Taxotere

Docetaxel

In combination w/ doxorubicin & cyclophosphamide for the adjuvant treatment of patients w/ operable node-positive or node-negative breast cancer. In combination w/ doxorubicin for the treatment of patients w/ locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Monotherapy for treatment of patients w/ locally advanced or metastatic breast cancer after failure of cytotoxic therapy including an anthracycline or an alkylating agent. In combination w/ trastuzumab for the treatment of patients w/ 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 patients w/ locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy including anthracycline. Treatment of patients w/ locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy. In combination w/ cisplatin for the treatment of patients w/ unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition. In combination w/ prednisone or prednisolone for the treatment of patients w/ metastatic castration-resistant prostate cancer. In combination w/ androgen-deprivation therapy (ADT), w/ or w/o prednisone or prednisolone for the treatment of patients w/ metastatic hormone-sensitive prostate cancer. In combination w/ cisplatin & 5-fluorouracil for the treatment of patients w/ 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 patients w/ locally advanced squamous cell carcinoma of the head & neck.

Administered as a 1-hr infusion every 3 wk. Adjuvant treatment of operable node-positive & node-negative breast cancer 75 mg/m² administered 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: 75 mg/m² in combination 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 bd for 2 wk followed by a 1-wk rest period. Non-small cell lung cancer Chemotherapy naïve patient 75 mg/m² immediately followed by cisplatin 75 mg/m² over 30-60 min. Non-small cell lung cancer after failure of prior platinum-based chemotherapy 75 mg/m² as a single agent. Metastatic castration-resistant prostate cancer 75 mg/m²; prednisone or prednisolone 5 mg bd PO administered continuously. Metastatic hormone-sensitive prostate cancer 75 mg/m² every 3 wk for 6 cycles; prednisone or prednisolone 5 mg bd PO administered continuously. 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/day given as a 24-hr continuous infusion for 5 days, starting at the end of the cisplatin infusion. Treatment is repeated every 3 wk. Head & neck cancer induction chemotherapy followed by radiotherapy 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/day as a continuous infusion for 5 days. Administer regimen every 3 wk for 4 cycles. Patient should receive radiotherapy following chemotherapy. Head & neck cancer induction chemotherapy followed by chemoradiotherapy 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/day as continuous infusion from day 1-4. Administer regimen every 3 wk for 3 cycles. Patient should receive chemoradiotherapy following chemotherapy.

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

Neutropenia. Frequently monitor complete blood counts on all patients. Consider primary G-CSF prophylaxis. GI complications; closely monitor patients for early manifestations of serious GI toxicity. Closely observe for hypersensitivity reactions especially during 1st & 2nd infusions. Risk of localised skin erythema of the extremities w/ oedema & desquamation; severe cutaneous adverse reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis); acute resp distress syndrome, interstitial pneumonia/pneumonitis, interstitial lung disease, pulmonary fibrosis, resp failure; heart failure if in combination w/ trastuzumab, particularly following anthracycline-containing chemotherapy; ventricular arrhythmia if in combination regimens; cystoid macular oedema; secondary primary malignancies; tumour lysis syndrome. Closely monitor patients w/ severe fluid retention eg, pleural effusion, pericardial effusion, ascites. Reduce dose in case of development of severe peripheral neurotoxicity. Patients w/ 4+ nodes (adjuvant treatment of breast cancer setting). Monitor patients for symptoms of CHF during therapy & follow-up period (adjuvant treatment of breast cancer setting). Avoid concomitant use of strong CYP3A4 inhibitors. Contains alcohol; harmful for those suffering from alcoholism. Patients w/ liver impairment or severely impaired renal function. May impair ability to drive & use machines. An effective method of contraception should be used during treatment. May alter male fertility. May cause foetal harm when administered to pregnant women. Discontinue breast-feeding while on therapy. Elderly.

Infection, neutropenic infection; neutropenia, anaemia, thrombocytopenia, febrile neutropenia; insomnia; hypersensitivity; anorexia, decreased appetite; peripheral sensory neuropathy, peripheral motor neuropathy, dysgeusia/parosmia, paresthesia, headache; hearing impaired; dyspnea, coughing, upper resp tract infection; lacrimation increased, conjunctivitis; hot flush; pharyngolaryngeal pain; stomatitis/pharyngitis, diarrhea, nausea, vomiting, constipation, abdominal pain, dyspepsia, flatulence, esophagitis/dysphagia, odynophagia; hand-foot syndrome, alopecia, skin reaction, nail disorders, rash pruritic; myalgia, arthralgia; amenorrhoea; fluid retention, asthenia, pain, pyrexia, flu-like symptoms, fatigue/weakness, oedema peripheral; wt decreased.

The amount of alcohol in this medicinal product may alter the effects of other medicines. Potential increased risk of adverse reactions w/ strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole).

Cytotoxic Chemotherapy

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

P₁S₁S₃