Composition
Inj: Per 0.5 ml: Docetaxel 20 mg; 0.5 ml (20 mg), 2 ml (80 mg), 3 ml (120 mg) and diluent. Inj: Per ml: Docetaxel 10 mg; 2 ml (20 mg), 8 ml (80 mg), 16 ml (160 mg).
Indications & Dosage
Locally advanced or metastatic breast cancer resistant or refractory to cytotoxic therapy where an anthracycline is indicated: BY IV INF: Adults: 60-100 mg/m2 IV over 1 hr every 3 week. Dosage adjustment may be required. Adjuvant treatment of operable node-positive and operable node-negative breast cancer (in combination): Neutrophil Count >1500 cells/cubic mm: 75 mg/m2 1 hr after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/ m2 every 3 wk x 6 courses. Dosage adjustment may be required. Non-Small Cell Lung Cancer: BY IV INF: Adults: 75 mg/m2 IV over 1 hr every 3 week. Dosage adjustment may be required. Hormone-Refractory Metastatic Prostate Cancer: BY IV INF: Adults: 75 mg/ m2 IV over 1 hr every 3 wk with prednisone 5 mg twice daily Dosage adjustment may be required. Initial treatment of metastatic gastric adenocarcinoma, including adenocarcinoma of the gastro-oesophageal junction (with cisplatin and fluorouracil), Induction treatment of locally advanced squamous cell carcinomaof the head and neck (with cisplatin and fluorouracil): BY IV INF: Adults: (consult product literature or local protocols). Children: Not recommended.
Administration
Anaphylactoid-like reactions have been reported: Pre-medication with dexamethasone (4-8 mg orally twice daily for 3 or 5 days starting 1 day prior to administration of docetaxel). Prevention of fluid retention (e.g. pleural effusion, ascites, peripheral oedema); Patients receiving docetaxel should be treated with a steroid (e.g. dexamethasone 8-10 mg orally twice daily) for 3-5 days. beginning the day before docetaxel administration. Admin-ister IV infusion over 1 hour through non-absorbing (non-polyvinylchloride) tubing; in-line filter is not necessary. When administered as sequential infusions, taxane derivatives should be administered before platinum derivatives (cisplatin, carboplatin) to limit myelosuppression and to enhance efficacy. Intact vials of solution should be diluted with 13% (w/w) ethanol/water to a final concentration of 10 mg/ml. Docetaxel dose should be further diluted with 0.9% NS or D5W to a final concentration of 0.3-0.9 mg/ml and must be prepared in a glass bottle, polypropylene, or polyolefin plastic bag to prevent leaching of plasticizers.
Compatibility
Stable in D5W, NS.
Stability
Refrigerate at 2C-25C. Protect it from exposure to light. Allow vial to stand at room temperature for 5 min prior to reconstitution. After reconstitution, may be stored refrigerated or at room temperature for up to 8 hours.
Contraindications
Previous severe hypersensitivity to docetaxel. Neutrophils, severe liver impairment, acute porphyrias
Precautions
Monitor blood counts; Perform liver function tests. Contraception must be used.
Interactions
Cyclosporin, terfenadine, ketoconazole, erythromycin, troleandomycin
Pregnancy
Positive evidence of risk: Avoid
Lactation
Contraindicated. Discontinue breast-feeding
Side Effects
Alopecia, bone-marrow suppression, cystoidmacular oedema, extravasation, fatal respiratory disorders, GI toxicity, heart failure, hypersensitivity reactions, hyperuricaemia, nausea, oral mucositis, peripheral neurotoxicity, persistent fluid retention, can be resistant to treatment, severe skin reactions, thromboembolism, tumourlysis syndrome, vomiting