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  • Fludarabin “Ebewe” 50 mg / 2 ml
    / Novartis

    Active Ingredient
    Fludarabine Phosphate 50 mg / 2 ml

    Status in Israel

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    Presentation Basket Yarpa Pharmasoft


    2 ml

    partial basket chart 88439 6415

    Related information


    Chronic Lymphocytic Leukemia (CLL): The recommended adult dose is 25 mg/m² administered intravenously over a period of approximately 30 minutes daily for five consecutive days.
    Each 5-day course of treatment should commence every 28 days.
    Renal Insufficiency: Adult patients with moderate impairment of renal function (creatinine clearance 30 to 70 mL/min/1.73 m²) should have 20% dose reduction.
    – Not indicated in patients with severe renal impairment.
    Use of Infusion Solutions: Fludarabine Phosphate Injection contains no antimicrobial preservative and should be used within 8 hours of opening. Care must be taken to assure sterility of infusion solutions. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
    See prescribing information for full details.


    Palliative treatment of patients with CLL refractory to other therapy. Treatment of less malignant Non-Hodgkin lymphoma of stage 3 to 4 in patients who have not responded to standard therapy with at least one alkylating agent or in whom the disease progressed during or after standard therapy. Fludarabine is indicated for the initial treatment of patients with B-cell chronic lymphocytic leukaemia (CLL) or after first line therapy, in patients with sufficient bone marrow reserves.



    Special Precautions

    See prescribing information for full details.

    Side Effects

    The most common adverse reactions include myelosuppression (neutropenia, thrombocytopenia and anemia), fever and chills, infection, and nausea and vomiting. Other commonly reported events include malaise, fatigue, anorexia, and weakness.
    Serious opportunistic infections have occurred in CLL patients treated with fludarabine phosphate.
    See prescribing information for full details.

    Drug interactions

    Pentostatin: The use of Fludarabine Phosphate Injection in combination with pentostatin is not recommended due to the risk of severe pulmonary toxicity.

    Pregnancy and Lactation

    Pregnancy: Category D.
    Lactation: It is not known whether fludarabine phosphate is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions including tumorigenicity in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug for the mother.


    High doses of fludarabine phosphate have been associated with an irreversible central nervous system toxicity characterized by delayed blindness, coma and death. High doses are also associated with severe thrombocytopenia and neutropenia due to bone marrow suppression. There is no known specific antidote for fludarabine phosphate overdosage.
    Treatment consists of drug discontinuation and supportive therapy.

    Ebewe Pharma
    Licence holder