What is Temozolomide Teva?
Temozolomide Teva is a medicine that contains the active substance temozolomide. It is available in white capsules (5, 20, 100, 140, 180 and 250 mg).
Temozolomide Teva is a 'generic medicine', which means that Temozolomide Teva is similar to a 'reference medicine' already authorized in the European Union (EU) called Temodal.
What is Temozolomide Teva used for?
Temozolomide Teva 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). Temozolomide Teva 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. In these patients Temozolomide Teva is used on its own.
The medicine can only be obtained with a prescription.
How is Temozolomide Teva used?
Treatment with Temozolomide Teva should be prescribed by a doctor experienced in the treatment of brain tumors.
The dosage of Temozolomide Teva 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 has been treated previously, on the fact that Temozolomide Teva is used alone or with other therapies and from the patient's response to treatment. Temozolomide Teva should be taken without food.
Before the administration of Temozolomide Teva, patients may also need to take an antiemetic (a drug that prevents vomiting). Temozolomide Teva 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 Temozolomide Teva work?
The active substance in Temozolomide Teva, 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 Temozolomide Teva been studied?
Because Temozolomide Teva 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 benefits and risks of Temozolomide Teva?
Because Temozolomide Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as the reference medicine.
Why has Temozolomide Teva been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, based on the requirements of EU legislation, Temozolomide Teva 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 Temozolomide Teva be given marketing authorization.
More information on Temozolomide Teva
On 28 January 2010, the European Commission granted Teva Pharma BV a marketing authorization for Temozolomide Teva, valid throughout the European Union. The marketing authorization is valid for five years and can be renewed after this period.
The full EPAR for Temozolomide Teva can be found here.
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 12-2009.
