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Trisenox (Arsenic Trioxide) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Clinical Studies Experience

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 EventAll Adverse Events,
Any Grade
Grade 3 & 4
Events
n%n%
General disorders and administration site conditions
Fatigue256325
Pyrexia (fever)256325
Edema - non-specific1640
Rigors1538
Chest pain102525
Injection site pain820
Pain - non-specific61513
Injection site erythema513
Injection site edema410
Weakness41025
Hemorrhage38
Weight gain513
Weight loss38
Drug hypersensitivity2513
Gastrointestinal disorders
Nausea3075
Anorexia923
Appetite decreased615
Diarrhea2153
Vomiting2358
Abdominal pain (lower & upper)2358410
Sore throat1435
Constipation112813
Loose stools410
Dyspepsia410
Oral blistering38
Fecal incontinence38
Gastrointestinal hemorrhage38
Dry mouth38
Abdominal tenderness38
Diarrhea hemorrhagic38
Abdominal distension38
Metabolism and nutrition disorders
Hypokalemia2050513
Hypomagnesemia1845513
Hyperglycemia1845513
ALT increased82025
Hyperkalemia71825
AST increased51313
Hypocalcemia410
Hypoglycemia 38
Acidosis25
Nervous system disorders
Headache246013
Insomnia174313
Paresthesia133325
Dizziness (excluding vertigo)923
Tremor 513
Convulsion3825
Somnolence38
Coma2525
Respiratory
Cough2665
Dyspnea2153410
Epistaxis1025
Hypoxia923410
Pleural effusion82013
Post nasal drip513
Wheezing513
Decreased breath sounds410
Crepitations410
Rales410
Hemoptysis38
Tachypnea38
Rhonchi38
Skin & subcutaneous tissue disorders
Dermatitis1743
Pruritus133313
Ecchymosis820
Dry skin615
Erythema - non-specific513
Increased sweating513
Facial edema38
Night sweats38
Petechiae38
Hyperpigmentation38
Non-specific skin lesions38
Urticaria38
Local exfoliation25
Eyelid edema25
Cardiac disorders
Tachycardia2255
ECG QT corrected interval prolonged
> 500 msec
1640
Palpitations410
ECG abnormal other than QT interval prolongation38
Infections and infestations
Sinusitis820
Herpes simplex513
Upper respiratory tract infection51313
Bacterial infection - non-specific3813
Herpes zoster38
Nasopharyngitis25
Oral candidiasis25
Sepsis2525
Musculoskeletal, connective tissue and
bone disorders
Arthralgia133338
Myalgia102525
Bone pain923410
Back pain71813
Neck pain513
Pain in limb51325
Hematologic disorders
Leukocytosis205013
Anemia82025
Thrombocytopenia718513
Febrile neutropenia51338
Neutropenia410410
Disseminated intravascular coagulation3838
Lymphadenopathy38
Vascular disorders
Hypotension102525
Flushing410
Hypertension410
Pallor410
Psychiatric disorders
Anxiety1230
Depression820
Agitation25
Confusion25
Ocular disorders
Eye irritation410
Blurred vision410
Dry eye38
Painful red eye25
Renal and urinary disorders
Renal failure3813
Renal impairment38
Oliguria25
Incontinence25
Reproductive system disorders
Vaginal hemorrhage513
Intermenstrual bleeding38
Ear disorders
Earache38
Tinnitus25

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.



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: 2008-12-22

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