Bendeka

— THERAPEUTIC CATEGORIES —
  • Leukemias, lymphomas, and other hematologic cancers

Bendeka Generic Name & Formulations

General Description

Bendamustine HCl 25mg/mL; soln for IV infusion after dilution; preservative-free.

Pharmacological Class

Alkylating agent.

How Supplied

Multi-dose vial (4mL)—1

Manufacturer

Generic Availability

NO

Bendeka Indications

Indications

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.

Bendeka Dosage and Administration

Adult

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.

Children

Not established.

Bendeka Contraindications

Not Applicable

Bendeka Boxed Warnings

Not Applicable

Bendeka 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. Monitor for infusion or skin reactions (may be fatal), tumor lysis syndrome. 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).

Bendeka Pharmacokinetics

See Literature

Bendeka Interactions

Interactions

May be potentiated by CYP1A2 inhibitors or antagonized by CYP1A2 inducers; if needed, consider alternatives.

Bendeka Adverse Reactions

Adverse Reactions

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).

Bendeka Clinical Trials

See Literature

Bendeka Note

Not Applicable

Bendeka Patient Counseling

See Literature