Composition, form of production and packaging
Liofilizate for the preparation of a solution for s / c introduction of white, in the form of loose or porous mass, hygroscopic.
tumor necrosis factor-thymosin-1 recombinant 100,000 units
[PRING] mannitol, sodium chloride, sodium phosphate dihydrate, sodium phosphate dodecahydrate.
Vials (1) - packs of cardboard.
Vials (1) - packings, cellular planimetric (1) - packs cardboard.
Vials (1) - packings cassette outline (1) - packs cardboard.
Vials (5) - packs of cardboard.
Vials (5) - packings, cellular planimetric (1) - packs cardboard.
Vials (5) - packings cassette outline (1) - packs cardboard.
Vials (10) - packs of cardboard.
Vials (10) - packings, cellular planimetric (1) - packs cardboard.
Vials (10) - packings cassette outline (1) - packs cardboard.
Vials (20) - packs cardboard.
Vials (20) - packings cellular planimetric (1) - packs cardboard.
Vials (20) - packings cassette outline (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2012.
The drug Refnot В® has a direct antitumor effect in vitro and in vivo on various lines of tumor cells. According to the spectrum of cytotoxic and cytostatic effects on tumor cells, does the drug correspond to the tumor necrosis factor? (TNF), however, Refnot В® has a more than 100-fold lower total toxicity than TNF.
The mechanism of the antitumor effect in vivo includes several ways of destroying the tumor or stopping its growth:
- direct exposure of the tumor necrosis factor-thymosin alpha 1 (TNF-T) protein to the target tumor cell through appropriate receptors on its surface, resulting in apoptosis of the cell (cytotoxic action) or arrest of the cell cycle (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 coagulation system of blood and local inflammatory reactions caused by activated action of the drug by 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 has been closely associated with the presence of TNF-T molecules on their surface or the maturation / activation of these cells is associated with a response to TNF-T.
Combinations of Refnot В® with? 2 - or? -terferons have a synergistic cytotoxic effect. The drug increases the antiviral activity of recombinant interferon gamma 100-1000 times (against the virus of vesicular stomatitis).
Refnot В® increases the effectiveness of chemotherapy drugs: actinomycin D, cytosar, doxorubicin against tumor cells, weakly sensitive to them, eliminating this resistance. This allows us to consider Refnot В® as a modifier of the antitumor effect of chemical cytotoxic drugs in cases of multiple drug resistance of tumor cells.
Refnot В® does not have a cytotoxic effect on normal cells and at high concentrations in vitro stimulates the proliferation of spleen and lymph nodes. Enhances the production of antibodies to T-dependent antigens, has a stimulating effect on the cytotoxic effect of natural killer cells, has a stimulating effect on phagocytosis, enhances the expression of H-2K, H-2K, CD-4 and CD-8 antigens, as a differentiation factor for T-helpers and T-killers.
- Breast cancer in complex therapy with chemotherapy.
For treatment of breast cancer in combination with chemotherapy, the average daily dose of the drug is 200,000 units. Introduce the drug SC on the day of chemotherapy (for 30 minutes) and for 4 days after chemotherapy 1 time / day.
Immediately before use, the contents of the vial are dissolved in 1 ml of water for injection.
The development of reactions of individual hypersensitivity was noted.
In some patients, short-term (up to several hours) increase in body temperature by 1-2 В° C, chills.
To reduce the intensity of side effects, it is recommended to take indomethacin or ibuprofen, which does not affect the cytotoxic effect of the drug.
- the period of lactation (breastfeeding);
- hypersensitivity to the tumor necrosis factor-thymosin alfa-1 or any other component of the drug.
PREGNANCY AND LACTATION
The use of Refnot В® is contraindicated in pregnancy and lactation.
Data on the overdose of Refnot В® are not available.
Drug interaction of the drug Refnot В® is not known.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a dry, protected from light, out of reach of children at a temperature of 2 В° to 10 В° C. Do not freeze. Shelf life - 2 years. Dissolved drug is not subject to storage.