Filgrastim (Neupogen ®)
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Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]
| [300 mcg] [19 ml] [15-30 min]
Stability / Miscellaneous
Note: if Neupogen is diluted to a concentration below 15 mcg/ml, it should be protected from absorption to glass and plastic by the addition of albumin to a final concentration of 2 mg/ml.
ANC (absolute neutrophil count)= (% segs + % bands) x WBC.
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 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 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 containing Filgrastim at a specific activity of 1.0 ± 0.6 x 108 U/mg (as measured by a cell mitogenesis assay). The product is available in single use vials and prefilled syringes. The single use vials contain either 300 mcg or 480 mcg Filgrastim at a fill volume of 1.0 mL or 1.6 mL, respectively. The single use prefilled syringes contain either 300 mcg or 480 mcg Filgrastim at a fill volume of 0.5 mL or 0.8 mL, respectively.
Endogenous G-CSF is a lineage specific colony-stimulating factor which is produced by monocytes‚ fibroblasts, and endothelial cells. G-CSF regulates the production of neutrophils within the bone marrow and affects neutrophil progenitor proliferation‚ differentiation and selected end-cell functional activation (including enhanced phagocytic ability priming of the cellular metabolism associated with respiratory burst antibody dependent killing and the increased expression of some functions associated with cell surface antigens). G-CSF is not species specific and has been shown to have minimal direct in vivo or in vitro effects on the production of hematopoietic cell types other than the neutrophil lineage.
DOSAGE AND ADMINISTRATION
Cancer Patients Receiving Myelosuppressive Chemotherapy
NEUPOGEN® should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. NEUPOGEN® should not be administered in the period 24 hours before the administration of chemotherapy (see package insert for PRECAUTIONS). NEUPOGEN® should be administered daily for up to 2 weeks‚ until the ANC has reached 10‚000/mm3 following the expected chemotherapy-induced neutrophil nadir. The duration of NEUPOGEN® therapy needed to attenuate chemotherapy-induced neutropenia may be dependent on the myelosuppressive potential of the chemotherapy regimen employed. NEUPOGEN® therapy should be discontinued if the ANC surpasses 10‚000/mm3 after the expected chemotherapy-induced neutrophil nadir (see package insert for PRECAUTIONS). In phase 3 trials‚ efficacy was observed at doses of 4 to 8 mcg/kg/day.
Cancer Patients Receiving Bone Marrow Transplant
During the period of neutrophil recovery‚ the daily dose of NEUPOGEN® should be titrated against the neutrophil response as follows:
Peripheral Blood Progenitor Cell Collection and Therapy in Cancer Patients
In all clinical trials of NEUPOGEN® for the mobilization of PBPC‚ NEUPOGEN® was also administered after reinfusion of the collected cells (see CLINICAL EXPERIENCE).
Patients With Severe Chronic Neutropenia
Congenital Neutropenia: The recommended daily starting dose is 6 mcg/kg BID SC every day.
Idiopathic or Cyclic Neutropenia: The recommended daily starting dose is 5 mcg/kg as a single injection SC every day.
Chronic daily administration is required to maintain clinical benefit. Absolute neutrophil count should not be used as the sole indication of efficacy. The dose should be individually adjusted based on the patients’ clinical course as well as ANC. In the SCN postmarketing surveillance study, the reported median daily doses of NEUPOGEN® were: 6.0 mcg/kg (congenital neutropenia), 2.1 mcg/kg (cyclic neutropenia), and 1.2 mcg/kg (idiopathic neutropenia). In rare instances, patients with congenital neutropenia have required doses of NEUPOGEN® ≥ 100 mcg/kg/day.
Dilution of NEUPOGEN® to a final concentration of less than 5 mcg/mL is not recommended at any time. Do not dilute with saline at any time; product may precipitate.
Use only one dose per prefilled syringe. Discard unused portions. Do not save unused drug for later administration.
Single-dose‚ preservative-free vials containing 480 mcg (1.6 mL) of Filgrastim (300 mcg/mL). Dispensing packs of 10 (NDC 55513-546-10).
Prefilled Syringes (SingleJect®)
Single-dose‚ preservative-free, prefilled syringes with 27 gauge, ½ inch needles with an UltraSafe® Needle Guard, containing 480 mcg (0.8 mL) of Filgrastim (600 mcg/mL). Dispensing packs of 10 (NDC 55513-209-10).
The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex).
NEUPOGEN® should be stored at 2° to 8°C (36° to 46°F). Avoid shaking.