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Clinical Pharmacology

Neupomax has a leukopoetic effect.


The active ingredient of the drug is filgrastim - recombinant human granulocyte colony-stimulating factor (G-CSF). Filgrastim has the same biological activity as the endogenous human G-CSF, and differs from the latter only in that it is a non-glycosylated protein with an additional N-terminal methionine residue. Filgrastim, produced by recombinant DNA technology, is isolated from the cells of the bacterium Escherichia coli, the gene encoding the protein G-CSF is introduced into the genetic apparatus.

Filgrastim stimulates the formation of functionally active neutrophils and their release into the peripheral blood from the bone marrow, is used in the treatment of patients with neutropenia of various origins.


Both intravenous and subcutaneous administration of filgrastim, there is a positive linear dependence of its serum concentration on the dose. The volume of distribution in the blood is approximately 150 ml / kg.

The average half-life of filgrastim from serum is about 3.5 hours, and the clearance rate is approximately 0.6 ml / min / kg.

Continuous infusion of filgrastim for up to 28 days in patients after an autologous bone marrow transplant is not accompanied by signs of cumulation and an increase in half-life.


  • Neutropenia (including in patients receiving cytotoxic drugs for non-myeloid malignant neoplasms);
  • reduction of the duration of the period of neutropenia and its clinical consequences in patients preparing for bone marrow transplantation;
  • persistent neutropenia in patients with advanced HIV infection (absolute neutrophil count 1000 cells / mcl or less);
  • mobilization of peripheral stem cells (including after myelosuppressive therapy);
  • neutropenia (hereditary, intermittent or idiopathic - the number of neutrophils is less than or equal to 500 cells / mcl) and severe or recurrent infections (in history) in the last 12 months.


Active substance: filgrastim 300 mcg (30 million ED.);

Excipients: acetic acid glacial, sodium hydroxide (soda), sorbitol (sorbitol), polysorbate 80, water for injection

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Dosage and Administration

Neupomax can be administered by daily subcutaneous (sc) injection or daily short (30 minute) intravenous (iv) infusion. Also, the drug can be administered in the form of 24-hour intravenous or subcutaneous infusion.

The choice of route of administration should depend on the specific clinical situation, but in most cases, the subcutaneous route of administration is preferred.

In order to avoid pain, with the introduction it is best to change the injection site daily.

Standard Cytotoxic Chemotherapy Schemes 
At 5 mcg / kg of body weight 1 time per day, daily subcutaneously or intravenously, for 30 minutes. until, after the occurrence of the expected maximum reduction in the level of neutrophils, their number does not return to the normal level, at which the drug can be canceled.

The first dose of Neipomax should be administered no earlier than 24 hours after the end of the course of cytotoxic chemotherapy. The duration of therapy is up to 14 days. After induction and consolidation therapy of acute myeloid leukemia, the duration of use of Neipomax may increase up to 38 days depending on the type, doses and chemotherapy regimen used.

Usually a transient increase in the number of neutrophils is observed 1-2 days after the start of treatment with filgrastim. To achieve a stable therapeutic effect, it is not recommended to interrupt treatment until normal neutrophil values ​​are reached after the expected maximum reduction in their level. With an absolute number of neutrophils in excess of 10,000 / μl, treatment with Neipomax is stopped.

Myeloablative therapy followed by autologous or allogeneic bone marrow transplantation 
The initial dose is 10 mcg / kg per day intravenous drip for 30 minutes or 24 hours, or as a 24-hour s / c infusion.

The first dose of Neipomax should be administered no earlier than 24 hours after cytotoxic chemotherapy, and for bone marrow transplantation, no later than 24 hours.

The duration of therapy is not more than 28 days. The daily dose of the drug is corrected depending on the dynamics of the content of neutrophils. With an absolute neutrophil count of more than 1000 / μl for three consecutive days, the dose of Neipomax is reduced to 5 μg / kg / day. If during the use of this dose for another 3 consecutive days, the absolute number of neutrophils exceeds 1000 / mcl, the administration of Neupmax is stopped. If during treatment the absolute number of neutrophils is reduced to a level of less than 1000 / μl, the dose of Neipomax is increased again, in accordance with the above scheme.

Mobilization of peripheral blood stem cells in patients with neoplastic diseases. 
At 10 mcg / kg 1 time per day, s / c or by continuous 24-hour s / c infusion for 6 consecutive days. In this case, they usually spend 2 leukapheresis in a row, on the 5th and 6th days. In the case of additional leukapheresis, administration of Neipomax should be continued until the last leukapheresis.

Mobilization of PSKK after myelosuppressive chemotherapy 
At 5 mcg / kg per day by daily subcutaneous injections, starting from the first day after completion of chemotherapy and until the number of neutrophils reaches normal values. Leukapheresis should be carried out only when the absolute number of neutrophils exceeds normal values ​​(> 2000 / μl).

Mobilization of PSCC in healthy donors for allogeneic transplantation 
At 10 mcg / kg / day s / c for 4-5 days and carrying out 1 or 2 leukapheresis usually allows you to get more than 4 x 106 CD34 + cells / kg body weight of the recipient. There are no data on the safety and efficacy of filgrastim in healthy donors younger than 16 and older than 60 years.

Severe chronic neutropenia (TCN) 
Neupomax administered at an initial dose of 12 mcg / kg / day for congenital neutropenia and 5 mcg / kg / day for idiopathic or periodic neutropenia subcutaneously once or by several injections daily until the number of neutrophils consistently exceeds 1500 / mcl.After reaching a therapeutic effect, determine the minimum effective dose to maintain this level. After 1-2 weeks of treatment, the initial dose can be doubled or reduced by half, depending on the patient's response to therapy. Subsequently, every 1–2 weeks, individual dose adjustment can be made to maintain the average number of neutrophils in the range of 1500–10,000 / μl. In patients with severe infections, a regimen with a faster dose increase can be applied. The safety of filgrastim in the long-term treatment of patients with TCN doses of more than 24 mg per day has not been established.

Neutropenia in HIV infection 
The initial dose of 1-4 mcg (0.1 -0.4 million units) / kg subcutaneously 1 time per day until normalization of the number of neutrophils. The maximum daily dose should not exceed 10 mcg / kg. After achieving a therapeutic effect, it is recommended to apply Grasalva in a maintenance dose: 300 μg of s / c every other day. Subsequently, doses are adjusted individually for each individual case in order to maintain an average neutrophil count of more than 2000 / μl.

Application in children's practice 
Dosing recommendations for pediatric patients are the same as for adults.

Elderly patients, patients with impaired renal or hepatic function. 
Neapomax dose adjustment is not required.

Breeding instructions 
Subcutaneous the drug should not be further diluted.

When preparing a solution for infusion Neupomax diluted with only 5% dextrose solution. Dilution with 0.9% sodium chloride solution is not allowed (pharmaceutical incompatibility).

Neupomax in diluted form in a concentration of from 2 to 15 μg / ml can be adsorbed by glass and plastics. In this case, to prevent absorption, it is necessary to add human serum albumin in the required amount to achieve its concentration in the final solution of 2 mg / ml. For a diluted solution of Neipomax at a concentration of more than 15 μg / ml, the addition of albumin is not required.

It is impossible to dilute Neipomaks to a concentration of less than 2 μg / ml.

Adverse reactions

From the musculoskeletal system:pains in bones, muscles and joints, osteoporosis.

From the digestive system: anorexia, diarrhea, hepatomegaly, nausea and vomiting.

Allergic reactions: skin rash, urticaria, swelling of the face, wheezing, shortness of breath, lowering blood pressure, tachycardia.

From the side of blood-forming organs: neutrophilia and leukocytosis (as a result of the pharmacological action of filgrastim), anemia, thrombocytopenia, enlargement and rupture of the spleen.

On the part of the respiratory system: adult respiratory distress syndrome, pulmonary infiltrates.

Since the cardiovascular system: decrease or increase in blood pressure, cutaneous vasculitis.

From the laboratory indicators: reversible increase in lactate dehydrogenase, alkaline phosphatase, gamma-glutamyltransferase, uric acid, transient hypoglycemia after a meal; very rarely: proteinuria, hematuria.

Other: headache, fatigue, weakness, nosebleeds, petechiae, erythema nodosum.


Hypersensitivity, severe congenital neutropenia with abnormal cytogenetics (Kostmann syndrome), increased doses of cytotoxic chemotherapeutic agents higher than recommended, hepatic and / or renal failure, up to 1 year old.

Special instructions

During treatment with the drug Neipomaks blood tests should be carried out.

Studies and clinical trials of Filgrastim (Click to expand)
  1. Prospective and randomized comparison of early versus delayed prophylactic administration of granulocyte colony-stimulating factor (filgrastim) in children with cancer
  2. Phase I trial of paclitaxel, carboplatin, and topotecan with or without filgrastim (granulocyte-colony stimulating factor) in the treatment of patients with advanced, refractory cancer
  3. Prospective, concurrent comparison of the Cobe Spectra and Haemonetics MCS-3P cell separators for leukapheresis after high-dose filgrastim in patients with hematologic malignancies
  4. A phase I trial to assess the value of recombinant human granulocyte colony stimulating factor (r-MetHuG-CSF, filgrastim) in accelerating the dose rate of chemotherapy for intermediate and high-grade non-Hodgkin's lymphoma (NHL)
  5. Oral combination chemotherapy in conjunction with filgrastim (G-CSF) in the treatment of AIDS-related non-Hodgkin's lymphoma: Evaluation of the role of G-CSF; Quality-of-life analysis and long-term follow-up
  6. Pharmacodynamics and pharmacokinetics of single doses of subcutaneous pegylated human G-CSF mutant (Ro 25-8315) in healthy volunteers: Comparison with single and multiple daily doses of filgrastim
  7. Lenograstim and filgrastim effects on neutrophil motility in patients undergoing chemotherapy: Evaluation by computer-assisted image analysis
  8. Stimulation of Kaposi's sarcoma-associated herpesvirus viremia during hematopoietic stem cell mobilization with filgrastim
  9. Rapid diffuse alveolar hemorrhage associated with all-trans-retinoic acid and filgrastim
  10. Reduced dose of lenograstim is as efficacious as standard dose of filgrastim for peripheral blood stem cell mobilization and transplantation: A randomized study in patients undergoing autologous peripheral stem cell transplantation
  11. Treatment of chronic neutropenia associated with large granular lymphocytosis with cyclosporine a and filgrastim
  12. Targeted filgrastim support in patients with early-stage breast carcinoma : Toward the implementation of a risk model
  13. Granulocyte–colony-stimulating factor (filgrastim) may overcome imatinib-induced neutropenia in patients with chronic-phase chronic myelogenous leukemia
  14. Phase II trial of dose-dense paclitaxel, cisplatin, 5-fluorouracil, and leucovorin with filgrastim support in patients with squamous cell carcinoma of the head and neck
  15. Granulocyte—colony-stimulating factor (Filgrastim) may overcome imatinib-induced neutropenia in patients with chronic-phase myelogenous leukemia
  16. Dose-dense vinorelbine and docetaxel with Filgrastim support in patients with advanced nonsmall cell lung carcinoma
  17. Comparison of hospitalization risk and associated costs among patients receiving sargramostim, filgrastim, and pegfilgrastim for chemotherapy-Induced neutropenia
  18. Comparison of hospitalization risk and associated costs among patients receiving sargramostim, filgrastim, and pegfilgrastim for chemotherapy-induced neutropenia
  19. Reply to Comparison of hospitalization risk and associated costs among patients receiving sargramostim, filgrastim, and pegfilgrastim for chemotherapy-induced neutropenia
  20. Comparison of fixed dose pegfilgrastim and daily filgrastim after autologous stem cell transplantation in patients with multiple myeloma autografted on a outpatient basis
  21. Harvesting peripheral blood progenitor cells from healthy donors: retrospective comparison of filgrastim and lenograstim
  22. Collection efficiency on the fenwal CS3000 when using filgrastim (recombinant methionyl human granulocyte colony-stimulating factor) as a peripheral blood stem cell mobilization agent
  23. Polyethylene glycol modification of filgrastim results in decreased renal clearance of the protein in rats
  24. High-dose epirubicin and r-met-hu G-CSF (Filgrastim) in the treatment of patients with advanced breast cancer: A hellenic cooperative oncology group study

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