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What is the drug DASATINIB-CHEMRAR

The drug DASATINIB-CHEMRAR contains the active substance dasatinib, which belongs to antitumor agents – protein kinase inhibitors. Dasatinib blocks the transmission of signals in the tumor cells, which leads to its death. 

Dosage form

Round biconvex tablets, film-coated in white or almost white color. On a cross-section, the tablet core is white or almost white in color.

For dosages of 20 mg, 50 mg, 70 mg: 60 tablets in a high-density polyethylene bottle, sealed with a polypropylene cap with a desiccant, first opening control and child protection.

1bottle together with a leaflet insert is placed in a pack of cardboard.

For a dosage of 100 mg: 30 tablets in a high-density polyethylene bottle, sealed with a polypropylene cap with a desiccant, first opening control and child protection.

Indications for use

The drug DASATINIB-CHEMRAR is used for the treatment of cancer in adults over 18 years of age:

- Newly diagnosed chronic myeloid leukemia with Philadelphia chromosome positive (CMLPh+) in the chronic phase;

- CML in the chronic phase, progressive phase (acceleration) or phase of myeloid or lymphoid blast crisis (characterized by a very high content of tumor cells in the blood) with immunity (resistance) or intolerance to previous therapy, including imatinib;

- Acute Philadelphia chromosome-positive lymphoblastic leukemia ( ALL Ph+) with resistance or intolerance to previous therapy.

The drug DASATINIB-CHEMRAR is used for the treatment of cancer in children aged 3 to 18 years:

- CMLPh+ in the chronic phase;

- Newly diagnosed ALLPh+ in combination with chemotherapy.

Efficacy and safety studies

In accordance with current legislation, the drug has proven its effectiveness, safety and quality during state registration. For registration purposes, a bioequivalence study was conducted with the original (reference) medicinal product.