Posted on December 4th, 2008 by

Class: Chemotherapy

Generic Name: Arsenic trioxide (ARE-sen-ik try-OX-ide)
Trade Name: Trisenox®

For which conditions is this drug approved? Arsenic trioxide is FDA approved for the treatment of acute promyelocytic leukemia (APL) with specific genetic subtypes in patients who have already received prior treatment with an anthracycline and/or retinoid.  It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action? Arsenic trioxide is a chemotherapy agent that kills cancer cells. The way in which arsenic trioxide works is not completely understood at present; however, it is believed to cause damage to the cancer cell and its DNA, which prompts the cell to destroy itself. Arsenic trioxide may also inhibit the cell from replicating, and inhibit the supply of nutrients to the cell needed for growth. It is cleared from the body mainly through the urine.

How is arsenic trioxide typically given (administered)? Arsenic trioxide is given in a vein (intravenous), typically over 1 to 2 hours.  The dose depends on several factors, including the condition being treated, the size of the patient, the particular treatment regimen being used, and the overall health of the patient.

How are patients typically monitored? While being treated with arsenic trioxide, patients typically have frequent blood tests to monitor their electrolyte levels, blood cell levels, glucose levels, kidney function and blood coagulation time. In addition, patients typically receive an electrocardiogram (ECG) to monitor heart function prior to treatment and possibly while on treatment with arsenic trioxide. Patients may also undergo scans or other measures to assess response to therapy. Uncommonly, a serious condition called APL differentiation syndrome may occur with treatment involving arsenic trioxide. Differentiation syndrome may produce fever, difficulty breathing, lung problems, heart problems, fluid retention and weight gain. Therefore, patients may also be checked for these symptoms. If patients experience fever, sudden weight gain, difficulty breathing or chest discomfort at any time, they should call a healthcare provider immediately. APL differentiation syndrome can be successfully treated with high-dose steroids.

What are the common (occur in 30% or more of patients) side effects of treatment with arsenic trioxide?

• APL differentiation syndrome (see above)
• Nausea and vomiting
• Cough
• Fatigue
• Fever
• Headache
• Changes in heart rate or rhythm
• Abdominal pain
• Diarrhea
• Difficulty breathing
• Abnormalities in electrolyte levels or glucose levels as determined by blood tests
• Fluid retention and swelling of the face, hands, feet or legs
• Sore throat
• Difficulty sleeping
• Rash
• Joint pain
• Muscle pain
• Itching
• Numbness or tingling of hands or feet
• Chills
• Anxiety

What are the less common (occur in 10% to 29% of patients) side effects of treatment with arsenic trioxide?

• Leukocytosis (temporary increase in number of white blood cells)
• Low levels of white blood cells – increases risk of infection
• Low levels of red blood cells – increases risk of anemia and need for blood transfusions
• Low levels of platelets – increases risk of bleeding
• Constipation
• Chest pain
• Low blood pressure
• Loss of appetite
• Unexplained bleeding or bruising
• Depression
• Muscle, bone or generalized pains
• Dizziness
• Runny nose
• Inflamed sinuses
• Abnormal liver function levels
• Weight gain
• Vaginal bleeding
• Dry skin
• Pleural effusion (fluid in the space between the lungs and chest wall)

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• If possible, avoid large crowds or people who are sick or not feeling well, as this drug may leave some patients susceptible to infection.
• Wash hands often to reduce the risk of infection.
• Eat small meals frequently to help alleviate nausea.
• If patients have been prescribed an anti-nausea medication, they should be sure to take the prescribed doses.
• Avoid activities that may cause injury or bruising.
• Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.
• Patients who experience hot flashes may wish to wear light clothing, stay in a cool environment, and place cool cloths on their body or head to relieve their symptoms.
Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
• Patients should avoid seafood, or speak with their physician about ingesting seafood, as it may contain arsenic.
When should patients notify their physician?

• Fever
• Difficulty breathing
• Sudden weight gain
• Cough
• Sore throat
• Chills
• Signs of infection
• Noticeable changes in heart rate or rhythm
• Chest pain
• Prolonged diarrhea
• Prolonged nausea and vomiting
• Extreme pain
• Blood in the urine
• Black, tarry stools
• Nosebleeds
• Bruising
• Fainting
• Persistent or severe fatigue
• Lightheadedness
• Headache
What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Copyright © 2016 CancerConnect Last updated 07/10.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.



The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

Tags: Chemotherapy, Drug Dictionary, T

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