Active substanceFilgrastimFilgrastim
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  • Dosage form: & nbspsolution for subcutaneous and intravenous administration
    Composition:

    In 1 ml of solution contains:

    active substance: filgrastim 300 μg;

    Excipients: sodium chloride, sodium acetate, rheopolyglucin, water for injection.

    Description:

    Colorless, clear liquid.

    Pharmacotherapeutic group:Leukopoiesis stimulant
    ATX: & nbsp

    L.03.A.A.02   Filgrastim

    Pharmacodynamics:

    The active substance of the drug is filgrastim recombinant human granulocyte colony-stimulating factor (G-CSF). 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.

    Pharmacokinetics:

    Both intravenous and subcutaneous administration of filgrastim, a linear dependence of its serum concentration on dose is observed. The half-life of filgrastim from serum is about 3.5 hours.

    Indications:

    - Neutropenia, febrile neutropenia, due to myelosuppressive cytotoxic chemotherapy for malignant diseases (with the exception of chronic myelogenous leukemia and myelodysplastic syndrome);

    - tsevere congenital, periodic or idiopathic neutropenia (absolute number of neutrophils ≤500 / μl) in children and adults with severe or recurrent infections in the anamnesis.

    Contraindications:

    - Hypersensitivity to filgrastimu or other components of the drug;

    - fromIndus Kostmann (severe hereditary neutropenia with cytogenetic disorders);

    - PThe use of the drug in order to increase the doses of cytotoxic chemotherapeutic drugs is higher than recommended.

    Carefully:

    Malignant and premalignant diseases of myeloid nature (including acute myelogenous leukemia), sickle cell disease.

    Pregnancy and lactation:

    The drug category C.

    Safety filgrastim for pregnant women is not established. When prescribing filgrastim, pregnant women should correlate the expected therapeutic effect with the possible risk to the fetus.

    It is not known whether the filgrastim in breast milk. Use filgrastim in nursing mothers is not recommended.

    Dosing and Administration:

    Subcutaneously or intravenously drip for 30 minutes. To avoid pain during subcutaneous administration, it is recommended to change the injection site daily.

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

    Standard schemes of cytotoxic chemotherapy

    At 5 μg / kg body weight 1 time per day daily until the normal values ​​of the number of neutrophils.

    The first dose of Neutrostim ® should be administered no earlier than 24 hours after the end of the course of cytotoxic chemotherapy. Duration of therapy up to 14 days. After induction and consolidation therapy of acute myelogenous leukemia, the duration of Neustrostim® application can increase up to 38 days depending on the type, dosage and chemotherapy scheme used.

    Usually a transient increase in the number of neutrophils is observed 1-2 days after initiation of treatment with Neutrostim ®. To achieve a stable therapeutic effect, interrupt treatment until normal neutrophil values ​​are not recommended. With an absolute number of neutrophils greater than 10,000 / μL, Neurostim® treatment is discontinued.

    Severe chronic neutropenia (THC)

    Neutrostim® is given at an initial dose of 12 μg / kg / day for congenital neutropenia and 5 μg / kg / day for idiopathic or intermittent neutropenia subcutaneously single or by several administrations daily,until the number of neutrophils is stably greater than 1500 / μl. Once the therapeutic effect is achieved, the minimum effective dose is determined to maintain this level. After 1-2 weeks of treatment, the initial dose can be doubled or halved, depending on the patient's response to therapy. Subsequently, every 1-2 weeks, individual dose adjustment can be performed to maintain the average number of neutrophils in the range of 1500-10000 / μL. In patients with severe infections, a scheme with a faster increase in dose can be used. The safety of filgrastim with prolonged treatment of patients with TCN doses greater than 24 μg per day is not established.

    Side effects:

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

    On the part of the digestive system: anorexia, diarrhea, hepatomegaly, nausea and vomiting.

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

    From the hematopoiesis: neutrophilia and leukocytosis (as a consequence 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, infiltrates in the lungs.

    From the side of the cardiovascular system: decrease or increase of arterial pressure, cutaneous vasculitis.

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

    Other: headache, fatigue, general weakness, epistaxis, petechiae, erythema nodosum.

    Filgrastim does not increase the incidence of adverse reactions of cytotoxic therapy.

    Overdose:

    The effect of filgrastim in overdose is not established.

    Interaction:

    The safety and efficacy of filgrastim administration on the same day as myelosuppressive antitumor drugs have not been established.

    There are some reports of increased severity of neutropenia with the simultaneous administration of filgrastim and 5-fluorouracil.

    Data on the possible interaction with other hematopoietic growth factors and cytokines are currently not available.

    Lithium, stimulating the release of neutrophils, can enhance the action of filgrastim.

    It is pharmaceutically incompatible with 0.9% sodium chloride solution.

    Special instructions:

    Treatment with Neutrostim® should only be performed under the supervision of a physician who has experience with colony-stimulating factors, provided that the necessary diagnostic capabilities are available.

    The safety and efficacy of filgrastim in patients with myelodysplastic syndrome and chronic myeloid leukemia have not been established, and in connection with these diseases, filgrastim Not recommended. Particular attention should be given to the differential diagnosis between acute myelogenous leukemia and blast crisis of chronic myelogenous leukemia.

    Before the appointment of Neutrostim® to patients with severe chronic neutropenia (TCN), a differential diagnosis should be carefully conducted to exclude other hematologic diseases such as aplastic anemia, myelodysplasia and chronic myeloid leukemia (morphological and cytogenetic bone marrow analysis should be performed before the start of therapy).

    When filgrastim was used in patients with THC, cases of myelodysplastic syndrome (MDS) and acute myeloblastic leukemia were noted.Despite the fact that the relationship of the development of these diseases with filgrastim is not established, the drug should be used with TCN with caution under the control of the morphological and cytogenetic analysis of the bone marrow (1 every 12 months). When cytogenetic abnormalities appear in the bone marrow, the risk and benefit of further therapy with filgrastim should be carefully assessed. With the development of MDS or leukemia, Neutrostim® should be discontinued.

    Treatment with Neutrostim® should be carried out under regular control of a general blood test, with a calculation of the leukocyte count and the number of platelets (before starting therapy and then twice a week with standard chemotherapy).

    With a stable platelet count of less than 100,000 / μL, it is recommended that you temporarily discontinue Neutrostim® therapy or reduce its dose.

    Filgrastim does not prevent, caused by myelosuppressive chemotherapy, thrombocytopenia and anemia.

    During treatment with Neurostim®, urine tests should be performed regularly (to exclude hematuria and proteinuria) and control the size of the spleen.

    Neutrostim® should be used with caution in patients with sickle cell disease due to the possible development of a marked increase in the number of sickle cells.

    The safety and efficacy of filgrastim in newborns and patients with autoimmune neutropenia have not been established.

    Patients with bone pathology and osteoporosis receiving continuous treatment with Neutrostim® for more than 6 months are shown to control the density of bone tissue.

    Form release / dosage:A solution for subcutaneous administration, 0.3 mg / ml.
    Packaging:

    At 300 mcg / ml in glass clear ampoules or vials sealed with rubber stoppers and wound with aluminum caps.

    For 5 or 10 ampoules (vials), together with instructions for use in a cardboard pack or a box of PVC.

    Storage conditions:

    At temperatures from 4 ° C to + 6 ° C in a dry, protected from light and out of reach of children.

    Shelf life:

    1 year.

    Do not use the product after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-010185/08
    Date of registration:15.12.2008 / 25.04.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:Vector WB SSC FGUNVector WB SSC FGUN Russia
    Manufacturer: & nbsp
    Information update date: & nbsp28.06.2018
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