MedeliX
Start asking

arsenic trioxide

Trisenox · ATC code L01XX27

Also known as: Arsentrioxid · Brand names: Trisenox, Arsentrioxid Stada, Arsentrioxid Tillomed, Igos, Leusenox

Key facts
Active substance
arsenic trioxide
ATC code
L01XX27
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
TRISENOX 1 mg/ml concentrate for solution for infusion / TRISENOX 2 mg/ml concentrate for solution for infusion
Marketing authorisation holder
Teva B.V.
Information as of
2026-10-27

Key facts

Arsenic trioxide (TRISENOX) is an antineoplastic medicine given by infusion. It is used for induction of remission and consolidation in adults with acute promyelocytic leukaemia (APL).

What it is used for

  • Newly diagnosed low-to-intermediate risk APL, in combination with all-trans-retinoic acid (ATRA)
  • Relapsed/refractory APL with t(15;17) translocation and/or PML/RAR-alpha gene, after prior retinoid and chemotherapy

Dosing

  • All schedules: 0.15 mg/kg/day intravenously; same dose for adults and elderly
  • Newly diagnosed APL, induction: daily until complete remission; stop if no remission by day 60
  • Newly diagnosed APL, consolidation: 5 days per week, 4 weeks on and 4 weeks off, for 4 cycles
  • Relapsed/refractory APL: daily induction, stop if no remission by day 50; consolidation of 25 doses over 5 weeks
  • Toxicity grade 3 or greater: interrupt, then resume at 50% of the preceding daily dose
  • Caution in hepatic or renal impairment; must be given under supervision of a physician experienced in acute leukaemias

Contraindications

  • Hypersensitivity to the active substance or any of the excipients

Important warnings

  • APL differentiation syndrome (leukocyte activation syndrome)
  • QT prolongation, torsade de pointes and complete heart block may occur; monitor ECG and electrolytes
  • Hepatotoxicity
  • Clinically unstable patients need more frequent electrolyte, glycaemia, haematologic, hepatic, renal and coagulation tests

Side effects

  • Most common: hyperglycaemia, hypokalaemia, neutropenia, increased ALT
  • Leucocytosis in 50% of patients with relapsed/refractory APL
  • Serious: differentiation syndrome, QT prolongation, atrial fibrillation, haemorrhage, infections

Interactions

  • QT-prolonging medicines (e.g. macrolide antibiotics, thioridazine): caution
  • Medicines causing hypokalaemia or hypomagnesaemia (e.g. diuretics, amphotericin B): higher torsade de pointes risk
  • Hepatotoxic medicines: see the full product information

Pregnancy and breastfeeding

  • Embryotoxic and teratogenic in animals; women must use effective contraception during and for 6 months after treatment, men for 3 months after

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Austria

  • Arsentrioxid StadaStada Arzneimittel Gmbh · 1 register entry
  • Arsentrioxid TillomedTillomed Malta Ltd · 1 register entry
  • IgosStada Arzneimittel Ag · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • Arsentrioxid StadaStadapharm Gmbh · 1 register entry
  • Arsentrioxid TillomedTillomed Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • LeusenoxKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 3 register entries
  • TrisenoxTEVA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 24 more European countries
Bulgaria
Арсенов Триоксид Tillomed
Croatia
Arsenov Trioksid Tillomed
Cyprus
Arsenic Trioxide Tillomed
Czechia
Arsenic Trioxide Tillomed
Denmark
Arsentrioxid Tillomed
Estonia
Arsenic Trioxide Tillomed
Finland
Arsenic Trioxide Tillomed
France
Arsenic Trioxide Tillomed
Greece
Arsenic Trioxide Tillomed
Hungary
Arsenic Trioxide Tillomed
Iceland
Arsenic Trioxide Accord, Arsenic Trioxide Medac, Trisenox
Italy
Arsenico Triossido Eg, Arsenico Triossido Tillomed
Latvia
Arsenic Trioxide Tillomed
Liechtenstein
Arsenic Trioxide Accord, Arsenic Trioxide Medac, Trisenox
Lithuania
Arsenic Trioxide Tillomed
Malta
Arsenic Trioxide Eugia, Arsenic Trioxide Tillomed
Netherlands
Arseentrioxide Cf
Norway
Arsenic Trioxide Accord, Arsenic Trioxide Medac, Arsenic Trioxide Tillomed, Trisenox
Poland
Arsenic Trioxide Tillomed
Portugal
Trióxido De Arsénio Generis
Romania
Trioxid De Arsen Tillomed
Slovenia
Arzenov Trioksid Tillomed
Spain
Trióxido De Arsénico Stada, Trióxido De Arsénico Tillomed
Sweden
Arsenic Trioxide Tillomed

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Trisenox – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/trisenox-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.