Active Ingredient: Arsenic trioxide
Arsenic trioxide is indicated for induction of remission, and consolidation in adult patients with:
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
0.15 - 0.15 mg per kg of body weight
From 0.15 To 0.15 mg per kg of body weight once every day
Arsenic trioxide must be administered intravenously at a dose of 0.15 mg/kg/day, given daily until complete remission is achieved. If complete remission has not occurred by day 60, dosing must be discontinued.
Arsenic trioxide must be administered intravenously at a dose of 0.15 mg/kg/day, 5 days per week. Treatment should be continued for 4 weeks on and 4 weeks off, for a total of 4 cycles.
Arsenic trioxide must be administered intravenously at a fixed dose of 0.15 mg/kg/day given daily until complete remission is achieved (less than 5% blasts present in cellular bone marrow with no evidence of leukaemic cells). If complete remission has not occurred by day 50, dosing must be discontinued.
Consolidation treatment must begin 3 to 4 weeks after completion of induction therapy. Arsenic trioxide is to be administered intravenously at a dose of 0.15 mg/kg/day for 25 doses given 5 days per week, followed by 2 days interruption, repeated for 5 weeks.
Treatment with arsenic trioxide must be temporarily interrupted before the scheduled end of therapy at any time that 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. Patients who experience such reactions that are considered arsenic trioxide related must resume treatment only after resolution of the toxic event or after recovery to baseline status of the abnormality that prompted the interruption. In such cases, treatment must resume at 50% of the preceding daily dose. If the toxic event does not recur within 7 days of restarting treatment at the reduced dose, the daily dose can be escalated back to 100% of the original dose. Patients who experience a recurrence of toxicity must be removed from treatment.
Arsenic trioxide must be administered intravenously over 1-2 hours. The infusion duration may be extended up to 4 hours if vasomotor reactions are observed.
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