Fonkopac 30

Indonesia • Ferron Par Pharmaceuticals

Indication

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.

Composition

Paclitaxel 30 mg

Package

1 vial of 5 ml

Dosage Forms

Solution for Infusion

ATC Classification

L01C

Warning

Alcohol
Consult Your Doctor
Safety of this item for use with alcohol has not been established. Please consult your doctor.
Machinery
Caution
This item may not be safe for use while operating heavy machinery. Use with caution and after consultation with your doctor.
Pregnancy
Not Recommended
This item is not safe for use during pregnancy.
Lactation
Not Recommended
This item is not safe for use during lactation.

Dosage

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.

See All Products