Expiration date: 01/2025
Active substance: Bendamustine
Dosage form
Powder for preparation of concentrate for solution for infusion.
Composition
1 bottle contains:
active substance: bendamustine hydrochloride 25 mg / 100 mg
auxiliary substances: mannitol 30,0 mg/120,0 mg
Description
Bendamustine is an anticancer drug with bifunctional alkylating activity. The mechanism of action is mainly associated with the formation of cross-linking molecules of single-stranded and double-stranded DNA due to alkylation. As a result, the matrix function of DNA and its synthesis is disrupted. There is also evidence that bendamustine has additional antimetabolic properties (effect of purine analog).
The antineoplastic effect of bendamustine has been confirmed in numerous in vitro studies on various tumor cell lines (breast cancer, non - small cell and small cell lung cancer, ovarian cancer and various types of leukemia, as well as colon cancer, melanoma, renal cell carcinoma, malignant tumors of the prostate and brain) and in vivo-on various experimental models of tumors (melanoma, breast cancer, sarcoma, lymphoma, leukemia and small cell lung cancer). Bendamustine does not demonstrate or demonstrates only a small degree of cross-resistance in human tumor cell lines with different mechanisms of resistance.
This is partly due to the interaction with DNA, which, compared with other alkylating agents, lasts longer (for example, only partial cross-resistance with other alkylating agents, such as cyclophosphamide, carmustine or cisplatin was detected). In addition, clinical studies have found that there is no complete cross-resistance between bendamustine and anthracyclines or alkylates.
Indications
Chronic lymphocytic leukemia (efficacy in first-line therapy compared with other chemotherapy drugs except chlorambucil has not been established).
Indolent non-Hodgkin's lymphomas in monotherapy in patients who had progression in the background or within 6 months after the end of therapy with the inclusion of rituximab and in combination therapy as a therapy of the 1st line.
Treatment of the first line of multiple myeloma (stage II with progression or stage III by Dury-Salmon) in combination with prednisolone for patients older than 65 years, who are not shown autologous stem cell transplantation and who have clinical manifestations of neuropathy at the time of diagnosis, preventing the use of therapy with the inclusion of thalidomide or bortezomib.
