Intaxel Dosage/Direction for Use

Recommended dosage: Ovarian Cancer: Combination therapy: For previously untreated patients, the recommended dosing regimen, given every 3 weeks, is INTAXEL administered intravenously over 3 hours at a dose of 175 mg/m² followed by a platinum compound.
Alternatively, a more myelosuppressive regimen of INTAXEL may also be administered intravenously at a dose of 135 mg/m² over 24 hours followed by a platinum compound, every 3 weeks.
Single-agent therapy, second-line therapy for the treatment of advanced metastatic carcinoma of the ovary: In patients previously treated with chemotherapy the recommended regimen is 175 mg/m² administered intravenously over 3 hours every 3 weeks.
Breast Cancer: Adjuvant therapy: INTAXEL 175 mg/m² administered intravenously over 3 hours every 3 weeks for 4 courses sequentially to standard combination therapy.
Single-agent second-line therapy after failure of anthracycline combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy which have included an anthracycline INTAXEL 175 mg/m² administered intravenously over 3 hours every 3 weeks.
Non-small cell lung cancer: Combination therapy: For previously untreated patients, the recommended dosing regimen given with a 3 week interval between courses is, INTAXEL 175 mg/m² administered intravenously over 3 hours followed by a platinum compound.
Alternatively, a more myelosuppressive regimen of INTAXEL may be administered intravenously 135 mg/m² over 24 hours followed by a platinum compound, with a 3 week interval between courses.
Kaposi's Sarcoma: Second-line therapy: INTAXEL 135 mg/m² administered intravenously over 3 hours with a 3 week interval between courses or 100 mg/m² administered intravenously over 3 hours with a 2 week interval between courses (dose intensity 45-50 mg/m²/week).
Based upon the immunosuppression observed in patients with advanced HIV disease, the following modifications are recommended in these patients.
The dose of dexamethasone as one of the three premedication drugs should be reduced to 10 mg orally.
Treatment with INTAXEL should be initiated or repeated only if the neutrophil count is at least 1,000 cells/mm³.
The dose of subsequent courses of INTAXEL should be reduced by 20% for those patients who experience severe neutropenia (<500 cell/mm³ for a week or longer).
Concomitant hematopoietic growth factor (G-CSF), should be initiated as clinically indicated.
Precautions and Premedication Regimen with Paclitaxel: All the patients should be pretreated with steroids; antihistamines and it needed H₂-receptor antagonist.
Cardiac functions should be checked before INTAXEL administrations.
PREMEDICATION REGIMENS: Dexamethasone 20 mg orally 12 and 6 hours prior INTAXEL therapy and; cimetidine 300 mg IV or ranitidine 50 mg IV 30 minutes prior to therapy and; diphenhydramine 50 mg IV 30 minutes prior to therapy.
Preparations and Administration Precaution: Paclitaxel is a cytotoxic anticancer drug and as with other potentially toxic compounds, caution should be exercised in handling INTAXEL injection. The use of glove is recommended. If INTAXEL solution contacts the skin, wash the skin immediately and thoroughly with soap and water. If INTAXEL contacts the mucous membranes, the membranes should be flushed thoroughly with water.
Preparations for Intravenous Administration: Paclitaxel Injection USP must be diluted prior to infusion. INTAXEL injection should be diluted in 0.9% Sodium chloride injection USP, 5% Dextrose Injection USP, 5% Dextrose and 0.9% Sodium chloride Injection USP to a final concentration of 0.3 to 1.2 mg/mL. The solutions are physically and chemically stable for up to 27 hours at ambient temperature (approximately 25°C) and room lighting conditions.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Upon preparation, solution may show haziness, which is attributed to the formulation vehicle. No significant losses in potency have been noted following stimulated delivery of the solution through I.V. tubing containing an in line (0.22 micron) filter. Published data for the presence of the extractable plasticizer DEHP [di-(2-ethylhexyl)phthalate] show that levels increase with time and concentration when dilutions are prepared in PVC containers and administration sets is not recommended. INTAXEL solutions should be prepared and stored in glass, polypropylene, or polyolefin containers. Non-PVC containing administration sets such as those that are polyethylene lined should be used. Intaxel should be administered through an in line filter with a microporous membrane not greater than 0.22 microns.