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.
|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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