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Epirubicin (Epirubicin Hydrochloride) - Drug Interactions, Contraindications, Overdosage, etc



Cardioactive Compounds

Do not administer epirubicin in combination with other cardiotoxic agents unless the patient’s cardiac function is closely monitored. Patients receiving epirubicin after stopping treatment with other cardiotoxic agents, especially those with long half-lives such as trastuzumab, may also be at an increased risk of developing cardiotoxicity. Avoid epirubicin-based therapy for up to 24 weeks after stopping trastuzumab when possible. If epirubicin is used before this time, monitor cardiac function carefully [see Dosage and Administration ( 2   ) and Warnings and Precautions ( 5.3 )].

Concomitant use of epirubicin hydrochloride injection with other cardioactive compounds that could cause heart failure (e.g., calcium channel blockers), requires close monitoring of cardiac function throughout treatment.


Cimetidine increases the exposure to epirubicin [see Clinical Pharmacology ( 12.3  )]. Stop Cimetidine during treatment with epirubicin hydrochloride injection.

Other Cytotoxic Drugs

Epirubicin hydrochloride injection used in combination with other cytotoxic drugs may show on-treatment additive toxicity, especially hematologic and gastrointestinal effects.


The administration of epirubicin immediately prior to or after paclitaxel increased the systemic exposure of epirubicin, epirubicinol and 7-deoxydoxorubicin aglycone [see Clinical Pharmacology ( 12.3  )].


The administration of epirubicin immediately prior to or after docetaxel did not have an effect on the systemic exposure of epirubicin, but increased the systemic exposure of epirubicinol and 7-deoxydoxorubicin aglycone [see Clinical Pharmacology ( 12.3  )].

Radiation Therapy

There are few data regarding the coadministration of radiation therapy and epirubicin hydrochloride injection. In adjuvant trials of epirubicin hydrochloride injection-containing CEF-120 or FEC-100 chemotherapies, breast irradiation was delayed until after chemotherapy was completed. This practice resulted in no apparent increase in local breast cancer recurrence relative to published accounts in the literature. A small number of patients received epirubicin hydrochloride injection-based chemotherapy concomitantly with radiation therapy but had chemotherapy interrupted in order to avoid potential overlapping toxicities. It is likely that use of epirubicin hydrochloride injection with radiotherapy may sensitize tissues to the cytotoxic actions of irradiation. Administration of epirubicin hydrochloride injection after previous radiation therapy may induce an inflammatory recall reaction at the site of the irradiation.

Concomitant Therapies-Hepatic Function

Epirubicin is extensively metabolized by the liver. Changes in hepatic function induced by concomitant therapies may affect epirubicin metabolism, pharmacokinetics, therapeutic efficacy, and/or toxicity.

Drug/Laboratory Test Interactions

There are no known interactions between epirubicin hydrochloride injection and laboratory tests.


There is no known antidote for overdoses of epirubicin hydrochloride injection. A 36 year old man with non-Hodgkin’s lymphoma received a daily 95 mg/m2 dose of epirubicin hydrochloride injection 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/m2 dose of epirubicin hydrochloride injection. 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 epirubicin hydrochloride injection. Additional instances of administration of doses higher than recommended have been reported at doses ranging from 150 to 250 mg/m2. The observed adverse events in these patients were qualitatively similar to known toxicities of epirubicin. Most of the patients recovered with appropriate supportive care.

If an overdose occurs, provide supportive treatment (including antibiotic therapy, blood and platelet transfusions, colony-stimulating factors, and intensive care as needed) until the recovery of toxicities. Delayed CHF has been observed months after anthracycline administration. Observe patients carefully over time for signs of CHF and provided with appropriate supportive therapy.


Patients should not be treated with epirubicin hydrochloride injection if they have any of the following conditions:

Cardiomyopathy and/or heart failure, recent myocardial infarction or severe arrhythmias [see Warnings and Precautions (5.3)]

Previous treatment with maximum cumulative dose of anthracyclines [see Warnings and Precautions (5)].

Hypersensitivity to epirubicin hydrochloride injection, other anthracyclines, or anthracenediones [see Adverse Reactions (6.2)].


  1. NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.
  2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html.
  3. American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006; 63:1172-1193.
  4. Polovich, M., White, J. M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. ed.) Pittsburgh, PA: Oncology Nursing Society.

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