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Trisenox

Last reviewed on RxList: 7/10/2017
Trisenox Side Effects Center

Last reviewed on RxList 7/10/2017

Trisenox (arsenic trioxide) is a cancer medication used to treat a cancer of the blood and bone marrow called acute promyelocytic leukemia, or APL. Common side effects of Trisenox include:

  • injection site reactions (pain, redness, or swelling),
  • nausea,
  • vomiting,
  • diarrhea,
  • stomach or abdominal pain,
  • constipation,
  • tiredness,
  • cough,
  • headache,
  • dizziness,
  • anxiety,
  • depression,
  • rash or itching,
  • sleep problems (insomnia),
  • numbness or tingly feeling,
  • joint or muscle pain, or
  • abnormal vaginal bleeding.

Tell your doctor if you have serious side effects of Trisenox including:

  • sharp chest pain, wheezing, rapid breathing, shortness of breath;
  • feeling weak, tired, or ill;
  • fever, chills, swelling in your ankles or feet, weight gain;
  • 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).

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, breastfeeding 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.

Trisenox Consumer Information

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.

Read the entire detailed patient monograph for Trisenox (Arsenic Trioxide Injection)

Trisenox Professional 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
n % n %
General disorders and administration site conditions
Fatigue 25 63 2 5
Pyrexia (fever) 25 63 2 5
Edema - non-specific 16 40    
Rigors 15 38    
Chest pain 10 25 2 5
Injection site pain 8 20    
Pain - non-specific 6 15 1 3
Injection site erythema 5 13    
Weakness 4 10    
Hemorrhage 4 10 2 5
Hemorrhage 3 8    
Weight gain 5 13    
Weight loss 3 8    
Drug hypersensitivity 2 5 1 3
Gastrointestinal disorders
Nausea 30 75    
Anorexia 9 23    
Appetite decreased 6 15    
Diarrhea 21 53    
Vomiting 23 58    
Abdominal pain (lower & upper) 23 58 4 10
Sore throat 14 35    
Constipation 11 28 1 3
Loose stools 4 10    
Dyspepsia 4 10    
Oral blistering 3 8    
Fecal incontinence 3 8    
Gastrointestinal hemorrhage 3 8    
Dry mouth 3 8    
Abdominal tenderness 3 8    
Diarrhea hemorrhagic 3 8    
Abdominal distension 3 8    
Metabolism and nutrition disorders
Hypokalemia 20 50 5 13
Hypomagnesemia 18 45 5 13
Hyperglycemia 18 45 5 13
ALT increased 8 20 2 5
Hyperkalemia 7 18 2 5
AST increased 5 13 1 3
Hypocalcemia 4 10    
    Hypoglycemia 3 8    
Acidosis 2 5    
Nervous system disorders
Headache 24 60 1 3
Insomnia 17 43 1 3
Paresthesia 13 33 2 5
Dizziness (excluding vertigo) 9 23    
    Tremor 5 13    
Convulsion 3 8 2 5
Somnolence 3 8    
Coma 2 5 2 5
Respiratory
Cough 26 65    
Dyspnea 21 53 4 10
Epistaxis 10 25    
Hypoxia 9 23 4 10
Pleural effusion 8 20 1 3
Post nasal drip 5 13    
Wheezing 5 13    
Decreased breath sounds 4 10    
Crepitations 4 10    
Rales 4 10    
Hemoptysis 3 8    
Tachypnea 3 8    
Rhonchi 3 8    
Skin & subcutaneous tissue disorders
Dermatitis 17 43    
Pruritus 13 33 1 3
Ecchymosis 8 20    
Dry skin 6 15    
Erythema - non-specific 5 13    
Increased sweating 5 13    
Facial edema 3 8    
Night sweats 3 8    
Petechiae 3 8    
Hyperpigmentation 3 8    
Non-specific skin lesions 3 8    
Urticaria 3 8    
Local exfoliation 2 5    
Eyelid edema 2 5    
Cardiac disorders
Tachycardia 22 55    
ECG QT corrected interval prolonged
> 500 msec
16 40    
Palpitations 4 10    
ECG abnormal other than QT interval
prolongation
3 8    
Infections and infestations
Sinusitis 8 20    
Herpes simplex 5 13    
Upper respiratory tract infection 5 13 1 3
Bacterial infection - non-specific 3 8 1 3
Herpes zoster 3 8    
Nasopharyngitis 2 5    
Oral candidiasis 2 5    
Sepsis 2 5 2 5
Musculoskeletal, connective tissue and bone
disorders
Arthralgia 13 33 3 8
Myalgia 10 25 2 5
Bone pain 9 23 4 10
Back pain 7 18 1 3
Neck pain 5 13    
Pain in limb 5 13 2 5
Hematologic disorders
Leukocytosis 20 50 1 3
Anemia 8 20 2 5
Thrombocytopenia 7 18 5 13
Febrile neutropenia 5 13 3 8
Neutropenia 4 10 4 10
Disseminated intravascular coagulation 3 8 3 8
Lymphadenopathy 3 8 3  
Vascular disorders
Hypotension 10 25 2 5
Flushing 4 10    
Hypertension 4 10    
Pallor 4 10    
Psychiatric disorders
Anxiety 12 30    
Depression 8 20    
Agitation 2 5    
Confusion 2 5    
Ocular disorders
Eye irritation 4 10    
Blurred vision 4 10    
Dry eye 3 8    
Painful red eye 2 5    
Renal and urinary disorders
Renal failure 3 8 1 3
Renal impairment 3 8    
Oliguria 2 5    
Incontinence 2 5    
Reproductive system disorders
Vaginal hemorrhage 5 13    
Intermenstrual bleeding 3 8    
Ear disorders
Earache 3 8    
Tinnitus 2 5    

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.

Postmarketing Experience

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.

Cardiac disorders : ventricular extrasystoles in association with QT prolongation, and ventricular tachycardia in association with QT prolongation.

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 BOX WARNING].

Read the entire FDA prescribing information for Trisenox (Arsenic Trioxide Injection)

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© Trisenox Patient Information is supplied by Cerner Multum, Inc. and Trisenox Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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