Arsenic trioxide Intravenous

AR-se-nik trye-OX-ide

Intravenous routeSolution

Experienced Physician and Institution: Arsenic trioxide injection should be administered under the supervision of a physician who is experienced in the management of patients with leukemia.

Acute promyelocytic leukemia (APL) Differentiation Syndrome: Some patients with APL treated with arsenic trioxide have experienced symptoms similar to a syndrome called the retinoic-acid-Acute Promyelocytic leukemia (RA-APL) or APL differentiation syndrome, characterized by fever, dyspnea, weight gain, pulmonary infiltrates and pleural or pericardial effusions, with or without leukocytosis. This syndrome can be fatal. The management of the syndrome has not been fully studied, but high-dose steroids have been used at the first suspicion of the APL differentiation syndrome and appear to mitigate signs and symptoms. At the first signs that could suggest the syndrome (unexplained fever, dyspnea and/or weight gain, abnormal chest auscultatory findings or radiographic abnormalities), high dose steroids (dexamethasone 10 mg intravenously twice daily) should be immediately initiated, irrespective of the leukocyte count, and continued for at least 3 days or longer until the signs and symptoms have abated. The majority of patients do not require termination of arsenic trioxide therapy during treatment of the APL differentiation syndrome.

ECG Abnormalities: Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block. QT prolongation can lead to a torsades de pointes-type ventricular arrhythmia, which can be fatal. The risk of torsades de pointes is related to the extent of QT prolongation, concomitant administration of QT prolonging drugs, a history of torsades de pointes, preexisting QT interval prolongation, congestive heart failure, administration of potassium-wasting diuretics, or other conditions that result in hypokalemia or hypomagnesemia. One patient (also receiving amphotericin B) had torsades de pointes during induction therapy for relapsed APL with arsenic trioxide.

ECG and Electrolyte Monitoring Recommendations: Prior to initiating therapy with arsenic trioxide, a 12-lead ECG should be performed and serum electrolytes (potassium, calcium, and magnesium) and creatinine should be assessed; preexisting electrolyte abnormalities should be corrected and, if possible, drugs that are known to prolong QT interval should be discontinued. For QTc greater than 500 msec, corrective measures should be completed and the QTc reassessed with serial ECGs prior to considering using arsenic trioxide. During therapy with arsenic trioxide, potassium concentrations should be kept above 4mEq/L and magnesium concentrations should be kept above 1.8 mg/dL. Patients who reach an absolute QT interval value greater than 500 msec should be reassessed and immediate action should be taken to correct concomitant risk factors, if any, while the risk/benefit of continuing versus suspending arsenic trioxide therapy should be considered. If syncope, rapid or irregular heartbeat develops, the patient should be hospitalized for monitoring, serum electrolytes should be assessed, arsenic trioxide therapy should be temporarily discontinued until the QTc interval regresses to below 460 msec, electrolyte abnormalities are corrected, and the syncope and irregular heartbeat cease. There are no data on the effect of arsenic trioxide on the QTc interval during the infusion .

Some patients with acute promyelocytic leukemia (APL) treated with arsenic trioxide have experienced symptoms similar to a syndrome called the retinoic-acid-Acute Promyelocytic leukemia (RA-APL) or APL differentiation syndrome, characterized by fever, dyspnea, weight gain, pulmonary infiltrates and pleural or pericardial effusions, with or without leukocytosis. This syndrome can be fatal. At the first signs that could suggest the syndrome, high dose steroids (dexamethasone 10 mg intravenously twice daily) should be immediately initiated. Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block, which can be fatal. Prior to initiating therapy, a 12-lead ECG should be performed and serum electrolytes (potassium, calcium, and magnesium) and creatinine should be assessed .

Commonly used brand name(s):

In the U.S.

  • Trisenox

Available Dosage Forms:

  • Solution

Therapeutic Class: Antineoplastic Agent

Uses For arsenic trioxide

Arsenic trioxide 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.

arsenic trioxide is available only with your doctor's prescription.

Before Using arsenic trioxide

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 trioxide or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on arsenic trioxide 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.

Geriatric

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.

Interactions with Medicines

Using arsenic trioxide with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Bepridil
  • Cisapride
  • Dronedarone
  • Foscarnet
  • Lidoflazine
  • Mesoridazine
  • Pimozide
  • Terfenadine
  • Thioridazine
  • Ziprasidone

Using arsenic trioxide with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acecainide
  • Acetazolamide
  • Ajmaline
  • Amiloride
  • Amiodarone
  • Amisulpride
  • Amitriptyline
  • Amoxapine
  • Amphotericin B
  • Aprindine
  • Asenapine
  • Astemizole
  • Azimilide
  • Azosemide
  • Bemetizide
  • Bendroflumethiazide
  • Benzthiazide
  • Bretylium
  • Bumetanide
  • Buthiazide
  • Canrenoate
  • Canrenone
  • Chloral Hydrate
  • Chloroquine
  • Chlorothiazide
  • Chlorpromazine
  • Chlorthalidone
  • Clarithromycin
  • Clopamide
  • Cyclothiazide
  • Desipramine
  • Dibenzepin
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Doxepin
  • Droperidol
  • Encainide
  • Enflurane
  • Eplerenone
  • Erythromycin
  • Ethacrynic Acid
  • Etozolin
  • Fenquizone
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Furosemide
  • Gemifloxacin
  • Glycerin
  • Halofantrine
  • Haloperidol
  • Halothane
  • Hydrochlorothiazide
  • Hydroflumethiazide
  • Hydroquinidine
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Indapamide
  • Isoflurane
  • Isradipine
  • Lapatinib
  • Levomethadyl
  • Lorcainide
  • Lumefantrine
  • Mannitol
  • Mefloquine
  • Methadone
  • Methyclothiazide
  • Metolazone
  • Moxifloxacin
  • Nilotinib
  • Nortriptyline
  • Octreotide
  • Ondansetron
  • Paliperidone
  • Pazopanib
  • Pentamidine
  • Pimozide
  • Piretanide
  • Pirmenol
  • Polythiazide
  • Prajmaline
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinethazone
  • Quinidine
  • Ranolazine
  • Risperidone
  • Sematilide
  • Sertindole
  • Sotalol
  • Spiramycin
  • Spironolactone
  • Sulfamethoxazole
  • Sultopride
  • Sunitinib
  • Tedisamil
  • Telavancin
  • Telithromycin
  • Tetrabenazine
  • Ticrynafen
  • Torsemide
  • Triamterene
  • Trichlormethiazide
  • Trifluoperazine
  • Trimethoprim
  • Trimipramine
  • Urea
  • Vasopressin
  • Xipamide
  • Ziprasidone
  • Zotepine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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.

Proper Use of arsenic trioxide

Dosing

The dose of arsenic trioxide will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of arsenic trioxide. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • 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.

Precautions While Using arsenic trioxide

It is very important that your doctor check your progress at regular visits to make sure that arsenic trioxide 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.

arsenic trioxide Side Effects

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

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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