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You are here: Home » eGM Resources » Health Information & Resources Portal|Home » RX Drug List (listed alphabetically) » Drug Reference (F's) » Filgrastim



DESCRIPTION

Filgrastim is a human granulocyte colony stimulating factor (G-CSF) produced by recombinant DNA technology. NEUPOGEN® is the Amgen Inc. trademark for Filgrastim which has been selected as the name for recombinant methionyl human granulocyte colony stimulating factor (r-metHuG-CSF).

NEUPOGEN is a 175 amino acid protein manufactured by recombinant DNA technology.1 NEUPOGEN is produced by Escherichia coli (E coli) bacteria into which has been inserted the human granulocyte colony stimulating factor gene. NEUPOGEN has a molecular weight of 18800 daltons. 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. Because NEUPOGEN is produced in E coli the product is nonglycosylated and thus differs from G-CSF isolated from a human cell.

NEUPOGEN is a sterile clear colorless preservative-free liquid for parenteral administration. Each single-use vial of NEUPOGEN contains 300 mcg/mL of Filgrastim at a specific activity of 1.0 ± 0.6 x 108 U/mg (as measured by a cell mitogenesis assay). The product is formulated in a 10 mM sodium acetate buffer at pH 4.0 containing 5% sorbitol and 0.004% Tween® 80. The quantitative composition (per mL) of NEUPOGEN is:

Filgrastim

300 mcg

Acetate

0.59 mg

Sorbitol

50.0 mg

Tween® 80

0.004%

Sodium

0.035 mg

Water for Injection
  USP q.s. ad

1.0 mL





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