Generic Name and Formulations:
Bendamustine HCl 25mg, 100mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution; contains mannitol; preservative-free.
Indications for TREANDA:
Chronic lymphocytic leukemia (CLL). 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.
Adult Dose for TREANDA:
CLL: Give by IV infusion over 30 minutes. 100mg/m2 on Days 1 and 2 of a 28-day cycle, up to 6 cycles. Hematologic toxicity (≥Grade 3): reduce dose to 50mg/m2 on Days 1 and 2 of each cycle; if toxicity recurs, reduce dose to 25mg/m2 on Days 1 and 2. Non-hematologic toxicity (clinically significant ≥Grade 3): reduce dose to 50mg/m2 on Days 1 and 2 of each cycle. Subsequent cycles: may consider dose re-escalation. NHL: Give by IV infusion over 60 minutes. 120mg/m2 on Days 1 and 2 of a 21-day cycle, up to 8 cycles. Hematologic toxicity (Grade 4) or non-hematologic toxicity (≥Grade 3): reduce dose to 90mg/m2 on Days 1 and 2 of each cycle; if toxicity recurs, reduce dose to 60mg/m2 on Days 1 and 2. Both: May give allopurinol prophylactically for those at high risk of tumor lysis syndrome. Delay treatment for Grade 4 hematologic toxicity or clinically significant ≥Grade 2 non-hematologic toxicity. Severe renal impairment (CrCl <40mL/min) or moderate to severe hepatic impairment: not recommended.
Children's Dose for TREANDA:
Myelosuppression; monitor leukocytes, platelets, hemoglobin, neutrophils closely; restart treatment based on ANC and platelet count recovery. Renal or hepatic impairment. Monitor for infection, infusion or skin reactions, tumor lysis syndrome. Avoid extravasation. Pregnancy (Cat.D); avoid use. Nursing mothers: not recommended.
May be potentiated or antagonized by CYP1A2 inhibitors, inducers.
Lymphopenia, anemia, thrombocytopenia, leukopenia, neutropenia, pyrexia, nausea, vomiting, asthenia, fatigue, malaise, dry mouth, somnolence, cough, constipation, headache, mucosal inflammation, stomatitis, increased bilirubin, increased AST or ALT; infection, infusion reactions (discontinue if severe), tumor lysis syndrome, skin reactions (if severe or progressive, withhold dose or discontinue), other malignancies (eg, myelodysplastic syndrome, acute myeloid leukemia).
Hepatic (CYP1A2). 94-96% protein bound.
Single-use vial (25mg/8mL, 100mg/20mL)—1