Epirubicin
Epirubicin is an anthracycline chemotherapy medication used to treat various cancers, including breast cancer, gastric cancer, bladder cancer, and lymphomas. As a cytotoxic agent, it works by intercalating into DNA and inhibiting nucleic acid synthesis, ultimately preventing cancer cell proliferation and causing cell death. It is typically administered via intravenous infusion in combination with other chemotherapy drugs or as a single agent.
Epirubicin is an anthracycline chemotherapy drug used to treat various cancers by interfering with cancer cell DNA and preventing their growth and division.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- L01DB03
- RxNorm
- 3995
- Generic
- Epirubicin
- Class
- atc-l01
- Brands
- Ellence
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 60-100 mg/m²
- Maximum
- consult physician
- Frequency
- every 3-4 weeks (single dose or divided over 2-3 days)
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 60-75 mg/m²
- Maximum
- consult physician
- Frequency
- every 3-4 weeks (dose based on body surface area)
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 60-90 mg/m²
- Maximum
- consult physician
- Frequency
- every 3-4 weeks (reduced dose recommended)
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
7 groupspregnancy
first trimesteravoid use
contraindicated in first trimester due to teratogenic potential; consider discontinuation if pregnancy occurs during treatment
regular fetal ultrasound monitoring and obstetric assessment
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
later trimesteravoid use
use only if absolutely necessary; consider delay of treatment until after delivery if clinically feasible
fetal growth monitoring, non-stress tests, and comprehensive obstetric evaluation
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingdiscontinue breastfeeding
breastfeeding should be discontinued before starting treatment and for at least 24 hours after last dose; milk excretion is likely due to cytotoxic nature
no specific monitoring required
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderlyno standard reduction; individualize based on performance status
use with caution due to potential increased sensitivity; assess cardiac function, renal function, and performance status before treatment
baseline and periodic cardiac monitoring (MUGA scan or echocardiogram); regular CBC and liver function tests
Use with caution and monitor for adverse effects.
pediatric_age
childrenweight-based dosing with careful titration
used for pediatric malignancies including acute lymphoblastic leukemia and solid tumors; dosing requires precise weight-based calculation and may vary by indication
frequent CBC monitoring, cardiac monitoring before each cycle, and assessment of growth and development
Use with caution and monitor for adverse effects.
renal_impairment
mild moderateno standard dose reduction for mild to moderate impairment
no significant dose adjustment needed for CrCl >30 mL/min; monitor renal function as epirubicin and metabolites may accumulate in severe impairment
monitor serum creatinine and CrCl before each cycle; dose adjustment based on individual tolerance
Use with caution and monitor for adverse effects.
hepatic_impairment
mild moderatereduce dose by 25-50% based on bilirubin and AST levels
dose reduction recommended when bilirubin 1.2-3.0 mg/dL or AST >2x ULN; avoid use in severe hepatic impairment unless benefits outweigh risks
baseline and periodic liver function tests including bilirubin, AST, ALT, and albumin; monitor for increased toxicity
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
FDA approval for Ellence (epirubicin) for adjuvant therapy in breast cancer
Drug class
Chemotherapeutic agent classification
Mechanism of action
Molecular mechanism of antineoplastic activity
Common indications
Approved therapeutic indications
Treatment of breast cancer, gastric cancer, bladder cancer, esophageal cancer, ovarian cancer, small cell lung cancer, and lymphomas (including Hodgkin's lymphoma and non-Hodgkin lymphoma). Often used as adjuvant therapy following surgery for early breast cancer.
Epirubicin is an anthracycline cytotoxic agent that intercalates between DNA base pairs, inhibiting DNA and RNA synthesis. It also generates free radicals that cause DNA strand breaks and interferes with topoisomerase II enzyme function, leading to cancer cell death.
Administered intravenously by healthcare professionals. Requires regular cardiac monitoring due to risk of cardiotoxicity and cumulative dose limits. Can cause severe myelosuppression, alopecia, and nausea. Contraindicated in patients with severe cardiac impairment, severe hepatic dysfunction, or previous anthracycline treatment at maximum cumulative doses. Must be handled with caution due to vesicant properties.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy