September 4, 2015
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Trisenox

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Trisenox




Side Effects
Interactions

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    
  Injection site edema 4 10    
  Weakness 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    
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 BOXED WARNING].

Read the Trisenox (arsenic trioxide injection) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Drugs That Can Prolong the QT/QTc Interval

Concomitant use of these drugs and TRISENOX may increase the risk of serious QT/QTc interval prolongation. Discontinue or replace with an alternative drug that does not prolong the QT/QTc interval while patient is using TRISENOX. Monitor ECGs more frequently in patients when it is not feasible to avoid concomitant use.

Drugs That Can Lead to Electrolyte Abnormalities

Electrolyte abnormalities increase the risk of serious QT/QTc interval prolongation. Avoid concomitant administration of drugs that can lead to electrolyte abnormalities. Monitor electrolytes more frequently in patients who must receive concomitant use of these drugs and TRISENOX.

Last reviewed on RxList: 3/6/2015
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions

Trisenox - User Reviews

Trisenox User Reviews

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