Taxitas-30/Taxitas-100/Taxitas-260

1st-line chemotherapy in ovarian cancer patients w/ advanced disease or a residual disease (>1 cm) after initial laparotomy, in combination w/ cisplatin. 2nd-line chemotherapy in patients w/ metastatic carcinoma of the ovary after failure of standard platinum based therapy. Adjuvant treatment in patients w/ node +ve breast carcinoma following anthracycline & cyclophosphamide (AC) therapy. Initial treatment of locally advanced or metastatic breast cancer either in combination w/ anthracycline in patients for whom anthracycline therapy is suitable, or in combination w/ trastuzumab, in patients who over-express human epidermal growth factor receptor 2 (HER-2) at a 3+ level as determined by immunohistochemistry & for whom an anthracycline is not suitable. Monotherapy in metastatic carcinoma of the breast in patients who have failed to respond adequately to standard treatment w/ anthracyclines or in whom anthracycline therapy has not been appropriate. In combination w/ cisplatin for the treatment of NSCLC in patients who are not candidates for potentially curative surgical intervention &/or RT. Treatment of advanced AIDS-related Kaposi's sarcoma in patients who have failed prior lipos anthracycline therapy.

1st-line treatment of ovarian cancer 175 mg/m² as IV infusion over 3 hr followed thereafter by 75 mg/m² of cisplatin; repeat therapy at 3-wk intervals. Alternatively, 135 mg/m² paclitaxel as IV infusion over 24 hr followed by 75 mg/m² cisplatin; repeat therapy at 3-wk intervals. 2nd-line treatment of ovarian cancer 175 mg/m² over 3 hr, w/ 3-wk interval between courses. Adjuvant chemotherapy in breast carcinoma 175 mg/m² over 3 hr every 3 wk for 4 courses, following AC therapy. 1st-line chemotherapy of breast carcinoma In combination w/ doxorubicin (50 mg/m²): Paclitaxel 220 mg/m² IV over 3 hr, w/ a 3-wk interval between courses. Paclitaxel should be administered 24 hr after doxorubicin. In combination w/ trastuzumab: Paclitaxel 175 mg/m² IV over 3 hr, w/ 3-wk interval between courses. Paclitaxel infusion may be started the day following the 1st dose of trastuzumab or immediately after the subsequent doses of trastuzumab if the preceding dose of trastuzumab was well tolerated. 2nd-line chemotherapy of breast carcinoma 175 mg/m² over 3 hr, w/ 3-wk interval between courses. Advanced NSCLC 175 mg/m² over 3 hr followed by 80 mg/m² cisplatin, w/ 3-wk interval between courses. AIDS-related Kaposi's sarcoma 100 mg/m² as 3-hr IV infusion every 2 wk.

Hypersensitivity to paclitaxel or macrogolglycerol ricinoleate (polyoxyl castor oil).

Risk of significant hypersensitivity reactions. Closely monitor infusion site for possible infiltration during drug administration. Can cause bone marrow suppression. Patients should not be retreated until neutrophil count is ≥1.5 x 10⁹/L (≥1 x 10⁹/L for Kaposi's sarcoma patients) & platelets recover to ≥100 x 10⁹/L (≥75 x 10⁹/L for Kaposi's sarcoma patients). If patients develop significant conduction abnormalities during administration, appropriate therapy should be administered & continuous cardiac monitoring should be performed during subsequent therapy. Hypotension, HTN, & bradycardia have been observed. Frequent vital signs monitoring, particularly during the 1st hr of infusion recommended. Monitor cardiac function when used in combination w/ doxorubicin or trastuzumab for initial treatment of metastatic breast cancer. Frequent occurrence of peripheral neuropathy. Increased risk of toxicity in patients w/ hepatic impairment. Do not administer in patients w/ severe hepatic impairment. May be harmful to patients suffering from alcoholism, childn & high risk groups w/ liver disease or epilepsy due to ethanol content. Avoid intra-arterial administration. Rare reports of pseudomembranous colitis. May promote development of interstitial pneumonitis when combined w/ pulmonary RT. Reduce dose in case of severe mucositis. Reports of reduced visual acuity due to cystoid macular oedema. Female & male patients of reproductive age must take contraceptive measures for themselves &/or their sexual partners during & for at least 6 mth after therapy. Possibility of irreversible male infertility. Not to be used during pregnancy. Discontinue breastfeeding for the duration of therapy. Not recommended in childn <18 yr.

Administration of paclitaxel after cisplatin treatment leads to greater myelosuppression & about 20% decrease in paclitaxel clearance. Elimination of doxorubicin & its active metabolite can be reduced when paclitaxel & doxorubicin are given closer in time. More profound neutropenic & stomatitis episodes when paclitaxel is administered before doxorubicin & using longer than recommended infusion times. Risk of toxicity may be increased w/ CYP2C8 or CYP3A4 inhibitors eg, ketoconazole & other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, clopidogrel, cimetidine, ritonavir, saquinavir, indinavir, & nelfinavir. Efficacy may be compromised w/ CYP2C8 or CYP3A4 inducers eg, rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine.

Cytotoxic Chemotherapy

L01CD01 - paclitaxel ; Belongs to the class of taxanes from plant alkaloids and other natural products. Used in the treatment of cancer.

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