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SaveGeneric Name: arsenic trioxide
FDA Alerts-
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Experience of Supervising Clinician
- Use under the supervision of a qualified clinician experienced in the management of acute leukemia.
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Acute Promyelocytic Leukemia (APL) Differentiation Syndrome
- Risk of developing potentially fatal APL differentiation syndrome.
- If signs or symptoms suggestive of APL differentiation syndrome (e.g., unexplained fever, dyspnea, weight gain, abnormal chest auscultatory findings, radiographic abnormalities) occur, initiate high-dose corticosteroid therapy (e.g., dexamethasone phosphate 10 mg IV twice daily for 3 days or longer until symptoms resolve) immediately regardless of the patient's leukocyte count; discontinuance of arsenic trioxide generally is not required.
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ECG Abnormalities
- Risk of potentially fatal atypical ventricular tachycardia (torsades de pointes) and complete atrioventricular block, particularly in patients with a history of torsades de pointes, CHF, or preexisting QT interval prolongation, and in those receiving drugs that might prolong the QT interval or produce electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia).
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ECG and Electrolyte Monitoring
- Prior to initiation of therapy, perform baseline ECG and determine serum electrolyte (potassium, calcium, and magnesium) and creatinine concentrations.
- If baseline QTc interval >500 msec, institute appropriate corrective measures and reassess with serial ECGs prior to considering arsenic trioxide therapy.
- Correct preexisting electrolyte abnormalities; if possible, discontinue drugs known to prolong the QT interval.
- During therapy, maintain serum potassium concentrations >4 mEq/L and serum magnesium concentrations >1.8 mg/dL and monitor ECGs weekly (more frequently in clinically unstable patients).
- If QT interval >500 msec during therapy, correct any concomitant risk factors immediately and weigh the risks/benefits of continued therapy.
- If syncope and/or rapid or irregular heartbeat occurs, hospitalize patient for careful monitoring; discontinue arsenic trioxide until QTc interval decreases to <460 msec, electrolyte abnormalities are corrected, and syncope and irregular heartbeat resolve.
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- Interactions
Other drugs that affect the way the heart beats may interact with arsenic trioxide and increase the risk of dangerous irregular heartbeats. Do not take any other prescription or over-the-counter medications, including herbal products, during treatment with arsenic trioxide without first talking to your doctor.
If you experience any of the following serious side effects from arsenic trioxide, contact your doctor immediately:
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an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
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acute promyelocytic leukemia (APL) differentiation syndrome (fever, shortness of breath, weight gain, and lung problems); or
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fainting or irregular heart beats.
Other, less serious side effects may be more likely to occur. Continue taking arsenic trioxide and talk to your doctor if you experience:
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fever;
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tiredness or weakness;
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swelling or fluid retention;
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pain, redness or swelling at the injection site;
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nausea, vomiting, or loss of appetite;
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diarrhea or loose stools;
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constipation;
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headache or dizziness;
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insomnia;
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numbness or tingling; or
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rash or skin problems.
Other side effects have also been reported. Discuss with your doctor any side effect that occurs during treatment with arsenic trioxide.
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