tbo filgrastim - Generic Medications

GRANIX (tbo-filgrastim) is a non-glycosylated recombinant methionyl human granulocyte colony-stimulating growth factor (r-metHuG-CSF) manufactured by recombinant DNA technology using the bacterium strain E coli K802. It has a molecular weight of approximately 18.8 kDa and is composed of 175 amino acids. The endogenous human G-CSF is glycosylated and does not have the additional methionine amino acid residue in its NH 2 terminal end. The product is a sterile, clear, colorless, preservative-free solution containing tbo-filgrastim, glacial acetic acid, sorbitol, polysorbate 80, sodium hydroxide, and Water for Injection. The product is available in single-dose prefilled syringes that contain either 300 mcg or 480 mcg of tbo-filgrastim at a fill volume of 0.5 mL or 0.8 mL, respectively and single-dose vials that contain either 300 mcg or 480 mcg of tbo-filgrastim at a fill volume of 1 mL or 1.6 mL, respectively. See table below for product composition of each presentation. Product Composition 300 mcg/0.5 mL Syringe 480 mcg/0.8 mL Syringe 300 mcg/1 mL Vial 480 mcg/1.6 mL Vial Tbo-filgrastim 300 mcg 480 mcg 300 mcg 480 mcg Glacial Acetic Acid 0.3 mg 0.48 mg 0.6 mg 0.96 mg Polysorbate 80 0.0275 mg 0.044 mg 0.055 mg 0.088 mg Sorbitol 25 mg 40 mg 50 mg 80 mg Sodium Hydroxide q.s. to pH 4.2 q.s. to pH 4.2 q.s. to pH 4.2 q.s. to pH 4.2 Water for Injection q.s. to 0.5 mL q.s. to 0.8 mL q.s. to 1 mL q.s. to 1.6 mL q.s. = quantity sufficient to make