Arsenic Trioxide is indicated for:

• Use in combination with tretinoin for the treatment of adults with newly diagnosed low-risk acute promyelocytic leukemia (APL), characterized by the presence of t(15;17) translocation or PML/RAR-alpha gene expression
• Induction of remission and consolidation therapy in patients with APL who are refractory to, or have relapsed after, retinoid and anthracycline-based chemotherapy, and who exhibit t(15;17) translocation or PML/RAR-alpha gene expression

The exact mechanism of action of Arsenic Trioxide is not fully established. It induces apoptosis by causing morphological changes and DNA fragmentation in leukemia cells. Additionally, it promotes degradation of the PML-RAR-alpha fusion protein, which plays a key role in the pathogenesis of acute promyelocytic leukemia.

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.

Arsenic Trioxide may interact with several drug groups:

• QT/QTc-prolonging drugs: Concomitant use may increase the risk of serious cardiac arrhythmias. Whenever possible, avoid or substitute such medications. If unavoidable, close ECG monitoring is required.
• Drugs causing electrolyte imbalance: These may enhance the risk of QT prolongation; electrolyte levels should be monitored frequently.
• Hepatotoxic drugs: Concurrent use, especially with tretinoin, may increase liver toxicity. Consider alternative agents or closely monitor liver function.

Arsenic Trioxide is contraindicated in patients with known hypersensitivity to arsenic or its components.

Common adverse reactions (occurring in more than 30% of patients) include nausea, cough, fatigue, fever, headache, abdominal pain, vomiting, tachycardia, diarrhea, shortness of breath, hypokalemia, leukocytosis, hyperglycemia, hypomagnesemia, insomnia, dermatitis, edema, QT prolongation, chills, sore throat, joint pain, tingling sensations, and itching.

Hepatotoxicity: Liver enzyme elevations may occur; monitor liver function frequently and adjust dose if needed

Carcinogenicity: Arsenic Trioxide is a known carcinogen; monitor for secondary malignancies

Embryo-fetal toxicity: May cause fetal harm; effective contraception is recommended during treatment

Pediatric use: Safety and effectiveness have not been established

Geriatric use: No significant difference in safety or efficacy compared to younger patients

Renal impairment: Drug exposure may increase in severe renal dysfunction

Hepatic impairment: Use with caution due to limited clinical data

Store at 20°C to 25°C. Do not freeze. Handle with care as it is a hazardous drug and follow appropriate safety and disposal procedures.