480 mcg/0.8 mL Injection for Subcutaneous Use


Tbo-filgrastim is a nonglycosylated 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 NH2 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-use 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. See table below for product composition of each single-use prefilled syringe.

  Product Composition
300 mcg/0.5 mL Syringe 480 mcg/0.8 mL Syringe
Tbo-filgrastim 300 mcg 480 mcg
Glacial Acetic Acid 0.3 mg 0.48 mg
Sorbitol 25 mg 40 mg
Polysorbate 80 0.0275 mg 0.044 mg
Sodium Hydroxide 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

Last reviewed on RxList: 10/12/2012
This monograph has been modified to include the generic and brand name in many instances.


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