Epirubicin

Registered South African indications:

• Breast carcinoma
• Gastric carcinomas
• Malignant lymphomas 
• Soft tissue sarcomas
• Advanced colorectal carcinoma 
• Malignant melanoma
• Lung cancer
• Ovarian cancer 

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients 
• Hypersensitivity to other anthracyclines or anthracenediones
• Pregnancy
• Breastfeeding
• Severe hepatic impairment
• Persistent myelosuppression
• Severe myocardial insufficiency
• Recent myocardial infarction
• Severe arrhythmias
• Previous treatments with maximum cumulative doses of epirubicin and/or other anthracyclines and anthracenediones
• Acute systemic infections
• Unstable angina pectoris
• Myocardiopathy
• Acute inflammatory heart diseases

Cautions

• Renal impairment
• Mild to moderate hepatic impairment
• Elderly
• High doses
• Cardiovascular risk factors
• Injection into a small vessel 
• Repeated injections into the same vein
• Men and women of child bearing potential

Forms avail. in SA and covered in this monograph:

Used for the treatment of

Breast carcinoma
Gastric carcinomas
Malignant lymphomas 
Soft tissue sarcomas
Advanced colorectal carcinoma 
Malignant melanoma
Lung cancer (additional agent required)
Ovarian cancer (additional agent required)

Consult specialist for dosages and regimens

Not established for use in children

Pregnancy

• FDA Pregnancy Category D

Breastfeeding

• Contraindicated

Renal Impairment

• Caution; dose adjustment recommended

Hepatic Impairment

• Mild to moderate: Caution; dose adjustment recommended
• Severe: Contraindicated

Elderly

• Caution; no dose adjustment recommended

Central Nervous System Disorders

• Dizziness
• Malaise
• Asthenia

Cardiovascular Disorders

• Congestive cardiac failure 
• Cardiotoxicity 
• ECG abnormalities
• Arrhythmias
• Cardiomyopathy
• Ventricular tachycardia
• Bradycardia
• Atrioventricular block
• Bundle-branch block
• Hot flushes
• Phlebitis
• Thrombophlebitis
• Shock
• Thromboembolism
• Asymptomatic decreases in left ventricular ejection fraction 

Respiratory Disorders

• Pneumonia

Gastrointestinal Disorders

• Mucositis
• Stomatitis
• Nauseas and vomiting
• Diarrhoea
• Loss of appetite 
• Abdominal pain
• Oral pain
• Mucosal burning sensation
• Oesophagitis
• Gastric erosion and ulcers
• Gastrointestinal haemorrhage
• Hyperpigmentation of the oral mucous membranes

Hepatobiliary Disorders

• Changes in transaminase levels

Genitourinary Disorders

• Red colouration of urine 
• Amenorrhoea
• Azoospermia
• Chemical cystitis

Endocrine and Metabolic Disorders

• Loss of appetite
• Dehydration
• Hyperuricemia

Skin and Subcutaneous Tissue Disorders

• Phlebosclerosis
• Infusion site erythema
• Tissue necrosis
• Local pain
• Severe cellulitis
• Alopecia
• Local skin and tissue toxicity
• Rash
• Pruritus
• Skin changes
• Erythema
• Flushes
• Skin and nail hyperpigmentation
• Photosensitivity
• Hypersensitivity to irradiated skin 
• Urticaria

Immune, Blood and Lymphatic System Disorders

• Infection
• Septic shock
• Sepsis
• Acute lymphocytic leukaemia
• Acute myelogenous leukaemia
• Myelosuppression 
• Haemorrhage and tissue hypoxia
• Anaphylaxis 
• Allergic reactions 
• Fever
• Chills

Sensory Disorders

• Conjunctivitis
• Keratitis

• Cardiotoxic agents 
• Radiotherapy 
• Live vaccines
• Cimetidine
• Paclitaxel 
• Dexverapamil 
• Docetaxel 
• Quinine 
• Interferon α2b 
• Agents which affects the bone marrow
• Dexrazoxane

• Full blood count with differential
• Hepatic function
• Renal function
• Electrolytes
• ECG
• Echocardiogram/ Multiple-Gated Acquisition scan

The mechanism of action of epirubicin is related to its ability to bind to DNA. Cell culture studies have shown rapid cell penetration, localisation in the nucleus and inhibition of nucleic acid synthesis and mitosis.

Injection (per 5ml) 10mg

• Accord Epirubicin (Accord)
• Aspen Epirubicin (Pharmacare)
• Epicord (Accord)
• Epirubicin Hexal (Sandoz)
• Epirubicin-Lemery 10mg (Teva Pharma) (Discontinued: 23/11/2021)

Injection (per 25ml) 50mg

• Accord Epirubicin (Accord)
• Aspen Epirubicin (Pharmacare)
• Epicord (Accord)
• Epirubicin Hexal (Sandoz)
• Epirubicin-Lemery 50mg (Teva Pharma) (Discontinued: 23/11/2021)

Injection (per vial) 10mg

• Aspen Epirubicin 10ml vial powder for reconstitution (Pharmacare)

Injection (per vial) 50mg

• Aspen Epirubicin 30ml vial powder for reconstitution (Pharmacare)
• Epirubicin-Lemery (Teva Pharma)