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 |