Fonkopac 300mg/50ml injection

18 YEARS OLD AND ABOVE
— Ovarian cancer:
- First-line treatment: Intravenous administration of 175 mg/m² of body surface area (BSA) over 3 hours, followed by 75 mg/m² of cisplatin, or 135 mg/m² of paclitaxel as an infusion over 24 hours, followed by 75 mg/m² of cisplatin. A therapy-free interval of three weeks is recommended between therapy courses.
- Second-line treatment: The recommended dosage of paclitaxel is 175 mg/m² of body surface area, administered as a 3 hours infusion, with a 3-week interval between courses.

— Breast cancer
The recommended dose of paclitaxel is 175 mg/m² of body surface area, administered over 3 hours, with a 3-week interval between courses.

— Non-small cell lung cancer
The recommended dose of paclitaxel is 175 mg/m² BSA administered over 3 hours followed by 80 mg/m² of cisplatin, with a 3-week interval between courses

PREMEDICATION
All patients must be given premedication consisting of corticosteroids, antihistamines and H2-receptor antagonists prior to paclitaxel therapy.

Premedication Dose Administration prior to Paclitaxel
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 30-60 minutes

Paclitaxel should be administered using a microporous filter with a pore size of ≤0.22 µm (in line filter). For strictly intravenous infusion after dilution.

DOSE ADJUSTMENT DURING TREATMENT
Subsequent dosing of paclitaxel depends on individual patient tolerance levels. Treatment courses with paclitaxel may be repeated only if blood counts with at least 1,500/mm³ of neutrophils and at least 100,000/mm³ of platelets have been achieved. In patients who exhibit severe neutropenia (neutrophils < 500/mm³ over a one-week period or longer) or severe peripheral neuropathies during paclitaxel therapy, dosage should be reduced by 20% in subsequent courses.

Ovarian cancer
– As first line chemotherapy for the treatment of ovarian cancer in patients with advanced ovarian cancer or residual tumors ( > 1 cm) after preceding laparotomy, in combination with cisplatin.
– For second line chemotherapy of metastatic ovarian cancer in patients who have failed conventional therapeutic treatment with platinum containing agents.

Breast cancer
Paclitaxel given as a single agent is indicated for the treatment of metastatic breast cancer in patients where standardized anthracycline therapy has either failed or is not suitable.

Advanced non-small cell lung cancer
Combination paclitaxel with cisplatin is indicated for the treatment of non-small cell lung cancer in patients for whom a potentially curative surgical treatment and/or radiation therapy is not suitable.