Generic Name and Formulations:
Arsenic trioxide 12mg/6mL; per vial; soln for IV inj after dilution; preservative-free.
Indications for TRISENOX:
Newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression, in combination with tretinoin. Induction of remission and consolidation in APL refractory to or relapsed from retinoid and anthracycline chemotherapy, and whose APL has the t(15;17) translocation or PML/RAR-alpha gene expression.
Infuse over 2hrs; may extend infusion up to 4hrs if acute vasomotor symptoms occur. May give prednisone prophylaxis when used in combination with tretinoin. Newly-diagnosed: Induction (1 cycle): 0.15mg/kg once daily in combination with tretinoin 22.5mg/m2 orally twice daily until bone marrow remission; max 60 days. Consolidation (4 cycles): 0.15mg/kg once daily for 5 days on Weeks 1–4 of an 8-week cycle; give in combination with tretinoin 22.5mg/m2 orally twice daily for 7 days on Weeks 1, 2, 5 and 6 (omit tretinoin on Weeks 5–6 of the 4th cycle). Relapsed/refractory: Induction (1 cycle): 0.15mg/kg once daily until bone marrow remission or up to max 60 days. Consolidation (1 cycle): 0.15mg/kg once daily for 25 doses for up to 5 weeks; begin 3–6wks after completion of induction therapy. Dose modifications: see full labeling.
Newly-diagnosed: not established. Relapsed/refractory (5–16yrs): doses of 0.15mg/kg/day have been used (see full labeling).
Differentiation syndrome. Cardiac conduction abnormalities.
Risk of differentiation syndrome (may be life-threatening or fatal); withhold treatment, initiate high-dose steroid (eg, dexamethasone IV 10mg) and monitor hemodynamically if suspected. Risk of cardiac conduction abnormalities (eg, QT prolongation, AV block, torsades de pointes). Assess QT interval and correct electrolyte abnormalities (maintain K+ above 4mEq/L and Mg++ above 1.8mg/dL) prior to initiation. Withhold treatment if QTc >500msec; resume at reduced dose. Monitor ECG weekly; more frequently in unstable patients. Patients with ventricular arrhythmia, prolonged QT interval: do not administer. History of torsades de pointes. CHF. Monitor for second primary malignancies. Monitor hematology, chemistries, LFTs at least 2–3 times weekly. Severe renal impairment (CrCl <30mL/min): may need lower doses; monitor. Hepatic impairment; monitor if severe. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Use effective contraception during and for 6 months (females) or 3 months (males) after last dose. Nursing mothers: not recommended (during and for 2 weeks after last dose).
Avoid concomitant drugs known to prolong QT interval; if unavoidable, monitor ECG more frequently. Concomitant drugs that can lead to electrolyte abnormalities (eg, diuretics, amphotericin B); avoid or monitor electrolytes more frequently. Concomitant hepatotoxic drugs: discontinue or consider alternatives.
Thrombocytopenia, neutropenia, hepatotoxicity, infection, fever, hypertriglyceridemia, hypercholesterolemia, leukocytosis, GI upset, fatigue, edema, hyperglycemia, dyspnea, cough, rash, itching, headaches, dizziness; differentiation syndrome, cardiac conduction abnormalities.
Single-dose vials (10mL)—10