Azacitidine
Cytostatic · Antimetabolite
Indications
Intermediate-2 and high-risk myelodysplastic syndromes, chronic myelomonocytic leukaemia with 10-29% blasts without myeloproliferative disorder and acute myeloid leukaemia with 20-30% blasts and multi-lineage dysplasia, in patients who are not eligible for haematopoietic stem cell transplantation.
Dosage
Adults: Myelodysplastic syndromes (MDS): 75 mg/days repeated every 4 wk. Dose may be increased to 100 mg/days 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; treatment may be continued as long as patient continues to benefit. Children: Not recommended.
Administration
To be administered by SC inj or IV inf. Premedicate for nausea and vomiting. Monitor patients for hematologic response and for renal toxicity, delay or reduce dosage as appropriate.
Risk Factor (Pregnancy/Lactation)
Pregnancy: Contraindicated in pregnancy. Lactation: Contraindicated or not recommended. Contraindications: Hypersensitivity to azacitidine, mannitol, advance malignant hepatic tumours. Precautions: Hepatotoxicity, progressive hepatic tumour, renal impairment, increased creatinine, renal tubular acidosis, elevated BUN or serum Creatinine or reduction in serum bicarbonate to <20mEq/L, neutropenia, thrombocytopenia, anaemia.
Advice to Patient
Contact prescriber if there is severe diarrhoea or constipation, headaches, muscle ache, cough, sore throat, difficulty in passing urine, feelings of cold and shiver, dizziness, blood in stool, skin rash, itching, difficulty in breathing, anxiety, flushing of face. Drink plenty of fluids. Avoid immunisation with live vaccines during treatment and for 6 months after completion of treatment. Get laboratory tests done as recommended by the physician.
Pharmacokinetics
Absorption: Rapidly and completely absorbed after SC inj. Bioavailability: Approx. 89% (SC). Metabolism: Hepatic. Half-life elimination: Approx. 4 hrs (SC/IV). Approx. 0.5 hrs (oral). Time to peak, plasma: 30 mins (SC). 1 hr (oral). Excretion: Mainly via urine (50-85% [SC/IV]; <2% as unchanged drug [oral]); faeces (<1% [SC/IV].
Brands with this active ingredient
Compiled by Healify Pharmacy from published drug references. How we compile it →
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