Important Safety Information
TRISENOX is indicated for induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. The response rate of other acute myelogenous leukemia subtypes to TRISENOX has not been examined.

Serious adverse events, grade 3 or 4, were common. Those events attributable to TRISENOX in the phase 2 study of 40 patients with refractory or relapsed APL included QTc interval prolongation (n=16), APL differentiation syndrome (n=3), hyperleukocytosis (n=3), atrial dysrhythmias (n=2), hyperglycemia (n=2), and torsade de pointes (n=1).

In clinical trials, most patients taking TRISENOX 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.

A differentiation syndrome, like retinoic acid syndrome, has been reported with the use of TRISENOX for the treatment of malignancies other than APL from postmarketing surveillance. Due to unknown population size, it is not possible to provide precise estimates of frequency.

In a pediatric clinical trial of 13 patients (ages 4-20), additional drug-related toxicities included: gastrointestinal disorders, metabolic disorders, respiratory disorders, cardiac failure congestive, neuralgia, and enuresis. One case each of pulmonary edema and caecitis were considered serious reactions.

TRISENOX contains arsenic trioxide, a human carcinogen. Carcinogenicity studies have not been conducted with TRISENOX by intravenous administration.

TRISENOX may cause fetal harm when administered to a pregnant woman. TRISENOX is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from TRISENOX, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Refer to the Full Prescribing Information.