High Alert
Absorption: IV administration results in complete bioavailability.
Distribution: Arsenic is stored in liver, kidney, heart, lung, hair, and nails.
Half-Life: Unknown.
Contraindicated in:
Use Cautiously in:
History of torsades de pointes, QT interval prolongation, HF, hypokalemia, hypomagenesemia, or concurrent use of other drugs that cause QT interval prolongation;
CV: QT interval prolongation
Derm: dermatitis
Endo: hyperglycemia, hypoglycemia
F and E: acidosis, hyperkalemia, hypocalcemia, hypokalemia, hypomagnesemia
GI: ↑liver enzymes, abdominal pain, constipation
GU: ↓fertility (men), renal failure
Hemat:
differentiation syndrome
, leukocytosis, anemia, DISSEMINATED INTRAVASCULAR COAGULATION, NEUTROPENIA, THROMBOCYTOPENIAMS: back pain, arthralgia, bone pain, limb pain, myalgia, neck pain
Neuro: ENCEPHALOPATHY (INCLUDING WERNICKE ENCEPHALOPATHY), fatigue, headache, insomnia, POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME (PRES), weakness
Resp: hypoxia, dyspnea, pleural effusion
Misc: fever, hypersensitivity reactions, infection/sepsis, MALIGNANCY
Drug-drug:
Newly Diagnosed Low-Risk APL
Relapsed or Refractory APL
Assess for APL differentiation syndrome (fever, dyspnea, weight gain, pulmonary infiltrates, and pleural or pericardial effusions, with or without leukocytosis). Syndrome can be fatal. If signs and symptoms of syndrome (unexplained fever, dyspnea and/or weight gain, abnormal chest sounds, radiologic abnormalities) occur, temporarily hold arsenic trioxide and initiate high-dose corticosteroids (dexamethasone 10 mg IV every 12 hr for ≥3 days) until signs and symptoms resolve irrespective of leukocyte count. Resume therapy at 50% dose. If symptoms do not recur, ↑ dose after 7 days. If symptoms recur, ↓ dose to previous dose. Most patients do not require discontinuation of therapy.
Monitor ECG prior to starting therapy and weekly or more frequently for clinically unstable patients during induction or consolidation phase. May cause QT interval prolongation and may lead to torsades de pointes or complete atrioventricular block, both of which can be fatal. For QTc interval >450 msec (men) or >460 msec (women), discontinue drugs causing prolonged QT interval. Replace electrolytes. Once QTc interval normalizes, resume therapy at 50% dose for 7 days. If no QTc prolongation,↑ dose to 0.11 mg/kg daily for 7 days; if no QTc interval prolongation, ↑ dose to 0.15 mg/kg .
Monitor for signs and symptoms of encephalopathy (confusion, ↓ level of consciousness, seizures, cognitive deficits, ataxia, visual symptoms, ocular motor dysfunction) during therapy. In patients at risk for thiamine deficiency (chronic alcohol use, malabsorption, nutritional deficiency, concurrent use of furosemide), monitor thiamine levels to prevent Wernicke encephalopathy. Administer IV thiamine to patients at risk or with thiamine deficiency. If Wernicke encephalopathy occurs, hold arsenic trioxide and administer IV thiamine.
Lab Test Considerations:
Toxicity and Overdose:
IV Administration:
Advise patient to notify health care professional immediately if signs and symptoms of differentiation syndrome (fever; sudden weight gain; dizziness/light-headedness; labored breathing; accumulation of fluid in the lungs, heart, and chest), ECG abnormalities (fainting, irregular heartbeat), encephalopathy, or other severe or persistent symptoms occur.
NDC Code