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Arsenic Trioxide will be added
to formulary for induction of remission and consolidation in patients with
acute promyelocytic leukemia (APL) who are refractory or have relapsed from
retinoid and anthracycline chemotherapy. APL must be characterized by the
presence of the t (15; 17) translocation or PML/RAR-alpha gene expression. Use
of this agent will be restricted to certified oncologists.
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All patients will have an ECG to
document the QT interval and current medications will be screened by the
pharmacists for propensity to cause QT interval prolongation.
http://www.torsades.org
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Arsenic trioxide will only be
administered in the oncology unit or in the outpatient infusion center.
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A list of medications with risk
of Torsade de Pointes will be provided to the patient by nursing staff.
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ECG will be repeated weekly
during therapy.
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If administered in the
outpatient infusion center, documentation of weekly ECG will be required by
the infusion center.
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If absolute QT is >500 msec,
risk factors will immediately be corrected (electrolytes, concomitant drugs)
and will reassess risk/benefit of continuing versus suspending arsenic
trioxide.
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If syncope, rapid or irregular
heartbeat occur: hospitalize and monitor the patient continuously, and hold
TRISENOX® until QTc is <460 msec and symptoms resolve.
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5-HT3 receptor
antagonists will be used with caution as some cause QT interval prolongation (Anzemet
should not be used).
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Electrolytes will be monitored
and kept above the following values:
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Potassium 4 meq/l
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Magnesium 1.8 mg/dl
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The patient will be monitored
for APL differentiation syndrome:
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Fever, fluid retention,
musculoskeletal pain, pulmonary infiltrates and pleural or pericardial
effusions, with or without leukocytosis, and dyspnea.
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Patient weight will be recorded
daily and monitored for >2 lbs. gain in 24 hours by nursing staff.
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The patient will be taught signs
and symptoms of APL differentiation syndrome by nursing staff and will be
asked to report any signs and symptoms.
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At the first sign of APL
differentiation syndrome, dexamethasone 10 mg BID will be administered and
continued for at least 3 days until signs and symptoms have abated.
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