Arsenic trioxide causes morphologic changes and DNA fragmentation characteristics of apoptosis in NB4 human promyelocytic leukemia cells in vitro. Arsenic trioxide also causes damage or degradation of the fusion protein PML/RAR-alpha.

Adults and children five years of age and older:

• Induction, 0.15 mg per kg of body weight daily until bone marrow remission occurs (up to 60 doses).
• Consolidation, 0.15 mg per kg of body weight daily for 25 doses over a period of up to five weeks.

Induction of remission and consolidation in patients with acute promyelocytic leukemia (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.

Leukocytosis, nausea, vomiting, diarrhea, abdominal pain, fatigue, edema, hyperglycemia, dyspnea, cough, rash, headache, and dizziness.

Monitor for symptoms of APL differentiation syndrome during or after treatment, including fever, dyspnea, weight gain, pulmonary infiltrates and pleural or pericardial effusions, with or without leukocytosis. High-dose steroids and diuretics often manage these symptoms.

Prior to initiating therapy, ECG and serum electrolytes should be assessed and corrected.

If possible, discontinue drugs that prolong the QT interval.