Epirubicin
Epirubicin is a chemotherapy agent used as part of combination treatment for breast cancer in patients whose cancer has spread to the lymph nodes after surgery.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Ellence carries four serious FDA boxed warnings — the strongest safety alerts the FDA issues:
- Heart damage: Ellence can damage the heart muscle, including causing acute heart failure. The risk grows with the total amount of drug received over your lifetime. Your heart pumping function must be checked before, during, and after treatment. Having other heart-toxic treatments (like trastuzumab) increases this risk further.
- Secondary blood cancers: A small but real risk of developing secondary leukemia (AML) or myelodysplastic syndrome (MDS — a bone marrow disorder) exists with Ellence and similar drugs. These typically appear within 1 to 3 years of treatment.
- Tissue destruction from IV leakage: If Ellence leaks out of the vein during infusion, it can severely damage surrounding tissue, causing blistering and tissue death that may require surgery and skin grafting. The infusion must be stopped immediately and ice applied if this happens.
- Severe bone marrow suppression: Ellence can dramatically reduce the body's ability to produce blood cells, leading to life-threatening infections, septic shock, need for transfusions, hospitalization, and death.
📖 Epirubicin: Patient Information Guide
A plain-language walkthrough of Epirubicin — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
What Epirubicin is used for
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Epirubicin is a chemotherapy agent approved for use as part of combination treatment following breast cancer surgery.
- Ellence (intravenous injection) is indicated as a component of adjuvant (post-surgical) chemotherapy in patients with breast cancer who have evidence of tumor involvement in the axillary lymph nodes (lymph nodes under the arm) after removal of the primary breast tumor.
- Ellence is always used as part of a multi-drug combination — it is not approved for use as a single agent in this setting.
- Studied regimens include FEC-100 (fluorouracil, Ellence, and cyclophosphamide) and CEF-120 (cyclophosphamide, Ellence, and fluorouracil).
How Epirubicin works
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Epirubicin belongs to a class of drugs called anthracyclines. It works by slipping between the rungs of the DNA ladder inside cancer cells — a process called intercalation — and blocking the enzymes (topoisomerase II and helicase) that cancer cells need to copy and use their DNA. This triggers DNA strand breaks that kill the cell. Epirubicin also generates toxic free radicals (unstable, cell-damaging molecules) that add to its cancer-killing effect.
Because epirubicin targets rapidly dividing cells, it can also affect healthy fast-growing cells — which is why side effects like hair loss, mouth sores, and low blood counts occur.
How Epirubicin is taken (dosage)
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Ellence is given by intravenous (IV) infusion in a clinical setting — it cannot be taken by mouth or self-administered at home. It is given in cycles, typically repeating every 3 to 4 weeks, with the dose either given all on Day 1 or split between Day 1 and Day 8 of each cycle.
- Anti-nausea medications are often given before infusion to reduce nausea and vomiting.
- Patients on the higher-dose Ellence regimen also receive preventive (prophylactic) antibiotics.
- Doses may be adjusted based on blood counts and how your body tolerates each cycle — your oncology team will guide this.
Always follow your prescriber's instructions exactly; do not adjust your schedule without consulting your care team.
Epirubicin side effects in detail
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Ellence commonly causes a number of side effects, most of which your care team will monitor and help manage:
- Low white blood cell count (neutropenia/leukopenia) — the most common dose-limiting effect, peaking around 10–14 days after each dose
- Nausea and vomiting — very common; anti-nausea medications help significantly
- Hair loss (alopecia) — affects most patients but is usually reversible within 2–3 months after treatment ends
- Mouth sores (mucositis/oral stomatitis) — can range from mild discomfort to painful ulcers
- Anemia (low red blood cells) and fatigue
- Low platelet count (thrombocytopenia) — increases bleeding risk
- Diarrhea and loss of appetite
- Absence of periods (amenorrhea) — common; premature menopause can occur
Serious reactions — including heart damage, severe infections, blood clots, and tissue damage at the infusion site — require immediate medical attention. Contact your care team right away if you experience chest pain, shortness of breath, high fever, or pain at the IV site.
Epirubicin warnings and precautions
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- Heart damage (cardiomyopathy and heart failure): This is the most critical long-term risk. Ellence can weaken the heart's pumping ability, and the risk increases with the total lifetime dose received. Heart function (LVEF) must be checked before starting and regularly throughout and after treatment. Risk is higher with prior chest radiation, prior anthracycline therapy, or use of other heart-toxic drugs.
- Severe bone marrow suppression (myelosuppression): Ellence can critically reduce blood cell production, leading to life-threatening infections, septic shock, bleeding, and death. Blood counts must be checked before every treatment cycle.
- Tissue necrosis from IV leakage (extravasation): If Ellence leaks out of the vein, it can permanently destroy surrounding tissue, potentially requiring surgery. Report any burning, pain, or swelling at the IV site immediately.
- Secondary blood cancers: A small but real risk of secondary leukemia (AML) or myelodysplastic syndrome (MDS) exists, typically appearing 1–3 years after treatment.
- Liver impairment: Ellence is cleared mainly through the liver; patients with liver problems need dose reductions or may not be able to use this drug at all.
- Tumor lysis syndrome: Rapid breakdown of cancer cells can release substances that stress the kidneys and alter blood chemistry — your team will monitor for this.
- Pregnancy: Ellence can cause serious fetal harm; effective contraception is required during and after treatment.
Epirubicin interactions: what it interacts with
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Ellence can interact with several other medications and treatments — always give your full medication list to your oncology team:
- Trastuzumab (Herceptin) and other heart-toxic drugs: Combining with or starting Ellence too soon after trastuzumab (which can stay in the body up to 7 months) sharply raises the risk of heart damage — a waiting period is recommended when possible.
- Calcium channel blockers (e.g., amlodipine, diltiazem): Close heart monitoring is needed when used alongside Ellence.
- Cimetidine (an acid-reducing medication): Raises epirubicin blood levels; must be discontinued before and during Ellence treatment.
- Paclitaxel: Giving paclitaxel immediately before or after epirubicin increases epirubicin exposure in the body.
- Other chemotherapy drugs: Additive blood count suppression and gastrointestinal toxicity are possible when combining with other cytotoxic agents.
- Live vaccines (e.g., live flu vaccine, MMR, shingles vaccine Zostavax): Must be avoided — Ellence suppresses the immune system and live vaccines can cause life-threatening infections during treatment.
- Radiation therapy: Can worsen tissue damage; prior radiation sites may become re-inflamed (radiation recall) after Ellence is given.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
Before taking Epirubicin
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- Heart conditions: Ellence is contraindicated (must not be used) in patients with severe heart failure, recent heart attack, severe arrhythmias, or those who have already received the maximum lifetime dose of anthracycline drugs.
- Prior anthracycline chemotherapy: Patients who have previously been treated with anthracyclines (e.g., doxorubicin) are at increased risk of heart toxicity and should be monitored closely.
- Severe liver disease: Ellence is contraindicated in severe hepatic impairment (Child-Pugh Class C or bilirubin >5 mg/dL); dose reductions are required for milder liver problems.
- Kidney disease: Dose adjustment may be needed for patients with severely elevated creatinine; patients on dialysis have not been studied.
- Severe bone marrow suppression from prior drug treatment: Ellence is contraindicated if severe drug-induced myelosuppression is present.
- Pregnancy: Ellence can cause serious fetal harm, especially in the first trimester. Women of childbearing potential must use effective contraception during treatment and for 6 months after the last dose; men must use contraception during treatment and for 3 months after.
- Breastfeeding: Do not breastfeed during treatment or for at least 7 days after the last dose.
- Children: Safety and effectiveness have not been established in pediatric patients, who may face greater risk of heart side effects.
- Older women (over 70): The body clears Ellence more slowly in older women, increasing the risk of side effects — closer monitoring is needed.
- Allergy to anthracyclines: Ellence is contraindicated in patients with severe hypersensitivity to epirubicin, other anthracyclines, or related compounds (anthracenediones).
Epirubicin overdose: if you take too much
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There is no antidote for an epirubicin overdose. Too much Ellence can cause severe bone marrow failure, serious mouth sores, gastrointestinal bleeding, multi-organ failure, and death. If an overdose occurs, treatment focuses on supportive care — including antibiotics, blood and platelet transfusions, colony-stimulating factors (to help the bone marrow recover), and intensive monitoring. Heart failure can also develop weeks to months after an overdose, so ongoing cardiac monitoring is important.
Pharmacodynamics: what Epirubicin does in the body
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Epirubicin exerts its effects by disrupting DNA in rapidly dividing cells — blocking DNA replication and RNA and protein production — which leads to cell death. Its most measurable clinical effect on normal tissue is suppression of bone marrow activity, causing drops in white blood cells, red blood cells, and platelets. White blood cell counts typically reach their lowest point (nadir) 10 to 14 days after each dose and generally recover by Day 21. Heart muscle cells are also vulnerable, and cumulative exposure can lead to measurable reductions in heart pumping function (LVEF).
Pharmacokinetics: how your body processes Epirubicin
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After intravenous infusion, epirubicin spreads rapidly and widely throughout the body's tissues, and concentrates in red blood cells at about twice the levels found in plasma. It is extensively metabolized by the liver and red blood cells. The drug clears from the body in a multi-phase pattern, with a final elimination half-life of about 33 hours — meaning it takes roughly a day and a half for blood levels to fall by half in the last phase. Elimination occurs mainly through bile and feces (about 34%) and to a lesser extent in urine (about 27%). Clearance is reduced in patients with liver impairment and in older women, meaning those groups may be exposed to higher drug levels and face increased risk of side effects.
How to store Epirubicin
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Store refrigerated between 2°C and 8°C (36°F and 46°F). Do not freeze. Protect from light.
📄 Written from Epirubicin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Epirubicin
24 supplements and herbal products have documented interactions with Epirubicin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 14
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Epirubicin: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Epirubicin — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Ellence used for, and why am I getting it with other chemo drugs?
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What side effects should I expect, and which ones should make me call my doctor?
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I've heard this drug can affect my heart. How worried should I be?
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What should I do if I notice pain or burning at the spot where the IV goes in?
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Can I get vaccinated while I'm on Ellence?
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Does Ellence affect fertility or pregnancy?
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Is Epirubicin available over the counter?
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When was Epirubicin first available?
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Who makes Epirubicin?
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💬 Answers drafted from Epirubicin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 More about Epirubicin on HelloPharmacist
💊 Epirubicin forms and strengths (how it comes)
Epirubicin is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Ellence is indicated as part of adjuvant combination chemotherapy for breast cancer in patients with axillary lymph node involvement after surgical removal of the tumor
- Ellence is used as part of multi-drug regimens such as FEC-100 (with fluorouracil and cyclophosphamide) or CEF-120 (with cyclophosphamide and fluorouracil)
- Ellence is administered by intravenous infusion by a healthcare professional — never self-administered
- Ellence is given in repeated cycles every 3 to 4 weeks; the dose may be given on Day 1 alone or split between Day 1 and Day 8 of each cycle
- Ellence infusion should be given slowly into a freely running IV line; report any burning, stinging, or redness at the infusion site immediately
- Anti-nausea medication is often given before Ellence infusion; patients on the higher-dose regimen also receive preventive antibiotics
📊 Epirubicin on the U.S. market: products, makers and brands
How Epirubicin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 Compare Epirubicin products
A representative set of FDA-listed product records for Epirubicin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 2 mg/mL | Intravenous | Hikma Pharmaceuticals USA Inc. × 2 listings | ANDA | View NDC → |
| 2 mg/mL | Intravenous | Pharmacia & Upjohn Company LLC × 8 listings | NDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 g/g | — | Gemini PharmChem Mannheim GmbH | BULK INGREDIENT | View NDC → |
| 100 kg/100 kg | — | Sicor S.r.l. × 2 listings | BULK INGREDIENT | View NDC → |
Showing 13 of 13 products — FDA National Drug Code Directory. See every product, package size and price: browse all 13 Epirubicin NDCs →
📈 Epirubicin side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Epirubicin — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Epirubicin in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ Epirubicin FDA approval history
How Epirubicin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Epirubicin recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 3995 1 dose form · 2 strengths
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Dose form (SCDF) Injection RxCUI 1732171In current FDA listingsClinical drug / strength (SCD) 25 ML epirubicin hydrochloride 2 MG/MLRxCUI 1732182100 ML epirubicin hydrochloride 2 MG/MLRxCUI 1732186
Look up RxCUI 3995 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Epirubicin supply and shortage status
Whether Epirubicin is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Epirubicin brand names
🏭 Who makes Epirubicin: manufacturers and labelers
Epirubicin drug class (RxNorm)
Epirubicin belongs to the Anthracycline Topoisomerase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Sources for this Epirubicin page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Pharmacia & Upjohn Company LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.