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Hypomethylating Agent — MDS / AML

Azacitidine

Brand names: Vidaza, Onureg (oral formulation)

Azacitidine is a hypomethylating cytotoxic agent used for higher-risk myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukaemia in patients not suitable for stem cell transplantation.

Dosing — being independently re-sourced

ClinCalc Pro is rebuilding its dose data from primary open sources — the manufacturer SmPC (eMC), the WHO Model Formulary and other official references — under clinician review. This drug's structured dose is not yet published here. Confirm all doses against the product SmPC and your local formulary before prescribing.

Clinical monograph

How it works

As a pyrimidine nucleoside analogue it is incorporated into nucleic acids and inhibits DNA methyltransferase, causing DNA hypomethylation and direct cytotoxicity to abnormal haematopoietic cells.

Prescribing in practice

  • It causes marked myelosuppression, so monitor blood counts and manage neutropenia, anaemia and thrombocytopenia and associated infection and bleeding risk.
  • It is given in repeated treatment cycles, typically as a subcutaneous injection, with antiemetic cover.
  • Hepatic and renal impairment require caution, and it can cause serious tumour lysis and injection-site reactions.

Monitoring

Monitor full blood count before and during each cycle, along with renal and hepatic function.

Counselling the patient

  • Report fever, sore throat, bruising or bleeding, which may indicate low blood counts.
  • Treatment is given in cycles and several cycles may be needed before benefit is seen.
  • Effective contraception is required during treatment.

Evidence & guidelines

The landmark AZA-001 trial showed azacitidine improved overall survival compared with conventional care in higher-risk myelodysplastic syndromes.

Reference: AZA-001 Trial (Fenaux et al. Lancet Oncology 2009); NICE TA218; NICE TA666 (oral azacitidine); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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