Cytax 30/Cytax 100

Paclitaxel

1st-line chemotherapy of ovarian cancer in treatment of patients w/ advanced disease or a residual disease >1 cm after initial laparotomy, in combination w/ cisplatin. 2nd-line chemotherapy of ovarian cancer, in treatment of metastatic carcinoma of the ovary after failure of standard platinum-based therapy. In the adjuvant setting, treatment of 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 2 (HER-2) at a 3+level & for whom an anthracycline is not suitable. As single agent in treatment of 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 in treatment of non-small cell lung cancer (NSCLC) in patients who are not candidates for potentially curative surgical intervention &/or radiation therapy. Treatment of patients w/ advanced AIDS-related Kaposi's sarcoma (KS) have failed prior liposomal anthracycline therapy.

1st-line treatment of ovarian cancer 175 mg/m² of paclitaxel as IV infusion over a period of 3 hr followed thereafter by 75 mg/m² of cisplatin & the therapy is repeated at 3-wk intervals, or 135 mg/m² of paclitaxel as IV infusion over a period of 24 hr followed thereafter by 75 mg/m² of cisplatin & the therapy is repeated 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 a period of 3 hr every 3 wk for 4 courses, following AC therapy. 1st-line chemotherapy of breast carcinoma In combination w/ doxorubicin (50 mg/m²): 220 mg/m² IV over a period of 3 hr w/ 3-wk interval between courses. Administer paclitaxel 24 hr after doxorubicin. In combination w/ trastuzumab: 175 mg/m² IV over a period of 3 hr w/ 3-wk interval between courses. Start paclitaxel infusion 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 IV over a period of 3 hr w/ 3-wk interval between courses. Advanced NSCLC 175 mg/m² over 3 hr followed by 80 mg/m² of cisplatin w/ a 3-wk interval between courses. Treatment of AIDS-related KS 100 mg/m² as 3-hr IV infusion every 2 wk.

Severe hypersensitivity reactions to paclitaxel or to macroglycerol ricinoleate (polyoxyl castor oil). Patients w/ baseline neutrophils <1.5 x 10⁹/L (<1 x 10⁹/L for KS patients) or platelets <100 x 10⁹/L (<75 x 10⁹/L for KS patients). Pregnancy & lactation.

Extravasation. Monitor infusion site for possible infiltration during drug administration. Patients must be pretreated w/ corticosteroids, antihistamines & H₂ antagonists. Paclitaxel should be given before cisplatin when used in combination. Discontinue in case of severe hypersensitivity reactions. Bone marrow suppression; monitor blood counts frequently. Hypotension, HTN & bradycardia; monitor vital signs frequently during the 1st hr of infusion; severe CV events. Patients on initial treatment of metastatic breast cancer in combination w/ doxorubicin or trastuzumab should undergo baseline assessment including history, physical exam, ECG, echocardiogram, &/or multigated acquisition (MUGA) scan. Peripheral neuropathy. Contains 49.7% vol ethanol; patients w/ alcoholism. Avoid intraarterial administration. Pseudomembranous colitis. Combination of pulmonary radiotherapy may promote development of interstitial pneumonitis. Hepatic impairment particularly grade III-IV myelosuppression. Not recommended for severely impaired hepatic function. Severe mucositis in KS patients. May impair ability to drive or operate machinery. Female & male patients of reproductive age must take contraceptive measures during & for at least 6 mth after therapy. Childn.

Infection; myelosuppression, neutropenia, anaemia, thrombocytopenia, leucopenia; neurotoxicity (mainly peripheral neuropathy); hypotension; nausea, vomiting, diarrhoea, mucosal inflammation; alopecia. Bradycardia, transient & mild nail & skin changes; inj site reactions (including localized oedema, pain, erythema, induration, on occasion extravasation can result in cellulitis); severe elevation in AST, SGOT, alkaline phosphatase.

Increased risk of renal failure w/ cisplatin. May reduce elimination of doxorubicin & its active metabolites. May inhibit CYP2C8 or 3A4 inhibitor (eg, erythromycin, fluoxetine, gemfibrozil) or inducer (eg, rifampicin, carbamazepine, phenytoin, phenobarb, 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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