VIDACULEM 25mg / ml powder + solvent for injection suspension medication leaflet

L01BC07 • azacitidine • Antineoplastic and immunomodulating agents | Antimetabolites | Pyrimidine analogues

Azacitidine is a hypomethylating agent used in the treatment of myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), and acute myeloid leukemia (AML) in patients who are not eligible for intensive chemotherapy. It works by inhibiting DNA methyltransferases, reducing DNA methylation, and reactivating tumor suppressor genes.

Azacitidine is administered as subcutaneous or intravenous injections, usually for 7 consecutive days in a 28-day cycle. The treatment aims to improve blood cell production, reduce the need for transfusions, and prolong survival.

Common side effects include nausea, vomiting, diarrhea, fatigue, and bone marrow suppression, which can lead to anemia, neutropenia, and thrombocytopenia. In rare cases, severe allergic reactions or serious infections may occur. Regular monitoring of hematological parameters is essential during treatment.

Azacitidine represents an important therapeutic option for patients with hematologic malignancies, contributing to improved quality of life and prognosis.