What is it?

Temozolomide Sandoz 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 Sandoz is a ?generic medicine?. This means that Temozolomide Sandoz is similar to a ?reference medicine? already authorised in the European Union (EU) called Temodal. For more information on generic medicines, see the question-and-answer document here.

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Temozolomide Sandoz 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 Sandoz 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 Sandoz is used on its own in these patients.

The medicine can only be obtained with a prescription.

How is it used?

Treatment with Temozolomide Sandoz should be prescribed by a doctor with experience in the treatment of brain tumours.

The dose of Temozolomide Sandoz 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 Sandoz is being used alone or with other treatments, and how the patient responds to treatment. Temozolomide Sandoz should be taken without food.

Patients may also need to take medicines to prevent vomiting before taking Temozolomide Sandoz. Temozolomide Sandoz 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 it work?

The active substance in Temozolomide Sandoz, 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 it been studied?

Because Temozolomide Sandoz 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 benefits has it shown during the studies?

Because Temozolomide Sandoz 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.

What is the risk associated?

Because Temozolomide Sandoz 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.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Temozolomide Sandoz 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 Sandoz be given marketing authorisation.

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