Trisenox

DRUG DESCRIPTION

TRISENOX is a sterile injectable solution of arsenic trioxide. The molecular formula of the drug substance in the solid state is AsiOs, with a molecular weight of 197.8 g.

TRISENOX (arsenic trioxide injection) is available in 10 mL, single-use ampules containing 10 mg of arsenic trioxide. TRISENOX (arsenic trioxide injection) is formulated as a sterile, nonpyrogenic, clear solution of arsenic trioxide in water for injection using sodium hydroxide and dilute hydrochloric acid to adjust to pH 8. TRISENOX is preservative-free. Arsenic trioxide, the active ingredient, is present at a concentration of 1.0 mg/mL. Inactive ingredients and their respective approximate concentrations are sodium hydroxide (1.2 mg/mL) and hydrochloric acid, which is used to adjust the pH to 7.5 - 8.5.

What are the possible side effects of arsenic trioxide (Trisenox)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • sharp chest pain, wheezing, rapid breathing, feeling short of breath;
  • dry cough, feeling weak, tired, or ill;
  • fever, chills, swelling in your ankles or feet, weight gain;
  • dizziness, fainting, fast or pounding heartbeat;
  • pale skin, easy bruising or...

Read All Potential Side Effects and See Pictures of Trisenox

What are the precautions when taking arsenic trioxide injection (Trisenox)?

Before using this medication, tell your doctor or pharmacist if you are allergic to arsenic; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially: kidney disease, diabetes.

Arsenic trioxide may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs...

Read All Potential Precautions of Trisenox


Trisenox Consumer (continued)

SIDE EFFECTS: See also Warning section.

Pain/redness/swelling at the injection site, nausea, vomiting, diarrhea, stomach/abdominal pain, tiredness, cough, headache, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Both leukemia and this medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as unexplained fever, chills, or persistent sore throat.

Tell your doctor immediately if any of these unlikely but serious side effects occur: easy bleeding/bruising, nosebleed, increased thirst, change in the amount of urine, blurred vision, bone/joint pain, decreased appetite, unusual weight loss, muscle pain/stiffness/spasm, numbness/tingling, swollen hands/legs/feet.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, severe dizziness/fainting, fast/irregular heartbeat, coughing up blood, mental/mood changes (e.g., confusion), muscle weakness, seizures, bloody/black/tarry stool, vomit that looks like coffee grounds.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice any other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to arsenic; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially: kidney disease, diabetes.

Arsenic trioxide may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using arsenic trioxide, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using arsenic trioxide safely.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Wash your hands well to prevent the spread of infections. Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug should not be used during pregnancy. It may harm the unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. Talk with your doctor about effective forms of birth control.

This medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Trisenox Patient Information Including Side Effects

Brand Names: Trisenox

Generic Name: arsenic trioxide (Pronunciation: AR sen ik trye OX ide)

  • What is arsenic trioxide (Trisenox)?
  • What are the possible side effects of arsenic trioxide (Trisenox)?
  • What is the most important information I should know about arsenic trioxide (Trisenox)?
  • What should I discuss with my healthcare provider before taking arsenic trioxide (Trisenox)?
  • How is arsenic trioxide given (Trisenox)?
  • What happens if I miss a dose (Trisenox)?
  • What happens if I overdose (Trisenox)?
  • What should I avoid while using arsenic trioxide (Trisenox)?
  • What other drugs will affect arsenic trioxide (Trisenox)?
  • Where can I get more information?

What is arsenic trioxide (Trisenox)?

Arsenic trioxide is a cancer medication. Arsenic trioxide interferes with the growth of cancer cells and slows their growth and spread in the body.

Arsenic trioxide is used to treat a cancer of the blood and bone marrow called acute promyelocytic (pro-MYE-loe-SIT-ik) leukemia, or APL.

Arsenic trioxide may also be used for other purposes not listed in this medication guide.

What are the possible side effects of arsenic trioxide (Trisenox)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • sharp chest pain, wheezing, rapid breathing, feeling short of breath;
  • dry cough, feeling weak, tired, or ill;
  • fever, chills, swelling in your ankles or feet, weight gain;
  • dizziness, fainting, fast or pounding heartbeat;
  • pale skin, easy bruising or bleeding (nosebleeds);
  • high blood sugar (increased thirst, loss of appetite, fruity breath odor, increased urination, drowsiness, dry skin); or
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).

Less serious side effects may include:

  • nausea, vomiting, stomach pain, diarrhea, constipation;
  • headache;
  • anxiety, depressed mood;
  • mild rash or itching;
  • sleep problems (insomnia);
  • numbness or tingly feeling;
  • joint or muscle pain;
  • abnormal vaginal bleeding; or
  • pain, redness or swelling where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about arsenic trioxide (Trisenox)?

Call your doctor at once if you have a serious side effect such as sharp chest pain, wheezing, rapid breathing, feeling short of breath, dry cough, feeling weak or tired, dizziness, fainting, fast or pounding heartbeat, fever, or swelling in your ankles or feet.

Do not use arsenic trioxide without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before receiving arsenic trioxide, tell your doctor if you have congestive heart failure, a heart rhythm disorder, an electrolyte imbalance, high blood pressure, a history of "Long QT syndrome," liver disease, or kidney disease.

There are many other drugs that can interact with arsenic trioxide. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested on a regular basis. You must remain under the care of a doctor while you are using arsenic trioxide. Do not miss any follow-up appointments.

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