Contraindications
IV: Severe persistent myelosuppression, severe stomatitis associated by previous drug treatment or radiotherapy; acute systemic infections, 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; UTI, catherisation problems, haematuria. Lactation.
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Special Precautions
Patient with active, dormant or history of CV disease; previous or concurrent radiotherapy to the mediastinal or pericardial area; rapid tumour proliferation. Avoid concurrent vaccination with live vaccines. Mild to moderate hepatic impairment. Pregnancy. Monitoring Parameters Confirm pregnancy status before treatment initiation in females of reproductive potential. Monitor CBC with differential and platelet count, LFTs (ALT, AST, total bilirubin), serum creatinine, cardiac function (LVEF using ECG or multi-gated radionuclide angiography [MUGA]) before and periodically during treatment; serum electrolytes (e.g. Ca, K, phosphate), and uric acid. Assess for signs of extravasation or infusion-related reactions; signs and symptoms of tumour lysis syndrome and secondary malignancies.
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Adverse Reactions
Significant: Cardiomyopathy (including acute left ventricular failure), secondary malignancy (e.g. acute myeloid leukaemia, myelodysplastic syndrome), extravasation (may lead to severe local tissue injury and necrosis), tumour lysis syndrome resulting to hyperuricaemia, radiation recall (in patients who received prior radiation therapy).
Blood and lymphatic system disorders: Anaemia, leucopenia, granulocytopenia, neutropenia, thrombocytopenia, febrile neutropenia.
Cardiac disorders: Bradycardia, ventricular tachycardia, arrhythmias, atrioventricular and bundle branch block, congestive heart failure.
Eye disorders: Keratitis, infective conjunctivitis.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea stomatitis, mucositis, oesophagitis, gastrointestinal pain, haemorrhage, erosion and ulcer.
General disorders and administration site conditions: Fever, chills, lethargy, infusion site erythema, anaphylaxis.
Investigations: Abnormal transaminase values.
Metabolism and nutrition disorders: Decrease in appetite, dehydration, hyperuricaemia.
Nervous system disorders: Dizziness.
Renal and urinary disorders: Red colouration of urine for 1-2 days. Intravesical: increased frequency of urination, chemical and haemorrhagic cystitis, dysuria, haematuria, strangury, bladder constriction.
Reproductive system and breast disorders: Amenorrhoea. Rarely, azoospermia.
Skin and subcutaneous tissue disorders: Pruritus, rash, skin and nail hyperpigmentation, alopecia.
Vascular disorders: Hot flushes, phlebitis.
Potentially Fatal: Severe myelosuppression (resulting in serious infection, septic shock), thromboembolic events (e.g. thrombophlebitis, pulmonary embolism). |
Drug Interactions
Increased risk of cardiotoxicity with other antineoplastic agents (e.g. trastuzumab, cyclophosphamide, cisplatin, taxanes) and other cardioactive compounds (e.g. calcium channel blockers). Additive cardiotoxic effect with propranolol. Increased occurrence of bone marrow depression when co-administered with dexrazoxane. Increased serum concentration with cimetidine. Increased systemic exposure with paclitaxel (when given immediately after epirubicin). Increased bone marrow depression with dexverapamil. Increased myocardial toxicity with concurrent mediastinal radiotherapy. May disrupt haematopoiesis when co-administered with drugs that can affect bone marrow function (e.g. chloramphenicol, sulphonamide, antiretroviral agents). May decrease clearance and terminal elimination half-life of epirubicin when co-administered with interferon α-2b.
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CIMS Class
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ATC Classification
L01DB03 - epirubicin ; Belongs to the class of cytotoxic antibiotics, anthracyclines and related substances. Used in the treatment of cancer.
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