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  • Epirubicin “Ebewe” 2 mg/ml
    / Novartis


    Active Ingredient
    Epirubicin HCl 2 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    5 ml

    partial basket chart 75113 5438

    Vial

    25 ml

    partial basket chart 75114

    Related information


    Dosage

    Epirubicin injection is administered to patients by intravenous infusion.
    Epirubicin is given in repeated 3 to 4-week cycles. The total dose of epirubicin may be given on Day 1 of each cycle or divided equally and given on Days 1 and 8 of each cycle. To minimize the risk of thrombosis or perivenous extravasation. The usual infusion times range between 3 and 20 minutes depending upon dosage and volume of the infusion solution. The needle should be properly placed in the vein. This reduces the risk of thrombosis and extravasation that could lead to severe cellulitis and necrosis. In case of extravasation, administration should be stopped immediately. Injection in small veins and repeated injection in the same vein can lead to venous sclerosis.
    See prescribing information for full details.


    Indications

    For the treatment of a wide spectrum of neoplastic diseases including breast carcinoma, lung carcinoma (high doses), ovarian carcinoma, gastric carcinomas, soft tissue sarcoma.
    IV administration for the treatment of advanced bladder carcinoma.
    Intravesical (transitional cell carcinoma, carcinoma in – situ) and in the prophylaxis of recurrences after transurethral resection.


    Contra-Indications

    Hypersensitivity to epirubicin or any other component of the product, other anthracyclines or anthracenediones. Lactation.
    Intravenous use:
    – persistent myelosuppression
    – severe hepatic impairment
    – severe myocardial insufficiency (including 4th degree muscular
    heart failure, acute heart attack and previous heart attack which led to 3rd and 4th degree muscular heart failure, acute inflamma- tory heart diseases)
    – recent myocardial infarction
    – severe arrhythmias
    – previous treatments with maximum cumulative doses of epirubicin and/or other anthracyclines and anthracenediones.
    – patients with acute systemic infections
    – unstable angina pectoris
    – cardiomyopathy
    Intravesical use:
    – urinary tract infections
    – inflammation of the bladder
    – hematuria
    – invasive tumours penetrating the bladder
    – catheterization problems
    – large volume of residual urine
    – contracted bladder.


    Special Precautions

    See prescribing information for full details.


    Side Effects

    The most common undesirable effects are myelosuppres- sion, gastrointestinal side effects, anorexia, alopecia, infection.
    See prescribing information for full details.


    Drug interactions

    Heparin, anticytostatic agents, alkaline solutions.


    Pregnancy and Lactation

    Pregnancy: Women of child-bearing potential should be advised to avoid becoming pregnant during treatment and should use effective contraceptive methods.
    Experimental data in animals suggest that epirubicin may cause fetal harm when administered to a pregnant woman. If epirubicin is used during pregnancy (particularly in the first trimester) or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus and the cytostatic drugs should only be used on strict indication and when the potential benefits to the mother have been weight against possible risks of adverse effects on reproduction.
    There are no studies in pregnant women. Epirubicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
    Lactation: It is not known whether epirubicin is excreted in human milk.
    Because many drugs, including other anthracyclines, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from epirubicin, mothers should discontinue nursing prior to taking this drug.


    Overdose

    Acute overdosage with epirubicin will result in severe myelosuppression (mainly leukopenia and thrombocytopenia), gastrointestinal toxic effects (mainly mucositis) and acute cardiac complications.
    During this period a blood transfusion is required as well as isolation in a sterile room. Latent cardiac failure has been observed with anthracyclines several months to years after completion of treatment. Patients must be carefully monitored. If signs of cardiac failure occur, patients should be treated according to conventional guidelines.
    Treatment: Symptomatic. Epirubicin cannot be removed by dialysis.


    Manufacturer
    Ebewe Pharma
    Licence holder
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