SPL Set ID: 97cc73cc-b5b7-458a-a933-77b00523e193

Filgrastim is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. Filgrastim is produced by Escherichia coli (E coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. Filgrastim 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 is produced in E coli ‚ the product is non-glycosylated and thus differs from G-CSF isolated from a human cell. NEUPOGEN injection is a sterile‚ clear‚ colorless‚ preservative-free liquid containing filgrastim at a specific activity of 1.0 ± 0.6 × 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. The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastim. The NEUPOGEN 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 300 mcg 480 mcg 300 mcg 480 mcg acetate 0.59 mg 0.94 mg 0.295 mg 0.472 mg polysorbate 80 0.04 mg 0.064 mg 0.02 mg 0.032 mg sodium 0.035 mg 0.056 mg 0.0175 mg 0.028 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