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Differentiation Agent / Cytotoxic (Specialist Oncology Drug) Pregnancy: Embryotoxic and teratogenic in animal studies; no studies in pregnant women. Women of childbearing potential and men must use effective contraception during treatment. Breast-feeding must be discontinued prior to and throughout administration (arsenic excreted in human milk).

Arsenic Trioxide

Brand names: Trisenox

Arsenic trioxide is an intravenous agent used in acute promyelocytic leukaemia, often with all-trans retinoic acid, for induction and consolidation.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 0.15 mg/kg/day by intravenous infusion
Route: intravenous infusion over 1-2 hours (may extend up to 4 hours if vasomotor reactions occur)
Frequency: See notes — schedule differs for induction vs consolidation
Specialist use — must be administered under the supervision of a physician experienced in the management of acute leukaemias. Same dose recommended for adults and elderly. Acute promyelocytic leukaemia (APL). Newly diagnosed low-to-intermediate risk APL — Induction: 0.15 mg/kg/day daily until complete remission; discontinue if not achieved by day 60. Consolidation: 0.15 mg/kg/day, 5 days per week, 4 weeks on and 4 weeks off, for a total of 4 cycles. Relapsed/refractory APL — Induction: 0.15 mg/kg/day daily until complete remission (<5% blasts, no evidence of leukaemic cells); discontinue if not achieved by day 50. Consolidation: begins 3-4 weeks after induction; 0.15 mg/kg/day for 25 doses given 5 days per week followed by 2 days interruption, repeated for 5 weeks. Interrupt for any toxicity grade 3 or greater (NCI Common Toxicity Criteria) possibly related to treatment; resume at 50% of the preceding daily dose, escalating back to 100% if no recurrence within 7 days. A central venous catheter is not required; patients must be hospitalised at the beginning of treatment. Caution in hepatic or renal impairment (no data across groups).

Dose adjustments

Renal

Caution advised in patients with renal impairment (no data available across all renal impairment groups); no specific dose reduction stated.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients

Side effects

  • Hyperglycaemia
  • Hypokalaemia
  • Neutropenia / leukocytosis
  • Increased alanine aminotransferase (ALT)
  • QT interval prolongation (can lead to torsade de pointes)
  • APL differentiation syndrome (leukocyte activation syndrome)

Clinical monograph

How it works

It promotes degradation of the PML-RARA fusion protein and induces differentiation and apoptosis of leukaemic promyelocytes.

Prescribing in practice

  • It causes QT prolongation and risk of serious arrhythmia, so correct electrolytes, obtain a baseline ECG, and avoid other QT-prolonging drugs where possible.
  • Differentiation syndrome (APL differentiation syndrome) can be life-threatening and requires prompt recognition and corticosteroid treatment.
  • Administered by intravenous infusion under specialist haematology supervision.

Monitoring

Monitor ECG/QT interval, serum potassium, magnesium and calcium, full blood count, liver function, and for signs of differentiation syndrome.

Counselling the patient

  • Report breathlessness, weight gain, or fever, which may indicate differentiation syndrome.
  • Report palpitations or fainting; regular ECGs and blood tests are needed.
  • Treatment is given in a specialist haematology setting.

Evidence & guidelines

Arsenic trioxide combined with all-trans retinoic acid is the established treatment for acute promyelocytic leukaemia (e.g. the APL0406 evidence base); consult the SPC.

Reference: NICE TA611 (Arsenic trioxide for treating APL, 2020); European APL Study Group; ELN/EHA APL guidelines; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.