TREANDA for indolent B-cell NHL that has progressed

If you have been diagnosed with indolent B-cell non-Hodgkin's lymphoma (NHL) that has progressed, TREANDA® may be an important treatment option for you.

The goal of treatment is to reduce or eliminate the presence of indolent B-cell NHL cells in your body, and TREANDA has been shown to help many patients.

As a chemotherapy with alkylating properties, TREANDA can kill indolent B-cell NHL cells. In a clinical study, TREANDA provided a high overall response rate when used as a single agent. The overall response was 74% for patients whose disease progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen.* In addition, TREANDA maintained duration of response, which is the amount of time the response to treatment lasts. In this study, the median duration of response was 9.2 months for patients taking TREANDA*.

If your healthcare professional has recommended therapy with TREANDA, the information here will help you better understand its benefits, how it works, side effects, administration, and taking care of yourself during treatment.

*In a clinical study, TREANDA was examined alone (not combined with additional therapies). In total, 100 patients took TREANDA. The study included patients who were diagnosed with a form of indolent B-cell NHL and who had received prior treatment with rituximab or a rituximab-containing regimen and whose disease progressed during or within 6 months of treatment.

TREANDA for injection is indicated for the treatment of patients with indolent B-cell non-Hodgkin’s lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. TREANDA is also indicated for the treatment of patients with chronic lymphocytic leukemia (CLL). Efficacy relative to first-line therapies other than chlorambucil has not been established.

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.

Please see full Prescribing Information.