Generic name: ARSENIC TRIOXIDE 1mg in 1mL
Dosage form: injection, solution
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Induction Treatment Schedule: Administer TRISENOX intravenously at a dose of 0.15 mg/kg daily until bone marrow remission. Do not exceed 60 doses for induction.
Consolidation Treatment Schedule: Begin consolidation treatment 3 to 6 weeks after completion of induction therapy. Administer TRISENOX intravenously at a dose of 0.15 mg/kg daily for 25 doses over a period up to 5 weeks.
2.2 Dose Adjustment for Non-Hematologic Adverse Reactions
If a severe non-hematologic adverse reaction occurs (such as neurologic or dermatologic toxicity), consider delaying TRISENOX infusion until the event has resolved (≤ Grade 1).
Instructions for Preparation and Intravenous Administration
Administer TRISENOX intravenously over 1-2 hours. The infusion duration may be extended up to 4 hours if acute vasomotor reactions are observed. A central venous catheter is not required.
The TRISENOX ampule is single-use and does not contain any preservatives. Unused portions of each ampule should be discarded properly. Do not mix TRISENOX with other medications.
Dilute TRISENOX with 100 to 250 mL 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP, using proper aseptic technique, immediately after withdrawal from the ampule. Do not save any unused portions for later administration.
Safe Handling Procedures
TRISENOX is a cytotoxic drug. Follow applicable special handling and disposal procedures.1