Monograph Details
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Neoplasms
> Miscellaneous oncology agents
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TRISENOX |
| Manufacturer |
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Cephalon, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Antineoplastic. |
| Generic Name |
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Arsenic trioxide 1mg/mL; soln for IV inj after dilution; preservative-free. |
| Indications |
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Induction of remission and consolidation in acute promyelocytic leukemia (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. |
| Children |
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See literature. <5yrs: not recommended. 5–16yrs: doses of 0.15mg/kg per day have been used. |
| Adults |
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Give by IV infusion over 1–2 hours; may extend infusion up to 4 hours if acute vasomotor symptoms occur. Induction: 0.15mg/kg per day until bone marrow remission; max 60 doses. Consolidation treatment (begin 3–6 weeks after completion of induction therapy): 0.15mg/kg per day for 25 doses for up to 5 weeks. |
| Precautions |
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Renal or hepatic dysfunction. History of torsades de pointes. Preexisting QT interval prolongation. CHF. Monitor hematology, renal function, and electrolytes at least twice weekly, perform ECG at baseline then weekly (hospitalize if cardiac irregularities develop); unstable patients: monitor more frequently. Correct electrolyte imbalances before starting therapy (maintain K+ above 4mEq/dL and Mg++ above 1.8mg/dL). Pregnancy: (Cat.D), nursing mothers: not recommended. |
| Interactions |
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Caution with drugs that can cause QT prolongation (discontinue these before starting therapy, if possible) or electrolyte imbalances. |
| Adverse Reactions |
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Leukocytosis, GI upset, fatigue, edema, hyperglycemia, cough, rash, headache, dizziness, paresthesia, arthralgia, renal failure, electrolyte disorders (eg,hypokalemia, hypomagnesemia), abnormal LFTs; APL differentiation syndrome (eg, fever, dyspnea, weight gain, pulmonary infiltrates, pericardial effusion; give high-dose IV steroids at 1st sign), hyperleukocytosis, QT interval prolongation/heart block, atrial dysrhythmias, tachycardia, others (see literature). |
| How Supplied |
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Single-use amps (10mL)—10 |
| Additional Resources |
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• Related Prescribing Note |
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