What is Temozolomide Hospira?
Temozolomide Hospira is a medicine that contains the active substance temozolomide. It is available as capsules (white and green: 5 mg; white and yellow: 20 mg; white and pink: 100 mg; white and blue: 140 mg; white and brown: 180 mg; white: 250 mg).
Temozolomide Hospira is a 'generic medicine', which means that Temozolomide Hospira is similar to a 'reference medicine' already authorized in the European Union (EU) called Temodal.
What is Temozolomide Hospira used for?
Temozolomide Hospira is an anticancer medicine. It is indicated for the treatment of malignant gliomas (brain tumors) in the following groups of patients:
adults who have recently been diagnosed with glioblastoma multiforme (a particularly aggressive type of brain tumor). Temozolomide Hospira is used first with radiotherapy, then alone;
adults and children from three years of age with a malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, when the tumor has reappeared or worsened after a standard treatment. In these patients Temozolomide Hospira is used alone.
The medicine can only be obtained with a prescription.
How is Temozolomide Hospira used?
Treatment with Temozolomide Hospira should be prescribed by a doctor experienced in the treatment of brain tumors.
The dosage of Temozolomide Hospira, given 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 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 Temozolomide Hospira is used alone or with other therapies and from the patient's response to treatment. Temozolomide Hospira is given away from meals.
Patients may also need a drug that prevents vomiting prior to administration of Temozolomide Hospira. Temozolomide Hospira should be used with caution in patients with severe liver or kidney problems.
For complete information, see the summary of product characteristics (also included in the EPAR).
How does Temozolomide Hospira work?
The active substance in Temozolomide Hospira, 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 Hospira been studied?
Because Temozolomide Hospira is a generic medicine, studies have been limited to tests to show that the drug 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 Hospira?
Because Temozolomide Hospira 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 Hospira been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, based on the requirements of EU legislation, Temozolomide Hospira 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 Hospira be given marketing authorization.
More information on Temozolomide Hospira
On 15 March 2010, the European Commission issued a marketing authorization valid throughout the European Union for Temozolomide Hospira to Hospira UK Ltd.
The marketing authorization is valid for five years and can be renewed after this period.
For the full EPAR of Temozolomide Hospira, click here.
For more information on treatment with Temozolomide Hospira, read the package leaflet (also part of the EPAR).
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 03/2010.
