Flash VIG-news: Trisenox (arsenic trioxide): risk of medication errors due to the introduction of a new concentration of 2 mg/ml

date: 26/11/2020

The FAMHP warns healthcare professionals prescribing, delivering and administering Trisenox about the risk of dosing errors as a new presentation of the medicine is launched on the market.

In 2019, the European Medicines Agency (EMA) recommended the approval of a new presentation of the injectable cancer medicine Trisenox (arsenic trioxide) that contains 2 mg/ml of the active substance in each vial. The new presentation will replace the existing one, which contains 1 mg/ml in each vial. In addition, the new vial contains a total volume of 6 ml (and a total content of 12 mg arsenic trioxide) whereas the existing vial contains 10 ml (and a total content of 10 mg arsenic trioxide).

Teva, the company that markets Trisenox, has informed the FAMHP that this new presentation has now been launched on the Belgian market.

Both concentrations will temporarily coexist until the stock of the 1 mg/ml concentration has been exhausted.

When approving the new presentation, the EMA expressed concern regarding the coexistence of the two concentration as this may result in medication errors (overdosage or underdosage). While an underdosage is likely to result in an inadequate effect, an overdosage can result in serious and potentially fatal complications such as haemorrhages, severe infections and cardiac arrests.

Therefore, the EMA and the FAMHP warn healthcare professionals using Trisenox about the risk of dosing errors. The agencies also remind healthcare professionals to check the concentration of the available presentation and to follow the information leaflet carefully.

A Direct Healthcare Professionals Communication (DHPC) containing this information is now being distributed.

Last updated on 01/12/2020