What is Temozolomide Hexal?
Temozolomide Hexal is a medicine that contains the active substance temozolomide. It is available as capsules (white-green: 5 mg; white-yellow: 20 mg; white-pink: 100 mg; white-blue: 140 mg; white-brown: 180 mg; white: 250 mg).
Temozolomide Hexal 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 Temozolomide Hexal used for?
Temozolomide Hexal 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 brain tumor). Temozolomide Hexal is used first in conjunction with radiotherapy and later as a single agent (alone);
adults and children three years and older with malignant gliomas, such as glioblastoma multiforme or anaplastic astrocytoma, when the tumor recurs or worsens after standard therapy. In these patients Temozolomide Hexal is used on its own.
The medicine can only be obtained with a prescription.
How is Temozolomide Hexal used?
Treatment with Temozolomide Hexal should be prescribed by a doctor experienced in the treatment of brain tumors.
The dosage of Temozolomide Hexal, administered once a day, depends on the body surface (calculated using the height and weight of the patient) and ranges from 75 to 200 mg per square meter. 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 Temozolomide Hexal is used alone or with other therapies and on the patient's response to treatment. Temozolomide Hexal should be taken between meals.
Patients may also need a drug that prevents vomiting prior to administration of Temozolomide Hexal. Temozolomide Hexal 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 Hexal work?
The active substance in Temozolomide Hexal, 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 Hexal been studied?
Because Temozolomide Hexal is a generic medicine, studies have been limited to tests to show that it is bioequivalent to the reference medicine, Temodal. Two drugs are bioequivalent if, once in the body, they deliver the same levels of active ingredient.
What are the benefits and risks of Temozolomide Hexal?
Because Temozolomide Hexal 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 Hexal been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, based on the requirements of EU legislation, Temozolomide Hexal 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 Hexal be given marketing authorization.
More information on Temozolomide Hexal
On 15 March 2010, the European Commission issued a marketing authorization for Temozolomide Hexal to Hexal AG, valid throughout the European Union. The marketing authorization is valid for five years, after which it can be renewed.
The full EPAR for Temozolomide Hexal can be found here. For more information on treatment with Temozolomide Hexal, read the package leaflet (also part of the EPAR).
The full EPAR of the reference medicine is also available on the EMEA website.
Last update of this summary: 01/2010.
