Newtaxel-A

Docetaxel (as trihydrate)

Locally advanced or metastatic breast cancer as 1st-line therapy in combination w/ doxorubicin; after failure of prior chemotherapy as monotherapy. Adjuvant treatment in operable node +ve breast cancer in combination w/ doxorubicin & cyclophosphamide. Locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy. Androgen independent (hormone refractory) metastatic prostate cancer in combination w/ prednisone. 1st-line therapy in advanced ovarian carcinoma of epithelial in combination w/ carboplatin. Induction treatment in locally advanced squamous cell carcinoma of the head & neck; advanced gastric adenocarcinoma in combination w/ cisplatin & 5-fluorouracil. Advanced or relapsing esophageal squamous cell carcinoma.

Breast cancer 60-100 mg/m² IV over 1 hr every 3 wk. In combination: 75 mg/m² + doxorubicin 50 mg/m². 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 courses. Non-small cell lung cancer (NSCLC) 75-100 mg/m² IV over 1 hr every 3 wk, then 75 mg/m² IV followed by platinum-based chemotherapy. Hormone-refractory metastatic prostate cancer 75 mg/m² 1-hr IV infusion every 3 wk. Prednisone 5 mg PO bid continuously. Advanced epithelial ovarian carcinoma 75 mg/m² IV infusion 1 hr every 3 wk followed by carboplatin AUC 6 mg/mL·min IV as 30 min-1 hr infusion. Induction chemotherapy followed by radiotherapy: Locally advanced inoperable squamous cell carcinoma of the head & neck (SCCHN) 75 mg/m² 1-hr IV infusion followed by cisplatin 75 mg/m² IV over 1 hr on day 1, followed by fluorouracil 750 mg/m²/day for 5 days as continuous infusion. Induction chemotherapy followed by chemoradiotherapy: Locally advanced (unresectable, low surgical cure or organ preservation) SCCHN 75 mg/m² as 1-hr IV infusion on day 1, followed by cisplatin 100 mg/m² as 30 min-3 hr infusion, followed by 5-fluorouracil 1,000 mg/m²/day as continuous infusion from day 1-4 every 3 wk for 3 cycles. Gastric adenocarcinoma 75 mg/m² as 1-hr IV infusion followed by cisplatin 75 mg/m² as 1-3 hr IV infusion on day 1, followed by fluorouracil 750 mg/m²/day as 24-hr continuous IV infusion for 5 days starting at the end of cisplatin infusion, then repeat every 3 wk. Esophageal cancer Adult 70 mg/m² every 3-4 wk as 1-hr IV infusion once daily.

Hypersensitivity to docetaxel or polysorbate 80. Patients w/ neutrophil counts <1,500 cells/mm³, systemic infection; interstitial pneumonia, edema. Severe myelosuppression, hepatic & renal dysfunction. Pregnancy & lactation.

Metastatic breast cancer & NSCLC patients. Patients w/ abnormal liver function, receiving higher doses, NSCLC & history of prior treatment w/ platinum-based chemotherapy; bilirubin higher than upper limit of normal ULN or w/ SGOT &/or SGPT >1.5 x ULN, concomitant w/ alkaline phosphatase >2.5 x ULN; neutrophil counts <1,500 cells/mm³. Perform frequent CBC count. Severe fluid retention. Childn. Elderly ≥75 yr. Severe fluid retention.

Reversible marrow suppression, febrile neutropenia, thrombocytopenia, anemia, leukopenia, oligochromemia; hypersensitivity reactions; eruptions, reversible cutaneous reactions, cutaneous lupus erythematosus, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis; severe neurosensory symptoms (paresthesia, dysesthesia, pain); hypotension, sinus tachycardia, atrial flutter, dysrhythmia, unstable angina, pulmonary edema, HTN; alopecia, arthralgia, myalgia, asthenia, fatigue, excessive tearing.

May modify metabolism by drugs metabolized by CYP450 3A4 inducer/inhibitor eg, cyclosporine, terfenadine, ketoconazole, erythromycin & troleandomycin. Increased clearance w/ doxorubicin.

Cytotoxic Chemotherapy

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

Rx