Taxotere

Taxotere

docetaxel

Manufacturer:

Sanofi-Aventis

Distributor:

DKSH
Concise Prescribing Info
Contents
Docetaxel
Indications/Uses
Breast cancer: In combination w/ doxorubicin & cyclophosphamide for adjuvant treatment of operable node positive & node negative breast cancer. In combination w/ cyclophosphamide for adjuvant treatment of operable breast cancer w/ 1° tumour of 1-7 cm. In combination w/ doxorubicin for treatment of locally advanced or metastatic breast cancer in chemotherapy-naive patients. Monotherapy for treatment of locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy; prior therapy should have included an anthracycline or an alkylating agent. In combination w/ trastuzumab for treatment of HER2+ metastatic breast cancer in patients w/o prior chemotherapy for metastatic disease. In combination w/ capecitabine for treatment of locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy; previous therapy should have included an anthracycline. Non-small cell lung cancer (NSCLC): Treatment of locally advanced or metastatic NSCLC after failure of prior chemotherapy. In combination w/ cisplatin for treatment of unresectable, locally advanced or metastatic NSCLC in chemotherapy-naive patients. In combination w/ carboplatin as a treatment option to cisplatin-based therapy. Prostate cancer: In combination w/ prednisone or prednisolone for treatment of hormone-refractory metastatic prostate cancer. Gastric adenocarcinoma: In combination w/ cisplatin & 5-fluorouracil for treatment of advanced gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction in patients w/o prior chemotherapy for advanced disease. Head & neck cancer: In combination w/ cisplatin & 5-fluorouracil for treatment of locally advanced squamous cell carcinoma of the head & neck (SCCHN).
Dosage/Direction for Use
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. Adjuvant treatment of operable breast cancer w/ 1° tumour of 1-7 cm 75 mg/m2 administered 1 hr & cyclophosphamide 600 mg/m2 administered over 30-60 min on day 1 of a 21 day cycle for a total of 4 cycles, w/ oral dexamethasone 8 mg bid 1 day before administering docetaxel & continuing for a total of 5 doses. Treatment of locally advanced or metastatic breast cancer 100 mg/m2 in monotherapy. In 1st-line treatment, docetaxel 75 mg/m2 is given in combination w/ doxorubicin 50 mg/m2. In combination w/ trastuzumab, docetaxel 100 mg/m2 every 3 wk w/ trastuzumab wkly. In combination w/ capecitabine, docetaxel 75 mg/m2 every 3 wk is combined w/ capecitabine 1,250 mg/m2 bid for 2 wk followed by a 1 wk rest period. NSCLC Chemotherapy-naive patients 75 mg/m2 immediately followed by cisplatin 75 mg/m2 or carboplatin (AUC 6 mg/mL• min) over 30-60 min. Treatment after failure of prior platinum-based chemotherapy 75 mg/m2 as a single agent. Prostate cancer 75 mg/m2 w/ oral prednisone or prednisolone 5 mg bid administered continuously. Gastric adenocarcinoma 75 mg/m2 as a 1 hr infusion, followed by cisplatin 75 mg/m2 as a 1-3-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 (TAX 323)] Induction treatment of inoperable locally advanced SCCHN: Recommended dose: 75 mg/m2 as a 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. This regimen is administered every 3 wk for 4 cycles. Following chemotherapy, patients should receive radiotherapy. [Induction chemotherapy followed by chemoradiotherapy (TAX 324)] Induction treatment of locally advanced (unresectable, low surgical cure or organ preservation) SCCHN: Recommended dose: 75 mg/m2 as a 1-hr IV infusion on day 1, followed by cisplatin 100 mg/m2 administered as a 30-min to 3-hr infusion, followed by 5-fluorouracil 1,000 mg/m2/day as a continuous infusion from day 1-4. This regimen is administered every 3 wk for 3 cycles. Following chemotherapy, patients should receive chemoradiotherapy.
Contraindications
Hypersensitivity. Baseline neutrophil count of <1,500 cells/mm3. Severe liver impairment. Pregnancy & lactation.
Special Precautions
Patients should be premedicated w/ an oral corticosteroid. Monitor blood counts. Reduce subsequent doses if severe neutropenia (<500 cells/mm3 for ≥7 days). Monitor patient during infusion for hypersensitivity reactions; cutaneous reactions; monitor for fluid retention. Hepatic & renal impairment. Reduce dose in case of severe peripheral neurotoxicity. Cardiotoxicity w/ trastuzumab. Complicated neutropenia, GI reactions, CHF, leukemia, patients w/ 4+ nodes. Childn & adolescent. Elderly.
Adverse Reactions
Bone marrow suppression, neutropenia, thrombocytopenia, anemia, flushing, rash w/ or w/o pruritus, cutaneous reactions, fluid retention, nausea, vomiting, diarrhoea, anorexia, stomatitis, taste perversion, abdominal pain, constipation, esophagitis, GI bleeding, paresthesia, dysesthesia, pain including burning, hypotension, dysrhythmia, HTN, heart failure, alopecia, asthenia, dyspnea.
Drug Interactions
CYP3A inducers, inhibitors & substrates eg, cyclosporine, terfenadine, ketoconazole, erythromycin, troleandomycin & protease inhibitors (including ritonavir).
ATC Classification
L01CD02 - docetaxel ; Belongs to the class of plant alkaloids and other natural products, taxanes. Used in the treatment of cancer.
Presentation/Packing
Form
Taxotere inj soln 20 mg/mL
Packing/Price
(single-dose) 1's
Form
Taxotere inj soln 80 mg/4 mL
Packing/Price
1's
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