Step 1: Aseptically reconstitute each TREANDA vial as follows:
- 25 mg TREANDA vial: Add 5 mL of only Sterile Water for Injection, USP.
- 100 mg TREANDA vial: Add 20 mL of only Sterile Water for Injection, USP.
Step 2: Shake well to yield a clear; colorless to a pale yellow solution with a bendamustine HCI concentration of 5 mg/mL.
- The lyophilized powder should completely dissolve in 5 minutes. If particulate matter is observed, the reconstituted product should not be used.
Step 3: Aseptically withdraw the volume needed for the required dose (based on 5 mg/mL concentration) and immediately transfer to a 500 mL infusion bag of 0.9% Sodium Chloride Injection, USP (normal saline).
- The reconstituted solution must be transferred to the infusion bag within 30 minutes of reconstitution.
- As an alternative to 0.9% Sodium Chloride Injection, USP normal [saline], a 500 mL infusion bag of 2.5% Dextrose/0.45% Sodium Chloride Injection, USP, may be considered
- The resulting final concentration of bendamustine HCI in the infusion bag should be within 0.2-0.6 mg/mL.
Step 4: After transferring, thoroughly mix the contents of the infusion bag. The admixture should be a clear and colorless to slightly yellow solution.
- Use Sterile Water for Injection, USP, for reconstitution and then either 0.9% Sodium Chloride Injection, USP, or 2.5% Dextrose/0.45% Sodium Chloride Injection, USP, for dilution, as outlined above
- No other diluents have been shown to be compatible
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit
- Any unused solution should be discarded according to institutional procedure for antineoplastics
- TREANDA contains no antimicrobial preservative
- The admixture should be prepared as close as possible to the time of patient administration
- Once diluted with either 0.9% Sodium Chloride Injection, USP, or 2.5% Dextrose/0.45% Sodium Chloride Injection, USP, the final admixture is stable for 24 hours when stored refrigerated (2-8oC or 36-47oF) or for 3 hours when stored at room temperature (15-30oC or 59-86oF) and room light. Administration of TREANDA must be completed within this period
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.
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