Source: FDA, National Drug Code (US) Revision Year: 2021
Filgrastim is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. Filgrastim is produced by Escherichia coli (E coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. Filgrastim 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 filgrastim is produced in E coli‚ the product is non-glycosylated and thus differs from G-CSF isolated from a human cell.
NEUPOGEN injection is a sterile‚ clear‚ colorless‚ preservative-free liquid containing filgrastim at a specific activity of 1.0 ± 0.6 × 108 U/mg (as measured by a cell mitogenesis assay). The product is available in single-dose vials and prefilled syringes. The single-dose vials contain either 300 mcg/mL or 480 mcg/1.6 mL of filgrastim. The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastim. See table below for product composition of each single-dose vial or prefilled syringe.
| 300 mcg/mL Vial | 480 mcg/1.6 mL Vial | 300 mcg/0.5 mL Syringe | 480 mcg/0.8 mL Syringe | |
|---|---|---|---|---|
| filgrastim | 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 |
* quantity sufficient to make
| Dosage Forms and Strengths |
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NEUPOGEN is a clear, colorless, preservative-free solution available as: Vial:
Prefilled Syringe:
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| How Supplied |
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NEUPOGEN injection is a clear, colorless, preservative-free solution supplied as: Vials: Single-dose vials containing 300 mcg/mL of filgrastim. Dispensing packs of 10 vials (NDC 55513-530-10). Single-dose vials containing 480 mcg/1.6 mL (300 mcg/mL) of filgrastim. Dispensing packs of 10 vials (NDC 55513-546-10). Prefilled Syringes (SingleJect): Single-dose, prefilled syringe with 27 gauge, ½ inch needle with an UltraSafe Needle Guard, containing 300 mcg/0.5 mL of filgrastim.
Single-dose, prefilled syringe with 27 gauge, ½ inch needle with an UltraSafe Needle Guard, containing 480 mcg/0.8 mL of filgrastim.
The needle cap of the prefilled syringe contains dry natural rubber (a derivative of latex) [see Dosage and Administration (2.6)]. Manufactured by: Amgen Inc., One Amgen Center Drive, Thousand Oaks, California 91320-1799, U.S. License Number 1080 |
| Drug | Countries | |
|---|---|---|
| NEUPOGEN | Australia, Canada, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Singapore, Turkey, United Kingdom, United States, South Africa |
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