When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive it if you had an allergic reaction to arsenic trioxide or if you are pregnant or breastfeeding.

How to Use This Medicine:
Injectable

• 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.
• Your doctor will prescribe your dose and schedule. This medicine is given through a needle 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 foods and medicines can affect how arsenic trioxide works. Tell your doctor if you are using any of the following:
  
  • Amphotericin B
  • Diuretic (water pill)
  • Heart rhythm medicine

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 and after treatment.
• Do not breastfeed while you are using this medicine. Tell your doctor if you have kidney disease, liver disease, heart disease, heart failure, or a history of heart rhythm problems (such as QT prolongation).
• This medicine may cause the following problems:
  
  • APL differentiation syndrome
  • Changes in heart rhythm
  • Increased risk for other cancers
• 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
• 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
• Headache, trouble sleeping
• Nausea, vomiting, diarrhea, loss of appetite
• 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