March 28, 2017
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Zarxio

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Zarxio

ZARXIO®
(filgrastim-sndz) Injection

DRUG DESCRIPTION

ZARXIO (filgrastim-sndz) is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology.

ZARXIO is produced by Escherichia coli (E coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. ZARXIO has a molecular weight of 18‚800 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 ZARXIO is produced in E coli‚ the product is nonglycosylated and thus differs from G-CSF isolated from a human cell.

ZARXIO injection is a sterile‚ clear‚ colorless to slightly yellowish‚ preservative-free liquid containing filgrastim-sndz at a specific activity of 1.0 x 108 U/mg (as measured by a cell mitogenesis assay). The product is available in single-dose prefilled syringes. The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastimsndz. See Table 4 below for product composition of each single-dose prefilled syringe.

Table 4. Product Composition

  300 mcg/0.5 mL Syringe 480 mcg/0.8 mL Syringe
Filgrastim-sndz 300 mcg 480 mcg
Glutamic Acid 0.736 mg 1.178 mg
Polysorbate 80 0.02 mg 0.032 mg
Sorbitol 25 mg 40 mg
Sodium hydroxide q.s. q.s.
Water for Injection USP q.s. ad* ad 0.5 mL ad 0.8 mL
*quantity sufficient to make

Last reviewed on RxList: 3/2/2017
This monograph has been modified to include the generic and brand name in many instances.

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