Docetaxel

Docetaxel is an anti-mitotic drug used for chemotherapy.

Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions. Docetaxel binds to free tubulin and promotes the assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly. This leads to the production of microtubule bundles without normal function and to the stabilization of microtubules, which results in the inhibition of mitosis in cells. Docetaxel’s binding to microtubules does not alter the number of protofilaments in the bound microtubules, a feature which differs from most spindle poisons currently in clinical use.

Strength:

• Docetaxel Kabi 20 mg/1 ml
• Docetaxel Kabi 80 mg/4 ml
• Docetaxel Kabi 120 mg/6 ml

For all indications, toxicities may warrant dosage adjustments. Administer in a facility equipped to manage possible complications (e.g. anaphylaxis).

Breast Cancer

• For locally advanced or metastatic breast cancer after failure of prior chemotherapy, the recommended dose of Docetaxel is 60 mg/m2 to 100 mg/m2 administered intravenously over 1 hour every 3 weeks.

• For the adjuvant treatment of operable node-positive breast cancer, the recommended Docetaxel dose is 75 mg/m2 administered 1 hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 courses. Prophylactic G-CSF may be used to mitigate the risk of hematological toxicities

Non-Small Cell Lung Cancer

• For treatment after failure of prior platinum-based chemotherapy, Docetaxel was evaluated as monotherapy, and the recommended dose is 75 mg/m2 administered intravenously over 1 hour every 3 weeks. A dose of 100 mg/m2 in patients previously treated with chemotherapy was associated with increased hematologic toxicity, infection, and treatment-related mortality in randomized, controlled trials.

• For chemotherapy-naïve patients, Docetaxel was evaluated in combination with cisplatin. The recommended dose of Docetaxel is 75 mg/m2 administered intravenously over 1 hour immediately followed by cisplatin 75 mg/m2 over 30-60 minutes every 3 weeks.

Prostate cancer

• For hormone-refractory metastatic prostate cancer, the recommended dose of Docetaxel is 75 mg/m2 every 3 weeks as a 1 hour infusion. Prednisone 5 mg orally twice daily is administered continuously.

Gastric adenocarcinoma

• For gastric adenocarcinoma, the recommended dose of Docetaxel is 75 mg/m2 as a 1 hour intravenous infusion, followed by cisplatin 75 mg/m2, as a 1 to 3 hour intravenous infusion (both on day 1 only), followed by fluorouracil 750 mg/m2 per day given as a 24-hour continuous intravenous infusion for 5 days, starting at the end of the cisplatin infusion. Treatment is repeated every three weeks. Patients must receive premedication with antiemetics and appropriate hydration for cisplatin administration.

Head and Neck Cancer

• Patients must receive premedication with antiemetics, and appropriate hydration (prior to and after cisplatin administration). Prophylaxis for neutropenic infections should be administered. All patients treated on the Docetaxel containing arms of the TAX323 and TAX324 studies received prophylactic antibiotics.

Docetaxel Injection (Daxotel) is indicated for

• Advanced Gastric Adenocarcinoma
• Locally advanced squamous cell carcinoma of Head & Neck
• Hormon refractory metastatic prostate cancer
• Locally advanced or metastatic breast cancer
• Non Small Cell Lung Cancer

Strengths:

Docetaxel Kabi 20 mg/0.5 ml. Carton containing Solvent for Docetaxel Injection Concentrate 1.5ml vial.

Docetaxel Kabi 80 mg/2 ml. Carton containing Solvent for Docetaxel Injection Concentrate 6ml vial.

Docetaxel Kabi 120 mg/3 ml. Carton containing Solvent for Docetaxel Injection Concentrate 9ml vial.

For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory