Docetaxel Anhydrous USP
Daxotel-20: Each vial contains Docetaxel Anhydrous
Daxotel-80: Each vial contains Docetaxel Anhydrous USP 80mg/4ml.
Breast Cancer (BC): Docetaxel is indicated
for the treatment of patients with locally advanced or metastatic breast cancer
after failure of prior chemotherapy. Docetaxel in combination with Doxorubicin
and Cyclophosphamide is indicated for the adjuvant treatment of
patients with operable node-positive breast cancer. Non-small Cell Lung Cancer (NSCLC): Docetaxel as a single agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy. Docetaxel in combination with Cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition. Castration-Resistant Prostate Cancer (CRPC): Docetaxel in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer. Gastric Adenocarcinoma (GC): Docetaxel in combination with Cisplatin and Fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease. Squamous Cell Carcinoma of the Head and Neck (SCCHN): Docetaxel in combination with Cisplatin & Fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head & neck (SCCHN).
and Administration: Breast Cancer: For locally advanced
or metastatic breast cancer after failure of prior chemo therapy, the
recommended dose of Docetaxel is 60mg/m2 to 100mg/m2
administered intra venously over 1 hour every 3 weeks. • For the adjuvant treatment of operable node-positive breast
cancer, the recommended Docetaxel dose is 75mg/m2 administered 1
hour after Doxorubicin 50mg/m2 and Cyclophosphamide 500mg/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 75mg/m2 administered intravenously over 1 hour every 3 weeks. A dose of 100mg/m2 in patients previously treated with chemotherapy was associated with increased hematologic toxicity, infection, and treatment-related mortality in randomized controlled trials. • For chemotherapy-naive patients, Docetaxel was evaluated in combination with Cisplatin. The recommended dose of Docetaxel is 75mg/m2 administered intravenously over 1 hour immediately followed by Cisplatin 75mg/m2 over 30-60 minutes every 3 weeks. Prostate Cancer: For metastatic castration-resistant prostate cancer, the recommended dose of Docetaxel is 75mg/m2 every 3 weeks as a 1 hour intravenous infusion. Prednisone 5mg orally twice daily is administered continuously. Gastric Adenocarcinoma: For gastric adenocarcinoma, the recommended dose of Docetaxel is 75mg/m2 as a 1 hour intravenous infusion, followed by Cisplatin 75mg/m2, as a 1 to 3 hour intravenous infusion (both on day 1 only), followed by Fluorouracil 750mg/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: • 75mg/m2 followed by Cisplatin 75mg/m2 IV (Day 1), followed by Fluorouracil 750mg/m2 per day as a 24-hr IV (Days 1-5), starting at end of Cisplatin infusion; for 4 cycles, • 75mg/m2 followed by Cisplatin 100mg/m2 IV (Day 1), followed by Fluorouracil 1000mg/m2 per day as a 24-hr IV (Days 1-4); for 3 cycles. Or, as directed by the registered physicians.
in Pregnancy and Lactation: Docetaxel can cause fetal harm
when administered to a pregnant woman. If Docetaxel is used during pregnancy,
or if the patient becomes pregnant while receiving this drug, the patient
should be apprised of the potential hazard to the fetus. Women of childbearing
potential should be advised to avoid becoming pregnant during therapy with
Docetaxel. Lactating Mothers: It is
not known whether Docetaxel is excreted in human milk. Because many drugs are
excreted in human milk, and because of the potential for serious
adverse reactions in nursing infants from Docetaxel, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
DaxoteI-20: Each box contains one vial of Docetaxel
Anhydrous USP 20mg/ml solution for IV infusion.
Each box contains one vial of Docetaxel Anhydrous USP 80mg/4ml solution for IV