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.
ARSENIC TRIOXIDE (AR se nik trye OX ide) is a chemotherapy drug. It slows the growth of cancer cells. This medicine is used to treat acute promyelocytic leukemia (APL).
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
This drug is given as an infusion into a vein. It is administered in a hospital or clinic by a specially trained health care professional.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor for checks on your progress. This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.
This medicine may affect blood sugar levels. If you have diabetes, check with your doctor or health care professional before you change your diet or the dose of your diabetic medicine.
Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
This drug is given in a hospital or clinic and will not be stored at home.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
