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Drug Notebook

Generic Name: arsenic trioxide

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Trisenox
An antineoplastic - treats Acute Promyelocytic Leukemia
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FDA Alerts

    Experience of Supervising Clinician
  • Use under the supervision of a qualified clinician experienced in the management of acute leukemia.
    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.
    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).
    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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What is the most important information I should know about arsenic trioxide?

Arsenic trioxide should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of arsenic trioxide including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); acute promyelocytic leukemia (APL) differentiation syndrome (fever, shortness of breath, weight gain, and lung problems); heart problems; and others. Talk to your doctor about the possible side effects from treatment with arsenic trioxide.

What is arsenic trioxide?

Arsenic trioxide is a cancer medication. Arsenic trioxide interferes with the growth of cancer cells and slows their growth and spread in the body.

Arsenic trioxide is used in the treatment of acute promyelocytic leukemia (APL).

Arsenic trioxide may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking arsenic trioxide?

Serious side effects have been reported with the use of arsenic trioxide including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); acute promyelocytic leukemia (APL) differentiation syndrome (fever, shortness of breath, weight gain, and lung problems); heart problems; and others. Talk to your doctor about the possible side effects from treatment with arsenic trioxide.

Do not use arsenic trioxide without first talking to your doctor if you have

You may not be able to use arsenic trioxide, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Arsenic trioxide is in the FDA pregnancy category D. This means that it is known to be harmful to an unborn baby. Do not use arsenic trioxide without first talking to your doctor if you are pregnant or could become pregnant during treatment. Arsenic trioxide passes into breast milk and may be harmful to a nursing baby. Do not take arsenic trioxide without first talking to your doctor if you are breast-feeding a baby.
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·As a Drug
Acute Myeloid Leukemia (AML)
Chronic Myelogenous Leukemia (CML)
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