arsenic trioxide

Generic Name: arsenic trioxide (AR sen ik trye OX ide)Brand Names: Trisenox

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

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

What is the most important information I should know about arsenic trioxide?

Call your doctor at once if you have a serious side effect such as sharp chest pain, wheezing, rapid breathing, feeling short of breath, dry cough, feeling weak or tired, dizziness, fainting, fast or pounding heartbeat, fever, or swelling in your ankles or feet. Do not use arsenic trioxide without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before receiving arsenic trioxide, tell your doctor if you have congestive heart failure, a heart rhythm disorder, an electrolyte imbalance, high blood pressure, a history of "Long QT syndrome," liver disease, or kidney disease.

There are many other drugs that can interact with arsenic trioxide. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested on a regular basis. You must remain under the care of a doctor while you are using arsenic trioxide. Do not miss any follow-up appointments.

What should I discuss with my healthcare provider before taking arsenic trioxide?You should not use this medication if you are allergic to arsenic trioxide.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• congestive heart failure;

• a heart rhythm disorder or history of "Long QT syndrome";

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

• high blood pressure;

• liver disease; or
• kidney disease.

FDA pregnancy category D. Arsenic trioxide can cause harm to an unborn baby or cause birth defects. Before you receive this medication, tell your doctor if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Arsenic trioxide can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is arsenic trioxide given?

Arsenic trioxide is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

Arsenic trioxide must be given slowly through an IV infusion, and can take up to 4 hours to complete.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Arsenic trioxide must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

After mixing arsenic trioxide with a diluent, you may store the mixture in the refrigerator and use it within 48 hours. Do not freeze. Mixed medicine must be used within 24 hours if kept at room temperature.

Each single-use ampule (bottle) of this medicine is for one use only. Throw away the vial after one use, even if there is still some medicine left in it after injecting your dose.

Store unopened glass ampules of arsenic trioxide at room temperature. Throw away any unused ampules after the expiration date on the label has passed.

To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested on a regular basis. This will help your doctor determine how long to treat you with arsenic trioxide. Your heart function will also need to be checked using an electrocardiograph or ECG (sometimes called an EKG). This machine measures electrical activity of the heart.

You must remain under the care of a doctor while you are using arsenic trioxide. Do not miss any follow-up appointments.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of arsenic trioxide.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include confusion, muscle weakness, or seizure (convulsions).

What should I avoid while using arsenic trioxide?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using arsenic trioxide.

Arsenic trioxide side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• sharp chest pain, wheezing, rapid breathing, feeling short of breath;

• dry cough, feeling weak, tired, or ill;

• fever, chills, swelling in your ankles or feet, weight gain;

• dizziness, fainting, fast or pounding heartbeat;

• pale skin, easy bruising or bleeding (nosebleeds);

• high blood sugar (increased thirst, loss of appetite, fruity breath odor, increased urination, drowsiness, dry skin); or

• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).

Less serious side effects may include:

• nausea, vomiting, stomach pain, diarrhea, constipation;

• headache;

• anxiety, depressed mood;

• mild rash or itching;

• sleep problems (insomnia);

• numbness or tingly feeling;

• joint or muscle pain;

• abnormal vaginal bleeding; or

• pain, redness or swelling where the medicine was injected.

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 Dosing Information

Usual Adult Dose for Acute Promyelocytic Leukemia:

Induction Treatment Schedule: 0.15 mg/kg intravenously daily until bone marrow remission. Total induction dose should not exceed 60 doses. Arsenic trioxide should be administered intravenously over 1-2 hours. The infusion duration may be extended up to 4 hours if acute vasomotor reactions are observed. (A central venous catheter is not required.)Consolidation Treatment Schedule: Consolidation treatment should begin 3 to 6 weeks after completion of induction therapy. Arsenic trioxide should be administered intravenously at a dose of 0.15 mg/kg daily for 25 doses over a period up to 5 weeks.

What other drugs will affect arsenic trioxide?

Tell your doctor about all other medications you use, especially:

• droperidol (Inapsine);

• a diuretic (water pill);

• an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), levofloxacin (Levaquin), moxifloxacin (Avelox), or pentamidine (NebuPent, Pentam);

• an antidepressant such as amitriptylline (Elavil, Vanatrip), clomipramine (Anafranil), or desipramine (Norpramin);

• anti-malaria medications such as chloroquine (Arelan) or mefloquine (Lariam);

• heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), ibutilide (Corvert), procainamide (Procan, Pronestyl), propafenone (Rythmol), quinidine (Quinidex, Quin-Release Quin-G), or sotalol (Betapace);

• medicine to prevent or treat nausea and vomiting, such as dolasetron (Anzemet) or ondansetron (Zofran);

• medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (FazaClo, Clozaril), haloperidol (Haldol), pimozide (Orap), thioridazine (Mellaril), or ziprasidone (Geodon);

• migraine headache medicine such as sumatriptan (Imitrex) or zolmitriptan (Zomig); or

• narcotic medication such as levomethadyl (Orlaam), or methadone (Dolophine, Methadose).

This list is not complete and there are many other drugs that can interact with arsenic trioxide. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about arsenic trioxide.

• 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.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 4.01. Revision Date: 09/09/2009 12:45:35 PM.