Storage and handling
Storage
- TREANDA may be stored up to 25°C (77°F) with excursions permitted up to 30°C (86°F)
(see USP Controlled Room Temperature). Retain in original package until time of use to protect from light
Safe handling and disposal
- As with other potentially toxic anti-cancer agents, care should be exercised in the
handling and preparation of solutions prepared from TREANDA. The use of gloves and safety
glasses is recommended to avoid exposure in case of breakage of the vial or other accidental spillage.
If a solution of TREANDA contacts the skin, wash the skin immediately and thoroughly with soap and water.
If TREANDA contacts the mucous membranes, flush thoroughly with water
- Procedures for the proper handling and disposal of anti-cancer drugs should be considered.
Several guidelines on the subject have been published. There is no general agreement that all of the
procedures recommended in the guidelines are necessary or appropriate
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
