Epirubicin is an active pharmaceutical ingredient in the Anthracyclines and Related Substances group (L01DB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised September 1, 2025[1]
Epirubicin is used in the treatment of a range of neoplastic conditions including: − Carcinoma of the breast − Advanced ovarian cancer − Gastric cancer − Small cell lung cancer When administered intravesically, epirubicin has been shown to be beneficial in the treatment of: − Papillary transitional cell carcinoma of the bladder − Carcinoma-in-situ of the bladder − Intravesical prophylaxis of recurrences of superficial bladder carcinoma following transurethral resection.
How to take
CACanada· Health Canada
4 products
Uses
CAOfficial regulatory label· revised March 22, 2025[2]
AND CLINICAL USE .......................................................................................... 4 CONTRAINDICATIONS ................................................................................................................
4 WARNINGS AND PRECAUTIONS .............................................................................................. 5 ADVERSE REACTIONS ..............................................................................................................
11 DRUG INTERACTIONS ............................................................................................................... 14 DOSAGE AND ADMINISTRATION...........................................................................................
15 OVERDOSAGE ............................................................................................................................. 18 ACTION AND CLINICAL PHARMACOLOGY .........................................................................
Drug interactions
Known interactions involving Epirubicin. Select one for details. This list is informational and not a complete interaction checker.
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Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PL115870043 · revised September 1, 2025
[2]Health Canada (DPD) · 02413221 · revised March 22, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
GBOfficial regulatory label· revised September 1, 2025[1]
4). Conventional dose When epirubicin hydrochloride is used as a single agent, the recommended dose in adults is 60 – 90 mg/m² body surface area. Epirubicin hydrochloride should be injected intravenously over 3 – 5 minutes. The dose should be repeated at 21-day intervals, depending upon the patient’s haematological status and bone marrow function.
If signs of toxicity, including severe neutropenia/neutropenic fever and thrombocytopenia occur (which could persist at day 21), dose modification or postponement of the subsequent dose may be required. High dose Epirubicin as a single agent for the high dose treatment of lung cancer should be administered according to the following regimens: • Small cell lung cancer (previously untreated): 120 mg/m² epirubicin hydrochloride on day 1, every 3 weeks.
For high-dose treatment, epirubicin may be given as an intravenous bolus over 3 – 5 minutes or as an infusion of up to 30 minutes duration. Breast cancer In the adjuvant treatment of early breast cancer patients with positive lymph nodes, intravenous doses of epirubicin hydrochloride ranging from 100 mg/m² (as a single dose on day 1) to 120 mg/m² (in two divided doses on days 1 and 8) every 3 – 4 weeks, in combination with intravenous cyclophosphamide and 5-fluorouracil and oral tamoxifen, are recommended.
Lower doses (60 – 75 mg/m² for conventional treatment and 105 – 120 mg/m² for high-dose treatment) are recommended for patients whose bone marrow function has been impaired by previous chemotherapy or radiotherapy, by age, or neoplastic bone marrow infiltration.
The total dose per cycle may be divided over 2 – 3 successive days. The following doses of epirubicin hydrochloride are commonly used in monotherapy and combination chemotherapy for various other tumours, as shown: Epirubicin hydrochloride dose (mg/m²)a Cancer indication Monotherapy Combination therapy Advanced ovarian cancer 60 – 90 50 – 100 Gastric cancer 60 – 90 50 SCLC 120 120 Bladder cancer Intravesical administration of 50 mg/50 ml or 80 mg/50 ml (carcinoma-in-situ) Prophylaxis: 50 mg/50 ml weekly for 4 weeks then monthly for 11 months a Doses generally given day 1 or day 1, 2 and 3 at 21-day intervals Combination therapy If epirubicin hydrochloride is used in combination with other cytotoxic products, the dose should be reduced accordingly.
Commonly used doses are shown in the table above. Impaired liver function The major route of elimination of epirubicin is the hepatobiliary system. 4 – 3 mg/100 ml 50 % > 3 mg/100 ml > 4 times upper normal limit 75 % Impaired renal function Moderate renal impairment does not appear to require a dose reduction in view of the limited amount of epirubicin excreted by this route.
However, dose adjustment may be necessary in patients with serum creatinine > 5 mg/dl. Paediatric population The safety and efficacy of epirubicin in children have not yet been established. Method of administration Epirubicin is for intravenous or intravesical use only.
9 %) infusion after checking that the needle is properly placed in the vein. 4). In case of extravasation, administration should be stopped immediately. Intravesical administration Epirubicin can be given by intravesical administration for the treatment of superficial bladder cancer and carcinoma-in-situ.
It should not be given intravesically for the treatment of invasive tumours that have penetrated the bladder wall. 3). Epirubicin has also been successfully used intravesically as a prophylactic agent after transurethral resection of superficial tumours to prevent recurrence.
9 %) or water for injection).
If local toxicity is observed:
A dose reduction to 30 mg/50 ml is advised.
Carcinoma-in-situ:
Up to 80 mg/50 ml (depending on individual tolerability of the patient). For prophylaxis: 4 weekly administrations of 50 mg/50 ml followed by 11 monthly instillations at the same dose. 9 % sterile saline 30 mg 15 ml 35 ml 50 ml 50 mg 25 ml 25 ml 50 ml 80 mg 40 ml 10 ml 50 ml The solution should be retained intravesically for 1 – 2 hours.
To avoid undue dilution with urine, the patient should be instructed not to drink any fluids in the 12 hours prior to instillation. During the instillation, the patient should be rotated occasionally and should be instructed to void urine at the end of the instillation time.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised September 1, 2025[1]
Tabulated list of adverse reactions The following undesirable effects have been observed and reported during treatment with epirubicin with the following frequencies: More than 10 % of treated patients can expect to develop undesirable effects.
The most common undesirable effects are myelosuppression, gastrointestinal side effects, anorexia, alopecia, infection. System Organ Class Very common ≥ 1/10 Common ≥ 1/100 to < 1/10 Uncommon ≥ 1/1 000 to < 1/100 Rare ≥ 1/10 000 to < 1/1 000 Very Rare < 1/10 0 00 Not known (cannot be estimated from the available data) Infections and infestations Infection, conjunctivitis Bacterial cystitis§ Sepsis*, pneumonia* Septic shock, cellulitis Neoplasms benign, malignant and unspecified (incl.
4) Nervous system disorders Dizziness Headache Eye disorders Keratitis Cardiac disorders Ventricul ar tachycardi a, AV block, bundle- branch block, bradycard ia, (see section 4. g. 4) Hypersensiti vity to irradiated skin (radiation recall reaction) §Following intravesical administration *ADR identified post-marketing Description of selected adverse reactions Neoplasms benign, malignant and unspecified (including cysts and polyps) Secondary acute myeloid leukaemia with or without a pre-leukaemic phase, in patients treated with epirubicin in combination with DNA-damaging antineoplastic agents.
These leukaemias have a short (1 – 3 years) latency. Blood and lymphatic system disorders High doses of epirubicin have been safely administered in a large number of untreated patients having various solid tumours and have caused adverse events which are not different from those seen at conventional doses with the exception of reversible severe neutropenia (< 500 neutrophils/mm³ for < 7 days) which occurred in the majority of patients.
Only few patients required hospitalisation and supportive therapy for severe infectious complications at high doses. Skin and subcutaneous tissue disorders Alopecia, normally reversible, appears in 60 – 90 % of treated cases; it is accompanied by lack of beard growth in males.
General disorders and administration site conditions Mucositis may appear 5 – 10 days after the start of treatment, and usually involves stomatitis with areas of painful erosions, ulceration and bleeding, mainly along the side of the tongue and the sublingual mucosa.
Local pain and tissue necrosis (following accidental paravenous injection) may occur. Intravesical administration As only a small amount of the active ingredient is reabsorbed after intravesical instillation, severe systemic adverse reactions as well as allergic reactions are rare.
Commonly reported are local reactions like burning sensation and frequent voiding (pollakisuria). 4). These adverse reactions are mostly reversible. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised September 1, 2025[1]
General Epirubicin should be administered only under the supervision of qualified physicians experienced in the use of cytotoxic therapy. Patients should recover from acute toxicities (such as stomatitis, mucositis, neutropenia, thrombocytopenia, and generalised infections) of prior cytotoxic treatment before beginning treatment with epirubicin.
g. ≥ 90 mg/m² every 3 to 4 weeks) causes adverse events generally similar to those seen at standard doses (< 90 mg/m² every 3 to 4 weeks), the severity of the neutropenia and stomatitis/mucositis may be increased. Treatment with high doses of epirubicin hydrochloride does require special attention for possible clinical complications due to profound myelosuppression.
e. e. delayed) events. e. acute) events Early cardiotoxicity of epirubicin consists mainly of sinus tachycardia and/or electrocardiogram (ECG) abnormalities such as non-specific ST-T wave changes. Tachyarrhythmias, including premature ventricular contractions, ventricular tachycardia, and bradycardia, as well as atrioventricular and bundle-branch block have also been reported.
These effects do not usually predict subsequent development of delayed cardiotoxicity, are rarely of clinical importance, and are generally transient, reversible and not a consideration for the discontinuation of epirubicin treatment.
e. delayed) events Delayed cardiotoxicity usually develops late in the course of therapy with epirubicin or within 2 to 3 months after treatment termination, but later events (several months to years after completion of treatment) have also been reported.
Delayed cardiomyopathy is manifested by reduced left ventricular ejection fraction (LVEF) and/or signs and symptoms of congestive heart failure (CHF) such as dyspnoea, pulmonary oedema, dependent oedema, cardiomegaly and hepatomegaly, oliguria, ascites, pleural effusion, and gallop rhythm.
Life-threatening CHF is the most severe form of anthracycline-induced cardiomyopathy and represents the cumulative dose- limiting toxicity of the medicinal product. 1). Monitoring of cardiac function Cardiac function should be assessed before patients undergo treatment with epirubicin and must be monitored throughout therapy to minimise the risk of incurring severe cardiac impairment.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised September 1, 2025[1]
1 or to other anthracyclines or anthracenediones. 6). 4) • patients with acute systemic infections • unstable angina pectoris • myocardiopathy • acute inflammatory heart diseases • severe inflammation of the mucous membranes in the mouth and/or gastrointestinal tract Intravesical use • urinary tract infections • invasive tumours penetrating the bladder • catheterisation problems • inflammation of the bladder • haematuria • contracted bladder • large volume of residual urine
This is not medical advice. Consult a qualified healthcare professional.
18 STORAGE AND STABILITY ...................................................................................................... 20 SPECIAL HANDLING INSTRUCTIONS ....................................................................................
20 DOSAGE FORMS, COMPOSITION AND PACKAGING .......................................................... 22 PART II: SCIENTIFIC INFORMATION.................................................................................... 24 PHARMACEUTICAL INFORMATION ......................................................................................
31 PART III: CONSUMER INFORMATION .................................................................................. 37 IMPORTANT: PLEAS EPIRUBICIN HYDROCHLORIDE INJECTION PRODUCT MONOGRAPH Page 3 of 40 PrEPIRUBICIN HYDROCHLORIDE INJECTION PART I: HEALTH PROFESSIONAL INFORMATION CAUTION EPIRUBICIN HYDROCHLORIDE INJECTION IS A POTENT DRUG AND SHOULD BE USED ONLY BY PHYSICIANS EXPERIENCED WITH CANCER CHEMOTHERAPEUTIC DRUGS (SEE WARNINGS AND PRECAUTIONS).
BLOOD COUNTS AND HEPATIC FUNCTION TESTS SHOULD BE PERFORMED REGULARLY. IRREVERSIBLE CARDIAC TOXICITY MAY OCCUR AS THE CUMULATIVE DOSE APPROACHES 1000 mg/m2. CARDIAC MONITORING IS ADVISED IN THOSE PATIENTS WHO HAVE RECEIVED MEDIASTINAL RADIOTHERAPY, OTHER ANTHRACYCLINE OR ANTHRACENE THERAPY, WITH PRE-EXISTING CARDIAC DISEASE, OR RECEIVED PRIOR EPIRUBICIN CUMULATIVE DOSES EXCEEDING 650 mg/m2.
SECONDARY ACUTE MYELOID LEUKEMIA (AML) WITH OR WITHOUT A PRELEUKEMIC PHASE (MYELODYSPLASTIC SYNDROME OR MDS) HAS BEEN REPORTED IN PATIENTS TREATED WITH EPIRUBICIN-CONTAINING REGIMENS. 55% AT 8 YEARS. SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength Nonmedicinal Ingredients Intravenous Sterile solution for injection / 2 mg/mL Hydrochloric acid, Sodium chloride and water for injection IMPORTANT: PLEAS EPIRUBICIN HYDROCHLORIDE INJECTION PRODUCT MONOGRAPH Page 4 of 40 INDICATIONS AND CLINICAL USE Epirubicin Hydrochloride Injection has been used successfully as a single agent and in combination with other chemotherapeutic agents to produce regression in a variety of tumour types such as lymphoma, lung, cancer of the breast, ovary and stomach.
Epirubicin Hydrochloride Injection is recommended for the treatment of metastatic breast cancer. Epirubicin Hydrochloride Injection may also be used as a component in the adjuvant treatment of early stage breast cancer for pre- and peri- menopausal women.
Epirubicin Hydrochloride Injection is also recommended in small cell lung cancer (both limited and extensive disease) advanced non-small cell lung cancer, non-Hodgkin's lymphoma, Hodgkin's disease, Stage III and IV (FIGO) ovarian carcinoma and metastatic and locally unresectable gastric carcinoma.
CONTRAINDICATIONS • Hypersensitivity to epirubicin or any other component of the product, or other anthracyclines or anthracenediones such as doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone or mitomycin C. • marked persistent myelosuppression induced by prior treatment with other antitumour agents or by radiotherapy • severe hepatic impairment • severe myocardial insufficiency • recent myocardial infarction • severe arrhythmias • history of severe cardiac disease • previous treatments with maximum cumulative doses of epirubicin and/or other anthracyclines and anthracenediones (see WARNINGS AND PRECAUTIONS).
IMPORTANT:
PLEAS EPIRUBICIN HYDROCHLORIDE INJECTION PRODUCT MONOGRAPH Page 5 of 40 WARNINGS AND PRECAUTIONS Serious Warnings and Precautions • EPIRUBICIN HYDROCHLORIDE INJECTION IS A POTENT DRUG AND SHOULD BE USED ONLY BY PHYSICIANS EXPERIENCED WITH CANCER CHEMOTHERAPEUTIC DRUGS (SEE WARNINGS AND PRECAUTIONS).
BLOOD COUNTS AND HEPATIC FUNCTION TESTS SHOULD BE PERFORMED REGULARLY. IRREVERSIBLE CARDIAC TOXICITY MAY OCCUR AS THE CUMULATIVE DOSE APPROACHES 1000 mg/m2. CARDIAC MONITORING IS ADVISED IN THOSE PATIENTS WHO HAVE RECEIVED MEDIASTINAL RADIOTHERAPY, OTHER ANTHRACYCLINE OR ANTHRACENE THERAPY, WITH PRE- EXISTING CARDIAC DISEASE, OR RECEIVED PRIOR EPIRUBICIN CUMULATIVE DOSES EXCEEDING 650 mg/m2.
• SECONDARY ACUTE MYELOID LEUKEMIA (AML) WITH OR WITHOUT A PRELEUKEMIC PHASE (MYELODYSPLASTIC SYNDROME OR MDS) HAS BEEN […]
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[2]
Dose limiting toxicities are myelosuppression and cardiotoxicity (see WARNINGS AND PRECAUTIONS).
Other reactions reported are:
Cutaneous - Reversible partial or complete alopecia occurs in most patients. Alopecia and lack of beard growth in males are usually reversible. Recall of skin reaction associated with prior radiotherapy may occur with epirubicin administration.
Local toxicity, rash/itch and skin changes may also occur. Gastrointestinal - Acute nausea and vomiting occurs frequently in most patients. This may be alleviated by antiemetic therapy. Mucositis (stomatitis and esophagitis) has been reported to occur 5-10 days after administration.
This may lead to ulceration and represents a site of origin for severe infections. Diarrhea has been reported. Most patients recover from this adverse event by the third week of therapy. Local - Severe cellulitis, vesication, local pain and tissue necrosis can occur if epirubicin is extravasated during administration (see DOSAGE AND ADMINISTRATION).
Erythematous streaking and/or transient urticaria along the vein proximal to the site of administration may occur. Venous sclerosis may result from injection into small veins or repeated injection into the same vein. Following the recommended administration procedures may minimize the risk of phlebitis/thrombophlebitis at the injection site (see SPECIAL HANDLING INSTRUCTIONS).
Haematological - A dose-dependent, reversible leukopenia and/or granulocytopenia (neutropenia) are the predominant manifestations of epirubicin bone marrow/haematologic toxicity and represents the acute dose-limiting toxicity of this drug.
Leukopenia and neutropenia are usually more severe after administration of high-dose regimens; under these conditions appropriate bone marrow support (eg. peripheral blood progenitor cells and/or colony- stimulating factors) may be required.
Thrombocytopenia, anemia, pancytopenia, neutropenia and febrile neutropenia may also occur. Clinical consequences of severe myelosuppression include fever, infection, sepsis/septicemia, septic shock, hemorrhage, tissue hypoxia, or death.
Secondary Leukemia: see WARNINGS AND PRECAUTIONS. 5 and GFEA-05 (FASG-05), see CLINICAL TRIALS, Early Stage Breast Cancer Studies) evaluating epirubicin-containing combination regimens in patients with early breast cancer. Of the 1260 patients treated in these studies, 620 patients received the higher-dose epirubicin regimen (FEC-100/CEF-120), 280 patients received the lower-dose epirubicin regimen (FEC-50), and 360 patients received CMF.
Serotonin-specific anti-emetic therapy and colony-stimulating factors were not used in these trials. Clinically relevant acute adverse events are summarized in Table 1. Table 1. 2 0 FEC & CEF = cyclophosphamide + epirubicin + fluorouracil CMF = cyclophosphamide + methotrexate + flurouracil NA = not available Grade 1 or 2 changes in transaminase levels were observed but were more frequently seen with CMF than with CEF.
5 and GFEA-05 (FASG-05) trials. Table 2. 5 cardiac function was not monitored after 5 years. In study GFEA-05 (FASG-05) monitoring of cardiac function was optional. Within the first 5 year follow-up period, two cases of acute lymphoid leukemia (ALL) were also observed in patients receiving epirubicin.
However, an association between anthracyclines such as epirubicin and ALL has not been clearly established. Over the 10 year follow-up period for study GFEA-05 (FASG-05), the overall incidence of cardiac events in patients treated with FEC-100 remained similar to that reported in patients receiving FEC-50.
There […]
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[2]
Serious Warnings and Precautions • EPIRUBICIN HYDROCHLORIDE INJECTION IS A POTENT DRUG AND SHOULD BE USED ONLY BY PHYSICIANS EXPERIENCED WITH CANCER CHEMOTHERAPEUTIC DRUGS (SEE WARNINGS AND PRECAUTIONS). BLOOD COUNTS AND HEPATIC FUNCTION TESTS SHOULD BE PERFORMED REGULARLY.
IRREVERSIBLE CARDIAC TOXICITY MAY OCCUR AS THE CUMULATIVE DOSE APPROACHES 1000 mg/m2. CARDIAC MONITORING IS ADVISED IN THOSE PATIENTS WHO HAVE RECEIVED MEDIASTINAL RADIOTHERAPY, OTHER ANTHRACYCLINE OR ANTHRACENE THERAPY, WITH PRE- EXISTING CARDIAC DISEASE, OR RECEIVED PRIOR EPIRUBICIN CUMULATIVE DOSES EXCEEDING 650 mg/m2.
• SECONDARY ACUTE MYELOID LEUKEMIA (AML) WITH OR WITHOUT A PRELEUKEMIC PHASE (MYELODYSPLASTIC SYNDROME OR MDS) HAS BEEN REPORTED IN PATIENTS TREATED WITH EPIRUBICIN-CONTAINING REGIMENS. 55% AT 8 YEARS. , delayed) events. , Acute) Events.
Early cardiotoxicity of epirubicin consists mainly of sinus tachycardia and/or ECG abnormalities such as non-specific ST-T wave changes. Tachyarrhythmias, including premature ventricular contractions, ventricular tachycardia, and bradycardia, as well as atrioventricular and bundle-branch block have also been reported.
These effects do not usually predict subsequent development of delayed cardiotoxicity, are rarely of clinical importance, and are generally not a consideration for the discontinuation of epirubicin treatment. , Delayed) Events. Delayed cardiotoxicity usually develops late in the course of therapy with epirubicin or within 2 to 3 months after treatment termination, but later events several months to years after completion of treatment have also been reported.
Delayed cardiomyopathy is manifested by reduced left ventricular ejection fraction (LVEF) and/or signs and symptoms of congestive heart failure (CHF) such as dyspnea, pulmonary edema, dependent edema, IMPORTANT: PLEAS EPIRUBICIN HYDROCHLORIDE INJECTION PRODUCT MONOGRAPH Page 6 of 40 cardiomegaly and hepatomegaly, oliguria, ascites, pleural effusion, and gallop rhythm.
Life- threatening CHF is the most severe form of anthracycline-induced cardiomyopathy and represents the cumulative dose-limiting toxicity of the drug. Cardiac function should be assessed before patients undergo treatment with epirubicin and must be monitored throughout therapy to minimize the risk of incurring severe cardiac impairment.
This is not medical advice. Consult a qualified healthcare professional.
The risk may be decreased through regular monitoring of LVEF during the course of treatment with prompt discontinuation of epirubicin at the first sign of impaired function. The appropriate quantitative method for repeated assessment of cardiac function (evaluation of LVEF) includes multi-gated radionuclide angiography (MUGA) or echocardiography (ECHO).
A baseline cardiac evaluation with an ECG and either a MUGA scan or an ECHO is recommended, especially in patients with risk factors for increased cardiotoxicity. Repeated MUGA or ECHO determinations of LVEF should be performed, particularly with higher, cumulative anthracycline doses.
The technique used for assessment should be consistent throughout follow-up. Given the risk of cardiomyopathy, a cumulative dose of 900 mg/m² epirubicin hydrochloride should be exceeded only with extreme caution. Cardiomyopathy induced by anthracyclines is associated with persistent reduction of the QRS voltage, prolongation beyond normal limits of the systolic interval (PEP) and a reduction of the ejection fraction (LVET).
Electrocardiogram (ECG) changes may be indicative of anthracycline-induced cardiomyopathy, but ECG is not a sensitive or specific method for following anthracycline-related cardiotoxicity. g. 5) with an increased risk in the elderly.
Cardiac function monitoring must be particularly strict in patients receiving high cumulative doses and in those with risk factors. However, cardiotoxicity with epirubicin may occur at lower cumulative doses whether or not cardiac risk factors are present.
It is probable that the toxicity of epirubicin and other anthracyclines or anthracenediones is additive. 6). Cardiotoxicity in combination with trastuzumab Heart failure (New York Heart Association [NYHA] class II-IV) has been observed in patients receiving trastuzumab therapy alone or in combination with anthracyclines such as epirubicin.
This may be moderate to severe and has been associated with death. Trastuzumab and anthracyclines such as epirubicin should not be used currently in combination except in a well-controlled clinical trial setting with cardiac monitoring.
Patients who have previously received anthracyclines are also at risk of cardiotoxicity with trastuzumab treatment, although the risk is lower than with concurrent use of trastuzumab and anthracyclines. The reported half-life of trastuzumab is variable.
The substance may persist in the circulation for up to 7 months. Therefore, physicians should avoid anthracycline-based therapy for up to 7 months after stopping trastuzumab when possible. If anthracyclines are used before this time, careful monitoring of cardiac function is recommended.
If symptomatic cardiac failure develops during trastuzumab therapy after epirubicin therapy, it […]
The risk may be decreased through regular monitoring of LVEF during the course of treatment with prompt discontinuation of epirubicin at the first sign of impaired function. The appropriate quantitative method for repeated assessment of cardiac function (evaluation of LVEF) includes multi-gated radionuclide angiography (MUGA) or echocardiography (ECHO).
A baseline cardiac evaluation with an ECG and either a MUGA scan or an ECHO is recommended, especially in patients with risk factors for increased cardiotoxicity. Repeated MUGA or ECHO determinations of LVEF should be performed, particularly with higher, cumulative anthracycline doses.
The technique used for assessment should be consistent throughout follow-up. Congestive heart failure and/or cardiomyopathy may be encountered several weeks after discontinuation of Epirubicin Hydrochloride Injection therapy. Given the risk of cardiomyopathy, a cumulative dose of 900 to 1000 mg/m2 epirubicin should generally not be exceeded.
Risk factors for cardiac toxicity include active or dormant cardiovascular disease, prior or concomitant radiotherapy to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones, and concomitant use of other drugs with the ability to suppress cardiac contractility or cardiotoxic drugs.
Anthracyclines including epirubicin should not be administered in combination with other cardiotoxic agents unless the patient’s cardiac function is closely monitored. Patients receiving anthracyclines 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.
The reported half-life of trastuzumab is approximately 28-38 days and may persist in the circulation for up to 27 weeks. Therefore, physicians should avoid anthracycline-based therapy for up to 27 weeks after stopping trastuzumab when possible.
If anthracyclines are used before this time, careful monitoring of cardiac function is recommended. Cardiac function monitoring must be particularly strict in patients receiving high cumulative doses and in those with risk factors. While cardiotoxicity with epirubicin may occur at lower cumulative doses whether or not cardiac risk factors are present, it may be more likely to occur at lower cumulative doses in patients with these risk factors.
Available evidence appears to indicate that cardiotoxicity is cumulative across members of the anthracycline and anthracene class of drugs. Patients who have previously received other anthracyclines and anthracenes are at particular risk for possible cardiotoxic effects of Epirubicin Hydrochloride Injection at a lower total dose than previously untreated patients and, therefore, should be carefully monitored.
The total dose of Epirubicin Hydrochloride Injection administered to a patient should take into account: prior or concomitant therapy with related compounds such as doxorubicin and daunorubicin or anthracene derivatives; and/or radiotherapy to the mediastinal IMPORTANT: […]