Generic Name and Formulations:
Bendamustine HCl 25mg/mL; soln for IV infusion after dilution; preservative-free.
Indications for BENDEKA:
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.
CLL: Give by IV infusion over 10mins. 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 10mins. 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. Delay treatment for Grade 4 hematologic toxicity or clinically significant ≥Grade 2 non-hematologic toxicity.
Myelosuppression; monitor CBCs including leukocytes, platelets, hemoglobin, neutrophils frequently; restart treatment based on ANC and platelet count recovery. Monitor for signs of infection or reactivation of infections (eg, hepatitis B, CMV, tuberculosis, herpes zoster); prophylaxis and treat prior to therapy if occur. Monitor for infusion or skin reactions (may be fatal), tumor lysis syndrome. Monitor LFTs prior to and during therapy. Renal impairment (mild or moderate): caution; (CrCl <40mL/min): not recommended. Hepatic impairment (mild): caution; (moderate or severe): not recommended. Avoid extravasation. Embryo-fetal toxicity. Pregnancy (Cat.D); avoid during and for 3 months after therapy cessation. Nursing mothers: not recommended.
May be potentiated by CYP1A2 inhibitors (eg, fluvoxamine, ciprofloxacin) or antagonized by CYP1A2 inducers (eg, omeprazole, smoking); if needed, consider alternatives.
Lymphopenia, anemia, leukopenia, thrombocytopenia, neutropenia, pyrexia, nausea, vomiting, fatigue, diarrhea, constipation, anorexia, cough, headache, weight loss, dyspnea, stomatitis; infection, infusion reactions (discontinue if severe), tumor lysis syndrome, skin reactions (if severe or progressive, withhold dose or discontinue), hepatotoxicity, other malignancies (eg, myelodysplastic syndrome, acute myeloid leukemia, bronchial carcinoma).
Hepatic (CYP1A2). 94-96% protein bound.
Multi-dose vial (4mL)—1
Sign Up for Free e-newsletters
Psychiatry Advisor Articles
- Lithium Monotherapy Effective in Treating Bipolar Disorder in Children
- Transdermal Nicotine Boosts Mood and Cognitive Function in Late-Life Depression
- Computerized Training Programs for Schizophrenia Improve Cognitive Functioning
- Cognitive Behavioral Therapy May Alter Suicidal Ideation in Anxiety Disorders
- Ketamine Infusions Reduce Suicidal Ideation in Depression: Characterizing Different Responses
- Antidepressant Effects of Ketamine Appear to Require Opioid System Activation
- Attention-Deficit/Hyperactivity Disorder Increasing Among US Children and Adolescents
- Cost-Effective Telehealth Alternatives for Veterans With Depression
- Polygenic Risk Scores Could Aid in Identifying Bipolar Disorder, Schizophrenia
- Brief Impression Questionnaire Useful in Schizophrenia Diagnoses