REFNOT lyophilisate for preparing a solution for the subcutaneous injection of 100,000 IU bottles of 5 pieces
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Description
The drug is a loose or porous mass of white, hygroscopic.
Active ingredients
Release form
Pharmacological effect
REFNOT has a direct antitumor effect in vitro and in vivo on various tumor cell lines. According to the spectrum of cytotoxic and cytostatic effects on tumor cells, the preparation corresponds to the human tumor necrosis factor a (TNF), however, REFNOT has more than 100 times less overall toxicity than TNF.
The mechanism of antitumor action of REFNOT in vivo includes several ways in which the drug destroys a tumor or stops its growth:
- the direct effect of protein tumor necrosis factor-thymosin alpha 1 (TNF-T) on a target tumor cell through the corresponding receptors on its surface, resulting in cell apoptosis (cytotoxic effect) or cell cycle arrest (cytostatic action). In the case of the last event, the cell becomes more differentiated and expresses a number of antigens;
- a cascade of chemical reactions, including activation of the blood coagulation system and local inflammatory reactions caused by REFNOT-activated endothelial cells and lymphocytes and leading to "hemorrhagic" tumor necrosis;
- blocking of angiogenesis, leading to a decrease in germination by new vessels of a fast-growing tumor and, consequently, to a decrease in blood supply, up to necrosis of the tumor center;
- exposure of cells of the immune system, the cytotoxicity of which was closely associated with the presence of TNF-T molecules on their surface or the process of maturation / activation of these cells is associated with a response to TNF-T.
Combinations of REFNOT with α2- or γ-interferons have a synergistic cytotoxic effect. REFNOT enhances the antiviral activity of recombinant interferon gamma 100-1000 times (against vesicular stomatitis virus). REFNOT increases the effectiveness of chemotherapy drugs: actinomycin D, cytosar, doxorubicin, against tumor cells that are weakly sensitive to them, eliminating this resistance. This allows us to consider REFNOT as a modifier of the antitumor action of chemical cytostatics in cases of multidrug resistance of tumor cells.
REFNOT does not have a cytotoxic effect on normal cells, and in high concentrations in vitro stimulates the proliferation of spleen cells and lymph nodes. It enhances the production of antibodies on T-dependent antigens, has a stimulating effect on the cytotoxic effect of natural killer cells of anticancer cells, has a stimulating effect on phagocytosis, enhances the expression of class H-2K, CD-4 and CD-8 antigens of T-cell helper and killer t.
Indications
Breast cancer in the treatment of chemotherapy.
As an immunomodulator for melanoma in the disseminated stage of the disease.
Contraindications
Hypersensitivity to tumor necrosis factor -thymosin alpha 1 recombinant or any other component of the drug.
Pregnancy and lactation period.
Dosage and administration
For the treatment of breast cancer in combination with chemotherapy, the average daily dose of the drug is 200,000 U.
The drug is administered subcutaneously on the day of chemotherapy (30 minutes) and for 4 days after chemotherapy 1 time per day.
As an immunomodulator with melanoma in the disseminated stage of the disease, Refnot®® is administered subcutaneously at a dose of 100,000 IU once a day, five times a week (then 2 days break) or at a dose of 400,000 IU once a day, 3 times a week (every other day) for 2 to 4 weeks prior to chemotherapy. Perhaps the introduction of the drug subcutaneously at a dose of 400 000 IU in one or more places, injection sites should be alternated.
When applied without subsequent chemotherapy, the “Refnot®” drug is administered subcutaneously at a dose of 100,000 IU once a day, five times a week (then a 2-day break) for 4 weeks. In the absence of disease progression, administration of the drug can be continued.
Immediately before use, the contents of the vial are dissolved in 1 ml of water for injection.
Side effects
There is an individual sensitivity to the drug. In some patients, REFNOT causes a short-term (up to several hours) temperature increase of 1-2 ° С, chills.
Side effects are removed by the addition of indomethacin or ibuprofen, which do not affect the cytotoxic effect of the drug.
Storage conditions
In a dry, dark place and out of reach of children, at a temperature not higher than 2-10 ° C.
Do not freeze!
The dissolved drug is not subject to storage.