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DNA Methyltransferase Inhibitor / Hypomethylating Agent (Specialist Oncology Drug)

Azacitidine

Brand names: Vidaza (parenteral), Onureg (oral)

Adult dose

Dose: Refer to BNF, SmPC, and current SACT protocol
Route: Subcutaneous injection or intravenous infusion (Vidaza); oral (Onureg — AML maintenance)
Frequency: As per SACT/MDT guidance (typical: 75 mg/m² days 1–7 every 28-day cycle)

Clinical pearls

  • Hypomethylating agent: inhibits DNMT (DNA methyltransferase) → reactivation of silenced tumour suppressor genes
  • NICE TA218 (2011): SC azacitidine for intermediate-2 or high-risk MDS, CMML with WBC <13 × 10⁹/L, and AML with 20–30% blasts
  • NICE TA697 / TA765: oral azacitidine (Onureg) for AML maintenance post-induction in adults not eligible for HSCT
  • Treatment requires 4–6 cycles minimum before assessing response (partial response or better needed to continue)
  • G-CSF support may be required for febrile neutropenia prophylaxis per SACT protocol
  • SC injection site rotation mandatory; rotate sites systematically
  • AZALIN and AZA-001 trials established efficacy in MDS

Contraindications

  • Advanced malignant hepatic tumours (relative — monitor LFTs)
  • Hypersensitivity to azacitidine or mannitol
  • Pregnancy

Side effects

  • Myelosuppression (neutropenia, thrombocytopenia, anaemia — very common; dose-limiting)
  • Injection site reactions (erythema, pain, bruising — SC route)
  • Nausea, vomiting (common)
  • Fatigue
  • Fever, infection (due to neutropenia)
  • Elevated LFTs

Interactions

  • No major pharmacokinetic interactions with azacitidine SC
  • Oral azacitidine (Onureg): CYP3A4 and P-gp substrates — check SmPC

Monitoring

  • Full blood count before each cycle (dose-adjust or delay based on nadir counts)
  • LFTs and renal function at baseline and every cycle
  • Bone marrow biopsy to assess response (every 2–4 cycles)
  • Injection site reactions
  • Signs of infection (temperature, CRP) — neutropenic precautions

Reference: BNF; NICE TA218 (Azacitidine for MDS and AML, 2011); NICE TA765 (Oral azacitidine for AML maintenance, 2022); AZA-001 trial (Lancet 2009); ELN/EHA MDS Guidelines; https://bnf.nice.org.uk/drugs/azacitidine/. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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