Bendamustine

بنداموستین

⚠ Unverified

🎗️ Antineoplastic And Immunomodulating AgentsAlkylating agent

Market / country: 🇺🇸 USA

Bendeka (US) · Treanda (US)

🧮 Dose calculator

Chronic lymphocytic leukaemia (CLL) · Regimen source: FDA Bendeka · 2.1

  • • Only under an oncologist in an equipped centre. Calculator = label mg/m² × BSA (Mosteller); protocol, cycle interval and adjustment for CBC and renal/hepatic function rest with the oncology team. FDA Bendeka · 2.1

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🛡️ Safety & information

Contraindications

  • ⛔ Hypersensitivity to bendamustine, polyethylene glycol 400, propylene glycol or monothioglycerol. FDA Bendeka · 4

Warnings

  • • Myelosuppression; infections (including PML); anaphylaxis and infusion reactions; tumour lysis syndrome; severe skin reactions; hepatotoxicity; other malignancies; extravasation injury; embryo-fetal toxicity. FDA Bendeka · 5

Formulations

  • 25 mg/mL, 100 mg/4 mL multiple-dose vial — injection 🇺🇸 USA FDA Bendeka · 3

👥 Special populations

  • 🤰 PregnancyDangerous / avoid

    Label: can cause fetal harm; effective contraception required. FDA Bendeka · 5.10

    “Can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of the potential risk to a fetus and to use an effective method of contraception.”
  • 🤱 BreastfeedingDangerous / avoid

    Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Bendeka · 8.2

    “Because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with BENDEKA, and for 1 week after the last dose.”
  • 👶 ChildrenSafety not established

    Label: safety and effectiveness in children have not been established. FDA Bendeka · 8.4

    “Safety and effectiveness in pediatric patients have not been established.”
  • 👴 Older adultsNo specific problem stated

    Label: no specific difference or dose adjustment stated for older adults. FDA Bendeka · 8.5

    “No overall differences in safety were observed between patients ≥65 years of age and younger patients.”
  • ⚥ Females & males of reproductive potentialUse with caution

    Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Bendeka · 8.3

    “Contraception Females Advise female patients of reproductive potential to use effective contraception during treatment with BENDEKA and for 6 months after the last dose.”

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