Uses
Acute Promyelocytic Leukemia
Induction of remission and consolidation of acute promyelocytic leukemia (APL) that is refractory to retinoid and anthracycline therapy or has relapsed following such therapy; used in patients whose disease is characterized by the presence of the t(15;17) translocation or promyelocytic leukemia-retinoic acid receptor (PML-RAR)-α gene expression.
Actuarial 18-month relapse-free survival rate: 56%.
Use in combination with tretinoin and consolidation chemotherapy for the treatment of newly diagnosed APL† is being investigated.
Dosage and Administration
General
- Consult specialized references for procedures for proper handling and disposal of antineoplastic drugs.
Administration
Administer by IV infusion.
IV Administration
For solution compatibility information, see Compatibility under Stability.
IV solutions of the drug contain no preservatives; discard any unused portion of single-use ampul.
Do not mix with other drugs.
Dilution
Immediately after withdrawing the appropriate dose of the drug from the ampul, dilute with 100–250 mL of 5% dextrose injection or 0.9% sodium chloride injection.
Rate of Administration
Administer by IV infusion over 1–2 hours; if acute vasomotor reactions occur, longer infusion periods (e.g., up to 4 hours) may be used.
Dosage
Pediatric Patients
Acute Promyelocytic Leukemia
Induction Therapy
IV
In children ≥5 years of age, 0.15 mg/kg daily. Continue until bone marrow remission occurs or for a maximum of 60 doses.
Consolidation Therapy
IV
In children ≥5 years of age, 0.15 mg/kg daily for 25 doses, administered over a period of up to 5 weeks. Initiate 3–6 weeks after completion of induction therapy.
Adults
Acute Promyelocytic Leukemia
Induction Therapy
IV
0.15 mg/kg daily. Continue until bone marrow remission occurs or for a maximum of 60 doses.
Consolidation Therapy
IV
0.15 mg/kg daily for 25 doses, administered over a period of up to 5 weeks. Initiate 3–6 weeks after completion of induction therapy.
Cautions
Contraindications
Warnings/Precautions
Warnings
For warnings regarding experience of supervising clinician, APL differentiation syndrome, ECG abnormalities, and ECG and electrolyte monitoring, see Boxed Warning.
Hyperleukocytosis
Possible hyperleukocytosis (leukocyte count ≥10,000/mm3).
Carcinogenicity
Carcinogenicity studies not performed using IV arsenic trioxide; however, arsenic trioxide is a human carcinogen.
Fetal/Neonatal Morbidity and Mortality
May cause fetal harm; avoid pregnancy during therapy. If used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard.
General Precautions
Adequate Patient Monitoring
Perform hematologic and coagulation tests and determine serum electrolyte concentrations at least twice weekly during induction therapy (more frequently in clinically unstable patients) and at least weekly during consolidation therapy.
Monitor ECG weekly (more frequently in clinically unstable patients) during induction and consolidation therapy.
Specific Populations
Pregnancy
Category D. (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
Lactation
Arsenic is distributed into milk in humans; discontinue nursing or the drug.
Pediatric Use
Safety and efficacy not established in children <5 years of age.
Used in 7 children 5–16 years of age with APL; 5 of these children achieved complete responses.
Hepatic Impairment
Not studied in patients with hepatic impairment.
Renal Impairment
Not studied in patients with renal impairment.
Potential for prolonged elimination. Use with caution in patients with renal failure.
Common Adverse Effects
Leukocytosis, GI effects (nausea, vomiting, diarrhea, abdominal pain), fatigue, edema, hyperglycemia, dyspnea, cough, rash or itching, headaches, dizziness.
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