All patients must receive pre-medication treatment with corticosteroids, antihistaminic agents and H2-antagonists prior to paclitaxel therapy: See Table 1.
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Paclitaxel should be administered using a microporous filter with a pore size of 0.22μm (in-line filter)-(see Cautions for Usage: Instructions for Use).
For strictly intravenous infusion after dilution.
First-line chemotherapy of ovarian cancer: Although other dosage regimens are currently being evaluated, a combination therapy with paclitaxel and cisplatin is recommended for first-line treatment of ovarian cancer. Depending on the duration of infusion, two dosage regimens of paclitaxel are recommended: Intravenous administration of 175mg/m² of body surface area (BSA) over 3 hours, followed by 75mg/m² of cisplatin every 3 weeks, or 135mg/m² of paclitaxel as an infusion over 24 hours, followed by 75mg/m² of cisplatin. A therapy-free interval of three weeks is recommended between therapy courses (see Pharmacology: Pharmacodynamics under Actions).
Second-line chemotherapy of ovarian cancer: The recommended dosage is 175 mg/m2 of body surface area, administered as a three-hour infusion, with an interval of three weeks between therapy courses.
First-line chemotherapy of breast cancer: When used in combination with doxorubicin (50 mg/m2), paclitaxel 6 mg/ml should be administered 24 hours after doxorubicin. The recommended dose of paclitaxel is 220 mg/m2 administered intravenously over a period of 3 hours, with a 3-week interval between courses.
In combination with trastuzumab the recommended dosage of paclitaxel is 175mg/m² BSA, administered intravenously over 3 hours, with an interval of 3 weeks between therapy courses (see Pharmacology: Pharmacodynamics under Actions). Paclitaxel infusion may be initiated the day after the first dose of trastuzumab, or immediately after a follow-up dose of trastuzumab if the previous trastuzumab dose was well tolerated (for details on the use of trastuzumab see the SPC for Herceptin).
Second-line chemotherapy of breast cancer: The recommended dosage of paclitaxel is 175 mg/m2 BSA, administered over 3 hours, with an interval of 3 weeks between therapy courses.
Treatment of advanced non-small-cell lung cancer: The recommended dosage of paclitaxel is 175 mg/m2 BSA, administered over 3 hours, followed by 80 mg/m2 of cisplatin, with an interval of 3 weeks between therapy courses.
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 (see Precautions).
Patients with hepatic impairment: inadequate data are available to recommend dosage alterations in patients with mild to moderate hepatic impairments (see Pharmacology: Pharmacokinetics under Actions and Precautions). Patients with severe hepatic impairment should not be treated with paclitaxel.
Paediatric use: Paclitaxel is not recommended for use in children below 18 years due to lack of data on safety and efficacy.