Leaflet TRIOXID DE ARSEN TILLOMED 2mg / ml concentrate for solution for infusion

Indicated for: acute promyelocytic leukemia

Route of administration: infusion

Substance: arsenic trioxide (antineoplastic agent)

ATC: L01XX27 (Antineoplastic and immunomodulating agents | Other antineoplastic agents)

Precautions:
Fertility warning
Fertility warning

This medicine may affect fertility.

Dose adjustment in hepatic impairment
Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

Cytotoxic / special handling
Cytotoxic / special handling

Handle with special care.

Contraception required
Contraception required

Effective contraception is required during treatment.

Contraindicated during breastfeeding
Contraindicated during breastfeeding

Do not use this medicine while breastfeeding.

Contraindicated during pregnancy
Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Hepatotoxicity
Hepatotoxicity

This medicine may affect the liver.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Myelosuppression / agranulocytosis
Myelosuppression / agranulocytosis

This medicine may lower blood cell counts.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests
Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Severe skin reactions
Severe skin reactions

Stop taking the medicine and seek urgent medical help if a severe rash occurs.

Arsenic trioxide is a medication used in the treatment of acute promyelocytic leukemia (APL), a rare form of leukemia. It works by inducing apoptosis (programmed cell death) in cancer cells and promoting their differentiation into normal cells.

Arsenic trioxide is administered intravenously, usually as part of a combination regimen with other medications such as all-trans retinoic acid (ATRA). It is commonly used in cases of relapsed or refractory APL, as well as a first-line therapy in certain situations.

Common side effects include nausea, fatigue, fever, and elevated liver enzymes. In rare cases, severe complications such as differentiation syndrome or cardiac arrhythmias may occur.

Arsenic trioxide is an essential medication in the treatment of acute promyelocytic leukemia, helping to improve survival rates and patient outcomes.

General data about TRIOXID DE ARSEN TILLOMED 2mg / ml

  • Substance: arsenic trioxide
  • Date of latest medicines list: 01-03-2026
  • Product code: W71667001
  • Concentration: 2mg / ml
  • Pharmaceutical form: concentrate for solution for infusion
  • Quantity: 1
  • Product type: Generic medicine
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: TILLOMED MALTA LTD. - MALTA
  • Holder: TILLOMED MALTA LIMITED - MALTA
  • Number: 16394/2026/01
  • Shelf life: 2 years-after packaging for sale;dupa reconstit. sol.-48h la 15-30°C/96h la frigider

Concentrations available for arsenic trioxide

  • 1mg/ml
  • 2mg/ml