Unitaxel Dosage/Direction for Use

All patients should be premedicated prior to paclitaxel administration in order to minimize severe hypersensitivity reaction. Such premedication may consist of dexamethasone 20 mg orally approximately 12 and 6 hours before paclitaxel, diphenhydramine (or its equivalent) 50 mg IV 30 to 60 minutes prior to paclitaxel, and cimetidine (300 mg) or ranitidine (50 mg) IV 30 to 60 minutes before paclitaxel.
Paclitaxel at a dose of 175 mg/m² administered intravenously over 3 hours every three weeks has been shown to be effective in patients with metastatic carcinoma of the ovary or breast who have failed standard therapy. Single courses of paclitaxel should not be repeated until the neutrophil count is at least 1,500 cell/mm³ and the platelet count is at least 100,000 cells/mm³. Patients who experience severe neutropenia (neutrophil <500 cells/mm³) or severe peripheral neuropathy during PACLITAXEL therapy should have the dosage reduced by 20% for subsequent courses of paclitaxel. Or as prescribed by the physician.
Preparation for Intravenous Administration: Paclitaxel for Injection must be diluted prior to infusion. Paclitaxel should be diluted in 0.9% Sodium chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, or 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 27 hours at ambient temperature (15-30°C).
Upon preparation, solutions may show haziness, which is attributed to the formulation vehicle. No significant loss in potency has been noted following simulated delivery of the solution through IV tubing containing an in-line (0.22 micron) filter.
Data collected 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. Consequently, the use of plasticized PVC containers and administration sets is not recommended. Paclitaxel solutions should be prepared and stored in glass, polypropylene, or polyolefin containers. Non-PVC containing administration sets, such as those which are polyethylene-lined, should be used.
Pharmaceutical Precautions: Contact of the undiluted concentrate with plasticized polyvinyl chloride (PVC) equipment or devices used to prepare solutions for infusion is not recommended. In order to minimize patient exposure to the plasticizer DEHP di-(2-ethylhexyl)phthalate, which may be leached from PVC infusion bags or sets, diluted paclitaxel solutions should preferably be stored in bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene-lined administration sets.
Paclitaxel should be administered through an in-line filter with a microporous membrane not greater than 0.22 microns. Use of filter devices such as IVEX-2 filter which incorporate short inlet and outlet PCV-coated tubing has not resulted in significant leaching of DEHP.
Paclitaxel is a cytotoxic anticancer drug and, as with other potentially toxic compounds, caution should be exercised in handling paclitaxel. The use of gloves is recommended. If paclitaxel solution comes in contact with the skin, wash the skin immediately and thoroughly with soap and water. If paclitaxel contacts mucous membranes flush thoroughly with water.