Docetaxel Anhydrous USP
Composition: Daxotel-20:
Each
vial contains Docetaxel Anhydrous USP 20mg/ml.
Daxotel-80: Each vial contains Docetaxel Anhydrous USP 80mg/2ml.
Indications: 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).
Dosage 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 intravenously
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.
Use 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.
Packaging: DaxoteI-20: Each
box contains one vial of Docetaxel Anhydrous USP 20mg/ml solution for IV infusion.
Daxotel-80: Each box contains one vial of Docetaxel Anhydrous USP
80mg/2ml solution for IV infusion.
