Arsenic Trioxide Solution for injection

What is this medicine?

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:

• diabetes

• heart disease

• irregular heartbeat

• kidney disease

• liver disease

• low levels of potassium, calcium, or magnesium in the blood

• an unusual or allergic reaction to arsenic, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

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. While this drug may be prescribed for children as young as 4 years old for selected conditions, precautions do apply.

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:

• cisapride

• dofetlide

• dronedarone

• pimozide

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• other medicines that may cause electrolyte abnormalities (e.g., amphotericin)

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

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?

Your condition will be monitored carefully while you are receiving this medicine. 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.

You may need blood work done while you are taking this medicine.

Talk to your doctor about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.

If you notice an increased hunger or thirst, different from your normal hunger or thirst, or if you find that you have to urinate more frequently, you should contact your health care provider as soon as possible. You may need to have your blood sugar monitored. This medicine may cause changes in your blood sugar levels. You should monitor your blood sugar frequently if you have diabetes.

Do not become pregnant while taking this medicine or for a while after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for a while after stopping it. 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:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• fever

• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heartbeat; palpitations; feeling faint or lightheaded, falls; breathing problems

• unusual bleeding or bruising

• weight gain

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• cough

• diarrhea

• dizziness

• headache

• nausea, vomiting

• pain, redness, or irritation at site where injected

• stomach pain

• tiredness

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.