Medicine Overview

Adult Dose
Clinical InformationAdministration Information
Indication: Myelodysplastic Syndromes (subtypes: Refractory anemia (RA) or RA with ringed sideroblasts if accompanied by neutropenia or thrombocytopenia or requiring transfusions, refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), chronic myelomonocytic leukemia (CMMoL))
Dose: Intravenous or Subcutaneous – 75 mg/m2
Frequency: daily for 7 days
Duration: Each cycle is 4 weeks; repeat cycle every 4 weeks; treat for a minimum of 4-6 cycles; continue treatment as long as the patient continues to benefit
Note: May be increased to 100 mg/m2 if no benefit is observed after 2 treatment cycles and if no toxicity other than nausea and vomiting

Child Dose
Clinical InformationAdministration Information
Indication: Juvenile Myelomonocytic Leukemia
Age: greater than 1 month to less than 1 year
Dose: Intravenous – 2.5 mg/kg
Frequency: once daily
Duration: for 7 days in a 28-day cycle
Note: Treat for at least 3 cycles; not to exceed 6 cycles. May delay dose up to 14 days for nonhematologic toxicities. May continue treatment for up to 6 cycles if the patient continues to benefit.
Indication: Juvenile Myelomonocytic Leukemia
Age: greater than 1 year
Dose: Intravenous – 75 mg/m2
Frequency: once daily
Duration: for 7 days in a 28-day cycle
Note: Treat for at least 3 cycles; not to exceed 6 cycles. May delay dose up to 14 days for nonhematologic toxicities. May continue treatment for up to 6 cycles if the patient continues to benefit.

Renal Dose
Clinical InformationAdministration Information
Condition: Renal impairment Mild-severe (Creatinine Clearance 15-89 mL/min)
Dose: Dosage Form – No dosage adjustment necessary
Note: Monitor patients with severe renal impairment (Creatinine Clearance 15-29 mL/min) more frequently and modify dosage for adverse reactions
Administration

Administer Azacitidine intravenously as an infusion over 10 to 40 minutes or subcutaneously into the upper arm, thigh, or abdomen. For intravenous use, reconstitute each 100 mg vial with 10 mL of sterile water for injection and shake until dissolved; the solution must be administered within 45 minutes of reconstitution. For subcutaneous use, reconstitute with 4 mL of sterile water for injection to achieve a 25 mg/mL suspension, which must be re-suspended immediately prior to use and administered within 1 hour if at room temperature. Premedicate with anti-emetics for nausea and vomiting. Dosage adjustments or delays are required based on hematological nadir counts and for renal or hepatic impairment, particularly if serum creatinine or BUN levels rise. Use with caution in patients with severe cardiac or pulmonary disease and avoid in those with advanced malignant hepatic tumors.

Side Effect

Drug Interaction

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Disease Interaction

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Pregnancy
Lactation
Special Use
Precaution
Overdose
Pharmacology
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Data Sources

Clinical & regulatory information on this page is compiled from the following government sources:

DISCLAIMER: This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment.