Azacitidine

Treatment should be initiated and monitored under the supervision of a physician experienced in the use of chemotherapeutic agents. Patients should be premedicated with anti-emetics for nausea and vomiting. IMPORTANT: 'Injectable azacitidine should not be used interchangeably with oral azacitidine. Due to differences in the exposure, the dose and schedule recommendations for oral azacitidine are different from those for injectable azacitidine' — verify the product name, dose and administration route. LABORATORY TESTS: liver function tests, serum creatinine and serum bicarbonate should be determined prior to initiation of therapy and prior to each treatment cycle; complete blood counts prior to initiation and as needed to monitor response and toxicity, at a minimum prior to each treatment cycle. DOSE ADJUSTMENT FOR HAEMATOLOGICAL TOXICITY (defined as nadir platelets 50.0 x 10^9/L or below and/or ANC 1 x 10^9/L or below). Patients without reduced baseline blood counts (WBC 3.0 x 10^9/L or above, ANC 1.5 x 10^9/L or above and platelets 75.0 x 10^9/L or above before first treatment): delay the next cycle until platelets and ANC have recovered; if recovery is achieved within 14 days no dose adjustment is necessary, but if recovery has not been achieved within 14 days the next-cycle dose is 50% where the nadir ANC was 1.0 x 10^9/L or below and platelets 50.0 x 10^9/L or below, and 100% where the nadir ANC was above 1.0 x 10^9/L and platelets above 50.0 x 10^9/L. Patients with reduced baseline blood counts (WBC below 3.0 x 10^9/L or ANC below 1.5 x 10^9/L or platelets below 75.0 x 10^9/L before first treatment): if the decrease is 50% or less, or greater than 50% but with improvement in any cell line differentiation, do not delay and do not adjust; if the decrease is greater than 50% with no improvement in cell line differentiation, delay the next cycle until recovery — if recovery is not achieved within 14 days determine bone marrow cellularity, and if cellularity is above 50% make no dose adjustment, while if cellularity is 50% or less the next-cycle dose is 100% for recovery within 21 days or 50% (cellularity 15-50%) / 33% (cellularity below 15%) for recovery beyond 21 days. Following dose modifications the cycle duration should return to 28 days. Hepatic impairment: no formal studies conducted; no specific modification to the starting dose is recommended, with subsequent modifications based on haematology laboratory values; patients with severe hepatic organ impairment should be carefully monitored for adverse events; contraindicated in advanced malignant hepatic tumours. Elderly: no specific dose adjustments recommended, but monitoring renal function may be useful. PAEDIATRIC: 'The safety and efficacy of azacitidine in children aged 0-17 years have not yet been established... no recommendation on a posology can be made.' SOURCE: UK SPC for Azacitidine 25 mg/mL powder for suspension for injection (eMC product 15363).