Posology : מינונים

4.2 Posology and Method of Administration

Dosage and Method of Administration

First-line chemotherapy of ovarian cancer
Since other dosage regimens have not yet been evaluated, the recommended first- line treatment of ovarian cancer is 135 mg/m2 of Paclitaxel Teva as an infusion over 24 hours, followed by 75 mg/m2 of cisplatin and a therapy-free interval of three weeks (see “Interactions with Other Medicinal Products”).

Second-line chemotherapy of ovarian and metastatic breast cancer
The recommended dosage is 175 mg/m2 of Paclitaxel Teva, given as an intravenous infusion.
Paclitaxel Teva should be administered as a three-hour infusion, with an interval of three weeks between therapy courses.

Adjuvant therapy of node-positive breast cancer
Paclitaxel Teva 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 Paclitaxel Teva administered intravenously over 24 hours at a dose of 135 mg/m2 followed by cisplatin 75 mg/m2.

Kaposi's sarcoma
Paclitaxel Teva 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
Paclitaxel Teva 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 (see “Pharmacokinetic Properties”). 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 (see “Pharmacokinetic Properties”).

• 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 (see “Special Warnings and Precautions for Use”).

All patients must receive premedication treatment with corticosteroids, antihistaminic agents and H2 antagonists prior to paclitaxel therapy:

Active ingredient             Dosage               Interval prior to paclitaxel administration
Dexamethasone                 20 mg orally         approx. 12 and 6 hours Diphenhydramine               50 mg IV             30-60 minutes

Cimetidine or                 300 mg IV            30-60 minutes
Ranitidine                    50 mg IV



Paclitaxel Teva should be administered using a microporous filter with a pore size ≤0.22 μm (in-line filter) - see “Instructions for Use and Handling’.