Arsenic Trioxide (AR-se-nik trye-OX-ide)

Treats acute promyelocytic leukemia (APL).

Brand Name(s):

Trisenox

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how arsenic trioxide works. Tell your doctor if you are using any of the following:
  • Amphotericin B
  • Diuretic (water pill)
  • Medicine for heart rhythm problems

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 6 months after the last dose. Male patients with female partners should use an effective form of birth control during treatment with this medicine and for 3 months after the last dose.
• Do not breastfeed during treatment with this medicine and for 2 weeks after the last dose.
• Tell your doctor if you have kidney disease, liver disease, heart disease, heart failure, vitamin B1 deficiency, poor nutrition, malabsorption, electrolyte imbalance, or a history of heart rhythm problems (including QT prolongation). Tell your doctor if you drink alcohol regularly.
• This medicine may cause the following problems:
  • APL differentiation syndrome
  • Heart rhythm problems
  • Brain disease, including Wernicke's encephalopathy
  • Liver problems
  • Increased risk for other cancers
• Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children).
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Cancer medicine can cause nausea or vomiting, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any nausea or vomiting that might happen.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain
• Confusion, loss of consciousness, seizures, blurred vision or changes in vision, problems with memory or learning, shakiness or trembling, unsteady walk
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fainting, dizziness, lightheadedness
• Fast, pounding, or uneven heartbeat
• Fever, trouble breathing
• Rapid weight gain, swelling in your hands, ankles, or feet

If you notice these less serious side effects, talk with your doctor:

• Cough
• Diarrhea
• Headache, trouble sleeping
• Redness, pain, or swelling where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

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