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Treanda Generic Name & Formulations
Legal Class
Rx
General Description
Bendamustine HCl 25mg, 100mg; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.
Pharmacological Class
Alkylating agent.
How Supplied
Single-use vial—1
Manufacturer
Generic Availability
NO
Treanda Indications
Indications
Chronic lymphocytic leukemia (CLL). Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen.
Treanda Dosage and Administration
Adult
CLL: Give by IV infusion over 30mins. 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 60mins. 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.
Children
Not established.
Treanda Contraindications
Not Applicable
Treanda Boxed Warnings
Not Applicable
Treanda Warnings/Precautions
Warnings/Precautions
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. Discontinue treatment and consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressives if progressive multifocal leukoencephalopathy (PML) develops. Monitor for infusion or skin reactions (may be fatal), tumor lysis syndrome, secondary malignancies. Perform dermatologic evaluations. Monitor LFTs prior to and during therapy. Renal impairment (CrCl <30mL/min): not recommended. Hepatic impairment (total bilirubin 1.5–3×ULN and AST or ALT 2.5–10×ULN, or total bilirubin >3×ULN): not recommended. Avoid extravasation. Embryo-fetal toxicity. Advise to use effective contraception during and for ≥6 months (females of reproductive potential) or for ≥3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥1 week after the last dose).
Treanda Pharmacokinetics
See Literature
Treanda Interactions
Interactions
May be potentiated CYP1A2 inhibitors or antagonized by CYP1A2 inducers; if needed, consider alternatives.
Treanda Adverse Reactions
Adverse Reactions
Lymphopenia, anemia, leukopenia, thrombocytopenia, neutropenia, pyrexia, nausea, vomiting, fatigue, diarrhea, constipation, anorexia, cough, headache, weight loss, dyspnea, rash (if severe or progressive, withhold dose or discontinue), stomatitis; infection, PML, infusion reactions (discontinue if severe), tumor lysis syndrome, hepatotoxicity, other malignancies (eg, myelodysplastic syndrome, acute myeloid leukemia, bronchial carcinoma, non-melanoma skin cancer).
Treanda Clinical Trials
See Literature
Treanda Note
Not Applicable
Treanda Patient Counseling
See Literature
