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  • Cardioxane
    / Megapharm


    Active Ingredient
    Dexrazoxane (HCl) 500 mg/vial

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 X 500 mg

    partial basket chart 26704 3698

    Dosage

    Cardioxane is administered by a short intravenous infusion (15 minutes), approximately 30 minutes prior to anthracycline administration at a dose equal to 10 times the doxorubicin-equivalent dose and 10 times the epirubicin-equivalent dose.
    Thus it is recommended that Cardioxane is given at a dose of 500 mg/m² when the commonly used dosage schedule for doxorubicin of 50 mg/m² is employed or 600 mg/m² when the commonly used dosage schedule for epirubicin of 60 mg/m² is employed.
    Paediatric population: Cardioxane is contraindicated in children and adolescents up to 18 years of age.
    Renal impairment: In patients with moderate to severe renal impairment (creatinine clearance < 40 ml/min) the dexrazoxane dose should be reduced by 50%.
    Hepatic impairment: The dosage ratio should be kept, i.e. if the anthracycline dose is reduced the dexrazoxane dose should be reduced accordingly.
    Method of administration: Intravenous use.


    Indications

    Prevention of cardiotoxicity in adult women with advanced and/or metastatic breast cancer at high risk of heart failure who have received a prior cumulative dose of 300 mg/m2 of doxorubicin or a prior cumulative dose of 540 mg/m2 of epirubicin when further anthracycline treatment is required.


    Contra-Indications

    – Children and adolescents up to 18 years of age.
    – Hypersensitivity to dexrazoxane.
    – Breast-feeding.
    – Concomitant vaccination with yellow fever vaccine.


    Special Precautions

    See prescribing information for full details.


    Side Effects

    The most common adverse reactions are haematological and gastroenterological reactions, primarily anaemia, leukopenia, nausea, vomiting and stomatitis, as well as asthenia and alopecia. Myelosuppressive effects of
    Cardioxane may be additive to those of chemotherapy. An increased risk of the
    development of second primary malignancies, particularly AML, has been reported.
    See prescribing information for full details.


    Drug interactions

    Cardioxane is excreted unchanged via the kidney, as well as metabolized by dihydropyrimidine amidohydrolase (DHPase) in the liver and kidney to ring-opened metabolites. Co-administration of doxorubicin (50 to 60 mg/m²) or epirubicin (60 to 100 mg/m²) did not affect Cardioxane pharmacokinetics
    significantly.
    In studies, Cardioxane did not affect the pharmacokinetics of doxorubicin. There is limited evidence from studies that suggests that epirubicin clearance may be increased when dexrazoxane is pre-administered, this occurred at high doses of epirubicin (120-135 mg/m²).
    Cardioxane may increase haematological toxicity induced by chemotherapy or radiation, requiring careful monitoring of haematological parameters during the first two treatment cycles.
    Cardioxane should not be mixed with any other medicinal products during infusion.
    Concomitant use contraindicated:
    Yellow fever vaccine: Risk of fatal generalised vaccine disease.
    Concomitant use not recommended:
    Other live attenuated vaccines: risk of systemic, possible fatal disease. This risk is increased in subjects who are already immunosuppressed by their underlying disease. Use an inactivated vaccine where this exists (poliomyelitis).
    Phenytoin: cytotoxic agents may reduce the absorption of phenytoin leading to an exacerbation of convulsions. Dexrazoxane is not recommended in combination with phenytoin.
    Concomitant use to assess carefully:
    Ciclosporin, tacrolimus: Excessive immunosuppression with risk of lymphoproliferative disease.


    Pregnancy and Lactation

    Pregnancy: There are no adequate data from the use of dexrazoxane in pregnant women. Animal studies showed embryotoxic and teratogenic effects. The potential risk for humans is unknown. Cardioxane is used with anthracyclines known to have cytotoxic, mutagenic and embryotoxic properties. Cardioxane should not be used during pregnancy unless clearly necessary.
    Breast-feeding: There are no animal studies on the transfer of the active substance and/or its metabolites into milk. It is unknown whether dexrazoxane and/or its metabolites are excreted in human milk. Because of the potential for serious adverse reactions in infants exposed to Cardioxane, breast-feeding is contraindicated during Cardioxane treatment.


    Overdose

    The signs and symptoms of overdose are likely to consist of leucopenia, thrombocytopenia, nausea, vomiting, diarrhoea, skin reactions and alopecia. There is no specific antidote and symptomatic treatment should be provided.
    Management should include prophylaxis and treatment of infections, fluid regulation, and maintenance of nutrition.


    Important notes

    Shelf life: Before opening: 3 years. After reconstitution and dilution: Chemical and physical in-use stability of reconstituted and subsequently diluted Cardioxane is 4 hours at 25°C.
    Storage: Before opening: Do not store above 25°C. In order to protect from light store in the original package.


    Manufacturer
    Cenexi , France
    Licence holder
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