Vidaza Generic Name & Formulations
Azacitidine 100mg/vial; lyophilized pwd for SC inj after reconstitution or IV inj after reconstitution and dilution; contains mannitol; preservative-free.
Myelodysplastic syndromes (refractory anemias, chronic myelomonocytic leukemia) in adults. Newly diagnosed juvenile myelomonocytic leukemia (JMML) in children aged ≥1 month.
Vidaza Dosage and Administration
Premedicate for nausea & vomiting. Rotate SC inj sites. Initially 75mg/m2 SC (doses >4mL divide equally into 2 syringes and inject into 2 separate sites, must administer within 1hr of reconstitution) or IV (infuse over 10–40mins, must complete within 1hr of reconstitution) daily for 7 days; repeat cycle every 4 weeks. May increase to 100mg/m2 after 2 cycles if no response and no toxicity. Treat for at least 4–6 cycles. Adjust subsequent doses based on nadir counts, hematologic response, serum electrolytes, and renal toxicity; see full labeling.
MDS: not established. JMML: <1mo: not established. Premedicate for nausea & vomiting. Give as IV infusion (infuse over 10–40mins, must complete within 1hr of reconstitution) for 7 days in a 28-day cycle. 1mo–<1yr (or <10kg): 2.5mg/kg; ≥1yr (and ≥10kg): 75mg/m2. Treat for at least 3 cycles and max of 6 cycles. May consider a delay in dose not exceeding 14 days for non-hematologic toxicities. Monitor for hematologic response, serum electrolytes, and renal toxicity; adjust dose if necessary. If hematological toxicity within the first 3 cycles: dose reductions are not recommended. Discontinue therapy if neutrophil count <0.5x109/L at the end of cycle 3 or on day 1 of cycles 5 or 6.
Advanced malignant hepatic tumors.
Vidaza Boxed Warnings
Not substitutable with oral azacitidine. Myelosuppression. Monitor CBCs frequently for response and/or toxicity, at a minimum, prior to each dosing cycle. Renal or hepatic impairment. High tumor burden. Monitor serum bicarbonate, liver chemistries, serum creatinine, and electrolytes prior to initiation and with each cycle. Monitor for tumor lysis syndrome and treat as appropriate. Elderly. Embryo-fetal toxicity. Advise to use effective contraception during and for 6 months (females of reproductive potential) and for 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
Vidaza Adverse Reactions
Nausea, anemia, thrombocytopenia, vomiting, pyrexia, leukopenia, diarrhea, inj site erythema, constipation, neutropenia, ecchymosis, petechiae, rigors, weakness, hypokalemia, rash, upper RTI; renal failure/tubular acidosis, hepatic coma.
Vidaza Clinical Trials
Vidaza Patient Counseling