Epirubicin

Indications
 Intravenous
Lymphoma
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.
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.
Intravenous
Multiple myeloma
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.
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.
Intravenous
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.
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.
Intravenous
Acute leukaemias
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.
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.
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.
Renal impairment: 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.
Intravesical
Local treatment of bladder carcinoma
Adult: As 0.1% solution (in normal saline or sterile water): 50 mg wkly for 8 wk; may reduce to 30 mg in 50 ml if chemical cystitis develops. For carcinoma in-situ: May increase dose to 80 mg in 50 ml wkly. For prevention of recurrence in patients who have undergone transurethral resection: 50 mg wkly for 4 wk, followed by 50 mg once a mth for 11 mth; retain solution in the bladder for 1 hr during each admin.
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.

Special Populations: Dosage adjustment in hepatic impairment: Bilirubin 1.2-3 mg/dL or AST 2-4 times upper limit of normal: 50% of recommended doses. Bilirubin more than 3 mg/dL or AST exceeding 4 times upper limit of normal: 25% of recommended doses. In severe renal impairment (serum creatine >5 mg/dL), doses should be lowered. 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 nonhematogenic 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 nonhematogenic 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 nonhematologic toxicity: Omit day 8 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.
Warnings / 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.
Overdose Reactions
 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.
See Below for More epirubicin Drug Interactions
Lab Interactions
 Increased transaminases.
Food Interactions
 St. John's wort, alcohol, black cohosh, dong quai.
Mechanism of Actions
 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 by topoisomerase II. It also inhibits DNA helicase and generates cytotoxic free radicals.
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 Conditions
 Intravenous: Refrigerate at 2-8°C. Intravesical: Refrigerate at 2-8°C.
ATC Classification
 L01DB03 - epirubicin ; Belongs to the class of cytotoxic antibiotics, anthracyclines and related substances. Used in the treatment of cancer.
Storage
 Intravenous: Refrigerate at 2-8°C. Intravesical: Refrigerate at 2-8°C.
Available As
  • Epirubicin 10 mg
  • Epirubicin 100 mg
  • Epirubicin 50 mg

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