Trisenox

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Trisenox


Generic Name: Arsenic (ARE-seh-nick)
Brand Name: Trisenox

A severe and sometimes fatal side effect called retinoic acid-acute promyelocytic leukemia (RA-APL) or APL differentiation syndrome has been reported with use of Trisenox in some patients. Contact your doctor immediately if you experience fever, shortness of breath, tightness in the chest, or weight gain.

Use of Trisenox may increase your risk for serious and even fatal heart problems, including irregular heartbeat or heart block. Your risk may be higher if you are taking medicine that may also increase your risk for irregular heartbeat or certain types of diuretics (potassium-wasting), or if you have a history of irregular heartbeat or electrocardiogram (ECG) abnormalities, congestive heart failure, or low blood levels of potassium or magnesium.

Lab tests, including an ECG, blood electrolyte levels, and creatinine levels, should be performed before and during use of Trisenox to monitor your progress and to check for side effects. Contact your doctor immediately if you experience fainting of fast or irregular heartbeat.


Trisenox is used for:

Treating a certain type of cancer (APL) in certain patients. It may also be used for other conditions as determined by your doctor.

Trisenox is a chemotherapy agent. The way it works is not completely understood. It may work by blocking the growth of cancer cells.

Do NOT use Trisenox if:

  • you are allergic to any ingredient in Trisenox

Contact your doctor or health care provider right away if any of these apply to you.

Before using Trisenox :

Some medical conditions may interact with Trisenox . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a blood disorder, heart problems (eg, congestive heart failure, irregular heartbeat, abnormal ECG tests, torsades de pointes), low blood potassium or magnesium, or kidney problems

Some MEDICINES MAY INTERACT with Trisenox . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Antiarrhythmics (eg, amiodarone, disopyramide), cisapride, diuretics (eg, furosemide, hydrochlorothiazide), dofetilide, H1 antagonists (eg, astemizole, terfenadine), macrolides or ketolides (eg, erythromycin, telithromycin), phenothiazines (eg, thioridazine), pimozide, quinolones (eg, ciprofloxacin), or tricyclic antidepressants (eg, amitriptyline) because risk of severe side effects, such as irregular heartbeat, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Trisenox may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Trisenox :

Use Trisenox as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Trisenox is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using Trisenox at home, carefully follow the injection procedures taught to you by your health care provider.
  • If Trisenox contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
  • Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
  • If you miss a dose of Trisenox , contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Trisenox .

Important safety information:

  • Trisenox may cause drowsiness, dizziness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Trisenox . Using Trisenox alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
  • Seek immediate medical assistance if you experience rapid or irregular heartbeat for up to 8 weeks after the last infusion.
  • Trisenox may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.
  • Trisenox may lower your body"s ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rashes, or chills.
  • If nausea, vomiting, or loss of appetite occur, ask your doctor or pharmacist for ways to lessen these effects.
  • Before you begin taking any new medicine, either prescription or nonprescription, check with your doctor or pharmacist. This includes any medicine that contains quinine or terfenadine.
  • Avoid vaccinations with live virus vaccines (eg, measles, mumps, oral polio) while you are taking Trisenox and for several months after you stop treatment.
  • This medicine may cause high blood sugar (eg, thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, fruity breath odor). If these symptoms occur, tell your doctor immediately.
  • LAB TESTS, including complete blood cell counts, electrolyte levels, and ECG, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Trisenox with extreme caution in CHILDREN younger than 5 years of age. Safety and effectiveness in this age group have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Trisenox has been shown to cause harm to the fetus. Avoid becoming pregnant while you are using Trisenox . If you think you may be pregnant, discuss with your doctor the benefits and risks of using Trisenox during pregnancy. Trisenox is excreted in breast milk. Do not breast-feed while taking Trisenox .

Possible side effects of Trisenox :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Agitation; blurred vision; chills; constipation; cough; darkening of skin; diarrhea; dizziness; drowsiness; dry eyes, mouth, or skin; earache; eye pain or irritation; flushing; headache; increased sweating; indigestion; loss of appetite; mouth sores; muscle, joint, or bone pain; nausea; nosebleed; numbness or tingling of the skin; pain, swelling, or redness at the injection site; pale skin; postnasal drip; ringing in the ears; skin lesions; sore throat; stomach pain, tenderness, or bloating; swelling of the eyelid; tiredness; trouble sleeping; vomiting; weakness; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching, difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety, confusion, or depression; black or bloody stools; bleeding between menstrual periods; chest pain; convulsions; decreased urination; fainting; fast heartbeat; fever; increased thirst or urination; irregular heart rate; loss of bowel or bladder control; loss of consciousness; rapid breathing; seizures; severe dizziness; severe weakness; skin shedding at the injection site; spitting up of blood; sudden weight gain; swelling of ankles, feet, or hands; tremors; trouble breathing; unusual bruising or bleeding; vaginal bleeding; wheezing.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include confusion; convulsions; muscle weakness.

Proper storage of Trisenox :

Store Trisenox at 77 degrees F (25 degrees C). Storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Trisenox out of the reach of children and away from pets.

General information:

  • If you have any questions about Trisenox , please talk with your doctor, pharmacist, or other health care provider.
  • Trisenox is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Trisenox . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.




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