What is Docetaxel Teva?
Docetaxel Teva is a concentrate and solvent for the preparation of a solution for infusion (drip into a vein). Contains the active ingredient docetaxel.
Docetaxel Teva is a 'generic medicine', which means that Docetaxel Teva is similar to a 'reference medicine' already authorized in the European Union (EU) called Taxotere.
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 in combination with other anticancer drugs (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not received previous therapy for their disease or after failure of other treatments, based on the type of breast cancer to be treated and at the stage of progression;
non-small cell lung cancer. Docetaxel Teva can be used on its own after other treatments have failed. It can also be used in combination with cisplatin (another anticancer medicine) in patients who have not previously been subjected to other treatments for the cancer from which they are suffering;
prostate cancer, when the tumor does not respond to hormonal treatment. Docetaxel Teva is used in combination with prednisone or prednisolone (anti-inflammatory drugs);
gastric adenocarcinoma (a type of stomach cancer) in patients who have not previously received treatment for cancer. Docetaxel Teva used in combination with cisplatin and 5-fluorouracil (other anticancer drugs);
head and neck cancer in patients with advanced carcinoma (which has already begun to spread). Docetaxel Teva is used in combination with cisplatin and 5-fluorouracil.
For a detailed description, see the summary of product characteristics, included with the EPAR.
The medicine can only be obtained with a prescription.
How is Docetaxel Teva used?
The use of Docetaxel Teva must be limited to the departments specialized in chemotherapy and its administration must be carried out under the supervision of a doctor authorized to administer anti-cancer chemotherapy.
Docetaxel Teva is given as a one-hour infusion every three weeks. The dose, duration of treatment and its use in combination with other drugs depend on the type of cancer to be treated. Docetaxel Teva should only be used when the neutrophil count (a type of white blood cell) is at least 1 500 cells / mm3. For prostate cancer, treatment with dexamethasone (an anti-inflammatory drug) is required one day before starting therapy; for other types of cancer one day before and two days after treatment. For more information, see the summary of the product characteristics.
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 the cells' ability to destroy the internal "skeleton", which allows them to divide and multiply. In the presence of the skeleton the cells cannot divide and therefore die. Docetaxel also compromises non-tumor cells (eg blood cells) as it can cause side effects.
How has Docetaxel Teva been studied?
Since Docetaxel Teva is a generic medicine, the pharmaceutical company has presented data already published in the medical literature on docetaxel. No further studies were necessary as Docetaxel Teva is a generic medicine, given by infusion and containing the same active substance as the reference medicine, Taxotere. In addition, the company has presented studies to show that the Docetaxel Teva infusion solution has qualities comparable to those of Taxotere.
What are the benefits and risks of Docetaxel Teva?
Because Docetaxel Teva is a generic medicine, its benefits and risks 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 the requirements of the European Union, Docetaxel Teva proved to be comparable to Taxotere. Therefore, it is the opinion of the CHMP that, as in the case of Taxotere, the benefits outweigh the identified risks. The Committee recommended the release of the marketing authorization for Docetaxel Teva.
Why has Docetaxel Teva been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of the European Union, Docetaxel Teva proved to be comparable to Taxotere. Therefore, it is the opinion of the CHMP that, as in the case of Taxotere, the benefits outweigh the identified risks. The Committee recommended the release of the marketing authorization for Docetaxel Teva.
More information on Docetaxel Teva
On 26 January 2010, the European Commission granted a marketing authorization valid throughout the European Union for Docetaxel Teva to Teva Pharma BV. The marketing authorization is valid for five years, after which it can be renewed.
The full EPAR for Docetaxel Teva can be found here.
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 12-2009.
