Clipax Dosage/Direction for Use

Pre-medication: All patients must be given pre-medication consisting of corticosteroids, antihistamines and H2-receptor antagonists prior to Paclitaxel (CLIPAX) administration, in order to prevent severe hypersensitivity reactions.
Such pre-medication may consist of: See Table 1.

Click on icon to see table/diagram/image

Paclitaxel (CLIPAX) should be administered using an in-line filter with a microporous membrane of ≤0.22 microns.
Given the possibility of extravasation, it is advisable to monitor closely the infusion site for possible infiltration during administration.
First-line treatment of ovarian cancer: Although alternative medication regimens for Paclitaxel (CLIPAX) are under investigation at present, a combination therapy of Paclitaxel (CLIPAX) and Cisplatin is recommended.
Depending on the duration of infusion, two different dosages are recommended for Paclitaxel (CLIPAX) treatment: 175 mg/m² of Paclitaxel (CLIPAX) is administered as an intravenous infusion over a period of three hours followed thereafter by 75 mg/m² of Cisplatin and the therapy is repeated at 3-week intervals or 135 mg/m² of Paclitaxel (Clipax) is administered as an intravenous infusion over a period of 24 hours followed thereafter by 75 mg/m² of Cisplatin and the therapy is repeated at 3-week intervals.
Second-line treatment of ovarian cancer: The recommended dose of Paclitaxel (CLIPAX) is 175 mg/m² administered over 3 hours, with a 3-week interval between courses.
Adjuvant chemotherapy in breast carcinoma: The recommended dose of Paclitaxel (CLIPAX) 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 (CLIPAX) should be administered 24 hours after Doxorubicin. The recommended dose of Paclitaxel (CLIPAX) is 220 mg/m² administered intravenously over a period of 3 hours, with a 3-week interval between courses.
When used in combination with Trastuzumab, the recommended dose of Paclitaxel (CLIPAX) is 175 mg/m² administered intravenously over a period of 3 hours, with a 3-week interval between courses. Paclitaxel (CLIPAX) 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.
Second-line chemotherapy of breast carcinoma: The recommended dose of Paclitaxel (CLIPAX) is 175 mg/m² administered over a period of 3 hours, with a 3-week interval between courses.
Advanced non-small cell lung cancer: The recommended dose of Paclitaxel (CLIPAX) is 175 mg/m² administered over 3 hours followed by 80 mg/m² of Cisplatin, with a 3-week interval between courses.
Treatment of AIDS-related KS: The recommended dose of Paclitaxel (CLIPAX) is 100 mg/m² administered as a 3-hour intravenous infusion every two weeks.
Dose adjustment: Subsequent doses of Paclitaxel (CLIPAX) should be administered according to individual patient tolerance. Paclitaxel (CLIPAX) should not be re-administered until the neutrophil count is ≥1.5 x 10⁹/l (≥1 x 10⁹/l for KS patients) and the platelet count is ≥100 x 10⁹/l (≥75 x 10⁹/l for KS patients).
Patients who experience severe neutropenia (neutrophil count <0.5 x 10⁹/l for a minimum of 7 days) or severe peripheral neuropathy, should receive a dose reduction of 20% for subsequent courses (25% for KS patients).
Patients with hepatic impairment: Inadequate data are available to recommend dosage alterations in patients with mild to moderate hepatic impairments. Patients with severe hepatic impairment must not be treated with Paclitaxel (CLIPAX).
Paediatric use: Paclitaxel (CLIPAX) is not recommended for use in children below 18 years due to lack of data on safety and efficacy.
Direction for Reconstitution/Dilution: Paclitaxel (CLIPAX) Injection must be diluted prior to infusion. Paclitaxel (CLIPAX) Injection should be diluted in 0.9% sodium chloride solution, 5% glucose or 5% glucose Normal Saline and 5% dextrose in Ringer's injection to a final concentration of 0.3 to 1.2 mg/mL.
The solutions are physically and chemically stable for up to 24 hours at room temperature (30°C). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.