AMPOULES: 10 x 10 ml.
Should be diluted with 100-250 ml 5% dextrose injection, USP or 0.9% sodium chloride injection, USP. The ampoules are single-use. Unused portions of each ampoule should be discarded properly and not saved for later administration. Should not be mixed with other medications.
Should be administered IV over 1-2 hours. The infusion duration may be extended up to 4 hours if acute vasomotor reactions are observed.
Induction treatment schedule: Administer IV at a dose of 0.15 mg/kg daily until bone marrow remission. Total induction dose should not exceed 60 doses.
Consolidation treatment schedule: Consolidation treatment should begin 3-6 weeks after completion of induction therapy. Should be administered IV at a dose of 0.15 mg/kg daily for 25 doses over a period up to 5 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 translocation of PML/RAR-alpha gene expression.
Hypersensitivity to arsenic.
Should be administered under the supervision of a physician who is experienced in the management of patients with acute leukemia. Some patients treated have experienced symptoms similar to a syndrome called the retinoic-acid-Acute Promyelocytic Leukemia (RA-APL) or APL differentiation syndrome, characterized by fever, dyspnea, weight gain, pulmonary infiltrates and pleural or pericardial effusions with or without leukocytosis. This syndrome can be fatal. Treatment has been associated with the development of hyperleukocytosis. QT/QTc prolongation should be expected during treatment and torsade de pointes as well as complete heart block has been reported. The patients electrolyte, hematologic and coagulation profiles should be monitored at least 2 x weekly, and more frequently for clinically unstable patients during the induction phase and at least weekly during the consolidation phase. ECGs should be obtained weekly, and more frequently for clinically unstable patients, during induction and consolidation.
Pregnancy and lactation
: If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant. See prescribing information for full details.
Most patients experienced some drug-related toxicity, most commonly leukocytosis, GI (nausea, vomiting, diarrhea, and abdominal pain), fatigue, edema, hyperglycemia, dyspnea, cough, rash or itching, headaches and dizziness. These were not observed to be permanent or irreversible, nor do they usually require interruption of therapy. See prescribing information for full details.
No formal assessments of pharmacokinetic drug-drug interactions have been conducted. See prescribing information for full details.