PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED
What is Docefrez?
Docefrez is a powder and solvent used as a solution for infusion (drip into a vein), containing the active substance docetaxel.
Docefrez is a 'generic medicine', which means that Docefrez is similar to a 'reference medicine' already authorized in the European Union (EU) called Taxotere.
What is Docefrez used for?
Docefrez is used to treat the following types of cancer:
breast cancer. Docefrez can be used on its own after other treatments have failed. It can also be used with other anticancer drugs (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not already undergone previous therapy for their cancer or after failure of other treatments, based on the type of breast cancer treat and at the stage of progression;
non-small cell lung cancer. Docefrez 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 received previous treatment for their cancer;
prostate cancer, when the tumor does not respond to hormonal treatment. Docefrez is used with prednisone or prednisolone (anti-inflammatories);
gastric adenocarcinoma (a type of stomach cancer) in patients who have not previously received treatment for their cancer. Docefrez is used with cisplatin and 5-fluorouracil (other anticancer drugs);
head and neck cancer in patients with advanced cancer (which has begun to spread). Docefrez is used with cisplatin and 5-fluorouracil.
For more details, see the summary of product characteristics (also included with the EPAR).
The medicine can only be obtained with a prescription.
How is Docefrez used?
Docefrez should be used in departments specializing in chemotherapy (use of medicines to treat tumors) under the supervision of a doctor who is qualified in the use of chemotherapy.
Docefrez is given as an infusion lasting one hour every three weeks. The dose, duration of treatment and its use with other drugs depend on the type of cancer to be treated. Docefrez should only be used when the neutrophil count (a type of white blood cell) is at least 1 500 cells / mm3. For prostate cancer, the administration of dexamethasone (an anti-inflammatory drug) is required one day before the start of therapy; for other types of cancer, one day before and two days after treatment. For more information, see the summary of product characteristics.
How does Docefrez work?
The active substance in Docefrez, docetaxel, belongs to the group of anticancer drugs known as the taxanes. Docetaxel blocks the cells' ability to destroy the internal "skeleton" that allows them to divide and multiply. In the presence of the skeleton the cells cannot divide and therefore die. Docetaxel also affects non-cancer cells, such as blood cells, which can cause side effects.
How has Docefrez been studied?
Because Docefrez is a generic medicine, its benefits and risks are considered to be the same as the reference medicine.
What are the benefits and risks of Docefrez?
Because Docefrez is a generic medicine, its benefits and risks are considered to be the same as the reference medicine.
Why has Docefrez been approved?
The CHMP (Committee for Medicinal Products for Human Use) concluded that, in accordance with the requirements of the European Union, Docefrez has been shown to have qualities comparable to Taxotere. Therefore, the CHMP was of the opinion that, as with Taxotere, the benefits outweighed the identified risks. The Committee therefore recommended that Docefrez be given marketing authorization.
More information on Docefrez
On May 10, 2010, the European Commission granted a marketing authorization for Docefrez, valid throughout the European Union, to Sun Pharmaceutical Industries Europe BV. The marketing authorization is valid for five years, after which it can be renewed.
For the full EPAR for Docefrez, click here. For more information on Docefrez therapy, read the package leaflet (also part of the EPAR).
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 03-2010.
