Ebetaxel 6 mg/ml

/ Novartis

First-line chemotherapy of ovarian cancer: Since other dosage regimens have not yet been evaluated, the recommended firstline treatment of ovarian cancer is 135 mg/m² of paclitaxel as an infusion over 24 hours, followed by 75 mg/m² of cisplatin and a therapy-free interval of three weeks.
Second-line chemotherapy of ovarian and metastatic breast cancer: The recommended dosage is 175 mg/m² of paclitaxel, given as an intravenous infusion. Paclitaxel should be administered as a three-hour infusion, with an interval of three weeks between therapy courses.
Adjuvant therapy of node-positive breast cancer: EBETAXEL® 175 mg/m² administered intravenously over 3 hours every 3 weeks for 4 courses sequentially to standard combination therapy containing doxorubicin.
Advanced non-small cell lung cancer: The recommended regimen, given every 3 weeks, is EBETAXEL® administered intravenously over 24 hours at a dose of 135 mg/m² followed by cisplatin 75 mg/m².
Kaposi’s sarcoma: EBETAXEL® 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 45-50 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).
Advanced gastric carcinoma: EBETAXEL® administered at a dose of 210 mg/m² given intravenously over 3 hours every 3 weeks.
Dose adjustment during treatment: Treatment courses with paclitaxel may be repeated only if blood counts with at least 1,000/mm³ of neutrophils and at least 75,000/mm³ of platelets have been reached.
In patients who exhibit severe neutropenia (neutrophils <500/mm³ over a one-week period or longer) or severe peripheral neuropathies during paclitaxel therapy, subsequent dosing should be reduced by 25% to 75 mg/m².
Special therapeutic groups
Patients with hepatic insufficiency: Studies in patients with hepatic dysfunction have not been performed. The available data are insufficient to recommend a dose adjustment for these patients. Paclitaxel should not be administered to patients with severe hepatic dysfunction.
Patients with renal insufficiency: Studies in patients with renal impairment have not been performed. There are no sufficient data for dosage recommendations.
Paediatric use: Studies demonstrating the safety and efficacy of paclitaxel in children and adolescents (below 18 years of age) have not been performed. Paclitaxel is therefore not recommended for paediatric use.
Elderly patients:Studies demonstrating the safety and efficacy of paclitaxel in elderly patients (over 65 years of age) have not been performed. Paclitaxel is therefore not recommended for use in elderly patients.
Subsequent dosing of paclitaxel depends on individual patient tolerance levels.
Treatment with paclitaxel should only be continued after blood counts with at least 1,500/mm³ of neutrophils and at least 100,000/mm³ of platelets have been achieved. If patients develop severe neutropenia (with neutrophils <500/mm3 for 7 days or longer) or severe peripheral neuropathy, dosage should be reduced by 20% in subsequent courses.
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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 containdicated. For the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. 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. Kaposis’s sarcoma: In the second-line treatment of AIDS related Kaposi’s sarcoma. For the treatment of advanced gastric carcinoma.

Patients who have shown severe hypersensitivity to either paclitaxel or any of the excipients, or to macrogol glycerol ricinoleate, and patients with an initial blood count of <1,500 mm³ of neutrophils. Pregnancy. Discontinue breast feeding before treatment.
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All patients must undergo prior treatment with corticosteroids, antihistaminic agents and H₂ antagonists. Regular monitoring of the cardiac function must be performed throughout therapy. Frequent monitoring of hematological parameters. Dental treatment should only be carried out in exceptional cases. Should not be administered to patients with severe hepatic dysfunction. Herpes zoster, varicella zoster, serious infections or bone marrow depression. Immunization with live virus vaccines should be avoided.
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Infections and infestations. Blood and lymphatic system disorders. Immune system disorders. Cardiac disorders. GI disorders. Alopecia, arthralgia and myalgia, injection site reactions.
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Administer before cisplatin, protease inhibitors (ritonavir, saquinar, indinavir and nelfinavir). Special care must be exercised when using in combination with known substrates or inhibitors of CYP3A4. Immunization with live virus vaccines should be avoided.