Drug Formulary information is intended for use by healthcare professionals. It is not intended to be medical advice. Some of the information, including information about funding for cancer drugs, does not apply to all patients. Cancer treatment plans are unique to each patient. If you are a patient, please speak with your healthcare team to understand how this information applies to you.
EPIR(W)
Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR). Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.
Treatment of advanced breast cancer
REPEAT EVERY 28 DAYS
Until disease progression or limited by cardiotoxicity risk or other toxicities
Doses should be modified according to the protocol by which the patient is being treated.
Dosage with toxicity
|
Worst Toxicity / Counts in Prior Cycle |
Epirubicin Dose for Next Cycle |
|
Febrile neutropenia / Thrombocytopenic bleeding / ANC grade 4 ≥ 7 days |
Hold* |
|
Cardiotoxicity** |
Discontinue |
|
Grade 3 related organ / non-hematologic |
Hold* |
|
Grade 4 related organ / non-hematologic |
Discontinue |
*Do not start new cycle until organ toxicity ≤ grade 2, platelets ≥ 100 x 109/L and ANC ≥ 1.5 x 109/L
**including any signs and symptoms of heart failure, > 10% decline in LVEF to below the lower limit of normal, > 20% decline in LVEF from any level, or LVEF ≤ 45%.
Hepatic Impairment
| Hepatic Impairment | % of Epirubicin recommended starting Dose |
| Bilirubin 21-51 micromol/L or AST 2-4 x ULN | 50 |
| Bilirubin > 51 micromol/L or AST > 4 x ULN | 25 |
| Severe | Use is contraindicated |
Renal Impairment
Adjust dose with severe renal impairment (creatinine > 442 micromol/L).
Dosage in the Elderly
Use with caution; no adjustment required. Plasma clearance of epirubicin in female patients > 70 years of age was noted to be reduced by 35%.
Refer to EPIrubicin drug monograph(s) for additional details of adverse effects
| Very common (≥ 50%) | Common (25-49%) | Less common (10-24%) | Uncommon (< 10%), but may be severe or life-threatening |
|
|
|
|
Refer to EPIrubicin drug monograph(s) for additional details
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Avoid concomitant use with cimetidine and other drugs affecting hepatic metabolism.
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Patients treated with trastuzumab should avoid anthracycline-based therapy for up to 28 weeks after stopping trastuzumab.
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Caution if used in combination with taxanes. If concomitant use is warranted, administer epirubicin first and taxane at least 24 hours later.
Refer to EPIrubicin drug monograph(s) for additional details
Administration
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Slow push through sidearm of free flowing IV (5% Dextrose, Normal Saline). Doses of 100-120mg/m2 should be infused over 15-20 minutes. For lower dose volumes, the infusion time may be proportionally decreased to no less than 3-5 minutes.
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Do not admix with other drugs. Incompatible with heparin.
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Avoid contact with alkaline solutions since this can lead to hydrolysis of epirubicin.
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Slow down injection rate if erythematous streaking or facial flushing occurs.
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If any signs or symptoms of extravasation occur, the injection or infusion should be immediately terminated and restarted in another vein. Any known or suspected extravasation should be managed promptly as per local guidelines and should include application of ice to the affected area.
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Keep refrigerated (2-8oC). Protect from light.
Contraindications
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Hypersensitivity to epirubicin, any components of the product, other anthracyclines or anthracenediones
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Severe myelosuppression induced by prior chemotherapy or radiotherapy
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Severe hepatic impairment
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Severe myocardial insufficiency
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Recent myocardial infarction
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Severe arrhythmias
-
History of severe cardiac disease
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Previous treatment with maximum cumulative doses of anthracyclines or anthracenediones
Warnings/Precautions
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Avoid live vaccines; use may result in serious infections in immunocompromised patients.
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Patients who have received mediastinal radiotherapy, other anthracycline/ anthracenediones/ cardiotoxic drugs, pre-existing heart disease are at increased risk of cardiotoxicity.
Pregnancy/Lactation
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Epirubicin is not recommended for use in pregnancy. Adequate contraception should be used by both sexes during treatment, and for at least 6 months (general recommendation) after the last dose.
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Breastfeeding is not recommended.
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Fertility effects: probable.
Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.
Recommended Clinical Monitoring
- CBC; Baseline and before each dose
- Liver function tests; Baseline, prior to each dose, and/or as clinically indicated
- Renal function tests; Baseline, before each cycle, and as clinically indicated
- Cardiac function tests (Echo, RNA and/or MUGA scans) for all patients with cardiac risk factors and cumulative doses > 650mg/m2; Baseline and as clinically indicated.
- Clinical toxicity assessment of GI effects, dermatologic effects, tumour lysis syndrome, infection, bleeding, ocular effects, cardiotoxicity, local toxicity; At each visit
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Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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Barni S, Archili C, Lissoni P, et al. A weekly schedule of epirubicin in pretreated advanced breast cancer. Tumori 1993 Feb 28;79(1): 45-48.
Epirubicin drug monograph, Cancer Care Ontario.
Gasparini G, Dal Fior S, Panizzoni GA, et al. Weekly epirubicin versus doxorubicin as second line therapy in advanced breast cancer. A randomized clinical trial. Am J Clin Oncol 1991 Feb; 14(1): 38-44.
Nicolella D, Grimaldi G, Colantuoni G, et al. Weekly low dose epirubicin in elderly cancer patients. Tumori 1996 Jul;82(4): 369-371.
August 2019 Updated Adverse Effects, Dosing in Hepatic Impairment, Dosage in Elderly, Interactions, Drug Administration and Special Precautions and Monitoring sections
Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
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