Arsenic trioxide medac is used to treat adults (aged 18 years or over) with acute promyelocytic leukaemia (APL). APL is a rare form of leukaemia (cancer of the white blood cells) caused by a genetic ‘translocation’ (when there is a swap of genes between two chromosomes). The translocation affects the way the white blood cells grow, and as a result they lack the ability to use retinoic acid (vitamin A). Patients with APL are normally treated with retinoids (substances derived from vitamin A). Arsenic trioxide medac is used in: - patients with newly diagnosed low or intermediate risk APL where it is used together with the medicine all-trans-retinoic acid (ATRA); - patients with APL whose disease has not responded to previous treatment with a retinoid and cancer medicines, or when their disease has come back after this type of treatment. Arsenic trioxide medac is a ‘generic medicine’. This means that Arsenic trioxide medac contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Trisenox. Arsenic trioxide medac contains the active substance arsenic trioxide.
Therapeutic Indication
### Therapeutic indication Arsenic trioxide medac 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/?l) in combination with all-trans-retinoic acid (ATRA) - Relapsed/refractory 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 pro-myelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR?) gene. The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.
Therapeutic Area (MeSH)
ATC Code
L01XX27
ATC Item
arsenic trioxide
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
EMA Name
Arsenic trioxide medac
Medicine Name
Arsenic trioxide medac
Aliases
N/A