What is Temomedac?
Temomedac is a medicine that contains the active substance temozolomide. It is available in white capsules (5, 20, 100, 140, 180 and 250 mg).
Temomedac is a 'generic medicine', which means that it is similar to a 'reference medicine' already authorized in the European Union (EU) called Temodal.
What is Temomedac used for?
Temomedac is an anticancer medicine. It is indicated for the treatment of malignant gliomas (brain tumors) in the following groups of patients:
• adults with newly diagnosed glioblastoma multiforme (aggressive type of brain tumor). Temomedac is used first in conjunction with radiotherapy and later as a single agent (alone);
• adults and children from three years of age with malignant gliomas, such as glioblastoma multiforme or anaplastic astrocytoma, when the tumor returns or worsens after standard therapy. Temomedac is used on its own in these patients.
The medicine can only be obtained with a prescription.
How is Temomedac used?
Treatment with Temomedac should be prescribed by a doctor experienced in the treatment of brain tumors.
The dosage of Temomedac depends on the body surface area (calculated using the height and weight of the patient) and ranges from 75 to 200 mg per square meter once a day. The dosage and the number of doses depend on the type of tumor to be treated, on the possibility that the patient was previously treated, on the fact that Temomedac is used alone or with other therapies and on the patient's response to treatment. Temomedac should be taken without food.
Before the administration of Temomedac, patients may also need to take an antiemetic (a drug that prevents vomiting). Temomedac should be used with caution in patients with severe liver problems or kidney problems.
For complete information, see the summary of product characteristics (also included in the EPAR).
How does Temomedac work?
The active substance in Temomedac, temozolomide, belongs to a group of anticancer medicines called alkylating agents. In the organism temozolomide is converted into another compound called MTIC. MTIC binds to cell DNA during the reproductive phase, thereby blocking cell division. As a result, tumor cells cannot reproduce and tumor growth is slowed.
How has Temomedac been studied?
Because Temomedac is a generic medicine, studies have been limited to tests to show that it is bioequivalent to the reference medicine, Temodal. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the risks and benefits associated with Temomedac?
Because Temomedac is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.
Why has Temomedac been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, based on the requirements of EU legislation, Temomedac has been shown to have comparable quality and to be bioequivalent to Temodal. Therefore, it is the CHMP's view that, as in the case of Temodal, the benefits outweigh the identified risks. The Committee therefore recommended that Temomedac be given marketing authorization.
More information on Temomedac
On 25 January 2010, the European Commission issued a marketing authorization for Temomedac, valid throughout the European Union. The marketing authorization holder is Medac GmbH. The marketing authorization is valid for five years and can be renewed after this period.
The full EPAR for Temomedac can be found here.
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 04-2010.
