TYROSINE KINASE INHIBITOR OR ITS PHARMACEUTICAL SALT FOR TREATMENT OF SYSTEMIC MASTOCYTOSIS Russian patent published in 2022 - IPC A61K45/00 A61K45/06 A61P43/00 

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to a method for the treatment of severe forms of systemic mastocytosis. The method for the treatment of severe forms of systemic mastocytosis in human patients includes oral administration of masitinib or its pharmaceutically acceptable salt, or masitinib solvate. In this case, the specified severe form of systemic mastocytosis is associated with at least two disorders conditioned by mediator release from mast cells, selected from a group including: itching, hot flashes during the week, depression with an assessment on the Hamilton Depression Scale (HAMD-17), the number of acts of defecation per day, the number of acts of urination, pathological fatigue (asthenia) with an assessment measured on the Assessment Scale. Moreover, at least one of the specified at least two disorders associated with mediator release from mast cells is selected from a group including: itching, hot flashes during the week. At the same time, disorders have a certain value in points, the specified systemic mastocytosis is flaccid systemic mastocytosis or indolent systemic mastocytosis. In this case, masitinib or its pharmaceutically acceptable salt, or masitinib solvate is administered at an initial dose of 3.0 mg/kg/day for at least 4 weeks, then at a dose of 4.5 mg/kg/day for at least 4 weeks, and after that at a dose of 6 mg/kg/day for at least 4 weeks, providing control of toxicity at each dose increase, while dividing a daily dose into two takings.

EFFECT: above-described method allows for the effective treatment of systemic mastocytosis.

9 cl, 6 tbl, 3 ex