Daxotel Dosage/Direction for Use

The use of Docetaxel should be confined to specialized unit in the administration of cytotoxic agents/chemotherapy and it should only be administered under the supervision of a qualified physician in the use of anticancer chemotherapy.
Recommended dose: For breast, non-small cell lung, gastric and head and neck cancers, premeditation consisting of an oral corticosteroid, such as dexamethasone 16 mg per day (e.g. 8 mg BID) for 3 days starting 1 day prior to Docetaxel administration, unless contraindicated, can be used (see Precautions).
Prophylactic G-CSF may be used to mitigate the risk of hematological toxicities.
For prostate cancer, given the concurrent use of prednisone or prednisolone the recommended premeditation regimen is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the Docetaxel infusion. Docetaxel is administered as a one-hour infusion every three weeks.
Breast cancer: For the treatment of patients with locally advanced or metastatic breast cancer, the recommended dose of Docetaxel is 100 mg/m² once every 3 weeks in monotherapy. In first-line treatment, Docetaxel 75 mg/m² once every 3 weeks is given in combination therapy with Doxorubicin 50 mg/m².
In the adjuvant treatment of operable node-positive breast cancer, the recommended dose of Docetaxel is 75 mg/m² administered 1-hour after Doxorubicin 50 mg/m² and Cyclophosphamide 500 mg/m² every 3 weeks for 6 cycles.
In combination with Capecitabine the recommended dose of Docetaxel is 75 mg/m² every three weeks, combined with Capecitabine at 1,250 mg/m² twice daily (within 30 minutes after a meal) for 2 weeks followed by 1-week rest period. For Capecitabine dose calculation according to body surface area, see Capecitabine summary of product characteristics.
In combination with Trastuzumab the recommended dose of Docetaxel is 100 mg/m² every three weeks, with Trastuzumab administered weekly. In the pivotal trial the initial Docetaxel infusion was started the day following the first dose of Trastuzumab. The subsequent Docetaxel doses were administered immediately after completion of the Trastuzumab infusion, the preceding dose of Trastuzumab was well tolerated. For Trastuzumab dose and administration, see summary of product characteristics.
Non-small cell lung cancer: The recommended dose is 75 mg/m² as monotherapy administered IV over 1 hour every 3 weeks. In chemotherapy naive patients treated for non-small cell lung cancer, the recommended dose regimen is Docetaxel 75 mg/m² over 1 hour immediately followed by Cisplatin 75 mg/m² over 30-60 minutes every 3 weeks or Carboplatin (AUC 6 mg/ml-min) for treatment after failure of prior platinum-based chemotherapy.
Gastric adenocarcinoma: The recommended dose of Docetaxel is 75 mg/m² as 1 hour infusion, followed by cisplatin 75 mg/m² as a 1 to 3 hour infusion (both on day 1 only) followed by 5-fluorouracil 750 mg/m² per day given as a 24 hour continuous infusion for 5 days, starting at the end of the Cisplatin infusion. Treatment is repeated every three weeks. Patients must receive premeditation with antiemetic and appropriate hydration for cisplatin administration.
Prophylactic G-CSF should be used to alleviate the risk of hematological toxicities.
Head and neck cancer: Patients must receive antiemetic and appropriate hydration (prior to and after cisplatin administration).
Prophylactic G-CSF may be used to alleviate the risk of hematological toxicities.
The recommended dose of Docetaxel is 75 mg/m² as a 1 hour infusion followed by Cisplatin 75 mg/m² over 1 hour, on day one, followed by 5-fluorouracil as a continuous infusion at 750 mg/m² per day for five days. This regimen is administered every 3 weeks for 4 cycles. Following chemotherapy, patients should receive radiotherapy or the recommended dose of Docetaxel is 75 mg/m² as a 1 hour intravenous infusion on day 1 followed by Cisplatin 100 mg/m² administered as a 30-minute to 3 hour infusion, followed by 5-fluorouracil 1000 mg/m²/day as a continuous infusion from day 1 to day 4. This regimen is administered every 3 weeks for 3 cycles. Following chemotherapy, patients should receive chemoradiotherapy. Cisplatin and 5-fluorouracil dose can be adjusted, see the corresponding summary of product characteristic.
Prostate cancer: The recommended dose of Docetaxel is 75 mg/m² once every 3 weeks with Prednisone or prednisolone 5 mg orally twice daily is administered continuously.
Administration Precautions: If Docetaxel Injection concentrate, initial diluted solution, or final dilution for infusion should come into contact with the skin, immediately and thoroughly wash with soap and water. If Docetaxel Injection concentrate, initial diluted solution, or final dilution for infusion should come into contact with mucosa, immediately and thoroughly wash with water. Contact of the Docetaxel Injection concentrate with plasticized PVC equipment or devices used to prepare solutions for infusion is not recommended. In order to minimize patient exposure to the plasticizer DEHP (di-2-ethylhexyl phthalate), which may be leached from PVC infusion bags or sets, the final Docetaxel Injection concentrate dilution for infusion should be stored in bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene-lined administration sets.
PREPARATION AND ADMINISTRATION: Do not use the two-vial formulation (Injection Concentrate and diluent) with the one-vial formulation.
One-vial Docetaxel Injection Concentrate (Injection Concentrate).
Docetaxel Injection Concentrate (20 mg/mL) requires NO prior dilution with a diluent and is ready to add to the infusion solution.
1. Aseptically withdraw the required amount of Docetaxel Injection concentrate (20 mg docetaxel/ml) with a calibrated syringe and inject into a 250 mL infusion bag or bottle of either 0.9% Sodium Chloride solution or 5% Dextrose solution to produce a final concentration of 0.3 mg/mL to 0.74 mg/mL.
If a dose greater than 200 mg of Docetaxel Injection concentrate is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/mL Docetaxel Injection concentrate is not exceeded.
2. Thoroughly mix the infusion by gentle manual rotation.
3. As with all parenteral products, Docetaxel Injection concentrate should be inspected visually for particulate matter or discoloration prior to administration whenever the solution and container permit. If the Docetaxel Injection concentrate dilution for intravenous infusion is not clear or appears to have precipitation, it should be discarded.
The Docetaxel Injection concentrate dilution for infusion should be administered intravenously as a 1-hour infusion under ambient room temperature (below 25°C) and lighting conditions.