- TRISENOX contains arsenic trioxide and should not be used if you have an allergy to arsenic.
- TRISENOX may cause ECG abnormalities, including QT prolongation. QT prolongation is an increase in the time it takes the heart to relax between beats. If extreme, this prolongation has the potential to cause fainting, irregular heart beat, or more serious side effects. Immediately report any of these symptoms.
- Arsenic trioxide, the main ingredient in TRISENOX, is known to cause some types of cancer. Your doctor will monitor you for signs of other cancers.
- Let your doctor know if you are pregnant or are thinking of becoming pregnant, as TRISENOX can cause harm to unborn babies. You should avoid becoming pregnant while taking TRISENOX. Effective contraception should be used by both men and women during and after treatment with TRISENOX. One patient who became pregnant while receiving arsenic trioxide had a miscarriage.
- TRISENOX can also cause harm to nursing infants. Because of potential harm to nursing infants from TRISENOX, discontinue breastfeeding during treatment with TRISENOX.
- Your doctor should monitor your blood with blood tests and your heart with ECGs as long as you are taking TRISENOX. You may have these tests as often as a few times a week or as little as once a week, depending on where you are in your treatment and how your doctor checks your condition.
- You should tell your doctor about all the medications you are taking, because some medications may interact with TRISENOX and can lead to side effects such as electrolyte imbalances or an irregular heartbeat.
- In a study with children (ages 4–20), side effects of TRISENOX included stomach and intestinal problems, problems digesting and absorbing nutrients from food, breathing problems, a weakened heart, unexplained pain, and the inability to control urination. One case each of fluid in the lungs and inflammation of the large intestine were considered serious reactions. TRISENOX has not been studied in patients younger than 4 years old.
Let your doctor know if you have kidney or liver problems, which may interfere with how TRISENOX works in your body.
- Most patients experience some side effects with TRISENOX. The most common side effects of TRISENOX are the increased production of large numbers of white blood cells, stomach and intestinal problems (nausea, vomiting, diarrhea, and stomach pain), feeling weak or tired, swelling, high blood sugar, shortness of breath, cough, rash or itching, headaches, and dizziness. These side effects don’t seem to be permanent and you may not have to stop your TRISENOX therapy.
For more information, talk with your doctor and see the Full Prescribing Information.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.