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  • PacliAvenir
    / BioAvenir


    Active Ingredient
    Paclitaxel 6 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    10 X 30 mg / 5 ml

    partial basket chart 10415 16683

    Vial

    5 X 100 mg / 16.7 ml

    partial basket chart 10416 16684

    Vial

    4 X 300 mg / 50 ml

    partial basket chart 10417 16685

    Related information


    Dosage

    PACLIAVENIR SOLUTION FOR INJECTION should be administered through an in-line filter with a microporous membrane not greater than 0.22 microns.
    All patients should be premedicated prior to PACLIAVENIR SOLUTION FOR INJECTION administration in order to prevent hypersensitivity reactions. Such premedication may consist of dexamethasone 20 mg orally (or its equivalent) approximately 12 to 6 hours before PACLIAVENIR SOLUTION FOR INJECTION, diphenhydramine 50 mg I.V. (or its equivalent), 30 to 60 minutes prior to PACLIAVENIR SOLUTION FOR INJECTION, and cimetidine (300 mg) or ranitidine (50 mg) IV 30 to 60 minutes before PACLIAVENIR SOLUTION FOR INJECTION.
    PACLIAVENIR SOLUTION FOR INJECTION must be diluted prior to infusion.
    PACLIAVENIR SOLUTION FOR INJECTION is a cytotoxic anticancer drug and, as with other potentially toxic compounds, caution should be exercised in handling PACLIAVENIR SOLUTION FOR INJECTION. The use of gloves is recommended.
    Following topical exposure, tingling, burning, redness have been observed. If PACLIAVENIR SOLUTION FOR INJECTION solution contacts the skin, wash the skin immediately and thoroughly with soap and water. If PACLIAVENIR SOLUTION FOR INJECTION solution contacts mucous membranes, the membranes should be flushed thoroughly with water. Upon inhalation, dyspnea, chest pain, burning eyes, sore throat and nausea have been reported.
    Injection site reaction: Injection site reactions, including reactions secondary to extravasation, were usually mild and consisted of erythema, tenderness, skin discoloration, or swelling at the injection site. It is advisable to closely monitor the infusion site for possible infiltration during drug administration.
    Advanced Carcinoma of the Ovary: For previously untreated patients with carcinoma of the ovary, PACLIAVENIR SOLUTION FOR INJECTION is administered intravenously at 21 day intervals by a continuous infusion over 24 hours at a dose of 135 mg/m² followed by a dose of cisplatin at a dose of 75 mg/m2. In patients previously treated using chemotherapy for carcinoma of the ovary, PACLIAVENIR SOLUTION FOR INJECTION is administered at 21 day intervals over 3 hours at a dose of 135 mg/m² or 175 mg/m².
    Breast carcinoma: Adjuvant Treatment of Node-Positive Breast Cancer PACLIAVENIR SOLUTION FOR INJECTION is administered intravenously at 21 day intervals, by continuous infusion over 3 hours at a dose of 175 mg/m², for four courses administered sequentially to doxorubicin-containing combination therapy.
    For patients with advanced metastatic breast cancer, PACLIAVENIR SOLUTION FOR INJECTION is administered intravenously by continuous infusion over 3 hours at a dose of 175 mg/m² at 21 day intervals. Single courses of PACLIAVENIR SOLUTION FOR INJECTION should not be repeated until the neutrophil count is at least 1,500 cells/mm³ and the platelet count is at least 100,000 cells/mm³.
    Patients who experience severe neutropenia (neutrophil <500 cells/mm³) or severe peripheral neuropathy during PACLIAVENIR SOLUTION FOR INJECTION therapy should have the dosage reduced by 20% for subsequent courses of PACLIAVENIR SOLUTION FOR INJECTION.
    Non-Small Cell Lung Carcinoma: For patients with non-small cell lung carcinoma, PACLIAVENIR SOLUTION FOR INJECTION is administered intravenously by continuous infusion over 24 hours at a dose of 135 mg/m² followed by cisplatin, 75mg/m² at 21 day intervals.
    Single courses of PACLIAVENIR SOLUTION FOR INJECTION should not be repeated until the neutrophil count is at least 1,500 cells/mm³ and the platelet count is at least 100,000 cells/mm³. Patients who experience severe neutropenia (neutrophil <500 cells/mm³) or severe peripheral neuropathy during PACLIAVENIR SOLUTION FOR INJECTION therapy should have the dosage reduced by 20% for subsequent courses of PACLIAVENIR SOLUTION FOR INJECTION.
    AIDS Related Kaposi’s Sarcoma: Paclitaxel is administered intravenously at either 21 day intervals over 3 hours at a dose of 135 mg/m², or at 14 day intervals over 3 hours at a dose of 100 mg/m² (dose intensity 45-50 mg/m²
    /week). As with any patient showing signs of immunosuppression, the following modifications are recommended: Reduce dexamethasone premedication from 20 mg PO to 10 mg PO, initiate or repeat treatment with Paclitaxel only if the neutrophil count is at least 1000 cells/mm³, reduce the dose of subsequent courses of Paclitaxel by 20% for patients who experience neutrophil counts of <500 cells/mm³ for a week or longer, and initiate concomitant hematopoietic growth factor as clinically indicated.
    For patients with Gastric Carcinoma: Paclitaxel 210 mg/m² administered intravenously over 3 hours every 3 weeks. The dosage should be decreased according to patient’s age and performance status. Single courses of PACLIAVENIR SOLUTION FOR INJECTION should not be repeated until the neutrophil count is at least 1,500 cells/mm³ and the platelet count is at least 100,000 cells/mm³. Patients who experience severe neutropenia (neutrophil <500 cells/mm³) or severe peripheral neuropathy during PACLIAVENIR SOLUTION FOR INJECTION therapy should have the dosage reduced by 20% for subsequent courses of PACLIAVENIR SOLUTION FOR INJECTION.


    Indications

    Paclitaxel is indicated alone or in combination, for the treatment of advanced carcinoma of the ovary.
    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: Paclitaxel, associated with cisplatinum is indicated for the treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy.
    Keposi’s sarcoma: Paclitaxel is indicated in the second-line treatment of AID’S related Kaposi’s sarcoma.
    Paclitaxel is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy.
    For the treatment of advanced gastric carcinoma.


    Contra-Indications

    Paclitaxel is contraindicated in patients who have a history of severe hypersensitivity reactions to paclitaxel or other drugs formulated in Polyoxyl 35 castor oil.
    Paclitaxel should not be used in patients with severe baseline neutropenia (<1 500 cells/mm³).
    Paclitaxel is contraindicated in patients with severe hepatic impairment.
    Paclitaxel is also contraindicated in patients with concurrent, serious, uncontrolled infections.


    Manufacturer
    Biolyse Pharma Corporation
    Licence holder
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