Concentrate for preparing solution
for infusion 20 mg/ml
Trade name: Docetaxel.
International nonproprietary name: Docetaxel.
Description: clear light yellow solution.
Composition: each vial with a capacity of 1 ml, 2 ml, 4 ml contains
Active substance: docetaxel, mg 20, 40, 80.
Excipients: anhydrous citric acid mg 4, 8, 16, anhydrous ethanol pharmacopoeial, ml 0.5, 1, 2, polysorbate 80, ml to 1, to 2, to 4.
Pharmaceutical form: concentrate for solution for infusion.
ATC code: L01CD02.
Indications for use:
► Breast cancer (BC)
Operable BC (adjuvant chemotherapy combined with doxorubicin and cyclophosphamide):
– Involving regional lymph glands;
– Without involving regional lymph glands in patients indicated for chemotherapy according to the established international selection criteria for initial chemotherapy at early stages of BC (in case oa one or more factors of high risk of recurrence: tumor size more than 2 cm, negative status of estrogen and progesterone receptors, high histological level of tumor malignancy (level 2-3), age under 35 years old).
Metastatic and/or locally advanced BC:
– Locally advanced or metastatic BC (first line therapy combined with doxorubicin);
– metastatic BC with tumor hyperexpression HER2 (first line therapy combined with trastuzumab);
– locally advanced or metastatic BC in non-effective previous chemotherapy including anthracyclines or alkalising preparations (in monotherapy) or in non- effective previous chemotherapy including anthracyclines (combined with capecitabine).
► Non- small cell lung cancer non- operable, locally advanced or metastatic non-small cell lung cancer (combined with cisplatin or carboplatin) as first line therapy or in monotherapy as second line therapy.
► Metastatic ovarian cancer second line therapy.
► Head and neck cancer.
Locally advanced squamous cell carcinoma of head and neck (induction therapy combined with cisplatin and 5- fluorouracil).
► Prostate cancer.
Metastatic prostate cancer, refractory to hormonal therapy (combined with or prednisone or prednisolone).
► Stomach cancer metastatic stomach cancer including cancer of esophagogastric transition zone (first line therapy combined with cisplatin and 5- fluorouracil).
