Adult: As an adjuvant therapy component in patients with evidence of axillary node tumour involvement following resection of primary breast cancer: Usual dose: 100-120 mg/m2 given in repeated 3- to 4-week cycles; total dose for each cycle may be given as a single dose on Day 1 or as 2 equally divided doses on Days 1 and 8 of each cycle. All doses are given via IV bolus inj over 3-5 minutes or via IV infusion of up to 30 minutes; administer into a free-flowing infusion of NaCl 0.9% solution or dextrose 5% in water solution. Dosing interruption or dose reduction may be required according to individual safety or tolerability. Treatment protocols may vary among countries or individual products (refer to country- or product-specific guidelines).
Intravenous Acute leukaemia, Lymphoma, Multiple myeloma, Ovarian cancer, Small cell lung cancer
Adult: As a single agent: 60-90 mg/m2 as a single dose every 3 weeks. May give doses of up to 120 mg/m2 every 3 weeks if needed. Max total cumulative dose: 900-1,000 mg/m2. All doses are given via IV bolus inj over 3-5 minutes or via IV infusion of up to 30 minutes; administer into a free-flowing infusion of NaCl 0.9% solution or dextrose 5% in water solution. Dosing interruption or dose reduction may be required according to individual safety or tolerability. Treatment protocols may vary among countries or individual products (refer to country- or product-specific guidelines).
Intravesical Bladder cancer
Adult: Treatment of superficial bladder cancer: 50 mg (25 mL of 2 mg/mL epirubicin inj) in 25 mL of sterile water for inj or NaCl 0.9% solution to make 50 mL of bladder instillation solution, instilled weekly for 8 weeks; in case of local toxicity (chemical cystitis), instil 30 mg (15 mL of 2 mg/mL epirubicin inj) in 35 mL of sterile water for inj or NaCl 0.9% solution to make 50 mL of bladder instillation solution. For carcinoma in situ: May instil up to 80 mg (40 mL of 2 mg/mL epirubicin inj) in 10 mL of sterile water for inj or NaCl 0.9% solution to make 50 mL of bladder instillation solution. For prophylaxis of recurrence following transurethral resection: 50 mg (25 mL of 2 mg/mL epirubicin inj) in 25 mL of sterile water for inj or NaCl 0.9% solution to make 50 mL of bladder instillation solution, instilled weekly for 4 weeks; followed by 50 mg (25 mL of 2 mg/mL epirubicin inj) in 25 mL of sterile water for inj or NaCl 0.9% solution to make 50 mL of bladder instillation solution, instilled once a month for 11 months. All doses are instilled using a catheter and retained in the bladder for 1 hour. Treatment recommendations may vary among individual products and between countries (refer to specific product guidelines).
Special Patient Group
Intravenous:
Patients with reduced bone marrow function due to previous chemotherapy or radiotherapy, or those with neoplastic bone marrow infiltration: Dose reduction or longer intervals between cycles may be needed.
Renal Impairment
Intravenous:
Severe: Initiate at the lower end of the dosing range.
Incompatible with any solution of an alkaline pH (if prolonged contact); heparin, fluorouracil.
Contraindications
IV: Severe persistent myelosuppression, severe stomatitis induced by previous drug treatment or radiotherapy; acute systemic infections, severe myocardial insufficiency, recent MI, severe cardiac failure, severe arrhythmias, cardiomyopathy, unstable angina pectoris. Severe hepatic impairment. Prior treatment with Max cumulative doses of epirubicin and/or other anthracyclines and anthracenediones. Intravesical: Invasive tumours that penetrated the bladder wall, bladder inflammation or contraction; UTI, catheterisation problems, haematuria. Lactation.
Special Precautions
Patient with active or dormant CV disease; previous or concurrent radiotherapy to the mediastinal or pericardial area. Patients with reduced bone marrow function due to previous chemotherapy or radiotherapy, or those with neoplastic bone marrow infiltration. Concomitant administration with cardiotoxic drugs (e.g. trastuzumab). Avoid concurrent vaccination with live vaccines. Avoid extravasation. Mild to moderate hepatic and severe renal impairment. Pregnancy.
Adverse Reactions
Significant: Myocardial damage (including acute left ventricular failure), tachycardia (including premature ventricular contractions and ventricular tachycardia), bradycardia, AV block, bundle branch block, secondary acute myeloid leukaemia, myelodysplastic syndrome, extravasation, tumour lysis syndrome, hyperuricaemia; leucopenia, neutropenia, thrombocytopenia, anaemia; radiation recall (in patients who received prior radiation therapy); mucositis or stomatitis. Intravesical use: Chemical cystitis, bladder constriction. Eye disorders: Keratitis, conjunctivitis. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, oesophagitis, gastrointestinal pain, erosion or ulcer. General disorders and administration site conditions: Fever, infusion site erythema. Investigations: Abnormal transaminase values. Metabolism and nutrition disorders: Loss of appetite, dehydration. Nervous system disorders: Dizziness. Renal and urinary disorders: Red urine discolouration. Reproductive system and breast disorders: Amenorrhoea. Skin and subcutaneous tissue disorders: Pruritus, rash, skin or nail hyperpigmentation, alopecia. Vascular disorders: Hot flushes. Potentially Fatal: Severe myelosuppression resulting in serious infection and septic shock; thrombophlebitis, thromboembolic phenomena (including pulmonary embolism).
Confirm pregnancy status before treatment initiation in females of reproductive potential. Monitor CBC with differential, LFTs (ALT, AST, total bilirubin), serum creatinine; cardiac function (LVEF using ECG or multi-gated radionuclide angiography [MUGA]) before and periodically during and after treatment; serum electrolytes (e.g. Ca, K, phosphate), serum uric acid; cumulative anthracycline or epirubicin dose. Assess for signs of extravasation or infusion-related reactions; signs and symptoms of tumour lysis syndrome and secondary malignancies.
Overdosage
Symptoms: Severe myelosuppression, toxic gastrointestinal reactions, acute cardiac dysfunction. Management: Symptomatic and supportive treatment.
Drug Interactions
Increased risk of cardiotoxicity with other cardiotoxic agents (e.g. trastuzumab, cyclophosphamide, cisplatin) and other cardioactive compounds (e.g. calcium channel blockers). Increased risk of myelosuppression with dexrazoxane. Increased serum concentration with cimetidine, paclitaxel, docetaxel. Interferon alfa-2b may decrease the clearance of epirubicin.
Action
Description: Mechanism of Action: Epirubicin, an anthracycline antineoplastic, is a semisynthetic derivative of daunorubicin. It is believed to be involved in the inhibition of DNA and RNA synthesis through steric obstruction after intercalating between DNA base pairs. This intercalation triggers DNA cleavage by topoisomerase II, thereby causing cytocidal activity. Additionally, it prevents DNA helicase activity and generates cytotoxic free radicals. Pharmacokinetics: Distribution: Rapidly and extensively distributed into body tissues. Plasma protein binding: Approx 77%, mainly to albumin. Metabolism: Extensively metabolised in the liver into epirubicinol (13-hydroxyepirubicin) and glucuronides of epirubicin and epirubicinol. Excretion: Via faeces (34-35%); urine (20-27%). Terminal elimination half-life: Approx 30-40 hours.
Chemical Structure
Epirubicin
Storage
Powder for inj: Store below 30°C. Solution for inj: Store between 2-8°C. Protect from light. Do not freeze. This is a cytotoxic drug. Follow applicable procedures for receiving, handling, administration, and disposal.
L01DB03 - epirubicin ; Belongs to the class of cytotoxic antibiotics, anthracyclines and related substances. Used in the treatment of cancer.
References
Anon. Epirubicin. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 17/05/2023.Anon. Epirubicin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 01/02/2024.Buckingham R (ed). Epirubicin Hydrochloride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/02/2024.Ellence Injection, Solution (Pharmacia & Upjohn Company LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 01/02/2024.Epirubicin 2 mg/mL, Solution for Injection (Generics [UK] Limited t/a Mylan). MHRA. https://products.mhra.gov.uk. Accessed 17/05/2023.Epirubicin Hydrochloride 10 mg Powder for Solution for Injection (Dawa Ltd). MHRA. https://products.mhra.gov.uk. Accessed 01/02/2024.Epirubicin Hydrochloride 2 mg/mL, Solution for Injection or Infusion (Teva UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 01/02/2024.Joint Formulary Committee. Epirubicin Hydrochloride. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 17/05/2023.Mylan Epirubicin Hydrochloride 2 mg/mL Injection (Mylan Healthcare Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 17/05/2023.Sandoz New Zealand Limited. Epirubicin Ebewe Solution for Injection data sheet 20 March 2023. Medsafe. http://www.medsafe.govt.nz. Accessed 01/02/2024.
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