Dosage: All patients should be premedicated before paclitaxel is administered to prevent severe hypersensitivity reactions (see Precautions). Before every treatment cycle, patients should be premedicated with: dexamethasone 20 mg orally 12 hours and 6 hours prior to starting the paclitaxel infusion; promethazine 25 mg to 50 mg intravenously or other suitable H1-antagonist, 30 minutes prior to starting the paclitaxel infusion; cimetidine 300 mg or ranitidine 50 mg by intravenous infusion over 15 minutes, starting 30 minutes prior to the paclitaxel infusion.
For primary treatment of ovarian cancer, it is recommended that paclitaxel be used at a dose of: 175 mg/m2, administered intravenously over 3 hours, followed by cisplatin 75 mg/m2. The infusion should be repeated every three weeks; 135 mg/m2, administered intravenously over 24 hours, followed by cisplatin 75 mg/m2. The infusion should be repeated every three weeks.
For the treatment of metastatic ovarian cancer or metastatic breast cancer, it is recommended that paclitaxel be used as a single agent at a dose of 175 mg/m2. Paclitaxel should be administered as an intravenous infusion over 3 hours. The infusion should be repeated every 3 weeks as tolerated. Patients have tolerated treatment with up to 9 cycles of paclitaxel therapy, but the optimal course of therapy remains to be established.
For primary or secondary treatment of NSCLC, the recommended dose of paclitaxel is 175 mg/m2 administered intravenously over 3 hours with a 3 week interval between courses.
Dosage adjustment: Subsequent doses of paclitaxel should be administered according to individual patient tolerance. Repetition of a course of paclitaxel is not recommended until the patient's neutrophil count is at least 1.5 x 109 cells/L (1,500 cells/mm3) and the platelet count is at least 100 x 109 cells/L (100,000 cells/mm3). If there is severe neutropenia (neutrophil count less than 0.5 x 109 cells/L or severe peripheral neuropathy or severe mucositis during paclitaxel therapy, the dose of paclitaxel in subsequent courses should be reduced by 20% (see Precautions). The incidence of neurotoxicity and the severity of neutropenia increase with dose within a regime.
Hepatic impairment: Inadequate data are available to recommend dosage alterations in patients with mild, moderate and severe hepatic impairments (see Precautions).
Paediatric population: Paclitaxel is not recommended for use in children below 18 years due to lack of data on safety and efficacy.
Filtration: A microporous membrane of 0.22 microns or less in size is recommended as the in-line filter for all infusions of paclitaxel. The IMED 0.2 micron add on filter set composed of polysulfone and the IVEX II 0.2 micron filter composed of cellulose have both been found to be suitable for Anzatax Injection Concentrate.