Monograph Details
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Neoplasms
> Alkylating agents
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TREANDA |
| Manufacturer |
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Cephalon, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Alkylating agent. |
| Generic Name |
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Bendamustine HCl 100mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution; contains mannitol; preservative-free. |
| Indications |
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Chronic lymphocytic leukemia. |
| Children |
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Not recommended. |
| Adults |
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Give by IV infusion over 30 minutes. 100mg/m2 on Days 1 and 2 of a 28-day cycle, up to 6 cycles. 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. 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. Severe renal impairment (CrCl <40mL/min) or moderate to severe hepatic impairment: not recommended. |
| Precautions |
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Myelosuppression; monitor leukocytes, platelets, hemoglobin, neutrophils closely; restart treatment based on ANC and platelet count recovery. Renal or hepatic impairment. Monitor for infection, infusion reactions, tumor lysis syndrome. Pregnancy (Cat.D); avoid use. Nursing mothers: not recommended. |
| Interactions |
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May be potentiated or antagonized by CYP1A2 inhibitors, inducers. |
| Adverse Reactions |
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Neutropenia, pyrexia, thrombocytopenia, nausea, anemia, leukopenia, 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). |
| How Supplied |
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Single-use vial—1 |
| Additional Resources |
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• Related Prescribing Note |
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