Author: Aventis Pharma S.A.


Long information

What is it?

Taxotere is a medicine that contains the active substance docetaxel. It is available in two forms:

as two vials one containing a concentrated solution and the other containing a solvent, whose contents are mixed together before being made up into a solution for infusion drip into a vein

a single vial containing a concentrate that is ready to make up into a solution for infusion.

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Taxotere is used to treat the following types of cancer:

breast cancer. Taxotere 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. Taxotere 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. Taxotere 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. Taxotere is used with cisplatin and 5-fluorouracil other anticancer medicines

head and neck cancer in patients whose cancer is advanced has started to spread. Taxotere is used with cisplatin and 5-fluorouracil.

For full details, see the summary of product characteristics (also part of the EPAR).

The medicine can only be obtained with a prescription.

How is it used?

Taxotere should be used in wards specialising in chemotherapy (using medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.

Taxotere 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. Taxotere is only used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells/mm 3). Dexamethasone (an anti-inflammatory medicine) should also be given to the patient, starting on the day before the Taxotere infusion. For more information, see the summary of product characteristics.

How does it work?

The active substance in Taxotere, docetaxel, belongs to the group of anticancer medicines known as the taxanes. Docetaxel blocks the ability of cells to destroy the internal ?skeleton? that allows them to divide and multiply. With the skeleton still in place, 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 it been studied?

Taxotere has been studied in over 4,000 breast-cancer patients, around 2,000 small-cell-lung-cancer patients, 1,006 prostate-cancer patients, 457 gastric-adenocarcinoma patients and 897 head- and neck-cancer patients. In most of these studies, Taxotere was combined with other anticancer treatments and compared either with combinations of different treatments or with the same treatments but without Taxotere. The main measures of effectiveness were the number of patients whose cancer responded to treatment, how long the patients lived without their disease getting worse and how long the patients survived.

What benefits has it shown during the studies?

Adding Taxotere to other anticancer treatments produced increases in the number of patients whose cancer responded to treatment, how long the patients lived without their disease getting worse and how long the patients survived, in all five types of cancer. When used on its own, Taxotere was at least as effective as and sometimes more effective than the comparator medicines in breast cancer, and more effective than best supportive care (any medicines or techniques to help patients, but not other anticancer medicines) in lung cancer.

What is the risk associated?

The most common side effects with Taxotere (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils), anaemia (low red blood cell counts), thrombocytopenia (low blood platelet counts), febrile neutropenia (neutropenia with fever), peripheral sensory neuropathy (nerve damage in the hands and feet), peripheral motor neuropathy (damage to the nerves causing difficulty co-ordinating movements), dysgeusia (taste disturbances), dyspnoea (difficulty breathing), stomatitis (inflammation of the lining of the mouth), diarrhoea, nausea (feeling sick), vomiting, alopecia (hair loss), skin reactions, nail disorders, myalgia (muscle pain), loss of appetite, infections, fluid retention, asthenia (weakness), pain and hypersensitivity (allergic reactions). These side effects may be more severe when Taxotere is used with other anticancer medicines. For the full list of all side effects reported with Taxotere, see the package leaflet.

Taxotere should not be used in people who may be hypersensitive (allergic) to docetaxel or any of the other ingredients. Taxotere must not be used in patients who have a neutrophil count of less than 1,500 cells/mm 3 or who have severe problems with their liver.

Why has it been approved?

The CHMP decided that Taxotere?s benefits are greater than its risks and recommended that it be given marketing authorisation.

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