Active Substance: docetaxel
Common Name: docetaxel
ATC Code: L01CD02
Marketing Authorisation Holder: Teva B.V.
Active Substance: docetaxel
Authorisation Date: 2010-01-26
Therapeutic Area: Carcinoma, Non-Small-Cell Lung Prostatic Neoplasms Head and Neck Neoplasms Stomach Neoplasms Adenocarcinoma Breast Neoplasms
Pharmacotherapeutic Group: Antineoplastic agents
Docetaxel Teva 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.
For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.
Docetaxel Teva 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 Teva 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 Teva in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.
Docetaxel Teva 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.
Non-small-cell lung cancer
Docetaxel Teva is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.
Docetaxel Teva 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.
Docetaxel Teva in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Docetaxel Teva 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.
Head and neck cancer
Docetaxel Teva 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.
What is Docetaxel Teva?
Docetaxel Teva is a concentrate and solvent to be made up into a solution for infusion (drip) into a vein. It contains the active substance docetaxel.
What is Docetaxel Teva used for?
Docetaxel Teva is an anticancer medicine. It is used in the following types of cancer:
- breast cancer. Docetaxel Teva can be used on its own after other treatments have failed. It can also be used with other anticancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;
- non-small-cell lung cancer. Docetaxel Teva can be used on its own after other treatments have failed. It can also be used with cisplatin (another anticancer medicine) in patients who have not yet received any treatment for their cancer;
- prostate cancer, when the cancer does not respond to hormonal treatment. Docetaxel Teva is used with prednisone or prednisolone (anti-inflammatory medicines);
- gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer. Docetaxel Teva is used with cisplatin and 5-fluorouracil (other anticancer medicines);
- head and neck cancer in patients whose cancer is locally advanced (a cancer that has grown but has not spread). Docetaxel Teva is used with cisplatin and 5‑fluorouracil.
The medicine can only be obtained with a prescription.
How is Docetaxel Teva used?
Docetaxel Teva should be used in wards specialised in chemotherapy (medicines to treat cancer) and it should only be given under the supervision of a doctor who is qualified in the use of cancer chemotherapy.
Docetaxel Teva is given as a one-hour infusion every three weeks. The dose, duration of treatment and the medicines it is used with depend on the type of cancer being treated. Docetaxel Teva is only used when the neutrophil count (the level of a type of white blood cell) is normal (at least 1,500 cells/mm3). Dexamethasone (an anti‑inflammatory medicine) should also be given to the patient, starting on the day before the Docetaxel Teva infusion. For more information, see the package leaflet.
How does Docetaxel Teva work?
The active substance in Docetaxel Teva, docetaxel, belongs to the group of anticancer medicines known as the taxanes. Docetaxel blocks a stage of cell division, whereby the internal ‘skeleton’ is dismantled to allow the cell to divide. By keeping the skeleton intact the cells cannot divide and they eventually die. Docetaxel also affects non‑cancer cells such as blood cells, which can cause side effects.
How has Docetaxel Teva been studied?
Because Docetaxel Teva is a generic medicine, the company has provided data from the published literature on docetaxel. No additional studies were needed as Docetaxel Teva is given by infusion and contains the same active substance as the reference medicine, Taxotere. In addition, the company presented studies to show that the Docetaxel Teva solution for infusion has comparable quality to that of Taxotere.
What are the benefit and risk of Docetaxel Teva?
Because Docetaxel Teva is a generic medicine, its benefit and risk are taken as being the same as the reference medicine's.
Why has Docetaxel Teva been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Docetaxel Teva has been shown to have comparable quality to Taxotere. Therefore, the CHMP’s view was that, as for Taxotere, the benefit outweighs the identified risk. The Committee recommended that Docetaxel Teva be given marketing authorisation.
Other information about Docetaxel Teva
The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Teva on 26 January 2010.
For more information about treatment with Docetaxel Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Source: European Medicines Agency
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