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Trisenox

Last reviewed on RxList: 7/3/2019
Trisenox Side Effects Center

Last reviewed on RxList 7/3/2019

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:

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.

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Trisenox Consumer Information

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

Arsenic trioxide can cause a serious and sometimes fatal complication by changing the way your immune system works. Call your doctor at once if you have any signs of this condition, including:

  • fever, weight gain, feeling weak or tired;
  • swelling in your ankles or feet;
  • little or no urination;
  • cough, pain when you breathe, rapid heart rate, feeling short of breath; or
  • feeling like you might pass out.

Also call your doctor right away if you have:

  • fast or pounding heartbeats, fluttering in your chest;
  • shortness of breath, and sudden dizziness (like you might pass out);
  • fever, tiredness;
  • easy bruising or bleeding;
  • high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; or
  • low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

  • stomach pain, nausea, vomiting;
  • constipation, diarrhea;
  • cough, sore throat;
  • headache, dizziness;
  • anxiety, trouble sleeping;
  • numbness or tingly feeling;
  • joint or muscle pain; or
  • itching or rash.

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 clinically significant adverse reactions are described elsewhere in the labeling.

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.

Newly-Diagnosed Low-Risk APL

The safety evaluation of TRISENOX in combination with tretinoin is based on results from a randomized trial comparing TRISENOX plus tretinoin (n=129) versus chemotherapy plus tretinoin (n=137) in patients with newly-diagnosed APL (Study APL0406) [see Clinical Studies]. In the TRISENOX/tretinoin group, 98% of patients completed induction therapy and 89% completed at least three consolidation cycles. In the chemotherapy/tretinoin group, 96% completed induction therapy and 87% patients completed all three courses of consolidation therapy.

Fatal adverse reactions were reported in 1 (1%) patient on the TRISENOX/tretinoin arm and 8 (6%) patients on the chemotherapy/tretinoin arm. TRISENOX/tretinoin was discontinued due to toxicity in 1 patient during induction and in 4 patients during the first three consolidation courses, whereas chemotherapy/tretinoin was discontinued due to toxicity in 4 patients during induction and in 6 patients during consolidation. Serious adverse reactions reported in 25% on the TRISENOX/ tretinoin arm and 24% on the chemotherapy/tretinoin arm. The serious adverse reactions reported in ≥ 2% of patients receiving TRISENOX/tretinoin were abnormal liver tests, differentiation syndrome, dyspnea, pneumonia, and other infections.

Selected hematologic and nonhematologic toxicities that occurred during induction or consolidation are presented in Table 4 for the 129 patients treated with TRISENOX plus tretinoin and the 137 patients treated with chemotherapy plus tretinoin.

Table 4: Selected Adverse Reactions of Trisenox in Combination with Tretinoin in Patients with Newly-Diagnosed APL

Adverse Reaction Induction
n (%)
First Consolidation
n (%)
Second Consolidation
n (%)
Third Consolidation
n (%)
Thrombocytopenia > 15 days (Grade 3-4)
  TRISENOX/tretinoin 74 (58%) 6 (5%) 6 (5%) 8 (7%)
  Chemotherapy/tretinoin 120 (88%) 17 (14%) 77 (63%) 26 (22%)
Neutropenia >15 days (Grade 3-4)
  TRISENOX/tretinoin 61 (48%) 8 (7%) 7 (6%) 5 (4%)
  Chemotherapy/tretinoin 109 (80%) 40 (32%) 90 (73%) 28 (24%)
Hepatic toxicity (Grade 3-4)
  TRISENOX/tretinoin 51 (40%) 5 (4%) 1 (1%) 0 (0%)
  Chemotherapy/tretinoin 4 (3%) 1 (1%) 0 (0%) 0 (0%)
Infection and fever of unknown origin
  TRISENOX/tretinoin 30 (23%) 10 (8%) 4 (3%) 2 (2%)
  Chemotherapy/tretinoin 75 (55%) 8 (6%) 46 (38%) 2 (2%)
Hypertriglyceridemia
  TRISENOX/tretinoin 29 (22%) 22 (18%) 17 (14%) 16 (14%)
  Chemotherapy/tretinoin 29 (22%) 19 (15%) 10 (8%) 13 (11%)
Hypercholesterolemia
  TRISENOX/tretinoin 14 (10%) 19 (16%) 19 (16%) 16 (14%)
  Chemotherapy/tretinoin 12 (9%) 12 (10%) 12 (10%) 11 (9%)
QT prolongation
  TRISENOX/tretinoin 11 (9%) 3 (2%) 3 (2%) 2 (2%)
  Chemotherapy/tretinoin 1 (1%) 0 (0%) 0 (0%) 0 (0%)
Gastrointestinal toxicity (Grade 3-4)
  TRISENOX/tretinoin 3 (2%) 0 (0%) 0 (0%) 0 (0%)
  Chemotherapy/tretinoin 25 (18%) 1 (1%) 6 (5%) 0 (0%)
Neurotoxicity*
  TRISENOX/tretinoin 1 (1%) 5 (4%) 6 (5%) 7 (6%)
  Chemotherapy/tretinoin 0 (0%) 0 (0%) 0 (0%) 0 (0%)
Cardiac function (Grade 3-4)
  TRISENOX/tretinoin 0 (0%) 0 (0%) 0 (0%) 0 (0%)
  Chemotherapy/tretinoin 5 (4%) 0 (0%) 0 (0%) 0 (0%)
*Mostly cases of reversible peripheral neuropathy

Relapsed Or Refractory APL

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 whom 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.

SAEs, Grade ≥3 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 5 describes the adverse reactions that were observed in ≥ 5% patients, between the ages of 5-73 years, treated for APL with TRISENOX at the recommended dose. Similar adverse reactions profiles were seen in the other patient populations who received TRISENOX.

Table 5: Adverse Reactions (Any Grade) Occurring in ≥ 5% of Patients Treated with TRISENOX Monotherapy for Relapsed or Refractory APL

Body System
  Adverse reaction
Any Grade Adverse Reactions Grade ≥3 Adverse Reactions
n % n %
Gastrointestinal disorders        
Nausea 30 75    
Abdominal pain (lower & upper) 23 58 4 10
Vomiting 23 58    
Diarrhea 21 53    
Sore throat 14 35    
Constipation 11 28 1 3
Anorexia 9 23    
Appetite decreased 6 15    
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    
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    
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    
Weight gain 5 13    
Injection site edema 4 10    
Weakness 4 10 2 5
Hemorrhage 3 8    
Weight loss 3 8    
Drug hypersensitivity 2 5 1 3
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
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    
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    
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    
Skin and 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    
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
Psychiatric disorders        
Anxiety 12 30    
Depression 8 20    
Agitation 2 5    
Confusion 2 5    
Vascular disorders        
Hypotension 10 25 2 5
Flushing 4 10    
Hypertension 4 10    
Pallor 4 10    
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
Reproductive system disorders        
Vaginal hemorrhage 5 13    
Intermenstrual bleeding 3 8    
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    
Ear disorders        
Earache 3 8    
Tinnitus 2 5    

Leukocytosis

TRISENOX in combination with tretinoin can induce proliferation of leukemic promyelocytes resulting in a rapid increase in white blood cell count. Leukocytosis greater than 10 Gi/L developed during induction therapy in 43% patients receiving TRISENOX/tretinoin for newly-diagnosed low-risk APL and in 50% of patients receiving TRISENOX monotherapy for relapsed/refractory APL. In the relapsed/refractory setting, a relationship did not exist between baseline WBC counts and development of hyperleukocytosis nor baseline WBC counts and peak WBC counts. Hyperleukocytosis due to TRISENOX may warrant treatment with hydroxyurea [see DOSAGE AND ADMINISTRATION].

Postmarketing Experience

The following reactions have been reported from clinical trials and/or worldwide postmarketing surveillance. Because they are voluntarily reported from a population of unknown size, precise estimates of frequency or causal relationship to drug exposure cannot always be made.

Cardiac disorders: Ventricular extrasystoles in association with QT prolongation, ventricular tachycardia in association with QT prolongation, including torsade de pointes, atrioventricular block, and congestive heart failure

Nervous system disorders: Peripheral neuropathy, paresis, seizures, confusion, encephalopathy, Wernicke’s encephalopathy, posterior reversible encephalopathy syndrome

Hematologic disorders: Pancytopenia, bone marrow necrosis

Infections and infestations: Herpes zoster

Investigations: Gamma-glutamyltransferase increased

Musculoskeletal and connective tissue disorders: Bone pain, myalgia, rhabdomyolysis

Respiratory, thoracic, and mediastinal disorders: Differentiation syndrome, like retinoic acid syndrome, has been reported with the use of TRISENOX for the treatment of malignancies other than APL.

Ear and labyrinth disorders: Deafness

Neoplasms benign, malignant and unspecified: Melanoma, pancreatic cancer, squamous cell carcinoma

Skin and subcutaneous tissue disorders: Toxic epidermal necrolysis

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

Related Resources for Trisenox

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Read the Trisenox User Reviews »

© 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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