Lenograstim (Lenograstimum)

Pharmacodynamics Pharmacokinetics Indications Carefully Contraindications Dosing and Administration Side effects
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Clinical and pharmacological group: & nbsp

Stimulators of hematopoiesis

Included in the formulation
  • Granocyte® 34
    lyophilizate in / in PC 
    Shugai Sanofi Aventis     France
    • АТХ:

    L.03.A.A   Colony-stimulating factors

    L.03.A.A.10   Lenograstim

    Pharmacodynamics:

    Recombinant human granulocyte colony-stimulating factor, similar in effect to the corresponding endogenous compound. It is a glycosylated protein. Affects the mature myeloid progenitor cells of neutrophils and binds to their specific surface receptors. Dose-dependently stimulates their proliferation, differentiation (into neutrophils) and functional activation. The introduction of colony-stimulating factors to patients with depressed bone marrow (myelotoxic agents or as a result of AIDS) leads to an increase in the number of circulating progenitor cells. Has no significant effect on the number of red blood cells and platelets.

    Pharmacokinetics:

    Pharmacokinetics depends on the dose of the drug and the duration of its administration. The volume of distribution is about 1 l / kg. Metabolised to peptides.

    Half-life is 3-4 hours, when the equilibrium concentration is reached after repeated intravenous infusions, the elimination half-life is reduced to 1-1.5 hours. With urine unchanged, no more than 1% is output.

    When re-administered (intravenously or subcutaneously) Cmax the drug in the blood plasma is proportional to the administered dose; cumulation of the drug is not revealed. In recommended doses, absolute bioavailability is 30% with subcutaneous injection. The average time spent in the body with subcutaneous injection is 7 hours. Half-life with subcutaneous administration is approximately 3-4 hours, with intravenous repetition - 1-1.5 hours.

    Indications:

    Prevention and treatment of neutropenia: with the use of chemotherapeutic antitumor agents, after bone marrow transplantation, with aplastic diseases of the hematopoietic system, with HIV infection.

    ICD-10

    III.D70-D77.D70   Agranulocytosis

    XXI.Z80-Z99.Z94   Presence of transplanted organs and tissues

    Contraindications:

    Increased sensitivity to lenograstim, pregnancy, breast-feeding, myeloid formations (with the exception of the primary acute myelogenous leukemia), acute myeloblastic leukemia for the first time in patients younger than 55 years with favorable cytogenetic prognostic signs.

    Carefully:

    With special care for violations of the liver, kidneys. Myelodysplastic syndrome,pre-tumor states of myelogenous hematopoiesis, autoimmune diseases in the anamnesis or inflammatory conditions, cardiovascular pathology, sepsis, combination with high-dosage chemotherapy.

    Pregnancy and lactation:

    The use of lenograstm in pregnancy is not recommended.

    If it is necessary to use lactation during breastfeeding, it is recommended to stop breastfeeding.

    The category of FDA recommendations is not defined.

    Dosing and Administration:

    Individual, depending on the indications and treatment regimen. Introduced subcutaneously, intravenously drip for 30 minutes. When bone marrow transplantation, standard chemotherapy with cytostatics, the recommended dose is 150 μg (19.2 million IU) / m2 per day. The administration of the drug begins the day after bone marrow transplantation or the end of chemotherapy. The maximum duration of daily administration of the drug is 28 days.

    For the mobilization of hematopoietic progenitor cells, the recommended dose is 10 μg (1.28 million IU) / kg per day, daily subcutaneously for 4-6 days.

    Side effects:

    From the musculoskeletal system: pain in the muscles and in the bones.

    On the part of the hematopoiesis system: very rarely - enlargement of the spleen, thrombocytopenia, anemia, epistaxis.

    Other: dysuria; very rarely - headache, diarrhea, fever, transient increase in hepatic transaminases, alkaline phosphatase.

    Local reactions: pain in the injection site.

    There have been reports of lung infiltrates, which in several cases have led to the development of pulmonary insufficiency or respiratory distress syndrome in adults. If symptoms such as cough, fever, or shortness of breath occur in combination with radiological changes and respiratory disorders, appropriate therapy should be prescribed and consider stopping the administration of lenograstim.

    In very rare cases, various allergic reactions were noted, extremely rarely with the development of anaphylactic shock. Very rarely there were cases of vasculitis, nodal erythema, pyoderma, Lyell's syndrome.

    Overdose:

    Not described.

    Treatment is symptomatic.

    Interaction:

    Cytotoxic chemotherapy or radiotherapy - lenograstim should not be administered less than 24 hours before or after the administration of cytotoxic agents.

    With the simultaneous use with lenograstim antitumor drugs with cumulative myelodepression or predominant toxicity in relation to platelet sprout bone marrow (nitrosourea, mitomycin C) it is possible to increase the toxic effect of these drugs, especially regarding the production of platelets.

    Special instructions:

    With extreme caution apply for violations of the liver or kidneys.

    During the treatment with lenograstim, a systematic control of the peripheral blood pattern is necessary (including mandatory counting of the platelet count). In the case of an increase in the number of leukocytes more than 5×109/ l treatment should be stopped.

    It is possible to use lenograstim before the sampling of peripheral stem cells in order to increase their number.

    Against the background of treatment with antitumor chemotherapeutic agents lenograstim start to enter not earlier, than in day after last session of a chemotherapy. The safety of lenograstim in myeloid tumors has not been fully studied, therefore its use is not recommended.

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