Daxotel

Docetaxel

Locally advanced or metastatic breast cancer as monotherapy after failure of prior chemotherapy; in combination w/ doxorubicin in patients who have not received prior chemotherapy; in combination w/ capecitabine after failure of previous anthracycline-containing chemotherapy. In combination w/ trastuzumab for patients w/ metastatic breast cancer whose tumours overexpress HER2 & have not received chemotherapy for metastatic disease. In combination w/ doxorubicin & cyclophosphamide as adjuvant treatment of operable node-+ve breast cancer. Locally advanced or metastatic NSCLC after failure of prior platinum-based chemotherapy. In combination w/ cisplatin for unresectable, locally advanced or metastatic NSCLC in patients who have not previously received chemotherapy. In combination w/ cisplatin & 5-fluorouracil for advanced gastric adenocarcinoma, including adenocarinoma of gastro-esophageal junction; as induction treatment for locally advanced squamous cell carcinoma of the head & neck. In combination w/ prednisone or prednisolone for patients w/ hormone refractory metastatic prostate cancer.

IV Breast, NSCLC, gastric, head & neck cancers premed Oral dexamethasone 16 mg daily (8 mg bid) for 3 days starting day 1 prior to docetaxel administration. Prostate cancer premed Oral dexamethasone 8 mg, 12 hr, 3 hr & 1 hr before docetaxel infusion. Administer docetaxel as 1-hr infusion every 3 wk. Locally advanced or metastatic breast cancer Monotherapy: 100 mg/m² once every 3 wk. 1st-line treatment in combination w/ doxorubicin: 75 mg/m² w/ doxorubicin 50 mg/m² once every 3 wk. In combination w/ capecitabine: 75 mg/m² every 3 wk w/ capecitabine at 1,250 mg/m² bid for 2 wk followed by 1-wk rest period. In combination w/ trastuzumab: 100 mg/m² every 3 wk, w/ trastuzumab administered wkly. Adjuvant treatment of operable node-+ve breast cancer 75 mg/m² 1 hr after doxorubicin 50 mg/m² & cyclophosphamide 500 mg/m² every 3 wk for 6 cycles. NSCLC Monotherapy: 75 mg/m² over 1 hr every 3 wk. Chemotherapy naive patients Docetaxel 75 mg/m² over 1 hr immediately followed by cisplatin 75 mg/m² over 30-60 min every 3 wk or carboplatin (AUC 6 mg/mL-min). Gastric adenocarcinoma 75 mg/m² as 1-hr infusion, followed by cisplatin 75 mg/m² as 1- to 3-hr infusion (both on day 1 only) followed by 5-fluorouracil 750 mg/m² daily given as 24-hr continuous infusion for 5 days, starting at the end of cisplatin infusion & repeated every 3 wk. Head & neck cancer 75 mg/m² as 1-hr infusion followed by cisplatin 75 mg/m² over 1-hr on day 1, followed by 5-fluorouracil as continuous infusion at 750 mg/m² daily for 5 days every 3 wk for 4 cycles. Chemotherapy followed by RT: 75 mg/m² as 1-hr infusion on day 1 followed by cisplatin 100 mg/m² as 30-min to 3-hr infusion, followed by 5-fluorouracil 1,000 mg/m² daily as continuous infusion from days 1-4 every 3 wk for 3 cycles. Prostate cancer 75 mg/m² once every 3 wk w/ prednisone or prednisolone 5 mg orally bid.

History of severe hypersensitivity reactions to docetaxel or to other drugs formulated w/ polysorbate 80. Neutrophil count of <1,500 cells/mm³.

Significant hypersensitivity reactions. Discontinue immediately & do not re-challenge if severe hypersensitivity reactions (eg, hypotension, bronchospasm, generalized rashes); localized skin erythema of the extremities w/ oedema followed by desquamation occur. Not to be used in patients w/ combined abnormalities of transaminases & alkaline phosphatase. Closely monitor vital functions during infusion. Premed w/ oral corticosteroids eg, dexamethasone prior to docetaxel administration. Baseline neutrophil count <1,500/mm³. Monitor CBC regularly during therapy. Reduce subsequent dose in case of Grade IV neutropenia (neutrophil count <500/mm³) lasting for ≥7 days; peripheral neuropathy. May impair ability to drive or use machines. Women of childbearing potential should avoid becoming pregnant during therapy. Pregnancy. Discontinue lactation prior to use. Childn.

Infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, myalgia.

Concomitant use w/ cyclosporine, ketoconazole, erythromycin & troleandomycin. Increased blood conc w/ CYP3A4 inhibitors &/or substrates.

Cytotoxic Chemotherapy

L01CD02 - docetaxel ; Belongs to the class of taxanes from plant alkaloids and other natural products. Used in the treatment of cancer.

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