Chetax-20/Chetax-80

Adjuvant treatment in combination w/ doxorubicin & cyclophosphamide for patients w/ operable node +ve or -ve breast cancer. In combination w/ doxorubicin for patients w/ locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy. Monotherapy in patients w/ locally advanced or metastatic breast cancer after failure of cytotoxic therapy. In combination w/ trastuzumab for patients w/ metastatic breast cancer whose tumours overexpress HER2 & who previously have not received chemotherapy for metastatic disease. In combination w/ capecitabine for patients w/ locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Patients w/ locally advanced or metastatic NSCLC after failure of prior chemotherapy. In combination w/ cisplatin for patients w/ unresectable, locally advanced or metastatic NSCLC who have not previously received chemotherapy. In combination w/ prednisone or prednisolone for patients w/ hormone refractory metastatic prostate cancer. In combination w/ cisplatin & 5-fluorouracil in patients w/ metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Induction treatment in combination w/ cisplatin & 5-fluorouracil for patients w/ locally advanced squamous cell carcinoma of the head & neck.

Administer as 1-hr infusion every 3 wk. Premed: Breast, non-small cell lung, gastric, & head & neck cancer: Oral corticosteroid eg, dexamethasone 16 mg daily (eg, 8 mg bid) for 3 days starting 1 day prior to docetaxel. Prostate cancer: Oral dexamethasone 8 mg 12 hr, 3 hr & 1 hr prior to docetaxel in concurrent use w/ prednisone or prednisolone. Adjuvant treatment of operable node +ve & -ve breast cancer 75 mg/m² 1 hr after doxorubicin 50 mg/m² & cyclophosphamide 500 mg/m² every 3 wk for 6 cycles. Locally advanced or metastatic breast cancer Monotherapy: 100 mg/m². 1st-line treatment in combination w/ doxorubicin: 75 mg/m² w/ doxorubicin 50 mg/m². In combination w/ trastuzumab: 100 mg/m² every 3 wk w/ trastuzumab wkly. In combination w/ capecitabine: 75 mg/m² every 3 wk w/ capecitabine 1,250 mg/m² bid for 2 wk followed by 1-wk rest period. NSCLC Chemotherapy naïve patient 75 mg/m² immediately followed by cisplatin 75 mg/m² over 30-60 min. After failure of prior platinum-based chemotherapy 75 mg/m² as single agent. Prostate cancer 75 mg/m² w/ oral prednisone or prednisolone 5 mg bid administered continuously. Gastric adenocarcinoma 75 mg/m² as 1-hr infusion, followed by cisplatin 75 mg/m², as 1-3 hr infusion (both on day 1 only), followed by 5-fluorouracil 750 mg/m² daily as 24-hr continuous infusion for 5 days, starting at the end of cisplatin infusion. Repeat every 3 wk. Induction treatment of inoperable locally advanced squamous cell carcinoma of the head & neck (SCCHN) followed by RT (TAX 323) 75 mg/m² as 1-hr infusion followed by cisplatin 75 mg/m² over 1 hr, on day 1, followed by 5-fluorouracil 750 mg/m² daily as continuous infusion for 5 days. Repeat every 3 wk for 4 cycles. Induction treatment of locally advanced (technically unresectable, low probability of surgical cure, & aiming at organ preservation) SCCHN followed by chemoradiotherapy (TAX 324) 75 mg/m² as 1-hr IV 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 day 1-4. Repeat every 3 wk for 3 cycles.

Hypersensitivity. Patients w/ baseline neutrophil count of <1,500 cells/mm³. Severe liver impairment.

Closely observe for hypersensitivity reactions especially during 1st & 2nd infusions. Discontinue use in case of severe hypersensitivity reactions eg, severe hypotension, bronchospasm or generalised rash/erythema; cystoid macular oedema. Neutropenia. Localised skin erythema of the extremities (palms of the hands & soles of the feet) w/ oedema followed by desquamation. Acute resp distress syndrome, interstitial pneumonia/pneumonitis, ILD, pulmonary fibrosis & resp failure. Heart failure in combination w/ trastuzumab, particularly following anthracycline-containing chemotherapy. Ventricular arrhythmia including ventricular tachycardia in combination regimens including doxorubicin, 5-fluorouracil &/or cyclophosphamide. Frequently monitor CBC in all patients. Closely monitor patients receiving TCF (docetaxel, cisplatin, 5-fluorouracil) or TAC (docetaxel, doxorubicin, cyclophosphamide); those w/ severe fluid retention eg, pleural & pericardial effusion & ascites. Reduce dose in case of severe neutropenia <500 cells/mm³ for ≥7 days; development of severe peripheral neurotoxicity. Contains alcohol which is harmful for those suffering from alcoholism. Avoid concomitant use w/ strong CYP3A4 inhibitors. May impair ability to drive & use machines. Patients w/ liver impairment. No data in patients w/ severe renal impairment. Contraception must be taken by both men & women during treatment & for men at least 6 mth after cessation of therapy. Not to be used during pregnancy unless clearly necessary. Discontinue breastfeeding during therapy. Limited data on use in combination w/ doxorubicin & cyclophosphamide in the elderly >70 yr. Closely monitor elderly treated w/ TCF. Adjuvant treatment of breast cancer: GI reactions. Risk of delayed myelodysplasia or myeloid leukaemia in TAC-treated patients which requires haematological follow up. Patients w/ 4+ nodes. Consider G-CSF & dose reduction in patients who experience complicated neutropenia. Monitor patients for symptoms of CHF during therapy & follow-up period.

Flushing, rash w/ or w/o pruritus, chest tightness, back pain, dyspnoea & fever or chills; severe peripheral neurotoxicity; reversible cutaneous reactions, eruptions, severe nail disorders; hyperpigmentation, inflammation, redness or dryness of the skin, phlebitis or extravasation & swelling of the vein; peripheral oedema.

Alcohol content may alter effects of other medicinal products. Metabolism may be modified w/ compd which induce, inhibit or are metabolised by cytochrome P450-3A eg, ciclosporine, ketoconazole & erythromycin. Occurrence of adverse reactions may be increased w/ strong CYP3A4 inhibitors eg, ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin & voriconazole. Higher clearance of carboplatin.

Cytotoxic Chemotherapy

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

Rx