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Trisenox®

Brand Name: Trisenox®
Active Ingredient:   arsenic trioxide
Strength(s): 10 mg/mL (1mg/mL)
Dosage Form(s):   Intravenous injection
Company Name:    Cell Therapeutics, Inc
Availability:         Prescription only, hospital use only
*Date Approved by FDA:   September 25, 2000
*Approval by FDA does not mean that the drug is available for consumers at this time.




What is Trisenox used for? 

Trisenox is used to treat a form of leukemia (acute promyelocytic leukemia or APL) in adults who have not responded to other chemotherapy treatments, or in whom disease has returned after other chemotherapy.

Who should not be treated with Trisenox?

You should not be given Trisenox if you are allergic to arsenic.

Special Warning(s) with Trisenox:

Trisenox can cause changes in heart rhythms, which may cause symptoms, or in the worst case, could be fatal. The risk of these side effects may be increased if you:

  • have a history of abnormal heart rhythms
  • take other medications that affect the heart the same, such as:
    • erythromycin (antibiotic)
    • ketoconozole or amphotericin B (antifungals)
    • hydrochlorothiazide and furosemide (diuretics)
    • blood thinners
    • certain medicines to stabilize heart rhythms
    • thioridazine (mood and depression medicines)
  • have congestive heart failure
  • have other medical conditions or take medicines that significantly lower potassium and magnesium in the blood.

Before starting treatment with Trisenox, tell your doctor if you have any of these conditions.

General Precautions with Trisenox: 

Only doctors who are experienced in the treatment of acute leukemia should administer Trisenox.

Your doctor will test your blood and heart rate before treatment with Trisenox.

Trisenox may have the potential to cause harm to an unborn baby when given to a pregnant woman. Avoid becoming pregnant while being treated with Trisenox.

What should I tell my doctor or health care provider?

Because certain other medications can interact or interfere with Trisenox, review all medications that you are taking with your doctor or health care provider, including those that you take without a prescription (See Special Warnings).

Before starting treatment with Trisenox, tell your doctor or health care provider if you:

  • are pregnant, nursing, or planning to nurse your baby
  • have a history of kidney problems or kidney failure
  • have a history of heart disease or heart failure

What are some possible side effects of Trisenox? (This is NOT a complete list of side effects reported with Trisenox. Your health care provider can discuss with you a more complete list of side effects.)  

Most patients experience some side effects while being treated with Trisenox. The most common side effects include:

  • temporary increase in the number of white blood cells
  • Fever
  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Fatigue
  • Swelling
  • High blood sugar
  • Shortness of breath
  • Cough
  • Rash or itching
  • Headache
  • Dizziness

Some of these side effects can be severe. If you have any of these symptoms, contact your doctor right away.

For more detailed information about Trisenox, ask your health care provider.

Link to http://www.fda.gov/cder/foi/label/2000/21248lbl.pdf    Trisenox's Label 

Posted: 12/31/01

 

Back to Drug Side Effects


source: FDA


last update: December 2004





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