Taxtas 20/Taxtas 80

Docetaxel

In combination w/ doxorubicin & cyclophosphamide for the adjuvant treatment of operable node +ve breast cancer; operable node -ve breast cancer; in combination w/ doxorubicin treatment of locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy or after failure of cytotoxic therapy; in combination w/ trastuzumab for the treatment of metastatic breast cancer whose tumours over express HER2 & who previously have not received chemotherapy for metastatic disease; in combination w/ capecitabine for the treatment of locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of prior chemotherapy; in combination w/ cisplatin for the treatment of unresectable, locally advanced or metastatic NSCLC, in patients who have not previously received chemotherapy. In combination w/ prednisone or prednisolone for the treatment of hormone refractory metastatic prostate cancer. In combination w/ cisplatin & 5-fluorouracil for the treatment of metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. In combination w/ cisplatin & 5-fluorouracil for the induction treatment of locally advanced squamous cell carcinoma of the head & neck.

Adjuvant treatment of operable node +ve & node -ve breast cancer 75 mg/m² 1 hr after doxorubicin 50 mg/m² & cyclophosphamide 500 mg/m² every 3 wk for 6 cycles (TAC regimen). Treatment of patient w/ locally advanced or metastatic breast cancer 100 mg/m² in monotherapy. 1st-line treatment: 75 mg/m² given in combination therapy w/ doxorubicin (50 mg/m²). In combination w/ trastuzumab: 100 mg/m² every 3 wk w/ trastuzumab administered wkly. In combination w/ capecitabine: 75 mg/m² every 3 wk, combined w/ capecitabine 1,250 mg/m² bid (w/in 30 min after a meal) for 2 wk followed by a 1-wk rest period. NSCLC In chemotherapy naïve patient 75 mg/m² immediately followed by cisplatin 75 mg/m² over 30-60 min. Treatment after failure of prior platinum-based chemotherapy 75 mg/m² as a single agent. Prostate cancer 75 mg/m². Prednisone or prednisolone 5 mg orally bid is administered continuously. Gastric adenocarcinoma 75 mg/m² as a 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/day as a 24-hr continuous infusion for 5 days, starting at the end of the cisplatin infusion. Treatment is repeated every 3 wk. Induction treatment of inoperable locally advanced squamous cell carcinoma of the head & neck (SCCHN) 75 mg/m² as 1-hr infusion followed by cisplatin 75 mg/m² over 1 hr, on day 1, followed by 5-fluorouracil as a continuous infusion at 750 mg/m²/day for 5 days. Administer every 3 wk for 4 cycles. Following chemotherapy, patient should receive radiotherapy. Induction treatment of locally advanced (technically unresectable, low probability of surgical cure & aiming at organ preservation) SCCHN 75 mg/m² as 1-hr IV infusion on day 1, followed by cisplatin 100 mg/m² administered as 30-min to 3-hr infusion, followed by 5-fluorouracil 1,000 mg/m²/day as a continuous infusion from day 1 to day 4. Administer every 3 wk for 3 cycles. Following chemotherapy, patient should receive chemoradiotherapy.

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

Neutropenia. Frequently monitor CBC should be conducted on all patients receiving docetaxel. Discontinue in case of severe reactions & localised skin erythema of the extremities (palms of the hands & soles of the feet) w/ oedema followed by desquamation. Patients who developed severe hypersensitivity reactions should not be re-challenged w/ docetaxel. Severe fluid retention eg, pleural effusion, pericardial effusion & ascites. Acute resp distress syndrome, interstitial pneumonia/pneumonitis, interstitial lung disease, pulmonary fibrosis & resp failure. Radiation pneumonitis in patients receiving concomitant radiotherapy. Severe peripheral neurotoxicity. Monitor cardiac function during treatment (eg, every 3 mth). Patients w/ impaired vision. Discontinue in case of cystoid macular oedema. Concomitant w/ strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin & voriconazole). Patients who experience complicated neutropenia (prolonged neutropenia, febrile neutropenia or infection) & G-CSF. GI reactions. Monitor for symptoms of CHF during therapy & follow-up period. Risk of delayed myelodysplasia or myeloid leukaemia requires haematological follow-up. Alcoholism. Patients w/ liver impairment; elevated liver function test; renal impairment. May impair the patients ability to drive or use machines. Contraceptive measures must be taken by both men & women during treatment & for men at least 6 mth after cessation of therapy. Pregnancy & lactation. Elderly >70 yr.

In breast cancer (single agent): Infections including sepsis & pneumonia; neutropenia, anaemia, febrile neutropenia; hypersensitivity; anorexia; peripheral sensory neuropathy, peripheral motor neuropathy, dysgeusia; dyspnoea; stomatitis, diarrhoea, nausea, vomiting; alopecia, skin reaction, nail disorders; myalgia; fluid retention, asthenia, pain. In gastric adenocarcinoma cancer: Neutropenic infection, infection; anaemia; neutropenia, thrombocytopenia, febrile neutropenia; hypersensitivity; anorexia; peripheral sensory neuropathy; diarrhoea, nausea, stomatitis, vomiting; alopecia; lethargy, fever, fluid retention. In head & neck cancer: Infection, neutropenic infection; neutropenia, anaemia, thrombocytopenia; anorexia; dysgeusia/parosmia, peripheral sensory neuropathy; nausea, stomatitis, diarrhoea, vomiting; alopecia; lethargy, pyrexia, fluid retention, oedema. Induction chemotherapy followed by chemoradiotherapy (TAX 324): Infection; neutropenia, anaemia, thrombocytopenia, febrile neutropenia; anorexia; dysgeusia/parosmia, peripheral sensory neuropathy; impaired hearing; nausea, stomatitis, vomiting, diarrhoea, esophagitis/dysphagia/odynophagia, constipation; alopecia, pruritic rash; lethargy, pyrexia, fluid retention, oedema; decreased wt.

Modified metabolism w/ CYP450 3A inducer/inhibitor eg, ciclosporin, ketoconazole & erythromycin. May increase adverse reactions w/ CYP3A4 inhibitors. Concomitant use of strong CYP3A4 inhibitor (eg, ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin & voriconazole). Higher clearance of carboplatin (monotherapy).

Cytotoxic Chemotherapy

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

Rx