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 patient groups:
• adults with newly diagnosed glioblastoma multiforme (an aggressive type of brain tumor). Temozolomide Teva is used first in conjunction with radiotherapy and then on its own (alone);
• adults and children aged three years and over with malignant gliomas, such as glioblastoma multiforme or anaplastic astrocytoma, when the cancer comes back or gets worse after standard therapy. Temozolomide Teva is used on its own in these patients.
The medicine can only be obtained with a prescription.
How is Temozolomide Teva used?
Treatment with Temozolomide Teva should be prescribed by a doctor who has experience in the treatment of brain tumors.
The Temozolomide Teva dosage depends on the body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square meter once a day. The dosage and number of doses depend on the type of cancer being treated. , whether the patient has previously been treated, whether Temozolomide Teva is used alone or with other therapies, and the patient's response to treatment. Temozolomide Teva is taken without food.
Before being given Temozolomide Teva, patients may also need to take an antiemetic (a medicine 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 the DNA of cells during the reproductive phase, thereby blocking cell division. As a result, cancer cells cannot reproduce and tumor growth is slowed down.
How has Temozolomide Teva been studied?
Since Temozolomide Teva is a generic medicine, the studies have been limited to evidence to show that the medicine is bioequivalent to the reference medicine, Temodal. Two medicines are bioequivalent when they produce the same levels of the active substance 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 assumed 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, the CHMP is of the opinion that, as in the case of Temodal, the benefits outweigh the identified risks. The Committee therefore recommended the granting of marketing authorization for Temozolomide Teva.
Other information about Temozolomide Teva
On January 28, 2010, the European Commission released Teva Pharma B.V. a "Marketing Authorization" for Temozolomide Teva, valid throughout the European Union. The "Marketing Authorization" is valid for five years and can be renewed after that period.
For the full version of Temozolomide Teva EPAR click here.
The full EPAR version of the reference medicine can also be found on the Agency's website.
Last update of this summary: 12-2009.
The information on Temozolomide Teva 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.
