NIVESTYM™ Description

(filgrastim-aafi)

11 DESCRIPTION

Filgrastim-aafi is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. NIVESTYM is produced by Escherichia coli (E coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. NIVESTYM has a molecular weight of 18‚799 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 NIVESTYM is produced in E coli‚ the product is non-glycosylated and thus differs from G-CSF isolated from a human cell.

NIVESTYM is a sterile‚ clear‚ colorless‚ preservative-free liquid containing filgrastim-aafi injection for subcutaneous or intravenous use. The product is available in single-dose vials for subcutaneous or intravenous use and prefilled syringes for subcutaneous use. The single-dose vials contain either 300 mcg/mL or 480 mcg/1.6 mL of filgrastim-aafi. The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastim-aafi. The final pH range of the NIVESTYM drug product solution is 3.8 to 4.3. See Table 4 below for product composition of each single-dose vial or prefilled syringe.

Table 4. Product Composition
	300 mcg/mL Vial	480 mcg/1.6 mL Vial	300 mcg/0.5 mL Syringe	480 mcg/0.8 mL Syringe
* quantity sufficient to make
Filgrastim-aafi	300 mcg	480 mcg	300 mcg	480 mcg
Acetate	0.59 mg	0.94 mg	0.295 mg	0.472 mg
Polysorbate 80	0.04 mg	0.064 mg	0.02 mg	0.032 mg
Sodium	0.035 mg	0.056 mg	0.0175 mg	0.028 mg
Sorbitol	50 mg	80 mg	25 mg	40 mg
Water for Injection USP q.s. ad*	1 mL	1.6 mL	0.5 mL	0.8 mL

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11 DESCRIPTION

Table 4. Product Composition
	300 mcg/mL Vial	480 mcg/1.6 mL Vial	300 mcg/0.5 mL Syringe	480 mcg/0.8 mL Syringe
* quantity sufficient to make
Filgrastim-aafi	300 mcg	480 mcg	300 mcg	480 mcg
Acetate	0.59 mg	0.94 mg	0.295 mg	0.472 mg
Polysorbate 80	0.04 mg	0.064 mg	0.02 mg	0.032 mg
Sodium	0.035 mg	0.056 mg	0.0175 mg	0.028 mg
Sorbitol	50 mg	80 mg	25 mg	40 mg
Water for Injection USP q.s. ad*	1 mL	1.6 mL	0.5 mL	0.8 mL

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11 DESCRIPTION

Table 4. Product Composition
	300 mcg/mL Vial	480 mcg/1.6 mL Vial	300 mcg/0.5 mL Syringe	480 mcg/0.8 mL Syringe
* quantity sufficient to make
Filgrastim-aafi	300 mcg	480 mcg	300 mcg	480 mcg
Acetate	0.59 mg	0.94 mg	0.295 mg	0.472 mg
Polysorbate 80	0.04 mg	0.064 mg	0.02 mg	0.032 mg
Sodium	0.035 mg	0.056 mg	0.0175 mg	0.028 mg
Sorbitol	50 mg	80 mg	25 mg	40 mg
Water for Injection USP q.s. ad*	1 mL	1.6 mL	0.5 mL	0.8 mL

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