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  • Alexan
    / Novartis


    Active Ingredient
    Cytarabine 20 mg/ml, 50 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    5 ml X 20 mg/ml

    partial basket chart 88440 9295

    Vial

    20 ml X 50 mg/ml

    partial basket chart 71818 9804

    Vial

    40 ml X 50 mg/ml

    partial basket chart 88441 9296

    Related information


    Dosage

    Effective plasma levels are assumed to range between 0.01 and 0.15 μg/ml. The dose must be determined exactly for each individual patient, ideally in relation to the body surface area (BSA).
    See prescribing information for full details.


    Indications

    For induction and maintenance of clinical remission in patients with acute myeloid leukaemia, acute nonlymphoblastic leukaemias, acute lymphoblastic leukaemias, blast crises of chronic myeloid leukaemia, diffuse histiocytic lymphomas (non-Hodgkin’s lymphomas of high malignancy).


    Contra-Indications

    – Patients with existing bone marrow suppression should be excluded from treatment with cytarabine, unless the physician considers that the benefit of such treatment outweighs the risks for the individual patient.
    – Known hypersensitivity to cytarabine or to any other ingredient of the medicinal product.
    – Leukopenia and/or thrombocytopenia of non-malignant origin are also a contraindication.
    – High-dose therapy with cytarabine in patients older than 60 years should only be carried out after carefully weighing the benefits and risks.
    – Patients with severe hepatic and/or renal impairment, underlying serious infections, gastrointestinal ulcerations and patients who have recently undergone surgery.
    – Pregnancy and lactation.


    Special Precautions

    Pre-existing drug-induced bone marrow suppression. Leukocyte and platelet counts performed daily. Bone marrow examinations should be performed frequently after blasts have disappeared from the peripheral blood. Contraceptive measures, monitor closely. Hepatic dysfunction. Acute pancreatitis. Patients on high-dose: neuropathy.
    See prescribing information for full details.


    Side Effects

    Anemia, leukopenia, thrombocytopenia, megaloblastosis, reduced reticulocytes.
    High dose therapy: myelotoxicity. Infectious complications. GI disturbances. Toxic skin reactions in the form of maculopapular exanthemas, erythrodermias or erythemas can be observed. Alopecia may occur. Myalgias and/or arthralgias in the region of the neck and the legs after high doses, conjunctivitis, keratitis, photophobia, burning eyes, strong lacrimation, impaired vision, liver damage, increased plasma creatinine.
    See prescribing information for full details.

     


    Drug interactions

    In patients who had previously undergone therapy with L-asparaginase, acute pancreatitis may occur during treatment with cytarabine.
    Myelotoxic interactions with other treatment methods which have a toxic effect on the bone marrow (especially treatment with other cytotoxic agents and radiation therapy) must be expected according to the respective comedication.
    In individual cases, cytarabine has been shown to reduce the antimycotic efficacy of flucytosine.
    Digoxin: combination chemotherapy (including cytarabine) may decrease digoxin absorption even days after discontinuing chemotherapy. Digitoxin does not seem to be affected.


    Pregnancy and Lactation

    Alexan must not be given to pregnant and breastfeeding women.
    See prescribing information for full details.


    Overdose

    An antidote against cytarabine has not yet been established.
    If toxic reactions occur, immediate discontinuation of high-dose cytarabine therapy and careful patient monitoring are essential.
    Chronic overdose may lead to severe bone marrow depression, including massive haemorrhages, lifethreatening infections and neurotoxicity.
    Myelotoxicity is a dose-limiting factor of cytarabine. Therapy with cumulative doses of approximately 18 to 36 g cytarabine per treatment course, severe myelotoxicity progressing to myelophthisis must be expected, the full clinical symptoms of which become manifest only after 1 or 2 weeks. It is dependent both on the dosage and on other factors including a patient’s age, clinical condition and bone marrow reserves as well as any additional myelotoxic therapy. Therefore, if overdosage is suspected, careful monitoring of hematological parameters over a prolonged period is essential. Since no effective antidote has yet been established, utmost care must be exercised with any form of administration. Effective supportive measures (e.g. blood transfusion, antibiotic treatment) must be taken in case of overdosage. If accidental severe overdosing occurs during intrathecal administration, the cerebrospinal fluid must be immediately replaced with isotonic sodium chloride solution.
    Cytarabine is haemodialysable. However, no data are available as to the effect in case of overdosage.
    Doses of 4.5 g/m² by I.V. infusion over 1 hour every 12 hours for 12 doses have caused an unacceptable increase in irreversible CNS toxicity and death.


    Manufacturer
    Ebewe Pharma
    Licence holder
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