Infrequently, this medication may cause a serious condition called APL differentiation syndrome. Tell your doctor right away if the following effects occur: unusual/unexplained fever, shortness of breath/difficulty breathing, and/or weight gain. Your doctor may direct you to weigh yourself regularly and report any sudden weight gain. Your doctor may also perform certain exams or tests (e.g., lung exam, X-rays) to determine if this syndrome has developed.
Infrequently, this medication can also cause serious (rarely fatal) heart problems (e.g., AV block, torsades de pointes-type arrhythmias). Tell your doctor if you have any medical history of heart problems (e.g., fast/irregular heartbeat, heart failure), kidney problems, low levels of minerals in your blood (e.g., calcium, potassium, magnesium). Also tell your doctor if you take any medications that increase your risk for these heart problems or low levels of minerals (see also Drug Interactions section). To decrease your risk, your doctor may order a heart rhythm test (EKG) or blood tests before and during treatment.Who should not take Trisenox Ampul?
This medication is given by injection into a vein by a health care professional over 1 to 2 hours, usually once daily or as directed by your doctor. The injection may be injected more slowly (e.g., over 4 hours) if you have a reaction to the medication such as dizziness, flushing, or fast heartbeat.
The dosage and length of treatment is based on your weight, medical condition, and response to treatment. Your doctor will order tests (e.g., EKG, blood minerals) to find the right dose for you. Your next dose may need to be rescheduled if your heartbeat or blood tests are abnormal.
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.
People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk ofside effects. Careful monitoring by your doctor may decrease your risk.
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 right away if you have any serious side effects, including: easy bleeding/bruising, nosebleed, increased thirst, signs of kidney problems (such as 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.
Get medical help right away if you have any very serious side effects, including: 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, get medical help right away 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 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
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.
Arsenic trioxide may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using arsenic trioxide, tell your doctor or pharmacist of all the drugs you take and 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.
Arsenic trioxide can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.
To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.
Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).
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 right away. Talk with your doctor about effective forms of birth control.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Many drugs besides arsenic trioxide may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), ziprasidone, among others. Therefore, before using arsenic trioxide, report all medications you are currently using to your doctor or pharmacist.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: aspirin and other NSAIDs (e.g., ibuprofen), drugs that lower blood minerals (e.g., amphotericin B), drugs that may harm the immune system (e.g., chemotherapy, corticosteroids such as prednisone).
Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as ibuprofen, naproxen, or aspirin) that may increase your risk of bleeding. Low-dose aspirin should be continued if prescribed by your doctor for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day). Consult your doctor or pharmacist for more details.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: seizures, muscle weakness, confusion.
Laboratory and/or medical tests (e.g., electrolytes, complete blood count, EKG) should be performed while you are using the medication to monitor your progress or check for side effects. Consult your doctor for more details.
For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. Keep all medical/lab appointments. If you miss a dose, contact your doctor to establish a new dosing schedule.
Not applicable. This medication is given in a clinic and will not be stored at home.Information last revised November 2016. Copyright(c) 2016 First Databank, Inc.
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