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			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.
	Prescribing Information \| Important Safety Information \| Boxed Warning


			Important Safety Information The following serious adverse reactions have been associated with TREANDA: myelosuppression, infections, infusion reactions and anaphylaxis, tumor lysis syndrome, skin reactions including SJS/TEN, other malignancies, and extravasation. Some of these reactions have been fatal, including myelosuppression, infections, and SJS/TEN (when TREANDA was administered concomitantly with allopurinol and other medications known to cause SJS/TEN). Patients should be monitored closely for these reactions and treated promptly if any occur. Adverse reactions may require interventions such as decreasing the dose of TREANDA, or withholding or delaying treatment. Myelosuppression is frequently severe and should be expected when treating patients with TREANDA. TREANDA is contraindicated in patients with a known hypersensitivity to bendamustine or mannitol. Women should be advised to avoid becoming pregnant while using TREANDA. The most common non-hematologic adverse reactions associated with TREANDA (frequency ≥15%) are nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache, weight decreased, dyspnea, rash, and stomatitis. The most common hematologic abnormalities associated with TREANDA (frequency ≥15%) are lymphopenia, anemia, leukopenia, thrombocytopenia, and neutropenia. Refer to the Full Prescribing Information.
	Prescribing Information \| Important Safety Information

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