arsenic trioxide


TTY Biopharm


American Taiwan Biopharma
Concise Prescribing Info
Arsenic trioxide
Induction of remission & consolidation in patients w/ acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid & anthracycline chemotherapy, & whose APL is characterized by the presence of the (15;17) translocation or PML/RAR-α gene expression.
Dosage/Direction for Use
Diluted w/ 100-250 mL 5% dextrose inj or 0.9% NaCl inj IV over 1-2 hr; up to 4 hr if acute vasomotor reactions are observed. IV Induction treatment schedule 0.15 mg/kg daily until bone marrow remission. Total induction dose should not exceed 60 doses. Consolidation treatment schedule Begin 3-6 wk after completion of induction therapy at 0.15 mg/kg daily.
Special Precautions
Development of fatal APL differentiation syndrome. May cause QT prolongation & complete AV block which can lead to torsade de pointes-type ventricular arrhythmia. Prior to initiating therapy, perform a 12-lead ECG & assess serum electrolytes (K, Ca, & Mg) & creatinine; correct preexisting electrolyte abnormalities & discontinue use of possible QT prolonging drugs. During therapy, K conc should be kept ≥4 mEq/L & Mg conc ≥1.8 mg/dL. If syncope, rapid or irregular heartbeat develops, patient should be hospitalized for monitoring. Development of hyperleukocytosis. Complete AV block. Monitor electrolyte, hematologic & coagulation profiles at least twice wkly, ECGs wkly & more frequently for clinically unstable patients. Human carcinogen. Renal or hepatic impairment. Concomitant use w/ medications prolonging QT interval or lead to electrolyte abnormalities. Pregnancy & lactation. Childn <5 yr.
Adverse Reactions
Leukocytosis, GI (nausea, vomiting, diarrhea, & abdominal pain), fatigue, edema, hyperglycemia, dyspnea, cough, rash or itching, headaches, & dizziness.
Drug Interactions
Drugs that can prolong QT interval (eg, certain antiarrhythmics or thioridazine) or lead to electrolyte abnormalities (eg, diuretics or amphotericin B).
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01XX27 - arsenic trioxide ; Belongs to the class of other antineoplastic agents. Used in the treatment of cancer.
Asadin soln for inj 1 mg/mL
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