Arsenic Trioxide is an antineoplastic agent that belongs to the class of natural products. Initially, FDA approved it on September 25, 2000, for its medical use. 

Arsenic trioxide is an intravenously administered antineoplastic drug. It is used to treat newly diagnosed low to intermediate-risk acute promyelocytic leukemia (a type of bone cancer where too many immature blood cells accumulate in bone marrow) combined with other medication (tretinoin). It is also indicated in patients whose acute promyelocytic leukemia (APL) has not responded to other therapies or whose condition has worsened following treatment with other medications.

The drug should be administered only by physicians or nurses experienced with cancer chemotherapy. Your physician will determine the dose, frequency of administration, and duration of therapy based on the type of cancer and severity of the disease. Arsenic trioxide is available as an injectable solution. It is given as a drip (infusion) into the veins over 1 - 2 hours. You will be monitored for unwanted side effects during the infusion.  

The common side effects include swelling in the face and body, reduced blood pressure, itchy skin, increased blood sugar levels, abdominal pain, constipation or diarrhea, nausea, vomiting, bone pain, muscle pain, dizziness, headache, insomnia, pain in the throat, loss of appetite, bleeding from the nose, cough, difficulty breathing, fever and tiredness.  Other serious side effects are anemia, changes in heart rate, liver toxicity, hypersensitivity reactions, infections and sepsis, kidney problems, and pneumonia. 

The drug is intended to cause liver toxicity. Monitor liver function tests regularly, and dosing adjustments may be necessary if you have liver diseases. Arsenic trioxide is not recommended in pregnancy and breastfeeding because this may cause harm to your fetus. Arsenic trioxide itself is a human carcinogen, so monitoring for secondary cancers is recommended.  Notify your physician if you have any symptoms of fever, sudden weight gain, dizziness/lightheadedness, shortness of breath, and any symptoms of accumulation of fluids in the lungs, heart, and chest. 

Inform your physician if you have heart disease, kidney disease, liver disease, and vitamin deficiency. Inform your physician if you are allergic to the arsenic trioxide or its ingredients. If you are pregnant, breastfeeding, or planning for pregnancy, it is advisable to discuss it with your physician. Use effective contraceptives during the treatment to prevent pregnancy. Female patients with reproductive potential should use effective contraception during the therapy and for at least 6 months after completing the therapy. Male patients with female partners of reproductive potential should use the effective contraception method for at least 3 months after completing the therapy.

Your healthcare professional may advise you to take certain blood tests to monitor the effectiveness and side effects of the therapy. Inform your physician about all the medicines that your taking or have taken before, including prescription medicines, over-the-counter medications, nutritional or vitamin supplements, and herbal products. 

Store this medicine at 2– 8ºC. Do not freeze. Keep the medicine out of sight and reach from children and pets. If you forgot to take the injection on the scheduled day, inform your physician or healthcare professional immediately and reschedule the dose. Arsenic trioxide is not recommended in children and young people below 18 years of age.

1. “Arsenic Trioxide Phebra 1 Mg/Ml Concentrate for Solution for Infusion - Patient Information Leaflet (PIL) - (Emc).” Www.medicines.org.uk, 21 May 2020, www.medicines.org.uk/emc/product/10278/pil.  Accessed 14 Mar. 2023.
2. Highlights of prescribing information- Arsenic Trioxide: [Revised 2019] ; [cited 2023 Mar 14]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021248s018lbl.pdf

The drug information on this page is not a substitute for medical advice. It is meant for educational purposes only. For further details, consult your doctor about your medical condition to know if you can receive this treatment.