Bendamax Injection

• Generic Name: Bendamustine hydrochloride

• Formulation: Injection available in vials (typically 25 mg/mL; common strengths include 25 mg, 100 mg, 200 mg)

• Therapeutic Class: Alkylating antineoplastic agent (nitrogen mustard derivative) 

• Primary Uses:

  • Chronic lymphocytic leukemia (CLL)

  • Non-Hodgkin lymphoma (NHL) (especially indolent B-cell types and mantle‑cell lymphoma)

  • Multiple myeloma
    
    

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🧬 Mechanism of Action

• Alkylates DNA and RNA to form cross-links, thereby halting cancer cell growth and proliferation 

• Effective against both rapidly dividing and quiescent tumor cells .

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💉 Dosage & Administration

• CLL: 100 mg/m² IV over 10–60 min on Days 1–2 of a 28-day cycle (up to 6 cycles) 

• NHL: 120 mg/m² IV on Days 1–2 every 21 days (up to 8 cycles) 

• Multiple Myeloma: 120–150 mg/m² on Days 1–2 every 28 days; sometimes given with prednisone

• Handling: Reconstitute and infuse in sterile saline or 5% dextrose; always under supervision—never self-administered 

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⚠️ Warnings & Precautions

• Myelosuppression: Frequent monitoring needed; severe neutropenia, anemia, thrombocytopenia possible 1mg.com+3accessdata.fda.gov+3medex.com.bd+3.

• Infections: Higher risk—including sepsis, pneumonia, hepatitis B reactivation; monitor and take precautions .

• Infusion Reactions/Allergy: Fever, chills, rash; anaphylaxis possible—ensure observation during administration accessdata.fda.gov.

• Tumor Lysis Syndrome: Risk in first cycle—hydrate and monitor uric acid, electrolytes medex.com.bd+2accessdata.fda.gov+2m.arogga.com+2.

• Skin Reactions: Rare but serious (e.g., SJS/TEN)—discontinue if severe cutaneous symptoms occur medex.com.bd+2accessdata.fda.gov+2m.arogga.com+2.

• Renal & Hepatic Impairment: Caution or avoid use in severe renal (CrCl <30 mL/min) or hepatic dysfunction 1mg.com+3accessdata.fda.gov+3m.arogga.com+3.

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🕒 Storage & Stability

• Unreconstituted vials: 2°C–8°C (refrigerated).

• Prepared infusion: Stable 24 h refrigerated; 6 h at room temperature (saline), or 2 h at room temp (dextrose) accessdata.fda.gov.

• Multi‑dose vials: Good up to 28 days refrigerated after first puncture accessdata.fda.gov+1medex.com.bd+1.

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👥 Side Effects

• Common (≥15%): Myelosuppression (neutropenia, anemia), fatigue, nausea/vomiting, fever, lymphopenia, thrombocytopenia, elevated bilirubin accessdata.fda.gov+1m.arogga.com+1.

• Other: Infections, headache, rash, diarrhea, stomatitis, cough, infusion-site pain .

• Serious but rare: Sepsis, tumor lysis syndrome, SJS/TEN, anaphylaxis .

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👶 Pregnancy & Lactation

• Category D: Proven fetal risk—contraception required; men and women should use effective birth control medex.com.bd.

• Breastfeeding: Contraindicated due to potential toxicity in infants