If you have been diagnosed with chronic lymphocytic leukemia (CLL), TREANDA® may be an important treatment option for you.
The goal of any treatment for CLL is to reduce or eliminate the CLL cells in the blood and bone marrow. As a chemotherapy with alkylating properties, TREANDA can kill CLL cells. In a clinical study, TREANDA provided a significantly higher overall response rate versus chlorambucil,* another drug approved by the Food and Drug Administration to treat CLL. In addition, TREANDA delayed "disease progression," which means that the disease did not get worse for a significant period of time.
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 compared with chlorambucil. Both drugs were given without additional chemotherapeutic agents. There were 153 patients who took TREANDA, and 148 patients who took chlorambucil; patients were 75 years of age or younger and were Binet stage B or C (Rai stages I-IV). None of the patients had ever received treatment for their CLL.
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.