Ebetaxel (Paclitaxel Ebewe) Dosage/Direction for Use

Paclitaxel should only be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents (see Special precautions for disposal and other handling under Cautions for Usage).
All patients must be premedicated with corticosteroids, antihistamines, and H₂ antagonists prior to paclitaxel, e.g.: See table.

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For instructions on dilution of the product before administration, see Special precautions for disposal and other handling under Cautions for Usage. Paclitaxel should be administered intravenously through an in-line filter with a microporous membrane ≤0.22 μm (see Special precautions for disposal and other handling under Cautions for Usage).
First-line chemotherapy of ovarian carcinoma: Although other dose regimens are under investigation, a combination regimen of paclitaxel and cisplatin is recommended.
According to duration of infusion, two doses of paclitaxel are recommended: paclitaxel 175 mg/m² administered intravenously over 3 hours, followed by cisplatin at a dose of 75 mg/m² every three weeks or paclitaxel 135 mg/m², in a 24-hour infusion, followed by cisplatin 75 mg/m², with a 3 week interval between courses (see Pharmacology: Pharmacodynamics under Actions).
Second-line chemotherapy of ovarian carcinoma: The recommended dose of paclitaxel is 175 mg/m² administered over a period of 3 hours, with a 3 week interval between courses.
Adjuvant chemotherapy in breast carcinoma: The recommended dose of paclitaxel is 175 mg/m² administered over a period of 3 hours every 3 weeks for four courses, following AC therapy.
First-line chemotherapy of breast carcinoma: When used in combination with doxorubicin (50 mg/m²), paclitaxel 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 (see Interactions and Pharmacology: Pharmacodynamics under Actions).
When used in combination with trastuzumab, the recommended dose of paclitaxel is 175 mg/m² administered intravenously over a period of 3 hours, with a 3-week interval between courses (see Pharmacology: Pharmacodynamics under Actions).
Paclitaxel infusion may be started the day following the first dose of trastuzumab or immediately after the subsequent doses of trastuzumab if the preceding dose of trastuzumab was well tolerated (for detailed trastuzumab posology see the Summary of Product Characteristics of trastuzumab).
Second-line chemotherapy of breast carcinoma: The recommended dose of paclitaxel is 175 mg/m² administered over a period of 3 hours, with a 3-week interval between courses.
Treatment of advanced NSCLC: The recommended dose of paclitaxel is 175 mg/m² administered over a period of 3 hours, followed by cisplatin 80 mg/m², with a 3-week interval between courses.
Treatment of AIDS-related KS: The recommended dose of paclitaxel is 100 mg/m² administered as a 3-hour intravenous infusion every two weeks.
Subsequent doses of paclitaxel should be administered according to individual patient tolerance.
Paclitaxel should not be re-administered until the neutrophil count is ≥1,500/mm³ (≥1,000/mm³ for KS patients) and the platelet count is ≥100,000/mm³ (≥75,000/mm³ for KS patients).
Patients who experience severe neutropenia (neutrophil count <500/mm³ for a week or longer) or severe peripheral neuropathy should receive a dose reduction of 20% for subsequent courses (25% for KS patients) (see Precautions).
Patients with hepatic impairment: Inadequate data are available to recommend dose alterations in patients with mild to moderate hepatic impairments (see Precautions and Pharmacology: Pharmacokinetics under Actions). Patients with severe hepatic impairment should not be treated with paclitaxel.
Paediatric population: Paclitaxel is not recommended for use in children below 18 years due to lack of data on safety and efficacy.