Epirubicin


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Acute leukaemias; Lymphoma; Multiple myeloma; Solid tumours As a single agent: 60-90 mg/m2 3-4 wkly. Max (total cumulative dose): 0.9-1 g/m2. Palliative care: 12.5-25 mg/m2 once wkly. Adjuvant treatment in axillary-node positive breast cancer Recommended starting doses: 100-120 mg/m2 as a single dose on day 1 or as 2 divided doses on days 1 and 8 of each 28-day cycle. Repeat for 6 cycles. Intravesical Local treatment of bladder carcinoma As 0.1% solution (in normal saline or sterile water): 50 mg weekly for 8 weeks; may reduce to 30 mg in 50 mL  weekly, if chemical cystitis develops. For carcinoma in-situ: May increase dose to 80 mg in 50 mL weekly, if tolerated. For prevention of recurrence in patients who have undergone transurethral resection: 50 mg wkly for 4 weeks, followed by 50 mg once a month for 11 months; retain solution in the bladder for 1 hour during each admin.
Dosage Details
Intravenous
Acute Leukaemia, Lymphoma, Multiple myeloma, Solid tumours
Adult: As a single agent: 60-90 mg/m2 every 3-4 wk. May divide dose over 2-3 days if desired. May admin as an inj over 3-5 minutes or as an infusion over up to 30 minutes. Max (total cumulative dose limit): 0.9-1 g/m2. For palliative care: 12.5-25 mg/m2 once wkly.

Intravenous
Adjuvant treatment of axillary-node positive breast cancer
Adult: Recommended starting dose: 100-120 mg/m2. Dose may be given as a single dose on day 1 or in 2 equally-divided doses on days 1 and 8 of each 28-day cycle. Repeat for 6 cycles. Lower starting doses may be considered in patients with pre-existing bone marrow depression or in the presence of neoplastic bone marrow infiltration.

Intravesical
Local treatment of bladder carcinoma
Adult: As 0.1% solution (in normal saline or sterile water): 50 mg weekly for 8 weeks; may reduce to 30 mg in 50 mL  weekly, if chemical cystitis develops. For carcinoma in-situ: May increase dose to 80 mg in 50 mL weekly, if tolerated. For prevention of recurrence in patients who have undergone transurethral resection: 50 mg wkly for 4 weeks, followed by 50 mg once a month for 11 months; retain solution in the bladder for 1 hour during each admin.
Special Patient Group
Patients with heavy pre-treatment, preexisting bone marrow depression, or the presence of neoplastic bone marrow infiltration: Starting dose of 75-90 mg/m2. Dosage modifications after the 1st treatment cycle: Nadir platelet counts < 50,000/mm2, ANC < 250/mm2, neutropenic fever, or grades 3 or 4 nonhaematogenic toxicity: Reduce day 1 dose in subsequent cycles to 75% of the day 1 dose in the current cycle. Day 1 chemotherapy in subsequent courses of treatment should be delayed until platelet counts are exceeding 100,000/mm3, ANC exceeding 1500/mm3, and nonhaematogenic toxicities have recovered to almost grade 1. In addition, for patients receiving divided dose (day 1 and day 8) regimen: Day 8 platelet counts 75,000-100,000/mm3 and ANC 1000-1499/mm3: dose should be 75% of the day 1 dose. Day 8 platelet counts <75,000/mm3, ANC <1000/mm3 or grade 3 or 4 nonhaematologic toxicity: Omit day 8 dose.
Renal Impairment
Intravenous:
Adjuvant treatment in axillary-node positive breast cancer: Dosage adjustment may be needed in severe impairment.
Hepatic Impairment
Moderate liver dysfunction (serum bilirubin concentrations: 12-30 mcg/mL): Doses should be halved; severe liver impairment (serum bilirubin >30 mcg/mL): A quarter of the usual dose.
Contraindications
Cardiac impairment, severe or recent MI; previous full cumulative doses of anthracyclines. Hypersensitivity; severe hepatic dysfunction. Not for intravesical use where invasive tumours have penetrated the bladder wall; urinary infections, bladder inflammation or catheterisation problems. Pregnancy, lactation.
Special Precautions
Previous extensive radiotherapy, bone infiltration by tumour, severe renal and hepatic dysfunction. May cause tumor lysis syndrome or radiation recall. Elderly women >70 yr. CV disease, hypertensive cardiomyopathy; monitor hematological and cardiac function regularly. Extravasation during IV admin may result in severe local tissue necrosis. Do not give via IM/SC routes as extravasation can lead to severe local necrosis.
Adverse Reactions
Myelosuppression; cardiotoxicity, alopoecia; mucositis; hyperpyrexia; lethargy; amenorrhoea; nausea and vomiting; diarrhoea; fever; rash, skin changes, anorexia; anaphylaxis; photosensitivity; premature menopause; skin and nail hyperpigmentation; harmless reddish appearance of urine for 1-2 days.
Intravesical/IV/Parenteral: D
Overdosage
Treatment should be supportive (including antibiotic therapy, blood and platelet transfusions, colony-stimulating factors, and intensive care as needed) until the recovery of toxicities. Delayed CHF may be observed mth after anthracycline admin.
Drug Interactions
Paclitaxel and other anthracyclines. Cimetidine, heparin. Antineoplastic drugs, cardiotoxic drugs, radiation, hepatoactive drugs.
Food Interaction
St. John's wort, alcohol, black cohosh, dong quai.
Lab Interference
Increased transaminases.
Action
Description: Epirubicin, an anthracycline with cytotoxic properties. It inhibits DNA and RNA synthesis by steric obstruction after intercalating between DNA base pairs that triggers DNA cleavage by topoisomerase II. It also inhibits DNA helicase and generates cytotoxic free radicals.
Pharmacokinetics:
Distribution: Rapidly and extensively distributed into body tissues.
Metabolism: Hepatically metabolised.
Excretion: Eliminated mainly in bile. Terminal elimination half-life: About 30-40 hr.
Storage
Refrigerate at 2-8°C.
Disclaimer: This information is independently developed by MIMS based on Epirubicin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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