Docetaxel Trihydrate

1. Breast cancer:

- Docetaxel trihydrate in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:

operable node-positive breast cancer;

operable node-negative breast cancer.

-Docetaxel trihydrate in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.

- Docetaxel trihydrate monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.

- Docetaxel trihydrate combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumors over express HER2 and who previously have not received chemotherapy for metastatic disease.

-Docetaxel trihydrate in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.

2. Non-small cell lung cancer:

-Docetaxel trihydrate is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.

-Docetaxel trihydrate in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer , in patients who have not previously received chemotherapy for this condition.

3. Prostate cancer:

-Docetaxel trihydrate in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer .

4. Gastric adenocarcinoma:

-Docetaxel trihydrate in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.

5. Head and neck cancer:

-Docetaxel trihydrate in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

EP, USP

WC GMP, US DMF, CEP