Arsenic trioxide is used to treat a cancer of the blood and bone marrow called acute promyelocytic (pro-MYE-loe-SIT-ik) leukemia, or APL.

Arsenic trioxide is sometimes given in combination with another medicine called tretinoin.

Arsenic trioxide may also be used for other purposes not listed in this medication guide.

Arsenic trioxide can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if not treated. This condition may occur within 1 days to 2 months after you start taking this medicine.

Seek medical help right away if you have symptoms of differentiation syndrome: fever, dizziness, cough, trouble breathing, swelling, rapid weight gain, or decreased urination.

Arsenic trioxide can cause a serious heart problem. Your risk may be higher if you also use certain other medicines. Tell your doctor about all your current medicines and any you start or stop using.

Get emergency medical help if you have fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness.

Arsenic trioxide is given as an infusion into a vein. A healthcare provider will give you this injection.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results.

You may be given other medications to help prevent serious side effects or allergic reaction. Keep using these medicines for as long as your doctor has prescribed.

You must remain under the care of a doctor while you are using arsenic trioxide.

Usual Adult Dose for Acute Promyelocytic Leukemia:

INDUCTION CYCLE: 0.15 mg/kg IV over 1 to 2 hours once a day until bone marrow remission or up to a maximum of 60 days
CONSOLIDATION CYCLE: 0.15 mg/kg IV over 1 to 2 hours once a day for 25 doses over a period of up to 5 weeks; begin consolidation 3 to 6 weeks after completion of induction therapy

Use: Induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression

Usual Pediatric Dose for Acute Promyelocytic Leukemia:

4 YEARS AND OLDER:
INDUCTION CYCLE: 0.15 mg/kg IV over 1 to 2 hours once a day until bone marrow remission or up to a maximum of 60 days
CONSOLIDATION CYCLE: 0.15 mg/kg IV over 1 to 2 hours once a day for 25 doses over a period of up to 5 weeks; begin consolidation 3 to 6 weeks after completion of induction therapy

Use: Induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression

You should not be treated with arsenic trioxide if you are allergic to it.

Tell your doctor if you have ever had:

• heart problems, or a heart rhythm disorder;

• long QT syndrome (in you or a family member);

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

• kidney disease; or

• liver disease.

Arsenic trioxide can harm an unborn baby if the mother or the father is using arsenic trioxide.

• If you are a woman, do not use arsenic trioxide if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using arsenic trioxide.

It may be harder for you to get a woman pregnant while you are using this medicine. You should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Call your doctor for instructions if you miss an appointment for your injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Arsenic trioxide can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if not treated. This condition may occur within 1 days to 2 months after you start taking arsenic trioxide.

Seek medical help right away if you have symptoms of differentiation syndrome:

• fever, cough, trouble breathing;

• dizziness;

• rash;

• decreased urination;

• rapid weight gain; or

• swelling in your arms or legs.

Also call your doctor right away if you have:

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

• confusion, decreased consciousness;

• problems with vision, balance, or muscle movement;

• a seizure;

• fever, tiredness, night sweats;

• easy bruising or bleeding;

• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;

• low magnesium--dizziness, irregular heartbeats, feeling jittery, muscle cramps, muscle spasms, cough or choking feeling; or

• low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects of arsenic trioxide may include:

• stomach pain, nausea, vomiting, diarrhea;

• cough, sore throat, trouble breathing;

• fever, chills, tiredness, headache, joint pain;

• fast or irregular heartbeats;

• numbness or tingly feeling;

• low magnesium or potassium, high blood sugar;

• itching, rash;

• swelling;

• joint or muscle pain; or

• trouble sleeping.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Arsenic trioxide can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Other drugs may affect arsenic trioxide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.