular weight of 18‚800 daltons. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis‚ except for the addition of an N-terminal methionine necessary for expression in E coli . Because filgrastim-ayow is produced in E coli ‚ the product is non-glycosylated and thus differs from G-CSF isolated from a human cell. Kanamycin, 50 mcg/mL is final concentration, is used during the fermentation step of the manufacturing process. Kanamycin is not detectable in the final product. RELEUKO (filgrastim-ayow) injection is a sterile‚ clear‚ colorless‚ preservative-free liquid containing filgrastim-ayow at a specific activity of 1.0 ± 0.6 x 10 8 U/mg (as measured by a cell mitogenesis assay). The product is available in single-dose vials for subcutaneous or intravenous use and prefilled syringes for subcutaneous use. The single-dose vials contain either 300 mcg/mL or 480 mcg/1.6 mL of filgrastim-ayow. The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastim-ayow. The RELEUKO drug product has a pH of 4.0. See table below for product composition of each single-dose vial or prefilled syringe. 300 mcg/mL Vial 480 mcg/1.6 mL Vial 300 mcg/0.5 mL Syringe 480 mcg / 0.8 mL Syringe Filgrastim-ayow 300 mcg 480 mcg 300 mcg 480 mcg Acetic acid 0.604 mg 0.966 mg 0.302 mg 0.483 mg Polysorbate 80 0.04 mg 0.064 mg 0.02 mg 0.032 mg Sodium hydroxide 0.056 mg 0.090 mg 0.028 mg 0.045 mg Sorbitol 50 mg 80 mg 25 mg 40 mg Water for Injection, USP q.s. ad quantity sufficient to make. 1 mL 1.6 mL 0.5 mL 0.8 mL