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:

• irregular heartbeat
• kidney 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. 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:

• cisapride
• droperidol
• herbal or dietary supplements with hawthorn, Crataegus laevigata
• medicines for irregular heart beat like amiodarone, bepridil, dofetilide, encainide, flecainide, propafenone, quinidine
• methadone
• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
• ranolazine
• sodium phosphate monobasic monohydrate; sodium phosphate dibasic anhydrous
• some medicines for infection like chloroquine, gatifloxacin, gemifloxacin, halofantrine, levofloxacin, moxifloxacin, pentamidine, troleandomycin
• some medicines for mental problems like haloperidol, pimozide, ziprasidone
• some medicines to treat cancer like dasatinib, lapatinib, sunitinib, vorinostat

This medicine may also interact with the following medications:

• alfuzosin
• cyclobenzaprine
• dolasetron
• medicines for depression, anxiety, or psychotic disturbances
• medicines for numbness, pain prevention, or sleep during surgery
• octreotide
• some medicines for infection like, clarithromycin, erythromycin, mefloquine, norfloxacin, ofloxacin
• some medicines to treat cancer like daunorubicin, doxorubicin
• tacrolimus
• vardenafil

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.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

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:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine
• breathing problems
• chest pain, tightness
• confusion
• fast, irregular heartbeat
• feeling faint or lightheaded, falls
• muscle weakness
• pain, tingling, numbness in the hands or feet
• seizures
• swelling of the ankles, feet, hands
• 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):

• aches, pains
• diarrhea
• headache
• nausea, vomiting
• pain at site where injected
• stomach pain
• trouble sleeping

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.