Docetaxel Mylan

PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED

What is Docetaxel Mylan?

Docetaxel Mylan is a medicine that contains the active substance docetaxel. It is available as a concentrate for the preparation of a solution for infusion (drip into a vein).

Docetaxel Mylan is a "generic medicine". This means that Docetaxel Mylan is similar to a 'reference medicine' already authorized in the European Union (EU) called Taxotere. For more information on generic medicines, see the questions and answers by clicking here.

What is Docetaxel Mylan used for?

Docetaxel Mylan is used to treat the following types of cancer:

breast cancer. Docetaxel Mylan can be used on its own after other treatments have failed. It can also be used in combination with other anticancer drugs (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not received previous therapy for their disease or after failure of other treatments, based on the type of breast cancer to be treated and at the stage of progression;
non-small cell lung cancer. Docetaxel Mylan 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 previously been subjected to other treatments for the cancer from which they are suffering;
prostate cancer, when the tumor does not respond to hormonal treatment. Docetaxel Mylan 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 cancer. Docetaxel Mylan used in combination with cisplatin and 5-fluorouracil (other anticancer drugs);
head and neck cancer in patients with advanced carcinoma (which has already begun to spread). Docetaxel Mylan is used in combination with cisplatin and 5-fluorouracil.

For more information, see the summary of product characteristics (included with EPAR). The medicine can only be obtained with a prescription.

How is Docetaxel Mylan used?

Docetaxel Mylan should be used in wards specializing in the administration of chemotherapy (drugs to treat cancer) under the supervision of a physician qualified in the use of chemotherapy.

Docetaxel Mylan is given as a one-hour infusion every three weeks. The dose, duration of treatment and its use in combination with other drugs depend on the type of cancer to be treated. Docetaxel Mylan should only be used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1, 500 cells / mm3). The patient should also be given Dexamethasone (an anti-inflammatory drug) the day before the infusion of Docetaxel Mylan. For more information, see the summary of product characteristics.

How does Docetaxel Mylan work?

The active substance in Docetaxel Mylan, docetaxel, belongs to the group of anticancer medicines known as the taxanes. Docetaxel blocks the cells' ability to destroy the internal "skeleton" that allows them to divide and multiply. In the presence of the skeleton the cells cannot divide and end up dying. Docetaxel also compromises non-tumor cells (for example, blood cells) causing possible side effects.

How has Docetaxel Mylan been studied?

The company presented data from the scientific literature on docetaxel. The company also showed that the Docetaxel Mylan solution has qualities comparable to those of Taxotere. No further studies were necessary as Docetaxel Mylan is a generic medicine, given by infusion and containing the same active substance as the reference medicine, Taxotere.

What are the benefits and risks of Docetaxel Mylan?

Because Docetaxel Mylan is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why has Docetaxel Mylan been approved?

The CHMP concluded that, in accordance with EU requirements, Docetaxel Mylan was shown to be comparable to Taxotere. Therefore it is the opinion of the CHMP that, as in the case of Taxotere, the benefits outweigh the identified risks. The Committee recommended the release of the marketing authorization for Docetaxel Mylan.