2 Information about arsenic trioxide

2 Information about arsenic trioxide

Marketing authorisation indication

Arsenic trioxide (Trisenox, Teva) is indicated for the induction of remission, and consolidation in adults with:

  • newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (white blood cell count ≤10x103 per microlitre) in combination with all-trans-retinoic acid (ATRA)

  • relapsed/refractory acute promyelocytic leukaemia (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 PML/RAR-alpha gene.

Dosage in the marketing authorisation

For newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia:

  • 0.15 mg/kg per day intravenously. In induction, this is given daily until complete remission or for a maximum of 60 days. In consolidation, this is given 5 days per week for 4 weeks on and 4 weeks off, for a total of 4 cycles.

For relapsed and refractory acute promyelocytic leukaemia:

  • 0.15 mg/kg per day intravenously. In induction, this is given daily until complete remission or for a maximum of 50 days. Consolidation treatment must begin 3 to 4 weeks after completing induction therapy. In consolidation, treatment is given for 25 doses, 5 days per week, followed by 2 days interruption, repeated for 5 weeks.

Treatment with arsenic trioxide must be temporarily stopped before the scheduled end of therapy if a toxicity grade 3 or greater on the National Cancer Institute Common Toxicity Criteria is observed and judged to be possibly related to arsenic trioxide treatment. Treatment may be resumed at 50% of the preceding daily dose after the toxic event is resolved or after recovery to baseline status of the abnormality that prompted the interruption.

Price

£2,920 for 10 ampoules of 10 mg/10 ml concentrate for solution for infusion (excluding VAT; British national formulary [BNF] online [accessed March 2018]). Costs may vary in different settings because of negotiated procurement discounts.

  • National Institute for Health and Care Excellence (NICE)