Trisenox

Pronunciation

Generic Name: arsenic trioxide (Intravenous route)

AR-se-nik trye-OX-ide

Intravenous route(Solution)

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. QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, 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 Trisenox

Arsenic trioxide injection belongs to the general group of medicines called antineoplastics. It is used to treat a type of leukemia (cancer of the blood cells) called acute promyelocytic leukemia (APL) 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.

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

Before you begin treatment with arsenic trioxide, you and your doctor should talk about the benefit of this medicine as well as the risks of using it.

This medicine is to be administered only by or under the immediate supervision of your doctor.

Before Using Trisenox

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of arsenic trioxide in children. However, safety and efficacy have not been established in children younger than 4 years of age.

Geriatric

No information is available on the relationship of age to the effects of arsenic trioxide in geriatric patients.

Interactions with 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 receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine 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.

  • Amifampridine
  • Bepridil
  • Cisapride
  • Dronedarone
  • Foscarnet
  • Lidoflazine
  • Mesoridazine
  • Pimozide
  • Piperaquine
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Ziprasidone

Using this medicine 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
  • Alfuzosin
  • Amiloride
  • Amiodarone
  • Amisulpride
  • Amitriptyline
  • Amoxapine
  • Amphotericin B
  • Apomorphine
  • Aprindine
  • Artemether
  • Asenapine
  • Astemizole
  • Azimilide
  • Azithromycin
  • Azosemide
  • Bedaquiline
  • Bemetizide
  • Bendroflumethiazide
  • Benzthiazide
  • Bretylium
  • Bumetanide
  • Buthiazide
  • Canrenoate
  • Canrenone
  • Chloral Hydrate
  • Chloroquine
  • Chlorothiazide
  • Chlorpromazine
  • Chlorthalidone
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clopamide
  • Clozapine
  • Crizotinib
  • Cyclobenzaprine
  • Cyclothiazide
  • Dabrafenib
  • Dasatinib
  • Delamanid
  • Desipramine
  • Dibenzepin
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Doxepin
  • Droperidol
  • Encainide
  • Enflurane
  • Eplerenone
  • Erythromycin
  • Escitalopram
  • Ethacrynic Acid
  • Etozolin
  • Fenquizone
  • Fingolimod
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Formoterol
  • Furosemide
  • Gatifloxacin
  • Gemifloxacin
  • Glycerin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Halothane
  • Hydrochlorothiazide
  • Hydroflumethiazide
  • Hydroquinidine
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Indapamide
  • Isoflurane
  • Isradipine
  • Ivabradine
  • Ketoconazole
  • Lapatinib
  • Levofloxacin
  • Levomethadyl
  • Lopinavir
  • Lorcainide
  • Lumefantrine
  • Mannitol
  • Mefloquine
  • Methadone
  • Methyclothiazide
  • Metolazone
  • Moxifloxacin
  • Nilotinib
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Ondansetron
  • Paliperidone
  • Pasireotide
  • Pazopanib
  • Pentamidine
  • Perflutren Lipid Microsphere
  • Pimozide
  • Piretanide
  • Pirmenol
  • Polythiazide
  • Posaconazole
  • Prajmaline
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinethazone
  • Quinidine
  • Quinine
  • Ranolazine
  • Risperidone
  • Salmeterol
  • Saquinavir
  • Sematilide
  • Sertindole
  • Sevoflurane
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Spiramycin
  • Spironolactone
  • Sulfamethoxazole
  • Sultopride
  • Sunitinib
  • Tedisamil
  • Telavancin
  • Telithromycin
  • Tetrabenazine
  • Ticrynafen
  • Tizanidine
  • Toremifene
  • Torsemide
  • Trazodone
  • Triamterene
  • Trichlormethiazide
  • Trifluoperazine
  • Trimethoprim
  • Trimipramine
  • Urea
  • Vandetanib
  • Vardenafil
  • Vasopressin
  • Vemurafenib
  • Vilanterol
  • Vinflunine
  • Voriconazole
  • 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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Congestive heart failure or
  • Heart rhythm problems (e.g., prolonged QT interval or torsade de pointes), history of or
  • Hypokalemia (low potassium in the blood) or
  • Hypomagnesemia (low magnesium in the blood)—These medical problems may increase the risk of experiencing a life threatening heart rhythm problem while taking arsenic trioxide.
  • Kidney disease, severe or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Trisenox

A nurse or other trained health professional will give you this medicine in a hospital or cancer clinic. This medicine is given through a needle placed in one of your veins.

Arsenic trioxide often causes nausea and vomiting. However, it is very important that you continue to receive the medicine, even if you have an upset stomach. Ask your doctor for ways to lessen these effects.

Precautions While Using Trisenox

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

You should not receive this medicine if you are pregnant. Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Tell your doctor right away if you have chest pain or discomfort, chills, cough, difficulty with breathing, eye pain, fever, general feeling of illness, headache, shortness of breath, sore throat, unusual tiredness or weakness, or weight gain while using this medicine. These may be symptoms of a serious condition called retinoic-acid-APL (RA-APL) or APL differentiation syndrome.

This medication can cause serious heart rhythm problems and heart arrhythmias. Your doctor will monitor you during therapy to assess for heart rhythm problems. Talk to your doctor if you have concerns about this.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Trisenox 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 or nurse immediately if any of the following side effects occur:

More common
  • 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
Less common
  • Abdominal or stomach 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
  • unexplained weight loss
  • unusual bleeding or bruising
  • unusual weight gain
  • wheezing
Rare
  • 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

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

Symptoms of Overdose
  • Confusion
  • convulsions (seizures)
  • muscle weakness, severe

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
  • Diarrhea
Less common
  • Acid or sour stomach
  • back pain
  • belching
  • bloating or swelling of face, hands, lower legs, or feet
  • bone pain
  • constipation
  • flushing
  • heartburn
  • heavy nonmenstrual vaginal bleeding
  • indigestion
  • injection site pain, redness, or swelling
  • itching
  • itchy, red skin
  • 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
  • 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.

See also: Side effects (in more detail)

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