What is Temozolomide Sun - temozolomide?
Temozolomide Sun is a medicine that contains the active substance temozolomide. It is available as capsules (5, 20, 100, 140, 180 and 250 mg).
Temozolomide Sun is a "generic medicine". which means that Temozolomide Sun is similar to a 'reference medicine' already authorized in the European Union (EU) called Temodal.
What is Temozolomide Sun - temozolomide used for?
Temozolomide Sun 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 (a type of aggressive brain tumor). Temozolomide Sun is used first in conjunction with radiation therapy and then on its own;
adults and children from three years of age suffering from a malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, when the tumor has reappeared or has worsened after a standard treatment. In these patients Temozolomide Sun is used alone.
The medicine can only be obtained with a prescription.
How is Temozolomide Sun - temozolomide used?
Treatment with Temozolomide Sun should be prescribed by a doctor experienced in the treatment of brain tumors.
The dosage of Temozolomide Sun 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, by the fact that Temozolomide Sun is used alone or with other therapies and by the patient's response to treatment. Temozolomide Sun should be taken with food.
Patients may also need to take medicines to prevent vomiting before taking Temozolomide Sun. Temozolomide Sun should be used with caution in patients with severe liver problems or kidney problems.
For more information, see the summary of product characteristics (included with EPAR).
How does Temozolomide Sun - temozolomide work?
The active substance in Temozolomide Sun, temozolomide, belongs to a group of anticancer medicines called alkylating agents. In the body, 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 Sun - temozolomide been studied?
Because Temozolomide Sun is a generic medicine, studies in patients have been limited to tests to show that it is bioequivalent to the reference medicine, Temodal. Two medicines are considered bioequivalent when they produce the same levels of active ingredient in the body.
What are the benefits and risks of Temozolomide Sun - temozolomide?
Because Temozolomdie Sun is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Why has Temozolomide Sun - temozolomide been approved?
The CHMP (Committee for Medicinal Products for Human Use) concluded that, in accordance with EU requirements, Temozolomide has been shown to have comparable quality and to be bioequivalent to the reference medicine. 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 Sun be given marketing authorization.
More information on Temozolomide Sun - temozolomide
On 13 July 2011, the European Commission issued a marketing authorization for Temolozomide Sun, valid throughout the European Union. For more information about treatment with Temozolomide Sun, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
The full EPAR for the reference medicine can be found on the Agency's website.
Last update of this summary: 06-2011.
