Azacitidine 100 mg. Lyophilized powder for injectables

Therapeutical classification:


How supplied:

Lyophilized powder in 100 mg single-use vials packaged in cartons of 1 vial.


Azacitidine is indicated for the treatment of patients with the following myelodysplastic syndrome subtypes: Refractory anemia or refractory anemia with ringed sideroblasts  (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation  and chronic myelomonocytic leukemia.

Dosage and administration:

First treatment cycle: The recommended starting dose for the first treatment cycle, is 75 mg/m2 daily for 7 days to be administered by subcutaneous injection or intravenous infusion.

Following treatment  cycles: Repeat cycles every 4 weeks. After 2 cycles, may increase dose to 100 mg/m2  if no beneficial effect is seen and no toxicity other than nausea and vomiting has occurred. Patients should be treated for a minimum of 4 to 6 cycles. Complete or partial response may require additional treatment cycles.

Continue treatment as long as the patient continues to benefit.

For further information read the complete prospect.


Storage at room temperature between 15 °C and 30 °C.

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