Epirubicin Hydrochloride
Pronunciation: (eh-peer-ROO-bi-sin).
- Generic name
- epirubicin hydrochloride
- Brand names
- Epithra, Epirubicin Ebewe, Epirubicin Teva, Epirubicin Hydrochloride, Epirubicin Accord, Epirubicin DBL
- Drug class
- Antineoplastic agent (Anthracycline antibiotic)
Availability and supply rules vary by country
Trade names by country: United States · Canada
Australia: · Full directory
What epirubicin hydrochloride is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how epirubicin hydrochloride works
Epirubicin is an anthracycline antibiotic that exerts its antineoplastic effects by intercalating into DNA, inhibiting topoisomerase II, and generating free radicals. This leads to DNA strand breaks and inhibition of DNA and RNA synthesis, resulting in cell death, particularly in rapidly dividing cancer cells. (1) (2)
What epirubicin hydrochloride is used for
Breast cancer
Breast cancer (2)
Bladder cancer
Bladder cancer (2)
Lung cancer
Lung cancer (2)
Before taking epirubicin hydrochloride
Do not take / not appropriate for
- severe hepatic impairment, recent myocardial infarction, severe heart failure, persistent myelosuppression, and hypersensitivity to epirubicin or other anthracyclines. (Contraindication) (2)
Tell your clinician about
(2)How to take epirubicin hydrochloride
- General Instructions: Epirubicin is administered by a healthcare professional as an intravenous injection or infusion. Do not attempt to self-administer.. Adult Dosing: Typical dosing for breast cancer is 100–120 mg/m² intravenously, divided over 2–3 days per cycle, every 3–4 weeks. Dose may vary based on cancer type, regimen, and patient factors.. Pediatric Dosing: Safety and efficacy in children have not been established; use is rare and should be determined by a pediatric oncologist.. Administration: Administered slowly into a vein over 3–20 minutes. Ensure proper vein access to avoid tissue damage.. When To Stop: Treatment may be stopped if severe side effects occur, if blood counts drop too low, or if there are signs of heart damage.. Storage: Healthcare professionals store epirubicin under refrigeration (2–8°C/36–46°F) and protect it from light. Do not freeze.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (2)
Missed dose
If you miss an appointment for your epirubicin dose, contact your healthcare provider as soon as possible to reschedule. Do not attempt to make up the dose on your own.
Overdose
Symptoms of overdose may include severe bone marrow suppression, infection, bleeding, and heart problems. Seek emergency medical attention immediately if overdose is suspected. (2)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Myelosuppression
Incidence: Reported in the clinician-authored database; frequency not established
Cardiotoxicity
Incidence: Reported in the clinician-authored database; frequency not established
Nausea and vomiting
Incidence: Reported in the clinician-authored database; frequency not established
Alopecia
Incidence: Reported in the clinician-authored database; frequency not established
Mucositis
Incidence: Reported in the clinician-authored database; frequency not established
Extravasation
Incidence: Reported in the clinician-authored database; frequency not established
Secondary leukemia
Incidence: Reported in the clinician-authored database; frequency not established
Serious warnings
BOXED WARNING — Cardiac toxicity — serious
Symptoms: BOXED WARNING — Cardiac toxicity: epirubicin can cause myocardial damage, including acute left ventricular failure. Risk rises with cumulative dose (reported roughly 0.9% at 550 mg/m2, 1.6% at 700 mg/m2, 3.3% at 900 mg/m2) and is higher with concomitant cardiotoxic therapy. Heart function (LVEF) is checked before and regularly during and after treatment.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
BOXED WARNING — Secondary malignancies — serious
Symptoms: BOXED WARNING — Secondary malignancies: increased risk of secondary acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) after anthracycline treatment (reported cumulative incidence roughly 0.27% at 3 years, 0.46% at 5 years, 0.55% at 8 years).
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
BOXED WARNING — Extravasation and tissue necrosis — serious
Symptoms: BOXED WARNING — Extravasation and tissue necrosis: severe local tissue injury, blistering, ulceration, or necrosis (possibly requiring surgical excision or skin grafting) can occur if epirubicin leaks outside the vein during infusion; this is managed immediately by the infusion team.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
BOXED WARNING — Severe myelosuppression — serious
Symptoms: BOXED WARNING — Severe myelosuppression: can cause life-threatening infection, septic shock, hemorrhage, or death. Careful blood-count monitoring is required throughout treatment. Report fever, unusual bruising/bleeding, or signs of infection to the treatment team promptly.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Formal contraindications — serious
Symptoms: Formal contraindications: severe myocardial insufficiency; recent myocardial infarction or severe arrhythmias; previous anthracycline treatment that already reached the maximum cumulative dose; severe persistent drug-induced myelosuppression; severe hepatic impairment (Child-Pugh Class C, or bilirubin above 5 mg/dL); severe hypersensitivity to epirubicin, other anthracyclines, or anthracenediones. Use with caution in patients with prior anthracycline exposure, pre-existing cardiac disease, or impaired renal function.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Epirubicin may interact with other chemotherapy drugs, radiation therapy, and medications that affect liver function. It can increase the risk of heart toxicity when used with other anthracyclines or trastuzumab. Always inform your healthcare provider about all medicines and supplements you are taking. | (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Avoid use in the first trimester — animal studies showed embryo-fetal lethality and structural abnormalities at doses below the maximum recommended human dose; human data are insufficient to establish 2nd/3rd-trimester risk, and rare fetal/neonatal cardiotoxicity has been reported after in-utero exposure. Effective contraception is required during treatment and for 6 months after the final dose (for females of reproductive potential) or 3 months after (for males with partners of reproductive potential), with condom use advised for 7 days after treatment with a pregnant partner. (2)
Breastfeeding
Do not breastfeed during treatment or for at least 7 days after the final dose. Epirubicin is presumed to pass into human milk (based on animal data) and could cause serious harm to a nursing infant. (2)
Children
Frequency: Not applicable.. Weight Based: Not recommended for pediatric use.. Max Daily Dose: Not applicable.. Max Single Dose: Not applicable.. Age Restrictions: Safety not established in children. (2)
Renal_impairment
Renal: no dose adjustment needed if serum creatinine is below 5 mg/dL; a reduced dose should be considered in severe renal impairment (creatinine above 5 mg/dL), which has been associated with roughly a 50% reduction in plasma clearance; dialysis patients have not been studied. Hepatic: dose is reduced to 50% of the recommended dose for bilirubin 1.2-3 mg/dL or AST 2-4x the upper limit of normal, and to 25% for bilirubin above 3 mg/dL or AST above 4x the upper limit of normal; contraindicated in severe hepatic impairment. All adjustments must be made by the treating oncologist. (2)
Hepatic_impairment
Renal: no dose adjustment needed if serum creatinine is below 5 mg/dL; a reduced dose should be considered in severe renal impairment (creatinine above 5 mg/dL), which has been associated with roughly a 50% reduction in plasma clearance; dialysis patients have not been studied. Hepatic: dose is reduced to 50% of the recommended dose for bilirubin 1.2-3 mg/dL or AST 2-4x the upper limit of normal, and to 25% for bilirubin above 3 mg/dL or AST above 4x the upper limit of normal; contraindicated in severe hepatic impairment. All adjustments must be made by the treating oncologist. (2)
Monitoring
(2)Storage
Healthcare professionals store epirubicin refrigerated at 2-8C (36-46F), protected from light, and do not freeze it. Gelling can occur at refrigerated temperature but resolves within 2-4 hours at room temperature; once removed from refrigeration, it is used within 24 hours.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General
Indication: Breast cancer
Dose summary: The recommended dose for breast cancer is 60-90 mg/m² administered intravenously every 21 days. For bladder cancer, the recommended dose is 50-100 mg/m² every 3-4 weeks. For lung cancer, dosing may vary based on combination therapy.
Renal context: No dose adjustment needed if serum creatinine is below 5 mg/dL; consider a reduced dose in severe renal impairment (creatinine above 5 mg/dL), which is associated with roughly a 50% reduction in plasma clearance. Dialysis patients have not been studied. (1) (2)
Frequently asked questions
What is epirubicin used for?
Epirubicin is primarily used to treat breast cancer and may also be used for other cancers such as ovarian, gastric, and lung cancers, often in combination with other chemotherapy drugs.
How does epirubicin work?
Epirubicin works by interfering with the DNA inside cancer cells, preventing them from growing and dividing. This helps slow or stop the spread of cancer.
What are the most common side effects?
The most common side effects include nausea, vomiting, hair loss, mouth sores, and low blood cell counts.
Can epirubicin cause heart problems?
Yes, epirubicin can cause heart damage, especially at higher cumulative doses or in people with pre-existing heart conditions. Heart function should be monitored during treatment.
Is it safe to use epirubicin during pregnancy?
No, epirubicin is not recommended during pregnancy as it may harm the unborn baby. Effective contraception is advised during treatment.
What should I do if I miss a dose?
Contact your healthcare provider immediately to reschedule. Do not attempt to self-administer any dose.
Are there any foods or medicines I should avoid?
Avoid live vaccines, contact with sick individuals, and any medicines that may interact with epirubicin, especially those affecting the heart or liver. Always consult your doctor before starting new medications.
What happens if I take too much Epirubicin?
Taking too much Epirubicin can lead to severe side effects, including profound myelosuppression (low blood cell counts), cardiotoxicity, and gastrointestinal issues. If an overdose is suspected, it is crucial to seek immediate emergency medical attention. Healthcare providers will manage symptoms and provide supportive care to mitigate potential harm.
Can I drink alcohol while taking Epirubicin?
It is generally recommended to avoid or significantly limit alcohol consumption while undergoing treatment with Epirubicin. Alcohol can exacerbate common side effects like nausea and fatigue. Furthermore, both Epirubicin and alcohol can be metabolized by the liver, potentially increasing the risk of liver toxicity. Always consult your healthcare provider for personalized advice.
Is Epirubicin safe during pregnancy?
Epirubicin is generally not recommended during pregnancy due to its potential to cause harm to the developing fetus. It falls under a pregnancy category that advises against its use unless the potential benefits outweigh the risks. Women of childbearing potential should use effective contraception during treatment. Always consult your doctor to discuss the risks and benefits if you are pregnant or planning to become pregnant.
What is the mechanism of action of epirubicin hydrochloride?
Epirubicin is an anthracycline antibiotic that exerts its antineoplastic effects by intercalating into DNA, inhibiting topoisomerase II, and generating free radicals. This leads to DNA strand breaks and inhibition of DNA and RNA synthesis, resulting in cell death, particularly in rapidly dividing cancer cells. (1) (2)
What is the generic name of Epirubicin Hydrochloride?
The generic name is epirubicin hydrochloride. It is sold under brand names including Epithra, Epirubicin Ebewe, Epirubicin Teva, Epirubicin Hydrochloride, Epirubicin Accord, Epirubicin DBL.
What class of drug is epirubicin hydrochloride?
Epirubicin Hydrochloride is classed as: Antineoplastic agent (Anthracycline antibiotic).
References
- Epirubicin - MedGuideGlobal Medicine RecordMedGuideGlobal clinician-authored medicine record (internal database) · null · accessed 2026-08-06 · source 1
- ELLENCE (epirubicin hydrochloride injection) — prescribing informationU.S. Food and Drug Administration · United States · accessed 2026-08-06 · source 2
- Epirubicin — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 3
- Ellence — FDA approval record (Drugs@FDA NDA050778)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 4
- epirubicin — RxNorm normalized drug concept (RXCUI 203213)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 5
Brand names by country
Single-ingredient epirubicin hydrochloride names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Ellence2 mg/mL · pharmacia & upjohn company llc
Canada
- PHARMORUBICIN PFS