Clinical and pharmacological group: & nbsp

Other antineoplastic agents

Included in the formulation
  • Refnot®
    lyophilizate PC 
    Refnot-Farm, OOO     Russia
  • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    ONLS

    АТХ:

    L.01.X.X   Other antineoplastic agents

    Pharmacodynamics:

    Has direct antitumor effect in vitro and in vivo on different lines of tumor cells. According to the spectrum of cytotoxic and cytostatic effects on tumor cells, the drug corresponds to the tumor necrosis factor α human, but the drug has more than 100 times less overall toxicity than tumor necrosis factor.

    Mechanism of antitumor effect of the drug in vivo includes several ways in which the drug destroys the tumor or stops its growth:

    - direct effect of tumor necrosis factor-thymosin alpha-1 on the target tumor cell through appropriate receptors on its surface, resulting in apoptosis of the cell (cytotoxic action) or cell cycle arrest (cytostatic action);

    - a cascade of chemical reactions, including activation of the coagulation system of blood and local inflammatory reactions caused by activated endothelial cells and lymphocytes and leading to hemorrhagic necrosis of tumors;

    - Blocking of angiogenesis, leading to a decrease in the germination of new vessels of a rapidly growing tumor and, as a consequence, to a decrease in blood supply up to necrosis of the tumor center;

    - the effect of cells of the immune system, the cytotoxicity of which turned out to be closely related to the presence of molecules tumor necrosis factor-thymosin alpha-1 on their surface or the process of maturation / activation of these cells is associated with a response to tumor necrosis factor-thymosin alpha-1. Has direct antitumor effect in vitro and in vivo on different lines of tumor cells. According to the spectrum of cytotoxic and cytostatic effects on tumor cells, the drug corresponds to the tumor necrosis factor α human, but the drug has more than 100 times less overall toxicity than tumor necrosis factor α.

    Pharmacokinetics:

    Not studied.

    Indications:

    Breast cancer in complex therapy with chemotherapy.

    II.C50.C50   Malignant neoplasm of breast

    Contraindications:

    Hypersensitivity, pregnancy, breast-feeding.

    Carefully:

    Elderly and children's age, liver and kidney disease.

    Pregnancy and lactation:

    The category of recommendations for the FDA - D.

    Contraindicated in pregnancy and lactation.

    Dosing and Administration:

    For treatment of breast cancer in combination with chemotherapy, the average daily dose of the drug is 200,000 units. Enter the drug subcutaneously on the day of chemotherapy (30 minutes) and for 4 days after chemotherapy 1 time per day.

    Immediately before use, the contents of the vial are dissolved in 1 ml of water for injection.

    Side effects:

    Individual hypersensitivity to the drug is noted. In some patients, a short-term (up to several hours) temperature increase of 1-2 °C, chills.

    Side effects are removed with an additional intake of indomethacin or ibuprofen, which do not affect the cytotoxic effect of the drug.

    Overdose:

    Not described.

    Interaction:

    Combinations with α2 or γ interferons have a synergistic cytotoxic effect. Enhances the antiviral activity of recombinant interferon gamma 100-1000 times (against the virus of vesicular stomatitis).

    Increases the effectiveness of chemotherapy drugs: actinomycin D, cytarabine, doxorubicin against tumor cells weakly sensitive to them, eliminating this resistance.This allows us to consider the drug as a modifier of the antitumor effect of chemical cytostatics in cases of multiple drug resistance of tumor cells.

    Special instructions:

    Does not have a cytotoxic effect on normal cells and in high concentrations in vitro stimulates the proliferation of spleen cells and lymph nodes. Enhances the production of antibodies to T-dependent antigens, has a stimulating effect on the cytotoxic effect of natural killer cells of antitumor cells, has a stimulating effect on phagocytosis, enhances the expression of antigens the main histocompatibility complex of class I H-2K, CD-4 and CD-8, being a factor in the differentiation of T-helpers and T-killers.

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