Epirubicin

Epirubicin is an anthracycline cytotoxic agent. Although it is known that anthracyclines can interfere with a number of biochemical and biological functions within eukaryotic cells, the precise mechanisms of epirubicin's cytotoxic and/or antiproliferative properties have not been completely elucidated.

• ELLENCE is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [see Clinical Studies (14.1) ] . ELLENCE is an anthracycline topoisomerase inhibitor indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer ( 1 ).ICD-10: C50.919

• ELLENCE is contraindicated in patients with: • Severe myocardial insufficiency [see Warnings and Precautions (5.1) ] • Recent myocardial infarction or severe arrhythmias, or previous treatment with maximum cumulative dose of anthracyclines [see Warnings and Precautions (5.1) ] • Severe persistent drug-induced myelosuppression [see Warnings and Precautions (5.4) ] • Severe hepatic impairment (defined as Child-Pugh Class C or serum bilirubin level greater than 5 mg/dL) [see Warnings and Precautions (5.5) ] • Severe hypersensitivity to ELLENCE, other anthracyclines, or anthracenediones [see Adverse Reactions (6.1) ] • Severe myocardial insufficiency ( 4 ). • Recent myocardial infarction ( 4 ).contraindicated

• The recommended starting dose of ELLENCE is 100 to 120 mg/m 2 . Dosage reductions are possible when given in certain combinations ( 2.2 ). • Administer intravenously in repeated 3- to 4-week cycles, either total dose on Day 1 of each cycle or divided equally and given on Days 1 and 8 of each cycle ( 2.2 ). • Consider use of antiemetics when given in conjunction with other emetigenic drugs ( 2.1 ). • Patients administered the 120 mg/m 2 regimen of ELLENCE should receive prophylactic antibiotic therapy ( 2.1 ). • Adjust dosage after the first treatment cycle based on hematologic and nonhematologic toxicities ( 2.3 ). • Reduce dose in patients with hepatic impairment ( 2.3 , 8.6 ). • Consider lower doses in patients with severe renal impairment ( 2.3 , 8.7 ). 2.1 Important Administration Instructions When possible, to reduce the risk of developing cardiotoxicity in patients receiving ELLENCE after stopping treatment with other cardiotoxic agents, especially those with long half-lives such as trastuzumab, delay ELLENCE-based therapy until the other agents have cleared from the circulation [see Warnings and Precautions (5.1) ]. Antiemetics may reduce nausea and vomiting; consider use of antiemetics before administration of ELLENCE or when clinically indicated, particularly when given in conjunction with other emetigenic drugs [see Adverse Reactions (6.1) ]. Patients administered the 120 mg/m 2 regimen of ELLENCE should receive prophylactic antibiotic therapy.

• Use in Patients with Hepatic Impairment: Monitor serum total bilirubin and AST levels before and during treatment with ELLENCE. In patients with elevated serum AST or serum total bilirubin, dosage reductions or discontinuation may be required ( 2.3 , 5.5 ). • Tumor Lysis Syndrome: Evaluate blood uric acid levels, potassium, calcium, phosphate, and creatinine after initial treatment. Consider hydration, urine alkalinization, and prophylaxis with allopurinol to minimize potential complications of hyperuricemia and tumor lysis syndrome ( 5.7 ). • Thrombophlebitis and Thromboembolic Events: Thrombophlebitis and thromboembolic events, including pulmonary embolism (in some cases fatal) have been reported with the use of ELLENCE. Venous sclerosis may result from an injection into a small vessel or from repeated injections into the same vein ( 5.9 ). • Administration of live or live-attenuated vaccines in patients immunocompromised by chemotherapeutic agents including ELLENCE, may result in serious or fatal infections ( 5.7 ). • Potentiation of Radiation Toxicity and Radiation Recall: Administration of ELLENCE after previous radiation therapy may induce an inflammatory recall reaction at the site of the irradiation ( 5.10 ). • Embryo-Fetal Toxicity: ELLENCE can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception ( 5.11 , 8.1 , 8.3 ). 5.1 Cardiac Toxicity ELLENCE and other anthracycline drugs can result in either early (or acute) or late (delayed) cardiac toxicity.

The following clinically significant adverse reactions are described elsewhere in the labeling: • Cardiac Toxicity [see Warnings and Precautions (5.1) ] • Secondary Malignancies [see Warnings and Precautions (5.2) ] • Extravasation and Tissue Necrosis [see Warnings and Precautions (5.3) ] • Severe Myelosuppression [see Warnings and Precautions (5.4) ] • Tumor-Lysis Syndrome [see Warnings and Precautions (5.7) ] • Thrombophlebitis and Thromboembolic Events [see Warnings and Precautions (5.9) ] • Potentiation of Radiation Toxicity and Radiation Recall [see Warnings and Precautions (5.10) ] The most common adverse reactions (≥10%) are leukopenia, neutropenia, anemia, thrombocytopenia, amenorrhea, lethargy, nausea/vomiting, mucositis, diarrhea, infection, conjunctivitis/keratitis, alopecia, local skin toxicity, and rash/itch ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ELLENCE was evaluated in two studies (Studies MA-5 and GFEA-05) evaluating combination regimens in patients with early breast cancer [see Clinical Studies (14.1) ] .

• Lactation: Advise not to breastfeed ( 8.2 ). • Females and Males of Reproductive Potential: May impair fertility ( 8.3 ). 8.1 Pregnancy 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. Available human data do not establish the presence or absence of major birth defects and miscarriage related to the use of epirubicin during the 2 nd and 3 rd trimesters. There are reports of fetal and/or neonatal cardiotoxicity following in utero exposure to epirubicin (see Clinical Considerations ). In animal reproduction studies in pregnant rats, epirubicin was embryo-fetal lethal and caused structural abnormalities when administered during organogenesis at doses less than the maximum recommended human dose on a body surface area basis ( see Data ). Advise pregnant women and females of reproductive potential of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Metabolism

Epirubicin pharmacokinetics are linear over the dose range of 60 to 150 mg/m 2 and plasma clearance is not affected by the duration of infusion or administration schedule. Pharmacokinetic parameters for epirubicin following 6- to 10-minute, single-dose intravenous infusions of ELLENCE at doses of 60 to 150 mg/m 2 in patients with solid tumors are shown in Table 4.

There is no known antidote for overdoses of ELLENCE. A 36-year-old man with non-Hodgkin's lymphoma received a daily 95 mg/m 2 dose of ELLENCE for 5 consecutive days. Five days later, he developed bone marrow aplasia, grade 4 mucositis, and gastrointestinal bleeding. No signs of acute cardiac toxicity were observed. He was treated with antibiotics, colony-stimulating factors, and antifungal agents, and recovered completely. A 63-year-old woman with breast cancer and liver metastasis received a single 320 mg/m 2 dose of ELLENCE. She was hospitalized with hyperthermia and developed multiple organ failure (respiratory and renal), with lactic acidosis, increased lactate dehydrogenase, and anuria. Death occurred within 24 hours after administration of ELLENCE. Additional instances of administration of doses higher than recommended have been reported at doses ranging from 150 to 250 mg/m 2 . The observed adverse events in these patients were qualitatively similar to known toxicities of epirubicin. Most of the patients recovered with appropriate supportive care.

• Sep 15, 1999NDANDA050778Pfizer Inc

1. 1Myelosuppression64310%
2. 2Nausea5238.5%
3. 3White Blood Cell Count Decreased4607.5%
4. 4Alopecia4587.4%
5. 5Vomiting4006.5%
6. 6Febrile Neutropenia3645.9%
7. 7Pyrexia3185.2%
8. 8Asthenia3055.0%
9. 9Neutropenia2734.4%
10. 10Neutrophil Count Decreased2534.1%
11. 11Hepatic Function Abnormal2514.1%
12. 12Off Label Use2243.6%
13. 13Diarrhoea2193.6%
14. 14Fatigue1782.9%
15. 15Psychological Trauma1742.8%

Recent PubMed references pinned to Epirubicin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Development of folate-grafted poly-3-hydroxybutyrate nanoparticles-embedded chitosan thermosensitive hydrogel for sustained and targeted delivery of epirubicin.
  International journal of biological macromolecules · 2026 · Perveen K, Masood F, Aslam A, et al.
  PMID 42055375DOI 10.1016/j.ijbiomac.2026.152207
• Mucoadhesive tumor-penetrating nanomedicine for intravesical chemo-immunotherapy against bladder cancer.
  Science advances · 2026 · Zhao C, Hou D, Wang K, et al.
  PMID 41984946DOI 10.1126/sciadv.aeb9764
• Nitrogen doped carbon dots with antibacterial activity for dual mode fluorescence and smartphone-assisted colorimetric detection of epirubicin.
  Analytical methods : advancing methods and applications · 2026 · Swain S, Dehury S, Sahu SK, et al.
  PMID 41944247DOI 10.1039/d5ay01270h
• Hydroxypropyl-β-cyclodextrin/hyaluronic acid modified polydopamine nanoparticles co-loaded with BNN6 and epirubicin for synergistic photothermal/gas/chemotherapy of breast cancer.
  Journal of pharmaceutical sciences · 2026 · Liu D, Asghar S, Gao D, et al.
  PMID 41911973DOI 10.1016/j.xphs.2026.104266
• Biomimic colloidal self-assembly of epirubicin/ferric ion multi-enzyme delivery for synergistic photothermal therapy of metastatic triple-negative breast cancer.
  Colloids and surfaces. B, Biointerfaces · 2026 · Shen H, Chen Y, Qiu Y, et al.
  PMID 41864108DOI 10.1016/j.colsurfb.2026.115604
• Adjuvant pegylated liposomal doxorubicin versus epirubicin sequential paclitaxel in triple-negative breast cancer: comparable efficacy with a distinct safety profile.
  Frontiers in immunology · 2026 · Cai S, Yu S, Lin X, et al.
  PMID 41716408DOI 10.3389/fimmu.2026.1690888
• Optimal adjuvant intravesical therapy for intermediate risk non-muscle invasive bladder cancer; oncological and patient-reported outcomes of randomized controlled trial.
  Urologic oncology · 2026 · Elsawy AA, Laymon M, Ezzat O, et al.
  PMID 41689868DOI 10.1016/j.urolonc.2026.111006
• A hydrogen generator enhances immunogenic transarterial chemoembolization in hepatocellular carcinoma.
  Journal of controlled release : official journal of the Controlled Release Society · 2026 · Cao L, Ren L, Yin L, et al.
  PMID 41655909DOI 10.1016/j.jconrel.2026.114694

The 10 most recently updated of 662 ClinicalTrials.gov registrations naming Epirubicin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
  Recruiting · Phase 3 · Interventional · 2,400 enrolled · Merck Sharp & Dohme LLC
  NCT06966700updated 2026-06-12
• Evaluate the Efficacy and Safety of Adebrelimab Combined With Chemotherapy With or Without Radiotherapy as Neoadjuvant Treatment for HER2-Negative Locally Advanced Breast Cancer
  Recruiting · Phase 2 · Interventional · 170 enrolled · Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  NCT06908668updated 2026-06-10
• A Pilot Dose Escalation Trial of a Densified Chemotherapy Association of Docetaxel and Epirubicin Driven by Mathematical Modeling in Metastatic Breast Cancer Patients: The MODEL1 Study
  Completed · Phase 1 · Interventional · 17 enrolled · Hospices Civils de Lyon
  NCT02392845updated 2026-06-10
• Neoadjuvant Chemotherapy With WH002 in Women With HER2-negative Breast Cancer
  Completed · Phase 2 · Interventional · 40 enrolled · Beijing Wehand-Bio Pharmaceutical Co., Ltd
  NCT06513364updated 2026-06-09
• A Prospective, Multicenter, Phase II Clinical Study of Postoperative Chemotherapy Combined With QL1706 for High-risk Triple-negative Breast Cancer.
  Recruiting · Interventional · 59 enrolled · The First Affiliated Hospital with Nanjing Medical University
  NCT07622836updated 2026-06-03
• A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC
  Not yet recruiting · Phase 3 · Interventional · 236 enrolled · Suzhou Suncadia Biopharmaceuticals Co., Ltd.
  NCT07424287updated 2026-06-02
• Neoadjuvant Anlotinib and Epirubicin for T4 Sinonasal Adenoid Cystic Carcinoma
  Not yet recruiting · Phase 2 · Interventional · 76 enrolled · Eye & ENT Hospital of Fudan University
  NCT07616141updated 2026-06-01
• Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy
  Recruiting · Phase 2 · Interventional · 716 enrolled · Fudan University
  NCT05582499updated 2026-05-28
• HAIC vs. TACE Combined With Sintilimab and Bevacizumab for Intermediate HCC (Beyond Up-To-Seven)
  Recruiting · Phase 3 · Interventional · 300 enrolled · Binkui Li
  NCT07594340updated 2026-05-22
• Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma
  Recruiting · Phase 3 · Interventional · 250 enrolled · European Organisation for Research and Treatment of Cancer - EORTC
  NCT04031677updated 2026-05-22

CPIC-curated drug–gene pairs for Epirubicin. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• CBR3CPIC D (provisional)ClinPGx 3
• GSTP1CPIC D (provisional)ClinPGx 3
• HAS3CPIC D (provisional)
• NQO1CPIC D (provisional)ClinPGx 3

Frequently asked questions

How does Epirubicin work?

Epirubicin is an anthracycline cytotoxic agent. Although it is known that anthracyclines can interfere with a number of biochemical and biological functions within eukaryotic cells, the precise mechanisms of epirubicin's cytotoxic and/or antiproliferative properties have not been completely elucidated.

What is Epirubicin used for?

According to FDA labeling, Epirubicin carries indications including: ELLENCE is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [see Clinical Studies (14.1) ] . ELLENCE is an anthracycline topoisomerase inhibitor indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer ( 1 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Epirubicin?

Epirubicin is classified as Anthracyclines and related substances, Anthracycline Topoisomerase Inhibitor, Immunologic Adjuvants, Topoisomerase 2 Inhibitors, Topoisomerase Inhibitors, Cardiovascular Activity Alteration, Decreased DNA Integrity, Decreased RNA Integrity.

What are the brand names for Epirubicin?

Epirubicin is marketed under brand names including Ellence.

What are the contraindications for Epirubicin?

Epirubicin labeling lists contraindications including: ELLENCE is contraindicated in patients with: • Severe myocardial insufficiency [see Warnings and Precautions (5.1) ] • Recent myocardial infarction or severe arrhythmias, or previous treatment with maximum cumulative dose of anthracyclines [see Warnings and Precautions (5.1) ] • Severe persistent drug-induced myelosuppression [see Warnings and Precautions (5.4) ] • Severe hepatic impairment (defined as Child-Pugh Class C or serum bilirubin level greater than 5 mg/dL) [see Warnings and Precautions (5.5) ] • Severe hypersensitivity to ELLENCE, other anthracyclines, or anthracenediones [see Adverse Reactions (6.1) ] • Severe myocardial insufficiency ( 4 ). • Recent myocardial infarction ( 4 ).. Always consult the full prescribing information and a clinician.