Generic Name: arsenic (AR-se-nik)
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 of serious and even fatal irregular heartbeat (eg, QT prolongation, heart block). Your risk may be higher if you are taking medicine that may also increase your risk of irregular heartbeat or certain types of diuretics (eg, furosemide, hydrochlorothiazide), or if you have low blood potassium or magnesium levels, congestive heart failure, or a history of certain types of irregular heartbeat (QT prolongation, torsades de pointes). Tell your doctor about any other medicines or supplements you take. Contact your doctor immediately if you experience fainting or fast or irregular heartbeat.
Lab tests, including an electrocardiogram (ECG), blood electrolyte levels (eg, blood calcium, magnesium, and potassium), and blood creatinine levels, should be performed before and during use of Trisenox to monitor your progress and to check for side effects. Be sure to keep all doctor and lab appointments.
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
- you are taking dronedarone, nilotinib, tetrabenazine, toremifene, or vandetanib
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 able to become pregnant
- 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 low blood potassium or magnesium, or liver or kidney problems
- if you have a history of irregular heartbeat (eg, heart block, QT prolongation, torsades de pointes) or other heart problems (eg, congestive heart failure)
- if you take any medicine that may increase the risk of a certain type of irregular heartbeat (QT prolongation). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat
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, dofetilide), astemizole, bepridil, chloroquine, cisapride, citalopram, diuretics (eg, furosemide, hydrochlorothiazide), dolasetron, domperidone, doxepin, dronedarone, droperidol, fluconazole, halofantrine, haloperidol, iloperidone, lithium, macrolides or ketolides (eg, erythromycin, telithromycin), maprotiline, methadone, nilotinib, nortriptyline, paliperidone, pentamidine, phenothiazines (eg, thioridazine), pimozide, quinolones (eg, ciprofloxacin), romidepsin, tacrolimus, terfenadine, tetrabenazine, toremifene, tyrosine kinase receptor inhibitors (eg, sunitinib), vandetanib, or ziprasidone because the risk of severe and possibly fatal 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.
- Do not use Trisenox if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for 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. These effects may be worse if you take it with alcohol or certain medicines. Use Trisenox with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- 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. Avoid activities that may cause bruising or injury. Tell your doctor if you have any unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Trisenox may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- If nausea, vomiting, or loss of appetite occur, ask your doctor or pharmacist for ways to lessen these effects.
- Trisenox may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor immediately.
- Lab tests, including complete blood cell counts, blood electrolyte levels, blood clotting, and ECG, may be performed while you use Trisenox. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Trisenox should be used with extreme caution in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Trisenox has been shown to cause harm to the fetus. Do not become pregnant while you are using Trisenox. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Trisenox while you are pregnant. Trisenox is found 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:
Seek medical attention right away if any of these SEVERE side effects occur:
Blurred vision; 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; mild muscle, joint, or bone pain; mouth sores; nausea; nosebleed; 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.
Severe allergic reactions (rash; hives; itching, difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation, anxiety, confusion, or depression; black or bloody stools; bleeding between menstrual periods; burning, numbness, or tingling; chest pain; convulsions; decreased urination; fainting; fast heartbeat; fever, chills, or persistent cough or sore throat; irregular heartbeat; loss of bowel or bladder control; loss of consciousness; muscle pain, spasms, weakness, or cramping; rapid breathing; seizures; severe or persistent dizziness, headache, or light-headedness; skin shedding at the injection site; spitting up of blood; sudden weight gain; swelling of the ankles, feet, or hands; tremors; trouble breathing or shortness of breath; unusual bruising or bleeding; unusual tiredness or weakness; vaginal bleeding; wheezing.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; muscle weakness; seizures.Proper storage of Trisenox:
Trisenox is handled and stored by a health care provider. Keep Trisenox out of the reach of children and away from pets.
- 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Trisenox or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Trisenox. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Trisenox. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Trisenox.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.