Taxotere
Authorised
This medicine is authorised for use in the European Union
docetaxel
MedicineHumanAuthorised
Overview
Taxotere is a cancer medicine 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 cancer 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 cancer medicine) in patients who have not received any treatment for their cancer;
- prostate cancer, when the cancer has spread to other parts of the body (metastatic). Taxotere is used with prednisone or prednisolone (anti-inflammatory medicines) when the cancer cannot be treated by greatly reducing the body's production of testosterone (castration-resistant prostate cancer). It can also be used with androgen-deprivation therapy when hormonal treatment still works (hormone-sensitive prostate cancer);
- gastric adenocarcinoma (a stomach cancer) that has spread in patients who have not received any treatment for their cancer. Taxotere is used with cisplatin and fluorouracil (other cancer medicines);
- head and neck cancer in patients whose cancer is locally advanced (a cancer that has grown but has not spread). Taxotere is used with cisplatin and fluorouracil.
Taxotere contains the active substance docetaxel.
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.
Product information
Latest procedure affecting product information: T/0144
29/11/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Taxotere
- Active substance
- docetaxel
- International non-proprietary name (INN) or common name
- docetaxel
- Therapeutic area (MeSH)
- Head and Neck Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Adenocarcinoma
- Prostatic Neoplasms
- Stomach Neoplasms
- Breast Neoplasms
- Anatomical therapeutic chemical (ATC) code
- L01CD02
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Breast cancer
Taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
- operable node-positive breast cancer;
- operable node-negative breast cancer.
For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.
Taxotere in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.
Taxotere monotherapy is indicated for the treatment of patients with locally advanced ormetastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.
Taxotere in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.
Taxotere in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.
Non-small-cell lung cancer
Taxotere is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.
Taxotere in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.
Prostate cancer
Taxotere in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Gastric adenocarcinoma
Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.
Head and neck cancer
Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
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