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  • Paclitaxel Teva
    / Salomon, Levin & Elstein Ltd


    Active Ingredient
    Paclitaxel 6 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 x 30 mg / 50 ml

    partial basket chart 15930 16769

    Vial

    1 x 100 mg / 16.7 ml

    partial basket chart 15928 16768

    Vial

    1 x 300 mg / 50 ml

    partial basket chart 15927 16849

    Related information


    Dosage

    Note: Contact of the undiluted concentrate with plasticized PVC equipment or devices used to prepare solutions for infusion is not recommended. In order to minimize patient exposure to the plasticizer DEHP [di-(2-ethylhexyl)phthalate], which may be leached from PVC infusion bags or sets, diluted paclitaxel solutions should be stored in bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene-lined administration sets. All patients must be premedicated prior to paclitaxel administration in order to reduce the risk of severe hypersensitivity reactions. Such premedication may consist of dexamethasone 20 mg PO administered approximately 12 and 6 hours before paclitaxel, or 20 mg I.V. approximately 30 to 60 minutes before paclitaxel, diphenhydramine (or its equivalent) 50 mg IV 30 to 60 minutes prior to paclitaxel, and cimetidine (300 mg) or ranitidine (50 mg) IV 30 to 60 minutes before paclitaxel.
    For patients with carcinoma of the ovary, the following regimens are recommended:
    1) For previously untreated patients with carcinoma of the ovary, the recommended regimen given every 3 weeks is Paclitaxel Teva administered intravenously over 24 hours at a dose of 135 mg/m2 followed by cisplatin at a dose of 75 mg/m2.
    2) In patients previously treated with chemotherapy for carcinoma of the ovary, paclitaxel has been used at several doses and schedules; however, the optimal regimen is not yet clear. The recommended regimen is Paclitaxel Teva 135 mg/m2 or 175 mg/m2 administered intravenously over 3 hours every 3 weeks.
    For patients with carcinoma of the breast, the following regimens are recommended:
    1) Adjuvant therapy: Paclitaxel Teva 175 mg/m2 administered intravenously over 3 hours every 3 weeks for 4 courses sequentially to standard combination therapy.
    2) Metastatic breast cancer after failure of combination chemotherapy: Paclitaxel at a dose of 175 mg/m2 administered intravenously over 3 hours every 3 weeks has been shown to be effective after failure of chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.
    For patients with non-small cell lung carcinoma, the recommended regimen, given every 3 weeks, is Paclitaxel Teva administered intravenously over 24 hours at a dose of 135mg/m2 followed by cisplatin, 75 mg/m2.
    For patients with AIDS-related Kaposi’s sarcoma, Paclitaxel Teva administered at a dose of 135 mg/m2 given intravenously over 3 hours every 3 weeks or at a dose of 100 mg/m2 given intravenously over 3 hours every 2 weeks is recommended (dose intensity 45 to 50 mg/m2/week). In two clinical trials evaluating these schedules, the former schedule (135 mg/m2 every 3 weeks) was more toxic than the latter. In addition, all patients with low performance status were treated with the latter schedule (100 mg/m2 every 2 weeks).
    Based upon the immunosuppression in patients with advanced HIV disease, the following modifications are recommended in these patients:
    1) Reduce the dose of dexamethasone as one of the three premedication drugs to10 mg PO (instead of 20 mg PO);
    2) Initiate or repeat treatment with paclitaxel only if the neutrophil count is at least 1000 cells/mm3;
    3) Reduce the dose of subsequent courses of paclitaxel by 20% for patients who experience severe neutropenia (neutrophil < 500 cells/mm3 for a week or longer); and
    4) Initiate concomitant hematopoietic growth factor (G-CSF) as clinically indicated.
    For the therapy of patients with solid tumors (ovary, breast and NSCLC), courses of paclitaxel should not be repeated until the neutrophil count is at least 1500 cells/mm3and the platelet count is at least 100,000 cells/mm3. Paclitaxel should not be given to patients with AIDS-related Kaposi’s sarcoma if the baseline or subsequent neutrophil count is less than 1000 cells/mm3. Patients who experience severe neutropenia (neutrophil < 500 cells/mm3 for a week or longer) or severe peripheral neuropathy during paclitaxel therapy should have dosage reduced by 20% for subsequent courses of paclitaxel. The incidence of neurotoxicity and the severity of neutropenia increase with dose within a regimen.
    For full details see prescribing information.


    Indications

    Ovarian carcinoma: Alone or in combination, for the treatment of advanced carcinoma of the ovary.
    Breast carcinoma: Adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. For the treatment of metastatic breast cancer after failure of combination chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
    Advanced non small cell lung cancer: Associated with cisplatin, for treatment of patients who are not candidates for potentially curative surgery and/or radiation therapy.
    Kaposi’s sarcoma: Second-line treatment of AIDS related Kaposi’s sarcoma.


    Contra-Indications

    Severe hypersensitivity to paclitaxel or to any excipient, especially macrogolglycerol ricinoleate. Pregnancy and lactation. Patients with baseline neutrophils <1,500/mm3 (<1,000/mm3 for Kaposi’s sarcoma patients). In Kaposi’s sarcoma, also contraindicated in patients with concurrent, serious, uncontrolled infections.


    Special Precautions

    See prescribing information for full details.


    Side Effects

    See prescribing information for full details.


    Drug interactions

    See prescribing information for full details.


    Manufacturer
    Pharmachemie, Teva Group (S.L.E)
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