** Vidaza (Azacitdine) 100 mg (25 mg/ml) 1 vial. Powder for suspension for injection. Subcutaneous use.
** Therapeutic indications:
VIDAZA® is indicated for treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).
** Pharmacotherapeutic group:
Antineoplastic agents, pyrimidine analogues; ATC code: L01BC07
** Mechanism of action:
VIDAZA is a pyrimidine nucleoside analog of cytidine. VIDAZA is believed to exert its antineoplastic effects by causing hypomethylation of DNA and direct cytotoxicity on abnormal hematopoietic cells in the bone marrow. The concentration of azacitidine required for maximum inhibition of DNA methylation in vitro does not cause major suppression of DNA synthesis. Hypomethylation may restore normal function to genes that are critical for differentiation and proliferation. The cytotoxic effects of azacitidine cause the death of rapidly dividing cells, including cancer cells that are no longer responsive to normal growth control mechanisms. Non-proliferating cells are relatively insensitive to azacitidine.
Store unreconstituted vials at 25 degrees C (77 degrees F); excursions permitted to 15 – 30 degrees C (59 – 86 degrees F).