Arsenic Trioxide, Injection

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KEY POINTS

• This medicine is given by IV to treat acute promyelocytic leukemia.
• You may get infections more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause serious heart problems or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer)

Generic and brand names: arsenic trioxide, injection; Trisenox

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) to treat acute promyelocytic leukemia.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Heart failure or an irregular heart beat
• Kidney or liver problems
• Long QT syndrome (problems with electrical activity in the heart muscle)
• Problems with low levels of calcium, potassium or magnesium in your blood

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are receiving this medicine.

How do I use it?

This medicine is given in a hospital or clinic. The IV infusions may be given for 1 to 4 hours every day, depending on your response to the medicine. You may get the medicine for several weeks.

What should I watch out for?

This is a very strong medicine. It should only be given in a clinic or hospital where you can be monitored closely. You need frequent blood tests to check how this medicine is affecting you. Keep all appointments for tests.

This medicine may cause serious heart problems. Contact your provider right away if you have a fast or irregular heartbeat, severe dizziness, or fainting. You may need to have heart function tests every few days.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines unless you get your healthcare provider's approval first.

This medicine may make you dizzy or drowsy. Drinking alcohol may make it worse. Do not drink alcohol unless your healthcare provider approves. Do not drive or operate machinery unless you are fully alert. You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may help. If this problem is severe, contact your healthcare provider.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you have received this medicine.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives, itching, rash; trouble breathing, tightness in your chest; swelling of your lips, tongue, and throat); chest pain.

Serious (Report these to your healthcare provider right away.): signs of an infection such as fever, chills, cough, or sore throat; shortness of breath; unexplained weight gain; rapid or pounding heartbeat; fainting or dizziness; muscle weakness; severe confusion; seizures; swelling of the feet or ankles; unusual bruising or bleeding.

Other: Nausea; vomiting; diarrhea; stomach pain; tiredness; depression; headache; redness, pain or swelling at the injection site; constipation; trouble sleeping; nervousness; blurred vision; muscle or joint pain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alfuzosin (Uroxatral)
• Antiarrhythmic medicines (to treat irregular heartbeat) such as adenosine (Adenocard), amiodarone (Cordarone, Pacerone), digoxin (Lanoxin), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, ibutilide (Corvert), procainamide, propafenone (Rythmol), quinidine, ranolazine (Ranexa), and sotalol (Betapace, Sorine)
• Antibiotics such as azithromycin (Zithromax, Zmax), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), gatifloxacin (Zymaxid), gentamicin, levofloxacin (Levaquin), moxifloxacin (Avelox), pentamidine (NebuPent, Pentam), telithromycin (Ketek), and tobramycin
• Antidepressants such as amitriptyline, desipramine (Norpramin), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and sertraline (Zoloft)
• Antifungal medicines such as amphotericin b (Abelcet, AmBisome, Amphotec), fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral)
• Antipsychotic medicines such as chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), perphenazine, pimozide (Orap), prochlorperazine (Compro), risperidone (Risperdal), thioridazine, and ziprasidone (Geodon)
• Cancer medicines such as cisplatin, daunorubicin (Cerubidine), doxorubicin (Doxil), sunitinib (Sutent), vandetanib, and vorinostat (Zolinza)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Dextromethorphan/quinidine (Nuedexta)
• Diabetes medicines such as chlorpropamide, glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), pioglitazone (Actos), rosiglitazone (Avandia), and tolbutamide
• Diuretics (water pills) such as bumetanide, chlorothiazide (Diuril), furosemide (Lasix), hydrochlorothiazide (Microzide), indapamide, and metolazone (Zaroxolyn)
• Doxepin (Silenor)
• Foscarnet (Foscavir)
• HIV medicines such as emtricitabine/rilpivirine/tenofovir (Complera, Odefsey), lopinavir/ritonavir (Kaletra), and saquinavir (Invirase)
• Lithium (Lithobid)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Methadone (Dolophine, Methadose)
• Mifepristone (Korlym, Mifeprex)
• Natural remedies such as alfalfa, aloe, bilberry, fenugreek, garlic, ginger, ginseng, gymnema, hawthorn, and kelp
• Octreotide (Sandostatin)
• Paroxetine (Brisdelle, Paxil, Pexeva)

Do not take nonprescription medicines or natural remedies unless approved by your provider.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.