To reduce the duration and frequency of neutropenia, including that accompanied by a febrile reaction in patients receiving chemotherapy with cytotoxic agents, in non-myeloid malignant diseases. To reduce the duration of neutropenia and its clinical consequences in patients receiving myeloablative therapy with subsequent bone marrow transplantation. For the mobilization of autologous peripheral blood progenitor cells (PPC) after myelosuppressive therapy, to accelerate the recovery of hematopoiesis by introducing these cells after myelosuppression or myeloablation. With long-term therapy aimed at increasing the number of neutrophils, to reduce the frequency and duration of infectious complications in children and adults with severe congenital, periodic or malignant neutropenia (absolute number of neutrophils <500 in 1 mm 3) and a history of severe or recurrent infections.
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Filstim 0.3 mg Composition
active substance: filgrastim;
1 ml of solution contains 0.3 mg (30 million IU) of filgrastim granulocyte colony-stimulating factor (G-CSF);
excipients: sodium acetate, trihydrate; polysorbate 80; sorbitol (E 420); water for injections.
Filstim 0.3 mg Dosage form
Basic physical and chemical properties: transparent or slightly opalescent, colorless or slightly yellowish liquid.
Filstim 0.3 mg Pharmacotherapeutic group
Immunostimulants. Colony-stimulating factors. Filgrastim. ATX code L03A A02.
Filgrastim is a highly purified, non-glycolyzed polypeptide containing 175 amino acid residues.
It is produced by a genetically modified culture of Escherichia coli BL21 (DE3) / pES3-7 containing the gene of human granulocyte colony-stimulating factor (G-CSF).
Human G-CSF regulates the formation of functionally active neutrophilic granulocytes and their entry into the blood from the bone marrow.
Filstim®, containing recombinant G-CSF, markedly increases the number of neutrophilic granulocytes in the peripheral blood already within the first 24 hours after administration and at the same time causes a slight increase in the number of monocytes.
The increase in the number of neutrophilic granulocytes and their functional characteristics depend on the dose.
The use of filgrastim preparations significantly reduces the frequency and duration of neutropenia in patients after chemotherapy with cytostatics, myeloablative therapy followed by bone marrow transplantation.
In patients who received the drug, there is less need for hospitalization, they spend less time in the hospital, require lower doses of antibiotics compared to patients who received only cytotoxic therapy.
Filgrastim use (both primary and after chemotherapy) activates peripheral blood progenitor cells (PBPCs).
In children and adults with severe chronic neutropenia (severe congenital, periodic and malignant neutropenia), the drug steadily increases the number of peripheral blood neutrophilic granulocytes and reduces the incidence of infectious complications.
After completion of treatment with the drug, the number of neutrophilic granulocytes in the peripheral blood decreases by 50% within 1–2 days and returns to normal levels within 1–7 days.
After subcutaneous administration of the drug in recommended doses, its concentration in the blood serum exceeds 10 ng / ml for 8-16 hours; the volume of distribution in the blood is about 150 ml / kg. The average serum half-life of filgrastim is about 3.5 hours, and the clearance rate is about 0.6 ml / min per 1 kg of body weight. Continuous infusion for 28 days in patients recovering from autologous bone marrow transplantation was not accompanied by signs of cumulation and an increase in the half-life of the drug.
To shorten the duration and reduce the incidence of neutropenia, including accompanied by a febrile reaction, in patients receiving chemotherapy with cytotoxic agents for non-myeloid malignant diseases.
To reduce the duration of neutropenia and its clinical consequences in patients receiving myeloablative therapy followed by bone marrow transplantation.
For the mobilization of autologous peripheral blood progenitor cells (PBPC) after myelosuppressive therapy, to accelerate the recovery of hematopoiesis by introducing these cells after myelosuppression or myeloablation.
With long-term therapy aimed at increasing the number of neutrophilic granulocytes, to reduce the frequency and to reduce the duration of infectious complications in children and adults with severe congenital, periodic or malignant neutropenia (absolute number of neutrophilic granulocytes <500 in 1 mm3) and with severe or recurrent infections in anamnesis.
Hypersensitivity to filgrastim, colony-stimulating factors, Escherichia coli, or to any component of the drug.
Should not be used to increase tolerance to increased doses of cytotoxic chemotherapy drugs.
Severe congenital neutropenia (Kostman syndrome) with cytogenetic abnormalities and autoimmune neutropenia.
Terminal stage of chronic renal failure (CRF).
Chronic myeloid leukemia and myelodysplastic syndrome.