Bendamustine
بنداموستین
🎗️ 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
Enter age and weight.
🛡️ 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.”
🔗 Reference links
- FDA (approval record)NDA208194
- DailyMed (FDA label)FDA Bendeka
- MedlinePlus (NIH)Bendamustine Injection
- WHO ATC/DDDL01AA09
- Darooyab (Iran)Bendamustine
🇮🇷 Registered in Iran Darooyab · G-951/Bendamustine
Dosage forms with Iranian generic codes, per Darooyab.
- 13245 · BENDAMUSTIN 100MG INJ · فرآورده تزریقی بنداموستین ۱۰۰ میلیگرم
- 17381 · BENDAMUSTIN 25MG INJ · فرآورده تزریقی بنداموستین ۲۵ میلیگرم
- 52690 · BENDAMUSTINE HYDROCHLORIDE INJECTION PARENTERAL 25 mg/1mL 4 mL · فرآورده تزریقی بنداموستین هیدروکلراید ۲۵ میلیگرم / ۱ میلیلیتر ۴ میلیلیتر
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Bendeka · 3FDA Bendeka · 2.1FDA Bendeka · 2.2FDA Bendeka · 4FDA Bendeka · 5FDA Bendeka · 5.10FDA Bendeka · 8.2FDA Bendeka · 8.4FDA Bendeka · 8.5FDA Bendeka · 8.3FDA Bendeka · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-951/Bendamustine
- Clinical review⚠ Unverified