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  • Alkeran
    / Perrigo


    Active Ingredient
    Melphalan 2 mg, 50 mg/vial

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Tablets

    25 X 2 mg

    not in the basket chart 177 1199

    Vial

    1 X 50 mg

    not in the basket chart 26836 1645

    Related information


    Dosage

    Tablets:
    Since Alkeran is myelosuppressive, frequent blood counts are essential during therapy and the dosage should be delayed or adjusted if necessary.
    Oral administration in adults: The absorption of Alkeran after oral administration is variable.
    Dosage may need to be cautiously increased until myelosuppression is seen, in order to ensure that potentially therapeutic levels have been reached.
    Multiple myeloma: A typical oral dosage schedule is 0.15mg/kg bodyweight/day in divided doses for 4 days repeated at intervals of six weeks. Numerous regimens have, however, been used and the scientific literature should be consulted for details.
    The administration of oral Alkeran and prednisone may be more effective than Alkeran alone.
    The combination is usually given on an intermittent basis.
    Prolonging treatment beyond one year in responders does not appear to improve results.
    Advanced ovarian adenocarcinoma: A typical regimen is 0.2mg/kg bodyweight/day given orally in divided doses for 5 days. This is repeated every 4 to 8 weeks, or as soon as the bone marrow has recovered.
    Use in children: Alkeran is only rarely indicated in children and absolute dosage guidelines cannot be provided.
    Use in the elderly: Although Alkeran is frequently used at conventional dosage in the elderly, there is no specific information available relating to its administration to this patient sub-group. However, caution should be taken where there is renal impairment.
    Dosage in renal impairment: (see also Special Warnings and Special Precautions for Use). Alkeran clearance, though variable, is decreased in renal impairment.
    Currently available pharmacokinetic data do not justify an absolute recommendation on dosage reduction when administering Alkeran Tablets to patients with renal impairment, but it may be prudent to use a reduced dosage initially until tolerance is established.


    Indications

    Tablets: For the palliative treatment of and for the palliation of non-epithelial carcinoma of the ovary, multiple myeloma.
    Ampoules: For the palliative treatment of multiple myeloma and the palliation of non-rejectable epithelial cancer of the ovary.


    Contra-Indications

    Neutrophil count of less than 1,500/ml, concurrent radio or chemotherapy, low platelet count. Hypersensitivity reaction to melphalan.


    Special Precautions

    Alkeran is an active cytotoxic agent for use under the direction of physicians experienced in the administration of such agents. Careful attention should be paid to the monitoring of blood counts to avoid the possibility of excessive myelosuppression. Patients who have undergone recent radiotherapy or chemotherapy. Clearance may be reduced in patients with renal impairment, who may also have uraemic bone marrow suppression. Dosage reduction may therefore be necessary and these patients should be closely observed. Adequate contraceptive precautions should be practised when either partner is receiving Alkeran. Whenever possible during pregnancy, the potential hazard to the fetus must be balanced against the expected benefit to the mother. Mothers receiving Alkeran should not breast-feed.


    Side Effects

    Bone marrow suppression, leading to leucopenia and thrombocytopenia. Nausea and vomiting in up to 30% of patients. Stomatitis occurs rarely. Urticaria, edema, skin rashes and anaphylactic shock have been reported uncommonly. Maculopapular rashes and pruritis. Reports of fatal pulmonary fibrosis and hemolytic anemia after treatment.
    See prescribing information for full details.


    Drug interactions

    Nalidixic acid together with high-dose I.V. melphalan has caused deaths in children due to hemorrhagic enterocolitis. Impaired renal function has been described in bone marrow transplant patients who were conditioned with high-dose I.V. melphalan and who subsequently received cyclosporin to prevent graft-versus-host disease.


    Manufacturer
    GlaxoSmithKline Manufacturing S.p.A, Parma, Italy Excella GmbH, Germany
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