DOCEFREZ - MEDICATIONS

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 medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not already received prior therapy for their cancer or after other treatments have failed, depending on the type of breast cancer being treated. 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 cancer 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 started to spread). Docefrez is used with cisplatin and 5-fluorouracil.
For further details, see the Summary of Product Characteristics (also attached to the EPAR).

The medicine can only be obtained with a prescription.

How is Docefrez used?

Docefrez is used in wards specializing in chemotherapy (use of medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.
Docefrez is given as a "one-hour infusion" every three weeks. The dose, duration of treatment and its use with other drugs depend on the type of cancer being 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) one day before the start of therapy is required; for other types of cancer, one day before and two days after treatment. For more information, see the summary of the treatment. product features.

How does Docefrez work?

The active substance in Docefrez, docetaxel, belongs to the group of anticancer medicines known as taxanes. Docetaxel blocks the ability of cells 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.

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 comparable qualities to Taxotere. Therefore, the CHMP was of the opinion that, like Taxotere, the benefits were than the identified risks, the Committee therefore recommended the granting of a marketing authorization for Docefrez.

More information about Docefrez

On May 10, 2010, the European Commission released Sun Pharmaceutical Industries Europe B.V. a "Marketing Authorization" for Docefrez, valid throughout the European Union. The "Marketing Authorization" is valid for five years, after which it can be renewed.
For the full version of Docefrez's EPAR, click here. For more information on Docefrez therapy, read the package leaflet (included with the EPAR).
The full EPAR version of the reference medicine can also be found on the Agency's website.
Last update of this summary: 03-2010.

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