Proven safety profile
The safety of TRISENOX
® (arsenic trioxide) injection has been demonstrated in clinical trials:
- TRISENOX was generally well tolerated with manageable and reversible toxicities1,2
- TRISENOX exhibited low rates of grade 3 and 4 myelosuppression1,3
- There was no incidence of alopecia1,2
- Most common adverse events usually did not require interruption of TRISENOX1
QT interval prolongation and ECG abnormalities
- QT prolongation is an expected, reversible and manageable event4
- 16 of 40 patients had at least one on-study ECG that showed QTc prolongation3
- 2 of 40 patients had atrial dysrhythmias1
- 1 of 40 patients had torsades de pointes1
- For management of QT abnormalities, please see recommendations as noted in the BOXED WARNING
APL differentiation syndrome — effectively treated with dexamethasone
- 10 of 40 patients developed symptoms suggestive of APL differentiation syndrome (3 serious)1,3
- All 10 patients had leukocytosis and received dexamethasone (10 mg BID IV for ≥ 3 days)3
- 8 patients required brief therapy interruption (1 to 5 days)3
- All 10 patients achieved complete remission3
- The management of the syndrome has not been fully studied, but high-dose steroids have been used to mitigate signs and symptoms
- Termination of TRISENOX was not required in the majority of patients1; interruption of therapy is necessary if symptoms of APL syndrome do not respond to steroid treatment
Hyperleukocytosis — resolved with continuation of TRISENOX
- Of 20 patients who developed hyperleukocytosis, one was severe (grade 3 or 4)1
- With the continuation of therapy with TRISENOX, leukocytosis resolved a median 10.5 days after peak WBC count (range: 3 to 27 days)3
- Hyperleukocytosis was not treated with additional chemotherapy1
Other events typical of chemotherapy
- Neuropathy symptoms were mild, grade 1 in the majority3
- No significant hepatotoxicity was observed in the multicenter trial3
Drug interactions
- No formal assessments of pharmacokinetic drug-drug interactions between TRISENOX and other drugs have been conducted. The methyltransferases responsible for metabolizing arsenic trioxide are not members of the cytochrome P450 family of isoenzymes (see PRECAUTIONS in the full Prescribing Information)1
- Caution is advised when TRISENOX 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)1
TRISENOX is contraindicated in patients who are hypersensitive to arsenic.1
>> Click here to find out more about the medicinal role of arsenic.
1. TRISENOX Prescribing Information. Frazer, Pa: Cephalon, Inc.;2005.
2. Douer D, Tallman MS. Arsenic trioxide: new clinical experience with an old medication in hematologic malignancies. J Clin Oncol. 2005;23:2396-2410.
3. Soignet SL, Frankel SR, Douer D, et al. United States multicenter study of arsenic trioxide in relapsed acute promyelocytic leukemia. J Clin Oncol. 2001;19:3852-3860.
4. Barbey JT, Pezzullo JC, Soignet SL. Effect of arsenic trioxide on QT interval in patients with advanced malignancies. J Clin Oncol. 2003;21:3609-3615.