Epirubicin
اپیروبیسین
🎗️ Antineoplastic And Immunomodulating AgentsAnthracycline
Market / country: 🇺🇸 USA
Ellence (US)
🧮 Dose calculator
Breast cancer (hormonal therapy) · Regimen source: FDA Ellence · 2.2
- • 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 Ellence · 2.2
- • Calculator gives the lower bound. CEF-120: 60 mg/m² days 1 and 8; FEC-100: 100 mg/m² day 1. FDA Ellence · 2.2
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ Severe myocardial insufficiency; recent MI or severe arrhythmias; prior maximum cumulative anthracycline dose; severe persistent myelosuppression; severe hepatic impairment (Child-Pugh C or bilirubin >5 mg/dL); severe hypersensitivity to anthracyclines. FDA Ellence · 4
Warnings
- • Boxed warning: cumulative-dose cardiotoxicity (0.9% at 550 mg/m² to 3.3% at 900); secondary malignancies (AML); tissue necrosis with extravasation; severe myelosuppression. FDA Ellence · Boxed Warning
Formulations
- 2 mg/mL (50 mg/25 mL, 200 mg/100 mL) — injection 🇺🇸 USA FDA Ellence · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Ellence · 8.1
“Risk Summary Based on findings from animal studies and its mechanism of action, ELLENCE can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] ; avoid the use of ELLENCE during the 1 st trimester.”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Ellence · 8.2
“Because of the potential for serious adverse reactions in the breastfed child, advise lactating women not to breastfeed during treatment with ELLENCE and for at least 7 days after the last dose.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Ellence · 8.4
“Safety and effectiveness of ELLENCE have not been established in pediatric patients.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Ellence · 8.5
“In elderly female patients, closely monitor for increased toxicity due to the risk of decreased clearance of epirubicin [see Clinical Pharmacology (12.3) ].”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Ellence · 8.3
“Contraception Females ELLENCE can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] .”
🔗 Reference links
- FDA (approval record)NDA050778
- DailyMed (FDA label)FDA Ellence
- MedlinePlus (NIH)Epirubicin
- WHO ATC/DDDL01DB03
- Darooyab (Iran)Epirubicin
🇮🇷 Registered in Iran Darooyab · G-992/Epirubicin
Dosage forms with Iranian generic codes, per Darooyab.
- 00491 · EPIRUBICIN HCL 10MG VIAL · ویال اپیروبیسین هیدروکلراید ۱۰ میلیگرم
- 20696 · EPIRUBICIN HCL 200MG VIAL · ویال اپیروبیسین هیدروکلراید ۲۰۰ میلیگرم
- 15976 · EPIRUBICIN HCL 2MG/ML 10ML VIAL · ویال اپیروبیسین هیدروکلراید ۲ میلیگرم / میلیلیتر ۱۰ میلیلیتر
- 14532 · EPIRUBICIN HCL 2MG/ML 25ML VIAL · ویال اپیروبیسین هیدروکلراید ۲ میلیگرم / میلیلیتر ۲۵ میلیلیتر
- 18435 · EPIRUBICIN HCL 2MG/ML 5ML VIAL · ویال اپیروبیسین هیدروکلراید ۲ میلیگرم / میلیلیتر ۵ میلیلیتر
- 00492 · EPIRUBICIN HCL 50MG VIAL · ویال اپیروبیسین هیدروکلراید ۵۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Ellence · 3FDA Ellence · 2.2FDA Ellence · 4FDA Ellence · Boxed WarningFDA Ellence · 8.1FDA Ellence · 8.2FDA Ellence · 8.4FDA Ellence · 8.5FDA Ellence · 8.3FDA Ellence · 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-992/Epirubicin
- Clinical review⚠ Unverified