#高警訊藥品

Myelodysplastic syndromes: Treatment of high risk myelodysplastic syndrome(MDS), RA with excess blasts(RAEB), RAEB in transformation(RAEB-T), Chronic myelomonocytic leukemia(CMMoL), AML(unlabled).

Antineoplastic Agent, DNA Methylation Inhibitor
Vidaza is a pyrimidine nucleoside analog of cytidine. The antineoplastic effects may be a result of azacitidine's ability to promote hypomethylation of DNA leading to direct toxicity of abnormal hematopoietic cells in the bone marrow.

1. Bioavailability (SubQ): ~89%
2. Time to peak: 30 mins
3. Vd (IV): 76±26 L
4. Half-life elimination: ~4 hours
5. Excretion: Urine (50%-85%)

1. Advanced malignant hepatic tumors
2. Hypersensitivity to azacitidine or mannitol

D; If chemotherapy is indicated, it should not be administered in the first trimester but may begin in the second trimester.

Excretion in breast milk unknown/not recommended

Thrombocytopenia, anemia, nausea, vomiting, fever, fatigue, diarrhea, constipation, headache, dizziness, chest pain, pallor, pitting edema

Dosage:
75 mg/m²/day for 7 days repeated every 4 weeks. Dose may be increased to 100 mg/m²/day if no benefit is observed after 2 cycles and no toxicity other than nausea and vomiting have occurred. Treatment is recommended for at least 4 cycles.
Alternate schedules:
1. Repeat cycle every 28 days: 75 mg/m²/day for 5 days (Mon-Fri), 2 days rest (Sat, Sun), then 75 mg/m²/day for 2 days
2. Repeat cycle every 28 days: 50 mg/m²/day for 5 days (Mon-Fri), 2 days rest (Sat, Sun), then 50 mg/m²/day for 5 days
3. Repeat cycle every 28 days: 75 mg/m²/day for 5 days (Mon-Fri)

No dosage adjustments provided in the manufacturer's labeling (limited data available)

Renal impairment at baseline:
1. CrCl ≥30 mL/min: No dosage adjustment necessary.
2. CrCl <30 mL/min: No dosage adjustment necessary for cycle 1; azacitidine and its metabolites are excreted renally, monitor closely for toxicity.
Renal toxicity during treatment:
Unexplained increases in BUN or serum creatinine: Delay next cycle until values reach baseline or normal, then reduce dose by 50% for next treatment course.

1. No dosage adjustment provided in the manufacturer's labeling (has not been studied).
2. Use is contraindicated in patients with advanced malignant hepatic tumors.