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Safety information was available for 52 patients with relapsed or refractory APL who participated in clinical trials of TRISENOX (arsenic trioxide injection) . 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 (arsenic trioxide injection) 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 between the ages of 5 - 73 years treated for APL with TRISENOX (arsenic trioxide injection) 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 (arsenic trioxide injection) .
Adverse Events (any grade) Occurring in ≥ 5% of 40 Patients
with APL who Received TRISENOX (arsenic trioxide) injection at a dose of 0.15
|System organ class/Adverse Event||All Adverse Events, Any Grade||Grade 3 & 4 Events|
|General disorders and administration site conditions|
|Edema - non-specific||16||40|
|Injection site pain||8||20|
|Pain - non-specific||6||15||1||3|
|Injection site erythema||5||13|
|Injection site edema||4||10|
|Abdominal pain (lower & upper)||23||58||4||10|
|Metabolism and nutrition disorders|
|Nervous system disorders|
|Dizziness (excluding vertigo)||9||23|
|Post nasal drip||5||13|
|Decreased breath sounds||4||10|
|Skin & subcutaneous tissue disorders|
|Erythema - non-specific||5||13|
|Non-specific skin lesions||3||8|
|ECG QT corrected interval prolonged > 500 msec||16||40|
|ECG abnormal other than QT interval prolongation||3||8|
|Infections and infestations|
|Upper respiratory tract infection||5||13||1||3|
|Bacterial infection - non-specific||3||8||1||3|
|Musculoskeletal, connective tissue and bone disorders|
|Pain in limb||5||13||2||5|
|Disseminated intravascular coagulation||3||8||3||8|
|Painful red eye||2||5|
|Renal and urinary disorders|
|Reproductive system disorders|
The following additional adverse events were reported as related to TRISENOX (arsenic trioxide injection) 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=l) and caecitis (n=l) were considered serious reactions.
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 (arsenic trioxide injection) 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 »
No formal assessments of pharmacokinetic drug-drug interactions between TRISENOX (arsenic trioxide injection) and other agents have been conducted. Caution is advised when TRISENOX (arsenic trioxide injection) is coadministered with other medications that can prolong the QT interval (e.g., certain antiarrhythmics or thioridazine) or lead to electrolyte abnormalities (such as diuretics or amphotericin B).
Last reviewed on RxList: 8/13/2010
This monograph has been modified to include the generic and brand name in many instances.
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