What is Docetaxel Winthrop?
Docetaxel Winthrop is a concentrate and solvent for preparing a solution for infusion (drip into a vein). It contains the active ingredient docetaxel.
The medicine is similar to TAXOTERE, which is already authorized in the European Union. The company that makes TAXOTERE has agreed that its scientific data will be used for Docetaxel Winthrop.
What is Docetaxel Winthrop used for?
Docetaxel Winthrop is an anticancer medicine. It is indicated for the treatment of:
- breast cancer. It can also be used on its own after other treatments have failed. It can be used in combination with other anticancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not received previous therapy for their condition or after other treatments have failed, depending on the type of breast cancer being treated and at the stage of progression;
- non-small cell lung cancer. It can be used on its own after other treatments have failed. It can also be used in combination with cisplatin (another anticancer medicine) in patients who have not received previous treatment for this condition;
- prostate cancer, when the cancer does not respond to hormone treatment. It is used in combination with prednisone or prednisolone (anti-inflammatory drugs);
- gastric adenocarcinoma (a type of stomach cancer) in patients who have not previously received treatment for their cancer. It is used in combination with cisplatin and 5-fluorouracil (other anticancer drugs);
- head and neck cancer in patients with advanced cancer. It is used in combination with cisplatin and 5-fluorouracil.
For a detailed description, please refer to the Summary of Product Characteristics, enclosed with the EPAR.
The medicine can only be obtained with a prescription.
How is Docetaxel Winthrop used?
The use of Docetaxel Winthrop should be confined to specialized chemotherapy wards and should be administered under the supervision of a physician licensed to administer anticancer chemotherapy. Docetaxel Winthrop should only be used when the neutrophil count (a type of white blood cell ) is at least 1,500 cells / mm3 For prostate cancer, treatment with dexamethasone (an anti-inflammatory drug) is required one day before starting therapy; for other types of cancer, the day before and two days after treatment.
Docetaxel Winthrop is given as a one-hour infusion every three weeks. The dose, duration of treatment and its use in combination with other drugs depends on the type of cancer being treated. For more information, see the summary of the information. product features.
How does Docetaxel Winthrop work?
The active substance in Docetaxel Winthrop, docetaxel, belongs to the group of anticancer medicines known as taxanes. Docetaxel blocks the ability of cells to destroy the internal 'skeleton', which 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 (for example, blood cells) causing side effects.
How has Docetaxel Winthrop been studied?
Docetaxel Winthrop has been studied in a total of approximately 3,000 breast cancer patients, approximately 1,900 lung cancer patients, approximately 1,000 prostate cancer patients, 445 stomach cancer patients and 897 breast cancer patients. head and neck. In most of these studies, Docetaxel Winthrop was used in combination with other cancer treatments and compared with combinations of different treatments or with the same treatment without Docetaxel Winthrop. The main measures of effectiveness were response rates (percentage of patients whose cancer responded to treatment), time to progression, and increase in survival time.
What benefit has Docetaxel Winthrop shown during the studies?
The combination of Docetaxel Winthrop with other anticancer treatments resulted in a significant increase in response rates, disease progression or survival in all five tumor types treated (breast cancer, non-small cell lung cancer, carcinoma adenocarcinoma, gastric adenocarcinoma and head and neck cancer) Docetaxel Winthrop was at least as effective, and sometimes more effective, than the comparator medicines in the treatment of breast cancer used on its own; support in the treatment of lung cancer.
What is the risk associated with Docetaxel Winthrop?
The most common side effects in patients given Docetaxel Winthrop (seen in more than 1 in 10 patients) are neutropenia (decreased number of white blood cells), anemia (decreased number of red blood cells), thrombocytopenia (low number of platelets ), febrile neutropenia, peripheral sensory neuropathy (damage to the nervous system that causes numbness, irritation and pain in the hands and feet), peripheral motor nemopathy (damage to the nerves that causes difficulty in coordinating movements), dysgeusia (altered taste sensation) , dyspnoea (difficulty in breathing), stomatitis (inflammation of the mucous membranes covering the mouth), diarrhea, nausea, vomiting, alopecia (hair loss), skin reactions, nail changes, myalgia (muscle aches), anorexia (loss of appetite ), infections, fluid retention, asthenia (weakness), pain and hypersensitivity (allergic reactions). These side effects may increase when Docetaxel Winthrop is administered in combination with other anticancer medicines. For the full list of side effects reported with Docetaxel Winthrop, see the package leaflet.
Docetaxel Winthrop must not be used in people who are hypersensitive (allergic) to docetaxel or any of the other substances.Docetaxel Winthrop must not be used in patients whose neutrophil count is below 1 500 cells / mm3, who are pregnant or breastfeeding, or in patients with severe liver problems.
Why has Docetaxel Winthrop been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Docetaxel Winthrop's benefits are greater than its risks in the treatment of: breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma and squamous cell carcinoma of the lung. head and neck. The committee recommended the granting of a marketing authorization for Docetaxel Winthrop.
Learn more about Docetaxel Winthrop
On April 20, 2007, the European Commission released Aventis Pharma S.A. a "Marketing Authorization" for Docetaxel Winthrop, valid throughout the European Union.
For the full Docetaxel Winthrop evaluation (EPAR) version click here.
Last update of this summary: 11-2007
The information on Docetaxel Winthrop published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
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