Granokrin® (Granokrin®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbsphypodermic solution
Composition:

Active ingredient: recombinant human granulocyte colony stimulating factor (rchG-CSF)75 μg / vial, recombinant human granulocyte colony stimulating factor (rchG-CSF) 150 μg / vial

Excipients: sodium acetate buffer, mannitol, polysorbate 80, water for injection.

Description:Transparent colorless liquid.
Pharmacotherapeutic group:Leukopoiesis stimulant
ATX: & nbsp
  • Filgrastim
    • Pharmacodynamics:

    The active substance of the drug is recombinant granulocyte human colony-stimulating factor (rchG-CSF), obtained from a strain of the bacterium Escherichia coli, in the genome of which genetic engineering methods introduced the human G-CSF gene. Unlike the natural molecule of G-CSF, which undergoes O-glycosylation at the position of Tp-133, rchG-CSF does not contain a carbohydrate residue. According to the amino acid sequence and conformational structure, rchG-CSF is identical to the natural one and has the same biological activity under the conditions in vitro and in vivo.

    G-CSF is one of the main factors controlling the processes of granulocytopoiesis in the bone marrow. G-CSF selectively acts on the precursor cells of granulocytes, stimulates their growth, differentiation, and also regulates maturation processes in the bone marrow of active neutrophils and their release into the blood.

    The use of G-CSF reduces the frequency, severity, and duration of neutropenia caused by chemotherapy with cytostatics or myeloablative therapy followed by bone marrow transplantation. After the administration of cytostatics, the levels of neutrophils and leukocytes decrease, the depth of which depends on the used scheme of cytotoxic chemotherapy. The growth of neutrophil and leukocyte levels (restoration of hematopoiesis) occurs after the passage of the maximum level of leukocyte and neutrophil reduction (nadir).

    The use of G-CSF enhances the mobilization of hematopoietic progenitor cells from the bone marrow to the peripheral blood.

    In patients receiving cytostatic chemotherapy, the administration of G-CSF led to a significant increase in the level Cd 34+ cells in comparison with the group receiving only chemotherapy.

    Patients who received G-CSF are less likely to require hospitalization, require shorter hospital treatment, and fewer doses of antibiotics compared to patients receiving chemotherapy alone.

    Pharmacokinetics:

    An increase in the dose of the drug leads to a proportional increase in the concentration of G-CSF in the blood plasma.The half-life of G-CSF from serum with a subcutaneous injection is 3.5 hours. Long-term use of G-CSF for up to 28 days is not accompanied by signs of cumulation and an increase in the half-life.

    The clearance speed is 0.5 - 0.65 ml / min / kg. The concentration of G-CSF of blood serum exceeds 10 ng / ml for 8-16 hours after subcutaneous administration of therapeutic doses of the drug. There is a direct relationship between the concentration of G-CSF in plasma and the increase in the level of neutrophils in peripheral blood.

    Indications:

    Prevention of the development and treatment of neutropenia caused by cytotoxic chemotherapy of tumors. Granokrin prescribe after using cancer patients cytotoxic drugs that inhibit the functional activity of the bone marrow, especially when carrying out high-dosage chemotherapy.

    Mobilization of progenitor cells of hemopoiesis. The use of Granokrin alone or after chemotherapy activates hematopoietic progenitor cells in the peripheral blood that can be taken from the patient and administered to him after using cytostatics, instead of bone marrow transplantation or in addition to it.The introduction of hematopoietic progenitor cells accelerates the recovery of hematopoiesis, reduces the need for transfusion of platelet mass.

    Contraindications:

    - Hypersensitivity to rhG-CSF, excipients included in the preparation

    - severe congenital neutropenia (Costman's syndrome) with cytogenetic disorders

    - terminal stage of the disease

    - chronic renal failure

    - lactation

    Dosing and Administration:

    Treatment of neutropenia caused by cytotoxic chemotherapy of tumors.

    The drug is administered once a day subcutaneously 24-28 hours after the end of the course of chemotherapy.

    The dosage of the drug depends on the type, dosage and the used scheme of cytotoxic chemotherapy.

    The dose of the drug also depends on the degree of decrease in the level of neutrophils. If the level of neutrophils is below 1.0 x 109 / l, then the required initial dose of the drug is 5 μg / kg / day. The use of the drug may be discontinued if, on the 7th day of application, the level of neutrophils reaches 5.0 x 109 / l, and the number of leukocytes is 10.0 x 109/ l. If the content of neutrophils and leukocytes on the 7-14 day of the drug does not reach these values, then it is necessary to maintain a dose of 5 μg / kg / day until the neutrophil level reaches 5.0 × 109 / l.The level of neutrophils and the number of leukocytes should be monitored 2-3 times a week during the entire course of therapy with Granocrine.

    If before the start of treatment in a patient the level of neutrophils is higher than 1.0 x 109 / l, then the required dose is 2.5 μg / kg / day. The use of the drug may be discontinued if the level of neutrophils on the 7th or later day of use reaches 5.0 x 109 / l, and the number of leukocytes is 10.0 x 109/ l. If the neutrophil count and leukocyte counts do not reach the indicated values ​​on the 7-14th day of application, the dose should be kept 2.5 μg / kg / day until the neutrophil level reaches 5.0 x 109 / l.

    If the dose of chemotherapy is low and the level of inhibition of bone marrow cells is small, a dose of 1.25 μg / kg / day can be used to maintain the level of neutrophils. The use of the drug may be discontinued if the level of neutrophils on the 7th or later day of use reaches 5.0 x 109 / l, and the number of leukocytes is 10.0 x 109/ l. If the neutrophil count and leukocyte counts do not reach the indicated values ​​on the 7-14 day of the drug application, it is necessary to maintain a dose of 1.25 μg / kg / day until the neutrophil level reaches 5.0 × 109 / l.

    If necessary, the duration of the course of therapy can be up to 14 days, depending on the severity of the disease and the severity of neutropenia.

    Prevention of neutropenia.

    The drug is prescribed 24-28 h after the end of chemotherapy. In prophylactic purposes to maintain a safe level of neutrophils, the drug is administered subcutaneously at a dose of 1.25 μg / kg / day for 7-14 days. The level of neutrophils and the number of leukocytes should be monitored 2-3 times a week during the entire course of therapy with Granocrine.

    The use of the drug may be discontinued if the level of neutrophils on the 7th or later day of use reaches 5.0 x 109 / l, and the number of leukocytes is 10.0 x 109/ l

    Mobilization of hematopoietic progenitor cells

    To activate hematopoiesis precursor cells in peripheral blood, the drug is administered subcutaneously at a dose of 5 μg / kg / day for 7 days. In the case of cytotoxic chemotherapy, the drug is prescribed 24 to 28 hours after the end of chemotherapy. Procedures for leukapheresis should be carried out in the event of an increase in the number of peripheral blood leukocytes to 5.0 x 109 / l. Patients who did not receive intensive chemotherapy, there is enough one procedures of leukapheresis. In other cases, additional leukapheresis is recommended.

    Repeated administration of the drug according to the above schemes is allowed, if necessary, according to the results of the analysis of hematological parameters.

    Instructions for use

    If you need to dilute the drug is recommended to use only 5% solution of dextrose. Dilution of the preparation with 0.9% sodium chloride solution is not allowed.

    Side effects:

    The most common side effects are pain in the bones and generalized pain in the muscles (10%), sometimes more pronounced 3-4 degrees (1-2%). These phenomena are not continuous and are successfully stopped by the use of non-steroidal anti-inflammatory drugs.

    Sometimes (less than 1%) develops skin rash, fever, runny nose, chills, weakness, flu-like syndrome. These manifestations are usually mild and pass without additional intervention after the end of the drug.

    Observations on long-term safety of rchG-CSF can not be considered complete. Individual cases of enlarged spleen have been reported. With the use of Granokrin®, no such cases were noted.However, using similar foreign drugs, according to statistical analysis, the probability of such complications is 1/4000. There are rare cases of symptoms that indicate reactions of allergic types, with a decrease in blood pressure, rapid heart rate, shortness of breath, development of edema of the face, urticaria, skin rashes. Similar cases have not been observed with Granokrin®. According to the statistical analysis, these side effects can most often develop with the administration of the first dose within the first 30 minutes after the administration of rhG-CSF. In this case, it is recommended to introduce antihistamines, adrenocorticosteroids, bronchial spasmolytic drugs or preparations containing adrenal gland hormones, after which these symptoms should be stopped. With the development of such side effects, the drug should be discontinued.

    Overdose:

    The action of Granokrin® in case of an overdose is not established. After the drug is discontinued, the number of circulating neutrophils usually first decreases and then returns to normal.

    Interaction:

    Expediency and safety of drug administration for a day or the same day as cytotoxic chemotherapy have not been established. Since chemotherapeutic drugs actively affect the cells of the hematopoietic system, the drug is recommended to be administered 24 hours after the end of chemotherapy.

    Special instructions:

    1. The drug is prescribed 24-28 hours after the end of the course of chemotherapy. It is not recommended to use the drug before or during chemotherapy.

    2. The safety of the drug during pregnancy and lactation is not established. In pre-clinical studies on animals, there was no evidence of teratogenicity of the drug, however, when prescribing the drug, pregnant women should correlate the expected result with the possible risk to the fetus. It is not recommended to use the drug for nursing.

    3. During the use of the drug 2-3 times a week to monitor the main parameters of the blood, especially the level of neutrophils (see METHOD OF APPLICATION AND DOSES).

    4. The safety of the drug in patients with myelodysplastic syndrome and chronic myelogenous leukemia has not been established, therefore, it is not recommended to prescribe the drug for these diseases.It should be used with caution in acute myeloid leukemia. Particular attention should be paid to the differential diagnosis between the power crisis of chronic myelogenous leukemia and acute myeloid leukemia.

    5. Caution should be exercised in appointing patients with hereditary intolerance to fructose, since the drug contains mannitol.

    Apply only under medical supervision.
    Effect on the ability to drive transp. cf. and fur:

    The effect of G-CSF on the ability to drive vehicles or work with mechanisms has not been established.

    Form release / dosage:The solution for subcutaneous administration was 75 μg / 0.75 ml, 150 μg / 0.75 ml.
    Packaging:1 glass vial with instructions for medical use in a cardboard box.
    Storage conditions:

    Store at temperatures between 2 and 8 ° C out of the reach of children. Do not freeze. Transport all types of indoor transport at a temperature of 2 to 8 ° C. Do not freeze.

    Shelf life:2 years. The drug with expired shelf life is not subject to application.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-003499/09
    Date of registration:08.05.2009 / 07.11.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:RAFARMA, CJSC RAFARMA, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp09.05.2017
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