Arsenic Trioxide is an arsenical indicated:
- In combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t (15;17) translocation or PML/RAR-alpha gene expression.
- For induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t (15;17) translocation or PML/RAR-alpha gene expression.
Newly-diagnosed low-risk APL:
- Induction: Administer 0.15 mg/kg/day intravenously daily in combination with tretinoin until bone marrow remission. Do not exceed 60 days.
- Consolidation: Administer 0.15 mg/kg/day intravenously daily for 5 days per week during weeks 1-4 of each 8-week cycle for a total of 4 cycles in combination with tretinoin.
Relapsed or refractory APL:
- Induction: Administer 0.15 mg/kg/day intravenously daily until bone marrow remission. Do not exceed 60 days.
- Consolidation: Administer 0.15 mg/kg/day intravenously daily for 25 doses over a period of up to 5 weeks.
Newly-diagnosed low-risk APL:
- Induction: Administer 0.15 mg/kg/day intravenously daily in combination with tretinoin until bone marrow remission. Do not exceed 60 days.
- Consolidation: Administer 0.15 mg/kg/day intravenously daily for 5 days per week during weeks 1-4 of each 8-week cycle for a total of 4 cycles in combination with tretinoin.
Relapsed or refractory APL:
- Induction: Administer 0.15 mg/kg/day intravenously daily until bone marrow remission. Do not exceed 60 days.
- Consolidation: Administer 0.15 mg/kg/day intravenously daily for 25 doses over a period of up to 5 weeks.
Drugs That Can Lead to Electrolyte Abnormalities: Electrolyte abnormalities increase the risk of serious QT/QTc interval prolongation. Avoid concomitant use of drugs that can lead to electrolyte abnormalities. Monitor electrolytes more frequently in patients who must receive concomitant use of these drugs and Arsenic Trioxide.
Drugs That Can Lead to Hepatotoxicity: Concomitant use of these drugs and Arsenic Trioxide, particularly when given in combination with tretinoin, may increase the risk of serious hepatotoxicity. Discontinue or replace with an alternative drug that does not cause hepatotoxicity while the patient is using Arsenic Trioxide. Monitor liver function tests more frequently in patients when it is not feasible to avoid concomitant use.
Carcinogenesis: Arsenic trioxide is a human carcinogen. Monitor patients for the development of second primary malignancies.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception.
Geriatric Use: No overall differences in safety or effectiveness were observed between these patients and younger patients.
Renal Impairment: Exposure of Arsenic Trioxide may be higher in patients with severe renal impairment.
Hepatic Impairment: Since limited data are available across all hepatic impairment groups, caution is advised in the use of Arsenic Trioxide in patients with hepatic impairment.