Product Description

Posology

Paclitaxel should only be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents (see section 6.6).

All patients must be premedicated with corticosteroids, antihistamines, and H₂ antagonists prior to Paclitaxel 6 mg/ml, concentrate for solution for infusion, e.g.

*8–20 mg for KS patients

** or an equivalent antihistamine e.g. chlorpheniramine

First-line chemotherapy of ovarian carcinoma: although other dosage 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 section 5.1).

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 section 4.5 and 5.1). 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 section 5.1). 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 Herceptin®).

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.

The treatment of advanced non-small-cell lung carcinoma (NSCLC): the recommended dose of paclitaxel is 175 mg/m²administered over a period of 3 hours, followed by cisplatin 80 mg/m², with a 3 week interval between courses.

The 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 readministered 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 section 4.4).

Patients with hepatic impaired: Inadequate data are available to recommend dosage alterations in patients with mild to moderate hepatic impairments (see section 4.4 and 5.2). 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

Method of administration

Precautions to be taken before handling or administering the medicinal product

The concentrate for solution for infusion must be diluted before use (see section 6.6) and should only be administered intravenously.Paclitaxel should be administered intravenously through an in-line filter with a microporous membrane ≤0.22 μm (see section 6.6).