Taxotere

Taxotere can only be obtained with a prescription and should only be used in units specialising in giving chemotherapy (medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.

Taxotere is given as a 1-hour infusion (drip) into a vein every 3 weeks. The dose, duration of treatment and the medicines it is used with depend on the type of cancer being treated and the patient’s weight and height. An anti-inflammatory medicine such as dexamethasone should also be given to the patient, starting on the day before the Taxotere infusion.

The dose of Taxotere may need to be reduced, or treatment interrupted or discontinued, if the patient develops certain side effects.

For more information about using Taxotere, see the package leaflet or contact your doctor or pharmacist.

The active substance in Taxotere, docetaxel, belongs to the group of cancer medicines known as taxanes. Docetaxel blocks the ability of cells to break down the internal ‘skeleton’ that allows them to divide. With the skeleton still in place, the cells cannot divide and they eventually die. Because docetaxel works on dividing cells, it also affects affects non-cancer cells such as blood cells, which can cause side effects.

Taxotere has been studied in over 4,000 breast-cancer patients, around 2,000 non-small-cell-lung-cancer patients, around 2,700 prostate cancer patients, 457 gastric adenocarcinoma patients and 897 head- and neck-cancer patients. In most of these studies, Taxotere was combined with other cancer treatments and compared either with the medicines it is used in combination with or with a combination of different treatments. 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.

Adding Taxotere to other anticancer treatments was effective 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 treatment to help patients, but not other cancer medicines) in lung cancer.

The most common side effects with Taxotere (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, white blood cells that fight infection), anaemia (low red blood cell counts), stomatitis (inflammation of the lining of the mouth), diarrhoea, nausea (feeling sick), vomiting, alopecia (hair loss) and asthenia (weakness). These side effects may be more severe when Taxotere is used with other cancer medicines. For the full list of side effects of Taxotere, see the package leaflet.

Taxotere must not be used in patients who have a neutrophil count of less than 1,500 cells/mm3 or who have severe problems with their liver. For the full list of restrictions, see the package leaflet.

The European Medicines Agency decided that Taxotere’s benefits are greater than its risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Taxotere have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Taxotere are continuously monitored. Side effects reported with Taxotere are carefully evaluated and any necessary action taken to protect patients.

Taxotere received a marketing authorisation valid throughout the EU on 27 November 1995.