Taxol

Paclitaxel

In combination w/ cisplatin for the primary treatment of advanced ovarian carcinoma (FIGO-stage III, IV) or residual carcinoma (>1 cm) after laparotomy; for the treatment of NSCLC in patients who are not candidates for surgery &/or RT. In combination w/ trastuzumab for the treatment of metastatic breast carcinoma when tumors overexpress HER 2 & patients have not yet received chemotherapy. Treatment of metastatic ovarian carcinoma after failure of standard, platinum-containing chemotherapy; metastatic breast carcinoma in patients who have failed, or are not candidates, for standard anthracycline therapy. Adjuvant treatment in patients w/ breast carcinoma & affected local regional lymph nodes (node +ve) following anthracycline treatment w/ doxorubicin & cyclophosphamide.

Primary treatment of advanced ovarian carcinomas 175 mg/m² as 3-hr IV infusion, followed by cisplatin 75 mg/m²; or 135 mg/m² as 24-hr IV infusion, followed by cisplatin 75 mg/m². Observe a 3-wk interval between treatment courses. Always administer Taxol prior to cisplatin. Secondary treatment of metastatic ovarian carcinoma resistant to standard therapy 175 mg/m² as 3-hr IV infusion, w/ a 3-wk interval between treatment courses. Treatment of NSCLC 175 mg/m² as 3-hr IV infusion, followed by cisplatin, w/ a 3-wk interval between treatment courses. Limit therapy to 6 courses. Always administer Taxol prior to cisplatin. 1st-line therapy of metastatic breast carcinoma in combination w/ trastuzumab 175 mg/m² as 3-hr IV infusion, w/ a 3-wk interval between treatment courses. Initiate Taxol infusion the day following the 1st trastuzumab dose or immediately following the 2nd trastuzumab dose if the initial trastuzumab dose was well tolerated. Secondary treatment of metastatic breast carcinoma resistant to standard therapy 175 mg/m² as 3-hr IV infusion, w/ a 3-wk interval between treatment courses. Adjuvant treatment in patient w/ breast carcinoma Following administration of 4 courses of doxorubicin 60 mg/m² in combination w/ cyclophosphamide 600 mg/m², administer additional 4 courses of Taxol 175 mg/m² as 3-hr IV infusion, w/ a 3-wk interval between treatment courses. Always administer the 4 Taxol courses after the 4 doxorubicin/cyclophosphamide courses. Patient w/ transaminase levels 2-<10x ULN & bilirubin levels ≤1.5 mg/dL 135 mg/m² as 3-hr IV infusion or 100 mg/m² as 24-hr IV infusion. Patient w/ transaminase levels <10x ULN & bilirubin levels 1.5-5 mg/dL 90 mg/m² as 3-hr IV infusion or 50 mg/m² as 24-hr IV infusion.

Hypersensitivity. Neutropenia <1,500/mm³. Pregnancy & lactation.

Premedicate w/ corticosteroid, H₁ & H₂ antagonists. Immediately discontinue Taxol infusion if severe hypersensitivity reactions occur. Reduce dose in patients who develop severe neutropenia or severe peripheral neuropathy while on treatment. Frequently monitor vital functions, especially during the 1st hr of infusion. Possibility of extravasation; closely monitor infusion site for possible infiltration. Risk of myelosuppression (more pronounced w/ 24-hr infusion). Perform regular blood tests during treatment. Higher incidence of severe neurotoxicity w/ combination therapy of Taxol (3-hr infusion) & cisplatin, & after anthracycline treatment. Risk of CV toxicity. Rare reports of pseudomembranous colitis. Avoid concomitant use w/ live vaccines. Contains ethanol. May impair ability to drive or operate machinery. Increased risk of toxicity in case of mild hepatic impairment (especially grade III-IV myelosuppression). Not recommended in case of severe hepatic impairment. Effective contraception is required in both male & female patients during treatment & for up to 6 mth after the end of treatment. Can impair male fertility. Safety & effectiveness in ped patients have not been established. Treatment of NSCLC: Caution in individuals w/ brain metastases, >75 yr, or w/ non-compensated CV diseases.

Infection (mainly UTIs, URTIs); neutropenia, anaemia, thrombocytopenia, haemorrhage; milder hypersensitivity reactions (primarily reddening & skin rash); peripheral neuropathy (especially paraesthesia); ECG changes; hypotension; nausea/vomiting, diarrhoea, mucositis; alopecia; arthralgia, myalgia. Bradycardia (usually mild); severely elevated AST & alkaline phosphatase; transient & mild changes to nails & skin; local reactions at application site (localised oedema, pain, erythema, & induration).

Decreased clearance & greater myelosuppression when administered after cisplatin. More pronounced neutropenia & stomatitis (due to doxorubicin) when administered before doxorubicin/cyclophosphamide. Caution when used together w/ CYP2C8 or CYP3A4 inhibitors (eg, ketoconazole & other imidazole antimycotics, erythromycin, fluoxetine, gemfibrozil, clopidogrel, cimetidine, ritonavir, saquinavir, indinavir, nelfinavir) or 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.

P₁S₁S₃