Universal reference book for medicines
Name of the preparation: NEIPOGEN ® (NEUPOGEN ® )

Active substance: filgrastim

Type: Leukopoiesis stimulant

Manufacturer: F.Hoffmann-La Roche (Switzerland) trademark belongs to AMGEN (USA)
Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..
PHARMACHOLOGIC EFFECT
G-CSF. Immunomodulator. It is a highly purified, non-glycosylated protein. Regulates the production of functional neutrophils and their release into the blood from the bone marrow. Causes a marked increase in neutrophils within 24 hours and a slight increase in monocytes.
PHARMACOKINETICS
V d is about 150 ml / kg. Do not cumulate.
T 1/2 is about 3.5 hours, the clearance is about 0.6 ml / min / kg.
INDICATIONS
To reduce the duration of neutropenia and the frequency of febrile neutropenia in patients receiving chemotherapy with cytotoxic agents for malignant diseases (with the exception of chronic myelogenous leukemia and myelodysplastic syndrome), as well as reducing the duration of neutropenia and its clinical consequences in patients receiving myeloablative therapy followed by bone marrow transplantation.
To mobilize autologous progenitor cells of hemopoiesis in peripheral blood (including after myelosuppressive therapy), to accelerate the recovery of hemopoiesis by the administration of these cells after myelosuppression or myeloablation.
Long-term therapy to increase the number of neutrophils and reduce the frequency and duration of infectious complications in children and adults with severe congenital, periodic or malignant neutropenia (absolute neutrophil count <500 / μl) and severe or recurrent infections in the anamnesis.
DOSING MODE
Individual, depending on the indications and treatment regimen.
SIDE EFFECT
From the musculoskeletal system: pain in the muscles or bones is possible.
From the side of the urinary system: dysuria is possible.
From the side of the cardiovascular system: transient arterial hypotension is possible.
On the part of laboratory indicators: reversible increase in levels of LDH, APP and GGT, uric acid in blood plasma.
Other: rarely, mainly after IV introduction - symptoms indicating allergic reactions (about half of them were associated with the administration of the first dose).
CONTRAINDICATIONS
Severe congenital neutropenia (Costman's syndrome) with cytogenetic disorders, increased sensitivity to filgrastim.
PREGNANCY AND LACTATION
Safety of use in pregnancy is not established, so the expected benefit of therapy for the mother and the potential risk to the fetus should be assessed.
If necessary, use during lactation should stop breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
It is not recommended to use in patients with severe impairment of kidney function; The efficacy and safety of filgrastim in this category of patients has not been studied.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
It is not recommended to use in patients with severe impairment of liver function, t. The efficacy and safety of filgrastim in this category of patients has not been studied.
APPLICATION FOR CHILDREN
Safety and efficacy in newborns have not been established.
APPLICATION IN ELDERLY PATIENTS
Special studies of the efficacy and safety of filgrastim in elderly patients were not conducted.
SPECIAL INSTRUCTIONS
It is not recommended for patients with severe impairment of renal or hepatic function. The efficacy and safety of filgrastim in this category of patients has not been studied.
Patients with concomitant osteal pathology and osteoporosis who receive filgrastim continuously for more than 6 months are advised to control bone density.
The efficacy of filgrastim in patients with a significantly reduced number of myeloid progenitor cells has not been studied. Filgrastim increases the number of neutrophils by first affecting the neutrophil precursor cells. Therefore, in patients with a reduced content of progenitor cells (for example, those subjected to intensive radiation therapy or chemotherapy), the degree of increase in the number of neutrophils may be lower.
Human G-CSF can cause the growth of myeloid cells in vitro. Similar effects can be observed in vivo and in some nonmyeloid cells. The safety and efficacy of filgrastim in patients with myelodysplastic syndrome and chronic myeloid leukemia have not been established, therefore, it is not indicated in these diseases. A differential diagnosis should be made especially between the blastotransformation of chronic myelogenous leukemia and acute myeloid leukemia.
During the treatment period it is necessary to regularly determine the number of leukocytes. If after passing the expected minimum it exceeds 50,000 / μL filgrastim should be immediately canceled. If filgrastim is used to mobilize peripheral blood hematopoietic progenitor cells, it is abolished when the number of leukocytes exceeds 100,000 / μL.
With extreme caution should be used in patients receiving high-dose cytotoxic chemotherapy.
Monotherapy with filgrastim does not prevent thrombocytopenia and anemia caused by myelosuppressive chemotherapy. It is recommended to regularly determine the number of platelets and hematocrit. Particular caution should be exercised when using single-component or combined chemotherapeutic regimens known to be capable of causing severe thrombocytopenia.
Before filgrastim with severe chronic neutropenia, a differential diagnosis with other hematological diseases, such as aplastic anemia, myelodysplasia and myeloid leukemia, should be carried out especially carefully. Before the start of treatment should be an extensive blood test with the definition of the leukocyte formula and the number of platelets, as well as to investigate the morphological picture of the bone marrow and karyotype.
Care should be taken to monitor the blood picture, incl. number of platelets, especially during the first few weeks of treatment with filgrastim. When thrombocytopenia (the number of platelets stably below 100,000 / μL) should consider the temporary withdrawal of filgrastim or a decrease in dose. There are also other changes in the blood formula, which require its careful monitoring, incl. anemia and a transient increase in the number of myeloid progenitor cells.
During the period of treatment, the size of the spleen should be regularly monitored, urinalysis should be performed.
Estimating the number of progenitor cells mobilized in patients with filgrastim should pay special attention to the method of quantitative determination. The results of a flow cytometric analysis of the number of CD34 + cells differ depending on the particular methodology, and care should be taken for recommendations based on the number of studies conducted in other laboratories.
Special studies of the efficacy and safety of filgrastim in elderly patients were not conducted.
Safety and efficacy in newborns and patients with autoimmune neutropenia have not been established.
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