Azacitidine

ITERBIL®

Azacitidine 100 mg. Injectable lyophilized.


Therapeutical classification:

Antineoplastic.


How supplied:

Package containing 1 single-use vial of lyophilized powder with Azacitidine

100 mg. 


Indications:

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) and Refractory Anemia with Excess Blasts, Refractory Anemia with Excess Blasts in transformation, Chronic Myelomonocytic Leukemia and Acute Mieloid Leukemia with 20 - 30% of blasts.


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:

Storage at room temperature between 15°C and 30°C. For further information, read de full prospect.

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