Refnot, vials 100000 units, 5pcs

Composition

Active ingredient:

tumor necrosis factor-thymosin alpha-1 recombinant 100000 UNITS;

Auxiliary substances:  

mannitol (mannitol);

sodium chloride;

sodium phosphate dihydrate (sodium phosphate single-substituted dihydrate);

disodium phosphate dodecahydrate (sodium phosphate double-substituted duodenal)

Pharmacological action

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 drug corresponds to human tumor necrosis factor α (TNF), but REFNOT® has more than 100 times lower overall toxicity than TNF.

The mechanism of antitumor action of REFNOT® in vivo includes several ways in which the drug destroys the tumor or stops its growth:

– direct effects of tumor necrosis factor-thymosin alpha-1 (TNF-T) on the tumor cell target using the appropriate receptor on its surface, resulting in apoptosis (cytotoxic effect) or cell cycle arrest (cytostatic effect);

– the chemical cascade that includes activation of coagulation of the blood system and local inflammatory reactions due to REFNOT®-activated endothelial cells and lymphocytes, leading to hemorrhagic necrosis of tumors;

– blocking of angiogenesis, leading to a decrease of sprouting of new vessels growing tumor and, as a consequence, the decrease in blood flow until the necrotic center of the tumor;

– the impact of immune system cells, cytotoxicity which was closely related to the presence of molecules TNF-T on the surface or in the process of maturation/activation of these cells is associated with response to TNF-T.

Combinations of REFNOT® with α2-or γ-interferons have a synergistic cytotoxic effect. REFNOT® enhances the anti-viral activity of recombinant interferon gamma by 100-1000 times (against vesicular stomatitis virus).

REFNOT ® increases the effectiveness of chemotherapy drugs: actinomycin D, cytarabine, doxorubicin against tumor cells that are weakly sensitive to them, eliminating this resistance. This allows you to view the REFNOT® as a modifier of the antitumor effect of chemical cytostatics in cases of multiple drug 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 and lymph node cells. Increases the production of antibodies to T-dependent antigens, has a stimulating effect on the cytotoxic effect of natural killer cells of anti-tumor cells, has a stimulating effect on phagocytosis, increases the expression of H-2K, CD-4 and CD-8 GKGS class I antigens, being a factor in the differentiation of T-helpers and T-killers.

Indications

Breast cancer in complex therapy with chemotherapy drugs.

Contraindications

Hypersensitivity to TNF-T or any other component of the drug; pregnancy and lactation.

Side effects

Individual hypersensitivity to the drug is noted.

In some patients, REFNOT®causes a short-term (up to several hours) increased temperature by 1-2 °C, chills.

Side effects are relieved by an additional intake of Indometacin or ibuprofen, which do not affect the cytotoxic effect of the drug.

How to take, course of use and dosage

For the 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 (for 30 minutes) and for 4 days after chemotherapy 1 time a day.

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

Form of production

Lyophilizate for preparation of a solution for subcutaneous use

Storage conditions

Store in a dry place, protected from light, at a temperature of 2-10 °C

Shelf life

2 years

Active Ingredient

Tumor Necrosis Factor Alpha 1

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Description

Adult Doctor’s prescription