Filgrastim is a human granulocyte colony stimulating factor (G-CSF), produced by recombinant DNA technology by E.coli. It is 175 amino acid protein, non-glycosylated, and has a molecular weight of approximately 18.8kD. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis, except for the addition of an N-terminal methionine necessary for expression in E. coli.
l Indications
1. Neutropenia resulting from cancer chemotherapy.
2. Neutrophil decrease after bone marrow transplantation.
3. Neutropenia caused by Myelodysplastic syndrome, neutropenia caused by aplastic anemia; congenital neutropenia, idiopathic neutropenia, Myelodysplastic syndrome with neutropenia and Periodic neutropenia.
4. Patients undergoing peripheral blood progenitor cell collection and therapy.
l Pharmaceutical particulars
Sterile, clear and colorless liquid for injection in vial
Dosage: 75μg, 100μg, 150μg/vial, 200μg, 300μg and 480μg
Reference: current CP/Internal
Specific activity: ≥0.8×108IU/mg
Purity (HPLC, SDS-PAGE): ≥98%
l Composition
Active ingredients: Filgrastim (rHuG-CSF).
Inactive ingredients: Glacial Acetic Acid, Mannitol, Polysorbate 80 and Sodium Acetate.
l Shelf life and storage conditions
| Drug Product | Storage at 2-8℃ for 2 years |
| Drug Substance (Concentrated solution) | Storage at 2-8℃ for 12 months |
