Tbo-filgrastim
Tbo-filgrastim
480 mcg/0.8 mL Injection for Subcutaneous Use
DRUG DESCRIPTION
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.
Additional Tbo-filgrastim Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Women's Health
Find out what women really need.
Updated & New
