Filgrastim (rHuG-CSF)

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Description

Filgrastim is a recombinant human granulocyte colony stimulating factor (rHuG-CSF), produced by recombinant DNA technology using E.coli. It is a 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.

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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.

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Pharmaceutical particulars

Sterile, clear and colorless liquid for injection in vial

• Strength: (Vial) 150μg, 300μg and 480μg; (Prefilled syringe) 300μg/0.5ml
• Reference: Current EP/CP
• Specific activity: ≥0.9×10⁸IU/mg
• Purity (HPLC, SDS-PAGE): ≥98%

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Composition

• Active Ingredients: Filgrastim (rHuG-CSF).
• Inactive Ingredients: Glacial Acetic Acid, Mannitol, Polysorbate 80 and Sodium Acetate.

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Shelf life and storage conditions

• Drug Products: Storage at 2-8°C for 36 months
• Drug Substance (Concentrated solution): Storage at 2-8°C for 18 months