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.