What TRISENOX is
used for:

TRISENOX is a prescription medicine for people with APL (acute promyelocytic leukemia, a subtype of acute myelogenous leukemia) whose disease has returned or has not shown improvement after being treated with retinoid and anthracycline chemotherapy, and whose APL has a specific type of rearrangement in their chromosomes (called a t(15;17) translocation) or a gene called PML/RAR-alpha.

For more information, talk with your doctor and see the Full Prescribing Information.

Answering your questions about relapsed/refractory
APL and treatment with TRISENOX

The more you learn about the disease and how it is treated, the better you can work with your healthcare team, prepare for the journey ahead, and set your sights on recovery.

  • Understand
    relapsed/refractory APL

  • Learn about treatment
    with TRISENOX

  • Find more resources
    and information

  • Learn what relapsed or refractory APL is, its symptoms, and how it is treated.
  • Read about what TRISENOX is, how it's administered, what to expect from it, and why you need to watch for the return of APL.
  • Get questions to ask your doctor, see where you can find reimbursement assistance, and more.

WARNING: APL DIFFERENTIATION SYNDROME, CARDIAC CONDUCTION ABNORMALITIES, AND ELECTROLYTE MONITORING

  • Patients with APL who have been treated with TRISENOX may experience symptoms similar to a syndrome called the retinoic-acid-Acute Promyelocytic Leukemia (RA-APL) or APL differentiation syndrome, which can lead to death. You should tell your doctor immediately if you experience fever, shortness of breath, sudden weight gain, or chest pain. If you develop APL differentiation syndrome, your doctor may prescribe a steroid medication for you for at least 3 days or until your symptoms have subsided. During this time you may not have to discontinue your TRISENOX therapy.
  • Before you begin TRISENOX, your doctor should monitor electrocardiogram (ECG) readings of your heart, along with the levels of electrolytes and creatinine to ensure they are within the normal ranges. Any electrolyte imbalances should be corrected and, if possible, any other medications you are taking that may cause a QT prolongation (an irregular heart beat) should be discontinued. Treatment with TRISENOX may result in QT interval prolongation and a heart condition called complete atrioventricular block. QT prolongation can lead to a heart arrhythmia that may result in death. The risk of developing this arrhythmia is related to the severity of the irregular heartbeat you may experience, your history of other irregular heartbeats or heart problems, and possible side effects from other medications you may be taking. One patient also taking a medication called amphotericin B had a severe heart arrhythmia when first treated with arsenic trioxide for relapsed APL.
  • 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.

TO REPORT SIDE EFFECTS:

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.

CONTACT US:

Teva Pharmaceuticals
41 Moores Road
Frazer, PA 19355 USA

1-610-344-0200

www.tevausa.com
Contact Teva
Product Information Request

MEDICAL INFORMATION:

For healthcare professionals or patients with specific medical questions about TRISENOX, please contact us at:

Teva Medical Information
1-800-896-5855

USMedInfo@tevapharm.com

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©2016 Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. All rights reserved. The
information presented on this Web site is intended for US residents only. TRI-40211. October 2016.