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In the U.S.—

Trisenox

• Antineoplastic

Arsenic trioxide (AR-sen-ik try-OX-ide) belongs to the general group of medicines called antineoplastics. It is used to treat leukemia in patients who have not responded to other medication regimens. It may also be used to treat other kinds of cancer, as determined by your doctor.

Arsenic trioxide seems to interfere with the growth of cancer cells, which are then eventually destroyed by the body. Since the growth of normal body cells may also be affected by arsenic trioxide, other effects will also occur. Some of these may be serious and must be reported to your doctor.

This medicine is available only with your doctor's prescription, in the following dosage forms:

Parenteral
• Injection (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For arsenic trioxide, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to arsenic.

Pregnancy—There is a chance that this medicine may cause birth defects if it is taken at time of conception or if it is taken by the mother during pregnancy. Studies in rats and mice have shown that arsenic trioxide causes birth defects in the fetus and other problems (including miscarriage). Studies on the effects in pregnancy have not been done in humans.

Be sure that you have discussed these possible effects with your doctor before receiving this medicine. Before receiving arsenic trioxide make sure your doctor knows if you are pregnant or if you may become pregnant. It is best to use some kind of birth control while you are receiving arsenic trioxide. Tell your doctor right away if you think you have become pregnant while receiving arsenic trioxide.

Breast-feeding—Arsenic is distributed into human breast milk. Arsenic trioxide is not recommended during breast-feeding, because it may cause unwanted effects in nursing babies.

Children—Studies on this medicine have been done only in a limited number of patients over the age of 5 years, and there is no specific information comparing use of arsenic trioxide in children under the age of 5 with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of arsenic trioxide in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking arsenic trioxide, it is especially important that your health care provider know if you are taking any of the following:

• Amphotericin B by injection (e.g., Fungizone) or
• Antiarrhythmics (acebutolol [e.g., Sectral], adenosine [e.g., Adenocard], amiodarone [e.g., Cordarone], atenolol [e.g., Tenormin], digoxin [e.g., Lanoxin], digitoxin [e.g., Crystodigin], diltiazem [e.g., Cardizem], disopyramide [e.g., Norpace], encainide [e.g., Enkaid], esmolol [e.g., Brevibloc], flecainide [e.g., Tambocor], metoprolol [e.g., Lopressor], mexiletine [e.g., Mexitil], moricizine [e.g., Ethmozine], nadolol [e.g., Corgard], oxprenolol [e.g., Trasicor], phenytoin [e.g., Dilantin], procainamide [e.g., Procan], propafenone [e.g., Rythmol], propranolol [e.g., Inderal], quinidine [e.g., Quinaglute], sotalol [e.g., Betapace], timolol [e.g., Blocadren], tocainide [e.g., Tonocard], verapamil [e.g., Isoptin]) or
• Antifungals, azole (fluconazole [e.g., Diflucan], itraconazole [e.g., Sporanox], ketoconazole [e.g., Nizoral]) or
• Antihistamines or
• Fluoroquinolones (ciprofloxacin [e.g., Cipro], enoxacin [e.g., Penetrex], grepafloxacin [e.g., Raxar], levofloxacin [e.g., Levaquin], lomefloxacin [e.g., Maxaquin], norfloxacin [e.g., Noroxin], ofloxacin [e.g., Floxin], sparfloxacin [e.g., Zagam]) or
• Diuretics, potassium-depleting (bumetanide [e.g., Bumex], ethacrynic acid [e.g., Edecrin], furosemide [e.g., Lasix], indapamide [e.g., Lozol], thiazide diuretics [water pills]) or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Norpramin], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Pamelor], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])—These medicines may increase the risk of experiencing a life threatening heart rhythm problem while taking arsenic trioxide and concurrent use of these agents with arsenic trioxide may cause blood disorders or
• Thioridazine (e.g., Mellaril)—These medicines may increase the risk of experiencing a life threatening heart rhythm problem while taking arsenic trioxide.

Other medical problems—The presence of other medical problems may affect the use of arsenic trioxide. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal heart rhythms or
• Congestive heart failure or
• Low magnesium levels in the blood or
• Low potassium levels in the blood—These medical problems may increase the risk of experiencing a life threatening heart rhythm problem while taking arsenic trioxide.

• Kidney problems—Arsenic trioxide is removed from the body by the kidneys; kidney problems may cause the drug to build up.

Dosing—

The dose of arsenic trioxide will be different for different patients. The dose that is used may depend on a number of things, including the patient's body size, and whether or not other medicines are also being taken. If you have any questions about the proper dose of arsenic trioxide, ask your doctor.

• For injectable dosage form:
  • For acute promyelocytic leukemia:
    • Adults and children 5 years of age and older—Induction, 0.15 milligram (mg) per kilogram (kg) of body weight daily until bone marrow remission occurs (up to 60 doses). Consolidation, 0.15 mg per kg of body weight daily for 25 doses over a period of up to 5 weeks.
    • Children under 5 years of age—Use and dose must be determined by your doctor.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Acute promyelocytic leukemia (APL) can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. APL may also interact with medications which cause blood problems. Arsenic trioxide therapy may improve these conditions. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• More common (>50%)
  • Chills;  convulsions (seizures);  cough;  decreased urine output;  dry mouth;  eye pain;  general feeling of illness;  headache;  increased thirst;  irregular heartbeat ;  loss of appetite;  mood changes;  muscle pain or cramps;  nausea or vomiting;  numbness or tingling in hands, feet, or lips;  shortness of breath or trouble breathing ;  sore throat;  unusual tiredness or weakness 
  
  

• Symptoms of Overdose

  Get emergency help immediately if any of the following symptoms of overdose occur

  • Confusion;  convulsions (seizures);  muscle weakness, severe 
  
  

• Less common (10–50%)
  • Abdominal cramps;  black, tarry stools ;  bluish lips or skin;  blurred vision;  chest pain;  dizziness or lightheadedness;  fever;  flushed, dry skin;  fruit-like breath odor;  high or low blood pressure;  increased hunger;  increased urine output;  irregular or pounding heartbeat or pulse;  painful or difficult urination;  sores, ulcers, or white spots on lips or in mouth;  stomachache;  sweating;  swollen glands;  unusual bleeding or bruising;  unexplained weight loss;  unusual weight gain;  wheezing 
  
  

• Rare (<10%)
  • Anxiety;  behavior changes similar to drunkenness;  bleeding;  blood in urine or stools;  bluish fingernails, palms, or nailbeds;  bruising;  cloudy urine;  cold sweats;  cool pale skin;  drowsiness;  headache;  large hives;  persistent bleeding or oozing from puncture sites, mouth, or nose;  rash;  severe nausea;  shakiness;  sore mouth or tongue;  swelling of eyelids, lips, or face;  vomiting of blood or material that looks like coffee grounds;  white patches in mouth and/or on tongue 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• More common ( >50%)
  • Diarrhea 
  
  

• Less common (10–50%)
  • Acid or sour stomach;  back pain;  belching;  bloating or swelling of face, hands, lower legs, and/or feet;  bone pain;  constipation;  flushing;  heartburn;  heavy nonmenstrual vaginal bleeding;  indigestion;  itchy, red skin;  injection site pain, redness, or swelling;  itching;  joint or muscle pain;  limb pain;  loss of appetite;  mental depression;  neck pain;  nosebleeds;  pale skin;  shivering chills;  trouble sleeping or getting to sleep;  weight gain 
  
  

• Rare (<10%)
  • Agitation;  blisters inside the mouth ;  coughing or spitting up blood;  earache;  eye dryness, redness, or pain;  loss of bowel or bladder control;  night sweats;  rapid, shallow breathing;  ringing in the ears;  small red or purple spots on skin;  swelling of abdominal or stomach area;  swelling or puffiness of face or eyelids;  swollen, painful, or tender lymph glands in neck, armpit, or groin 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 12/01/2000

Revised: 08/05/2003