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TREANDA
Leukemias, lymphomas, and other hematologic cancers
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Drug Name:

TREANDA Rx

Generic Name and Formulations:
Bendamustine HCl 90mg/mL; per vial; soln for IV infusion after dilution; 25mg, 100mg; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.

Company:
Teva Pharmaceuticals

Therapeutic Use:

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:

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. 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:

Not established.

Warnings/Precautions:

Myelosuppression; monitor leukocytes, platelets, hemoglobin, neutrophils closely; 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); treat promptly if occur. Monitor for infusion or skin reactions, tumor lysis syndrome. Renal or hepatic impairment. Avoid extravasation. Pregnancy (Cat.D); avoid use. Nursing mothers: not recommended.

Interactions:

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

Pharmacological Class:

Alkylating agent.

Adverse Reactions:

Lymphopenia, anemia, leukopenia, thrombocytopenia, neutropenia, pyrexia, nausea, vomiting, fatigue, diarrhea, constipation, anorexia, cough, headache, weight loss, dyspnea, stomatitis, increased bilirubin, increased AST/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, bronchial carcinoma).

Metabolism:

Hepatic (CYP1A2). 94-96% protein bound.

Elimination:

Fecal (90%).

Generic Availability:

NO

How Supplied:

Single-use vial (soln: 45mg/0.5mL, 180mg/2mL; lyophilized pwd: 25mg, 100mg)—1

TREANDA

  • 100mg vials (Qty:1)
  • appx. price $2859.00
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