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Trisenox Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Trisenox (arsenic trioxide) is used to treat a cancer of the blood and bone marrow called acute promyelocytic leukemia, or APL. It is a cancer medication. Common side effects include pain/redness/swelling at the injection site, nausea, vomiting, diarrhea, stomach/abdominal pain, tiredness, cough, headache, or dizziness.
Trisenox is given intravenously under physician supervision at a dose of 0.15 mg/kg daily until bone marrow remission. Total induction dose should not exceed 60 doses. Consolidation treatment begins 3 to 6 weeks after completion of induction therapy and Trisenox is administered intravenously at a dose of 0.15 mg/kg daily for 25 doses for up to 5 weeks. Trisenox may interact with droperidol, diuretics (water pills), antibiotics, antidepressants, anti-malaria medications, heart rhythm medicines, medicine to prevent or treat nausea and vomiting, medicines to treat psychiatric disorders, migraine headache medicines, or narcotics. Tell your doctor all medications you use. Trisenox should not be used during pregnancy. It may harm the fetus. If you become pregnant or think you may be pregnant, tell your doctor. Consult your doctor about 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.
Our Trisenox (arsenic trioxide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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 Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Trisenox in Detail - Patient Information: Side Effects
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;
- 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.
Read the entire detailed patient monograph for Trisenox (Arsenic Trioxide Injection)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Trisenox Overview - Patient Information: Side Effects
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.
Read the entire patient information overview for Trisenox (Arsenic Trioxide Injection)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Trisenox FDA Prescribing Information: Side Effects
The following serious adverse reactions have been associated with TRISENOX in clinical trials and are discussed in greater detail in other sections of the label.
- APL Differentiation Syndrome [see WARNINGS AND PRECAUTIONS]
- Cardiac Conduction Abnormalities: Torsade de Pointes, Complete Heart Block, and QT Prolongation [see WARNINGS AND PRECAUTIONS]
- Carcinogenesis [see WARNINGS AND PRECAUTIONS]
- Embryo-Fetal Toxicity [see WARNINGS AND PRECAUTIONS]
- Laboratory Tests [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Safety information was available for 52 patients with relapsed or refractory APL who participated in clinical trials of TRISENOX. Forty patients in the Phase 2 study received the recommended dose of 0.15 mg/kg of which 28 completed both induction and consolidation treatment cycles. An additional 12 patients with relapsed or refractory APL received doses generally similar to the recommended dose. Most patients experienced some drug-related toxicity, most commonly leukocytosis, gastrointestinal (nausea, vomiting, diarrhea, and abdominal pain), fatigue, edema, hyperglycemia, dyspnea, cough, rash or itching, headaches, and dizziness. These adverse effects have not been observed to be permanent or irreversible nor do they usually require interruption of therapy.
Serious adverse events (SAEs), Grade 3/4 according to version 2 of the NCI Common Toxicity Criteria, were common. Those SAEs attributed to TRISENOX in the Phase 2 study of 40 patients with refractory or relapsed APL included APL differentiation syndrome (n=3), hyperleukocytosis (n=3), QTc interval ≥ 500 msec (n=16, 1 with torsade de pointes), atrial dysrhythmias (n=2), and hyperglycemia (n=2).
Table 1 describes the adverse events that were observed in patients, between the ages of 5-73 years, treated for APL with TRISENOX at the recommended dose at a rate of 5% or more. Similar adverse event profiles were seen in the other patient populations who received TRISENOX.
Table 1 : Adverse Events (Any Grade) Occurring in
≥ 5% of 40 Patients with APL Who Received TRISENOX (arsenic trioxide)
Injection at a Dose of 0.15 mg/kg/day
|System organ class Adverse event||All Adverse Events, Any Grade||Grade 3/4 Events|
|General disorders and administration site conditions|
|Edema - non-specific||16||40|
|Injection site pain||8||20|
|Pain - non-specific||6||15||1||3|
|Injection site erythema||5||13|
|Injection site edema||4||10|
|Abdominal pain (lower & upper)||23||58||4||10|
|Metabolism and nutrition disorders|
|Nervous system disorders|
|Dizziness (excluding vertigo)||9||23|
|Post nasal drip||5||13|
|Decreased breath sounds||4||10|
|Skin & subcutaneous tissue disorders|
|Erythema - non-specific||5||13|
|Non-specific skin lesions||3||8|
|ECG QT corrected interval prolonged > 500 msec||16||40|
|ECG abnormal other than QT interval prolongation||3||8|
|Infections and infestations|
|Upper respiratory tract infection||5||13||1||3|
|Bacterial infection - non-specific||3||8||1||3|
|Musculoskeletal, connective tissue and bone disorders|
|Pain in limb||5||13||2||5|
|Disseminated intravascular coagulation||3||8||3||8|
|Painful red eye||2||5|
|Renal and urinary disorders|
|Reproductive system disorders|
The following additional adverse events were reported as related to TRISENOX treatment in 13 pediatric patients (defined as ages 4 through 20): gastrointestinal (dysphagia, mucosal inflammation/stomatitis, oropharyngeal pain, caecitis), metabolic and nutrition disorders (hyponatremia, hypoalbuminemia, hypophosphatemia, and lipase increased), cardiac failure congestive, respiratory (acute respiratory distress syndrome, lung infiltration, pneumonitis, pulmonary edema, respiratory distress, capillary leak syndrome), neuralgia, and enuresis. Pulmonary edema (n=1) and caecitis (n=1) were considered serious reactions.
The following reactions have been reported from clinical trials and/or worldwide postmarketing surveillance. Because they are reported from a population of unknown size, precise estimates of frequency cannot be made.
Nervous system disorders: peripheral neuropathy
Hematologic disorders: pancytopenia
Investigations: gamma-glutamyltransferase increased
Respiratory, thoracic, and mediastinal disorders: A differentiation syndrome, like retinoic acid syndrome, has been reported with the use of TRISENOX for the treatment of malignancies other than APL [see BOXED WARNING].
Read the entire FDA prescribing information for Trisenox (Arsenic Trioxide Injection)
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