Tevagrastim solution in in p 60ME 0.8ml N1z Ig
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Description
Solution for iv and p / to the introduction of a transparent, colorless.
Active ingredients
Filgrastim
Release form
Solution
Composition
Filgrastim, glacial acetic acid, sorbitol, polysorbate 80, sodium hydroxide, water d / i.
Pharmacological effect
Stimulator leukopoiza. Filgrastim is a highly purified non-glycosylated protein consisting of 175 amino acids. It is produced by the Escherichia coli strain, into the genome of which the gene of human granulocyte colony-stimulating factor has been introduced by genetic engineering methods.
Human granulocyte colony-stimulating factor (G-CSF) is a glycoprotein that regulates the formation of functionally active neutrophils and their release into the blood from the bone marrow. Filgrastim, containing recombinant G-CSF, significantly increases the number of neutrophils in peripheral blood already in the first 24 hours after administration, with a slight increase in the number of monocytes. In patients with severe chronic neutropenia, filgrastim may cause a slight increase in the number of circulating eosinophils and basophils.
Filgrastim increases the number of neutrophils with normal or increased functional activity in a dose-dependent manner. After the end of treatment, the number of neutrophils in the peripheral blood decreases by 50% within 1-2 days and returns to normal levels over the next 1-7 days. The duration of action with the on / in the introduction can be shortened. Filgrastim significantly reduces the frequency, severity and duration of neutropenia and febrile neutropenia, reducing the need and duration of inpatient treatment in patients receiving cytotoxic chemotherapy or myeloablative therapy with subsequent bone marrow transplantation.
Human granulocyte colony-stimulating factor (G-CSF) is a glycoprotein that regulates the formation of functionally active neutrophils and their release into the blood from the bone marrow. Filgrastim, containing recombinant G-CSF, significantly increases the number of neutrophils in peripheral blood already in the first 24 hours after administration, with a slight increase in the number of monocytes. In patients with severe chronic neutropenia, filgrastim may cause a slight increase in the number of circulating eosinophils and basophils.
Filgrastim increases the number of neutrophils with normal or increased functional activity in a dose-dependent manner. After the end of treatment, the number of neutrophils in the peripheral blood decreases by 50% within 1-2 days and returns to normal levels over the next 1-7 days. The duration of action with the on / in the introduction can be shortened. Filgrastim significantly reduces the frequency, severity and duration of neutropenia and febrile neutropenia, reducing the need and duration of inpatient treatment in patients receiving cytotoxic chemotherapy or myeloablative therapy with subsequent bone marrow transplantation.
Indications
neutropenia, febrile neutropenia in patients receiving intensive myelosuppressive cytotoxic chemotherapy for malignant diseases (with the exception of chronic myeloid leukemia and myelodysplastic syndrome), as well as neutropenia and its clinical consequences in patients receiving myeloablative therapy followed by allogeneic or autologous transplantation.
mobilization of peripheral blood stem cells, incl. after myelosuppressive therapy,
severe congenital, intermittent or idiopathic neutropenia (absolute neutrophil count (ACN) ≤ 0.5 × 109 / l) in children and adults with a history of severe or recurrent infections,
persistent neutropenia (AChN ≤ 1.0 × 109 / l) in patients with advanced HIV infection to reduce the risk of bacterial infections when it is impossible to use other treatments.
mobilization of peripheral blood stem cells, incl. after myelosuppressive therapy,
severe congenital, intermittent or idiopathic neutropenia (absolute neutrophil count (ACN) ≤ 0.5 × 109 / l) in children and adults with a history of severe or recurrent infections,
persistent neutropenia (AChN ≤ 1.0 × 109 / l) in patients with advanced HIV infection to reduce the risk of bacterial infections when it is impossible to use other treatments.
Contraindications
severe congenital neutropenia (Kostmann syndrome) with cytogenetic disorders,
use of the drug to increase doses of cytotoxic chemotherapeutic drugs higher than recommended,
simultaneous appointment with cytotoxic chemotherapy and radiation therapy,
end-stage chronic renal failure,
lactation period (breastfeeding),
newborn age (up to 28 days of life),
Hypersensitivity to filgrastim or other components of the drug.
use of the drug to increase doses of cytotoxic chemotherapeutic drugs higher than recommended,
simultaneous appointment with cytotoxic chemotherapy and radiation therapy,
end-stage chronic renal failure,
lactation period (breastfeeding),
newborn age (up to 28 days of life),
Hypersensitivity to filgrastim or other components of the drug.
Precautionary measures
Application for violations of the liver
Dosage adjustment of filgrastim is not required in patients with severe renal or hepatic insufficiency, since their pharmacokinetic and pharmacodynamic parameters are similar to those of healthy volunteers.
Application for violations of kidney function
Dosage adjustment of filgrastim is not required in patients with severe renal or hepatic insufficiency, since their pharmacokinetic and pharmacodynamic parameters are similar to those of healthy volunteers.
Patients with end-stage renal disease drug is contraindicated.
Use in children
In children with severe chronic neutropenia and oncological diseases, the safety profile of filgrastim did not differ from that in adults. Dosing guidelines for children are the same as for adults receiving myelosuppressive or cytotoxic chemotherapy.
Use in elderly patients
For elderly patients, there are no special recommendations for dosing.
Dosage adjustment of filgrastim is not required in patients with severe renal or hepatic insufficiency, since their pharmacokinetic and pharmacodynamic parameters are similar to those of healthy volunteers.
Application for violations of kidney function
Dosage adjustment of filgrastim is not required in patients with severe renal or hepatic insufficiency, since their pharmacokinetic and pharmacodynamic parameters are similar to those of healthy volunteers.
Patients with end-stage renal disease drug is contraindicated.
Use in children
In children with severe chronic neutropenia and oncological diseases, the safety profile of filgrastim did not differ from that in adults. Dosing guidelines for children are the same as for adults receiving myelosuppressive or cytotoxic chemotherapy.
Use in elderly patients
For elderly patients, there are no special recommendations for dosing.
Dosage and administration
The method of application and the dosage regimen of a particular drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular preparation with the indications for use and the dosage regimen.
Side effects
General disorders and reactions at the injection site: headache, fatigue, reactions at the injection site (less than in 2% of patients with TCN).
On the part of the musculoskeletal system: pain in the bones and muscles (often mild or moderate, infrequently - severe, which in most cases are stopped by conventional analgesics), arthralgia, osteoporosis, acute gouty arthritis, exacerbation of rheumatoid arthritis.
On the part of the digestive system: diarrhea, constipation, anorexia, hepatomegaly.
Since the cardiovascular system: very rare - transient arterial hypotension that does not require medical correction, skin vasculitis (with long-term therapy in 2% of patients with TCN), arrhythmias (connection with filrastim is not installed), vascular disorders (veno-occlusive disease, communication with the reception of filgrastim not installed).
On the part of the respiratory system: sore throat, infiltrates in the lungs, adult respiratory distress syndrome, respiratory failure, interstitial pneumonia, possibly with an unfavorable prognosis (after chemotherapy).
On the part of the musculoskeletal system: pain in the bones and muscles (often mild or moderate, infrequently - severe, which in most cases are stopped by conventional analgesics), arthralgia, osteoporosis, acute gouty arthritis, exacerbation of rheumatoid arthritis.
On the part of the digestive system: diarrhea, constipation, anorexia, hepatomegaly.
Since the cardiovascular system: very rare - transient arterial hypotension that does not require medical correction, skin vasculitis (with long-term therapy in 2% of patients with TCN), arrhythmias (connection with filrastim is not installed), vascular disorders (veno-occlusive disease, communication with the reception of filgrastim not installed).
On the part of the respiratory system: sore throat, infiltrates in the lungs, adult respiratory distress syndrome, respiratory failure, interstitial pneumonia, possibly with an unfavorable prognosis (after chemotherapy).
Overdose
No cases of filgrastim overdose have been reported. 1-2 days after discontinuation of the drug, the number of circulating neutrophils is usually reduced by 50% and returns to normal levels after 1-7 days.
Interaction with other drugs
The efficacy and safety of administering filgrastim in one day with cytotoxic chemotherapy have not been established. Due to the high sensitivity of actively proliferating myeloid cells to antitumor cytotoxic drugs, it is not recommended to prescribe filgrastim 24 hours before or after the administration of these drugs.
Fluorouracil increases the severity of neutropenia while being administered with filgrastim. The possible interaction with other hematopoietic growth factors and cytokines is unknown.
Given that lithium stimulates the release of neutrophils, it is possible to enhance the action of filgrastim with a combined appointment, but such studies have not been conducted.
Filgrastim is pharmaceutically incompatible with 0.9% sodium chloride solution. When applying filgrastim to mobilize hematopoietic stem cells after chemotherapy, it should be borne in mind that when prescribing cytostatics such as melphalan, carmustine and carboplatin for a long time, the effectiveness of mobilization can be reduced.
Fluorouracil increases the severity of neutropenia while being administered with filgrastim. The possible interaction with other hematopoietic growth factors and cytokines is unknown.
Given that lithium stimulates the release of neutrophils, it is possible to enhance the action of filgrastim with a combined appointment, but such studies have not been conducted.
Filgrastim is pharmaceutically incompatible with 0.9% sodium chloride solution. When applying filgrastim to mobilize hematopoietic stem cells after chemotherapy, it should be borne in mind that when prescribing cytostatics such as melphalan, carmustine and carboplatin for a long time, the effectiveness of mobilization can be reduced.