Active Substance: temozolomide
Common Name: temozolomide
ATC Code: L01AX03
Marketing Authorisation Holder: Hospira UK Ltd
Active Substance: temozolomide
Authorisation Date: 2010-03-15
Therapeutic Area: Glioblastoma Glioma
Pharmacotherapeutic Group: Antineoplastic agents
For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.
For the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
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 maroon: 180 mg; white: 250 mg).
Temozolomide Hospira is a ‘generic medicine’. This means that Temozolomide Hospira is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Temodal.
What is Temozolomide Hospira used for?
Temozolomide Hospira is an anticancer medicine. It is used to treat malignant glioma (brain tumours) in the following groups of patients:
- adults with newly diagnosed glioblastoma multiforme (an aggressive type of brain tumour). Temozolomide Hospira is used first with radiotherapy and then on its own;
- adults and children three years of age and over with malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, when the tumour has returned or got worse after standard treatment. Temozolomide Hospira is used on its own 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 with experience in the treatment of brain tumours.
The dose of Temozolomide Hospira depends on body surface area (calculated using the patient’s height and weight) and ranges from 75 to 200 mg per square metre, once a day. The dose and the number of doses depend on the type of tumour being treated, whether the patient has been treated before, whether Temozolomide Hospira is being used alone or with other treatments, and how the patient responds to treatment. Temozolomide Hospira should be taken without food.
Patients may also need to take medicines to prevent vomiting before taking Temozolomide Hospira. Temozolomide Hospira should be used with caution in patients with severe liver problems or with kidney problems.
For full details, see the summary of product characteristics (also part of 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 to another compound called MTIC. MTIC binds to the DNA of cells while they are reproducing, which stops cell division. As a result, the cancer cells cannot divide, slowing down the growth of tumours.
How has Temozolomide Hospira been studied?
Because Temozolomide Hospira is a generic medicine, studies in patients have been limited to tests to determine that it 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 benefit and risk of Temozolomide Hospira?
Because Temozolomide Hospira is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk 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, in accordance with EU requirements, Temozolomide Hospira has been shown to have comparable quality and to be bioequivalent to Temodal. Therefore, the CHMP’s view was that, as for Temodal, the benefit outweighs the identified risk. The Committee recommended that Temozolomide Hospira be given marketing authorisation.
Other information about Temozolomide Hospira
The European Commission granted a marketing authorisation valid throughout the EU for Temozolomide Hospira to Hospira UK Ltd on 15 March 2010. The marketing authorisation is valid for five years, after which it can be renewed.
Source: European Medicines Agency
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