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Trisenox (Arsenic Trioxide) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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 or 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).

The following table describes the adverse events that were observed in patients 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.

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.

Post-Marketing Experience

The following reactions have been reported from clinical trials and/or world-wide post-marketing 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

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.



REPORTS OF SUSPECTED TRISENOX SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Trisenox. The information is not vetted and should not be considered as verified clinical evidence.

Possible Trisenox side effects / adverse reactions in 5 year old male

Reported by a physician from Japan on 2011-10-05

Patient: 5 year old male

Reactions: Respiratory Disorder

Suspect drug(s):
Trisenox



Possible Trisenox side effects / adverse reactions in 64 year old female

Reported by a physician from United Kingdom on 2011-10-06

Patient: 64 year old female

Reactions: Gamma-Glutamyltransferase Increased

Suspect drug(s):
Gemtuzumab Ozogamicin
    Dosage: 6 mg unit dose at unknown frequency
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-07-15
    End date: 2011-07-29

Atracurium Besylate
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-07-15
    End date: 2011-07-18

Atracurium Besylate
    Dosage: unk
    Indication: Myelodysplastic Syndrome
    Start date: 2011-08-04

Trisenox
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-07-15
    End date: 2011-07-29

Trisenox
    Indication: Myelodysplastic Syndrome

Gemtuzumab Ozogamicin
    Indication: Myelodysplastic Syndrome



Possible Trisenox side effects / adverse reactions in 64 year old female

Reported by a physician from United Kingdom on 2011-10-18

Patient: 64 year old female

Reactions: Gamma-Glutamyltransferase Increased

Suspect drug(s):
Atracurium Besylate
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-07-15
    End date: 2011-07-18

Gemtuzumab Ozogamicin
    Dosage: 6 mg unit dose at unknown frequency
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-07-15
    End date: 2011-07-29

Gemtuzumab Ozogamicin
    Indication: Myelodysplastic Syndrome

Trisenox
    Indication: Myelodysplastic Syndrome

Atracurium Besylate
    Dosage: unk
    Indication: Myelodysplastic Syndrome
    Start date: 2011-08-04

Trisenox
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-07-15
    End date: 2011-07-29



See index of all Trisenox side effect reports >>

Drug label data at the top of this Page last updated: 2014-04-04

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