# Arsenic trioxide

Arsenic trioxide (Trisenox, Teva B.V.) has 4 EU-approved indications in 1 tumour type. Each needs a biomarker result: PML::RARA (4).

## Approved indications

### Acute myeloid leukaemia

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| PML::RARA fusion (defines the disease) | + all-trans-retinoic acid (ATRA) | Induction | Acute promyelocytic leukaemia only; Low-to-intermediate risk; white blood cell count ≤ 10 x 103/μl |
| t(15;17) translocation or PML/RAR-alpha gene | Monotherapy | Induction | Acute promyelocytic leukaemia only; After previous treatment should have included a retinoid and chemotherapy |
| PML::RARA fusion (defines the disease) | + all-trans-retinoic acid (ATRA) | Consolidation | Acute promyelocytic leukaemia only; Newly diagnosed; low-to-intermediate risk; white blood cell count ≤ 10 x 103/μl |
| t(15;17) translocation and/or PML/RAR-alpha gene | Monotherapy | Consolidation | Acute promyelocytic leukaemia only; After previous treatment should have included a retinoid and chemotherapy; Relapsed/refractory |

## Products

### Trisenox

- Company: Teva B.V.
- Target: PML-RARA degrader
- Class: Other antineoplastic agents
- ATC: L01XX27
- EU approval: 5 Mar 2002
- Label revised: 30 Jan 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/trisenox-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/trisenox-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/trisenox
- Biosimilars and generics: Arsenic trioxide Accord, Arsenic trioxide medac

Mechanism (SmPC section 5.1): Arsenic trioxide causes apoptosis with DNA fragmentation and induces damage or degradation of the PML/RAR alpha fusion protein.

## Label wording

- **Arsenic trioxide** (Trisenox), Acute myeloid leukaemia, induction: “Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤ 10 x 103/μl) in combination with all-trans-retinoic acid (ATRA)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/trisenox-epar-product-information_en.pdf)
- **Arsenic trioxide** (Trisenox), Acute myeloid leukaemia, induction: “Relapsed/refractory acute promyelocytic leukaemia (APL) (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/trisenox-epar-product-information_en.pdf)
- **Arsenic trioxide** (Trisenox), Acute myeloid leukaemia, consolidation: “TRISENOX is indicated for induction of remission, and consolidation in adult patients with:
• Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤ 10 x 103/μl) in combination with all-trans-retinoic acid (ATRA)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/trisenox-epar-product-information_en.pdf)
- **Arsenic trioxide** (Trisenox), Acute myeloid leukaemia, consolidation: “TRISENOX is indicated for induction of remission, and consolidation in adult patients with:
• Relapsed/refractory acute promyelocytic leukaemia (APL) (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/trisenox-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/arsenic-trioxide