Trade name of drug: REFNOT (Refnot)
Active agent: Factor of necrosis of tumors Timosinums alfa-1 recombinant (Tumor necrosis factor-thymosine alpha-1 recombinant)
Drug represents the friable or porous mass of white color, is hygroscopic.
Pharmacotherapeutic group: antineoplastic.
The drug REFNOT® possesses direct antineoplastic action of in vitro and in vivo on various lines of tumor cells. On a range of cytotoxic and cytostatic action on tumor cells drug corresponds to tumor necrosis factor α (FNO) of the person, however the drug REFNOT® has more than by 100 times smaller general toxicity, than FNO.
The mechanism of antineoplastic effect of the drug REFNOT® in vivo includes several ways which drug destroys a tumor or stops its growth:
- immediate effect of a factor of necrosis of tumors Timosinums alfa-1 (FNO-T) on tumoral target cell through the corresponding receptors on its surface therefore there is cell apoptosis (cytotoxic action) or a stop of a cellular cycle (cytostatic action);
- the cascade of chemical changes including activation of a coagulative system of blood and the local inflammatory reactions caused РЕФНОТ®-активированными by cells of an endothelium and lymphocytes and leading to hemorrhagic necrosis of tumors;
- the angiogenesis blocking leading to germination reduction by new vessels of a fast-growing tumor and, as a result, to decrease in blood supply up to necrosis of the center of a tumor;
- influence of cells of the immune system which cytotoxicity was closely connected with existence of molecules FNO-T on their surface or process of maturing/activation of these cells it is connected with the answer to FNO-T.
Combinations РЕФНОТ® with α2- or γ-interferonam have synergy cytotoxic effect. РЕФНОТ® scale by 100–1000 times enhances protivirusny activity of recombinant interferon (against a virus of vesicular stomatitis).
РЕФНОТ® increases efficiency of khimiopreparat: Actinomycinum D, Cytarabinum, doxorubicine against tumor cells poorly sensitive to them, liquidating this resistance. It allows to consider РЕФНОТ® as the modifier of antineoplastic action of chemical tsitostatik in cases of multiple drug resistance of tumor cells.
РЕФНОТ® has no cytotoxic effect on normal cells and stimulates proliferation of cells of a spleen and lymph nodes in high concentrations of in vitro. Strengthens products of antibodies on T-dependent antigens, has the stimulating impact on cytotoxic effect of natural killer cells of protivopukholevy cells, has the stimulating impact on phagocytosis, strengthens an expression of GKGS I antigens of class H-2K, CD-4 and CD-8, being a factor of differentiation T-helperov and T-killers.
Indications of the drug REFNOT®:
Breast cancer in complex therapy from khimiopreparata.
Drug REFNOT® contraindications:
hypersensitivity to FNO-T or any other component of drug;
pregnancy and period of feeding by a breast.
Route of administration and doses:
For cancer therapy of a mammary gland in a combination with chemotherapy the average daily dose of drug makes 200000 PIECES. Administer the drug p / to in day of chemotherapy (in 30 min.) and within 4 days after chemotherapy of 1 times a day.
Just before use the contents of a bottle are dissolved in 1 ml of water for injections.
Side effect of the drug REFNOT®:
The individual hypersensitivity to drug is noted. РЕФНОТ® causes in some patients short-term (till several o'clock) temperature increase on 1–2 °C, a fever.
Side effects are removed additional intake of indometacin or an ibuprofen which do not influence cytotoxic effect of drug.
Storage conditions: In the dry, protected from light place, at a temperature of 2-10 °C. Not to freeze. The dissolved drug is not subject to storage.
To store out of children's reach.
Expiration date: 2 years.