filgrastim sndz - Generic Medications

Filgrastim-sndz is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. Filgrastim-sndz is produced by Escherichia coli ( E coli ) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. Filgrastim-sndz 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-sndz is produced in E coli ‚ the product is non-glycosylated and thus differs from G-CSF isolated from a human cell. ZARXIO (filgrastim-sndz) injection is a sterile‚ clear‚ colorless to slightly yellowish‚ preservative-free liquid containing filgrastim-sndz at a specific activity of 1 x 10 8 U/mg (as measured by a proliferation assay). The product is available in single-dose vials and single-dose prefilled syringes for subcutaneous or intravenous use. The single-dose vials contain either 300 mcg/mL or 480 mcg/1.6 mL of filgrastim-sndz. The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastim-sndz. The ZARXIO drug product has a pH of 4.4. See Table 4 below for product composition of each single-dose vial and prefilled syringe. Table 4. Product Composition 300 mcg/mL Vial 480 mcg/1.6 mL Vial 300 mcg/0.5 mL Syringe 480 mcg/0.8 mL Syringe Filgrastim-sndz 300 mcg 480 mcg 300 mcg 480 mcg Glutamic Acid 1.471 mg 2.354 mg 0.736 mg 1.178 mg Polysorbate 80 0.04 mg 0.064 mg 0.02 mg 0.032 mg Sorbitol 50 mg 80 mg 25 mg 40 mg Sodium hydroxide q.s. q.s. q.s. q.s. Water for Injection USP q.s. ad* ad 1 mL ad 1.6 mL ad 0.5 mL ad 0.8 mL *q.s.: quantity sufficient to make