TREANDA was generally well tolerated in 2 single-arm studies of patients with indolent
B-cell NHL that had progressed (N=176)
Hematologic laboratory abnormalities
62% percent of patients in the pivotal trial did not receive granulocyte growth factor support1,2
- Prophylactic use of growth factors was allowed in conjunction with the study drug;
use was discouraged during the first treatment cycle. Investigators were advised
to follow the American Society of Clinical Oncology (ASCO) guidelines
Please see Important Safety Information below and full Prescribing Information for more information.
Indications
TREANDA is indicated for the treatment of patients with chronic lymphocytic leukemia
(CLL). Efficacy relative to first-line therapies other than chlorambucil has not
been established.
TREANDA is indicated for the treatment of patients with indolent B-cell non-Hodgkin’s
lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab
or a rituximab-containing regimen.
Important Safety Information
- Serious adverse reactions, including myelosuppression, infections, infusion reactions
and anaphylaxis, tumor lysis syndrome, skin reactions including SJS/TEN, other malignancies,
and extravasation, have been associated with TREANDA. Some reactions, such as myelosuppression,
infections, and SJS/TEN (when TREANDA was administered concomitantly with allopurinol
and other medications known to cause SJS/TEN), have been fatal. 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
- 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 ≥30%) were nausea, fatigue, vomiting, diarrhea, and pyrexia. The most common hematologic abnormalities associated with TREANDA (frequency ≥15%) were lymphopenia, leukopenia, anemia, neutropenia, and thrombocytopenia
TO REPORT SIDE EFFECTS: Contact us at 1-800-896-5855 or usmedinfo@cephalon.com
- BS, Bartlett NL, Leonard JP, et al. Bendamustine is effective therapy in patients
with rituximab-refractory, indolent B-cell non-Hodgkin lymphoma: results from a
multicenter study. Cancer. 2010;116:106-114.
- Data on file. Cephalon, Inc.
