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 patient groups:
adults recently diagnosed with glioblastoma multiforme (a particularly aggressive type of brain tumor). Temozolomide Hospira is used first with radiation therapy, 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 got worse after standard treatment. Temozolomide Hospira is used alone in these patients.
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 area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square meter once a day. they depend on the type of cancer being treated, whether the patient has been treated previously, whether Temozolomide Hospira is being used alone or with other therapies, and the patient's response to treatment. Temozolomide Hospira should be administered between meals.
Before being given Temozolomide Hospira, patients may also need a medicine that prevents vomiting. 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 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 Hospira been studied?
Since Temozolomide Hospira is a generic medicine, the studies have been limited to evidence designed 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 Hospira?
Because Temozolomide Hospira is a generic medicine and is bioequivalent to the reference medicine, the benefits and risks of the medicine are assumed to be the same as the reference medicine.
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, 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 Hospira.
Other information about Temozolomide Hospira
On 15 March 2010, the European Commission granted Hospira UK Ltd a "Marketing Authorization" for Temozolomide Hospira, valid throughout the European Union.
The marketing authorization is valid for five years and can be renewed after this period.
For the full version of the Temozolomide Hospira EPAR, click here.
For more information on Temozolomide Hospira therapy, please read the package leaflet (included in the EPAR).
The full EPAR version of the reference medicine can also be found on the Agency's website.
Last update of this summary: 03/2010.
The information on Temozolomide Hospira 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.
