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  • BENDAMUSTINE MEDAC 25, 100 mg
    / Tzamal


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Powder for concentrate for solution for IV infusion

    1×25 mg

    VIAL

    not in the basket chart

    Powder for concentrate for solution for IV infusion

    1×100 mg

    VIAL

    not in the basket chart

    Dosage

    Monotherapy for chronic lymphocytic leukaemia 100 mg/m² body surface area bendamustine hydrochloride on days 1 and 2; every 4 weeks up to 6 times.
    Monotherapy for indolent non-Hodgkin’s lymphomas refractory to rituximab 120 mg/m² body surface area bendamustine hydrochloride on days 1 and 2; every 3 weeks for at least 6 times.
    Follicular non-Hodgkin’s lymphoma: Combination with rituximab -The dose is 90 mg/m² body surface area bendamustine hydrochloride on days 1 and 2 plus 375 mg/m² rituximab on day 1; repetition every 4 weeks.
    Hepatic impairment
    On the basis of pharmacokinetic data, no dose adjustment is necessary in patients with mild hepatic impairment (serum bilirubin < 1.2 mg/dl). A 30% dose reduction is recommended in patients with moderate hepatic impairment (serum bilirubin 1.2 – 3.0 mg/dl).
    No data is available in patients with severe hepatic impairment (serum bilirubin values of > 3.0 mg/dl).
    Renal impairment
    On the basis of pharmacokinetic data, no dose adjustment is necessary in patients with a creatinine clearance of > 10 ml/min. Experience in patients with severe renal impairment is limited.
    Paediatric population
    The safety and efficacy of bendamustine hydrochloride in children have not yet been established. Current available data is not sufficient to make a recommendation on posology.
    Elderly patients
    There is no evidence that dose adjustments are necessary in elderly patients.
    Method of administration
    For intravenous infusion over 30 – 60 minutes.
    Infusion must be administered under the supervision of a physician qualified and experienced in the use of chemotherapeutic agents.
    Poor bone marrow function is related to increased chemotherapy-induced haematological toxicity. Treatment should not be started if leukocyte and/or platelet values have dropped to < 3,000/μl or < 75,000/μl, respectively.
    Treatment can be continued after leukocyte values have increased to > 4,000/μl and platelet values to > 100,000/μl.
    The leukocyte and platelet Nadir is reached after 14-20 days with regeneration after 3-5 weeks. During therapy free intervals strict monitoring of the blood count is recommended. In case of non-haematological toxicity dose reductions have to be based on the worst CTC grades in the preceding cycle. A 50% dose reduction is recommended in case of CTC grade 3 toxicity. An interruption of treatment is recommended in case of CTC grade 4 toxicity.
    If a patient requires a dose modification the individually calculated reduced dose must be given on day 1 and 2 of the respective treatment cycle. Please refer to the license holder for further details.


    Indications

    First-line of chronic lymphocytic leukaemia (Binet stage B or C) in patients for whom fludarabine combination chemotheraphy is not appropiate. Indolent non-Hodgkin’s lymphomas as monotheraphy in patients, who have progressed during or within 6 months following treatment with rituximab or a rituximab containing regimen. Follicular non-Hodgkin’s lymphoma as first line treatment in combination with rituximab.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.
    Lactation.
    Severe hepatic impairment (serum bilirubin > 3.0 mg/dl).
    Jaundice.
    Severe bone marrow suppression and severe blood count alterations (leukocyte and/or platelet values dropped to < 3,000/μl or < 75,000/μl, respectively).
    Major surgery less than 30 days before start of treatment.
    Infections, especially involving leukocytopenia.
    Yellow fever vaccination.


    Manufacturer
    Medac Gesellschaft fur Klinische Spezialpraparate Mbh, Germany
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