Temodal

temozolomide

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This is a summary of the European public assessment report (EPAR) for Temodal. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Temodal.

What is Temodal?

Temodal is a medicine that contains the active substance temozolomide. It is available as capsules (5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg) and as a powder to be made up into a solution for infusion (drip into a vein).

What is Temodal used for?

Temodal 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). Temodal 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. Temodal is used on its own in these patients.

The medicine can only be obtained with a prescription.

How is Temodal used?

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

The dose of Temodal 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 Temodal is being used alone or with radiotherapy, and how the patient responds to treatment. Temodal capsules should be taken whole without food. If the solution for infusion is used, it should be given over a period of 90 minutes. Patients may also need to take medicines to prevent vomiting before taking Temodal.

For full details, see the summary of product characteristics (also part of the EPAR).

How does Temodal work?

The active substance in Temodal, 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 Temodal been studied?

Temodal capsules have been studied in four main studies.

The first study compared the effectiveness of Temodal and radiotherapy with that of radiotherapy on its own in 573 patients with newly diagnosed glioblastoma multiforme.

The other three main studies involved patients with malignant glioma that had come back or got worse after previous treatment. Two of these studies involved patients with glioblastoma multiforme: one looked at the effects of Temodal in 138 patients and the other compared Temodal with procarbazine (another anticancer medicine) in 225 patients. The final study looked at the safety and effectiveness of Temodal in the treatment of 162 patients with anaplastic astrocytoma who were in their first relapse.

The main measures of effectiveness were how long the patients survived or the length of time before the patient’s cancer started to get worse.

A further two studies were carried out in a total of 35 patients with brain tumours to show that the capsules and solution for infusion produce the same levels of temozolomide in the blood.

What benefit has Temodal shown during the studies?

In the study of newly diagnosed glioblastoma multiforme, patients survived for an average of 14.6 months when they received Temodal and radiotherapy, compared with 12.1 months with radiotherapy alone.

In the comparative study of glioblastoma multiforme that had come back or got worse after previous treatment, it took an average of 2.9 months until the cancer got worse in patients taking Temodal, compared with 1.9 months in the patients taking procarbazine. In anaplastic astrocytoma, it took an average of 5.4 months for the cancer to get worse in patients taking Temodal.

What is the risk associated with Temodal?

The most common side effects with Temodal (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, constipation, loss of appetite, alopecia (hair loss), headache, fatigue (tiredness), convulsions (fits), rash, neutropenia or lymphopenia (low white-blood-cell counts), and thrombocytopenia (low blood platelet counts). Patients receiving the solution for infusion may also have injection-site reactions, such as pain, irritation, itching, warmth, swelling and redness, as well as bruising. For the full list of all side effects reported with Temodal, see the package leaflet.

Temodal must not be used in people who are hypersensitive (allergic) to temozolomide, any of the other ingredients or dacarbazine (another anticancer medicine). Temodal must not be used in patients with severe myelosuppression (a condition in which the bone marrow cannot make enough blood cells).

Why has Temodal been approved?

The CHMP decided that Temodal’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Temodal

The European Commission granted a marketing authorisation valid throughout the European Union for Temodal on 26 January 1999.

For more information about treatment with Temodal, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Temodal : EPAR - Summary for the public BG = bălgarski 2009-03-05 2012-02-29
Temodal : EPAR - Summary for the public ES = español 2009-03-05 2012-02-29
Temodal : EPAR - Summary for the public CS = čeština 2009-03-05 2012-02-29
Temodal : EPAR - Summary for the public DA = dansk 2009-03-05 2012-02-29
Temodal : EPAR - Summary for the public DE = Deutsch 2009-03-05 2012-02-29
Temodal : EPAR - Summary for the public ET = eesti keel 2009-03-05 2012-02-29
Temodal : EPAR - Summary for the public EL = elliniká 2009-03-05 2012-02-29
Temodal : EPAR - Summary for the public EN = English 2009-03-05 2012-02-29
Temodal : EPAR - Summary for the public FR = français 2009-03-05 2012-02-29
Temodal : EPAR - Summary for the public IT = italiano 2009-03-05 2012-02-29
Temodal : EPAR - Summary for the public LV = latviešu valoda 2009-03-05 2012-02-29
Temodal : EPAR - Summary for the public LT = lietuvių kalba 2009-03-05 2012-02-29
Temodal : EPAR - Summary for the public HU = magyar 2009-03-05 2012-02-29
Temodal : EPAR - Summary for the public MT = Malti 2009-03-05 2012-02-29
Temodal : EPAR - Summary for the public NL = Nederlands 2009-03-05 2012-02-29
Temodal : EPAR - Summary for the public PL = polski 2009-03-05 2012-02-29
Temodal : EPAR - Summary for the public PT = português 2009-03-05 2012-02-29
Temodal : EPAR - Summary for the public RO = română 2009-03-05 2012-02-29
Temodal : EPAR - Summary for the public SK = slovenčina 2009-03-05 2012-02-29
Temodal : EPAR - Summary for the public SL = slovenščina 2009-03-05 2012-02-29
Temodal : EPAR - Summary for the public FI = suomi 2009-03-05 2012-02-29
Temodal : EPAR - Summary for the public SV = svenska 2009-03-05 2012-02-29

This EPAR was last updated on 29/07/2015 .

Authorisation details

Product details

Product details for Temodal
NameTemodal
Agency product numberEMEA/H/C/000229
Active substance

temozolomide

International non-proprietary name (INN) or common name

temozolomide

Therapeutic area GlioblastomaGlioma
Anatomical therapeutic chemical (ATC) code L01AX03

Publication details

Publication details for Temodal
Marketing-authorisation holder

Merck Sharp & Dohme Ltd.

Revision28
Date of issue of marketing authorisation valid throughout the European Union26/01/1999

Contact address:

Merck Sharp & Dohme Ltd.
Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
United Kingdom

Product information

Product information

27/05/2015  Temodal -EMEA/H/C/000229 -PSUSA/02886

Name Language First published Last updated
Temodal : EPAR - Product Information SV = svenska 2009-07-21 2015-07-29
Temodal : EPAR - Product Information SV = svenska 2009-07-21 2015-07-29
Temodal : EPAR - Product Information SV = svenska 2009-07-21 2015-07-29
Temodal : EPAR - Product Information SV = svenska 2009-07-21 2015-07-29
Temodal : EPAR - Product Information SV = svenska 2009-07-21 2015-07-29
Temodal : EPAR - Product Information SV = svenska 2009-07-21 2015-07-29
Temodal : EPAR - Product Information SV = svenska 2009-07-21 2015-07-29
Temodal : EPAR - Product Information SV = svenska 2009-07-21 2015-07-29
Temodal : EPAR - Product Information SV = svenska 2009-07-21 2015-07-29
Temodal : EPAR - Product Information SV = svenska 2009-07-21 2015-07-29
Temodal : EPAR - Product Information SV = svenska 2009-07-21 2015-07-29
Temodal : EPAR - Product Information SV = svenska 2009-07-21 2015-07-29
Temodal : EPAR - Product Information SV = svenska 2009-07-21 2015-07-29
Temodal : EPAR - Product Information SV = svenska 2009-07-21 2015-07-29
Temodal : EPAR - Product Information SV = svenska 2009-07-21 2015-07-29
Temodal : EPAR - Product Information SV = svenska 2009-07-21 2015-07-29
Temodal : EPAR - Product Information SV = svenska 2009-07-21 2015-07-29
Temodal : EPAR - Product Information SV = svenska 2009-07-21 2015-07-29
Temodal : EPAR - Product Information SV = svenska 2009-07-21 2015-07-29
Temodal : EPAR - Product Information SV = svenska 2009-07-21 2015-07-29
Temodal : EPAR - Product Information SV = svenska 2009-07-21 2015-07-29
Temodal : EPAR - Product Information SV = svenska 2009-07-21 2015-07-29
Temodal : EPAR - Product Information SV = svenska 2009-07-21 2015-07-29
Temodal : EPAR - Product Information SV = svenska 2009-07-21 2015-07-29
Temodal : EPAR - Product Information SV = svenska 2009-07-21 2015-07-29

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Temodal : EPAR - All Authorised presentations SV = svenska 2009-07-21 2014-01-22
Temodal : EPAR - All Authorised presentations SV = svenska 2009-07-21 2014-01-22
Temodal : EPAR - All Authorised presentations SV = svenska 2009-07-21 2014-01-22
Temodal : EPAR - All Authorised presentations SV = svenska 2009-07-21 2014-01-22
Temodal : EPAR - All Authorised presentations SV = svenska 2009-07-21 2014-01-22
Temodal : EPAR - All Authorised presentations SV = svenska 2009-07-21 2014-01-22
Temodal : EPAR - All Authorised presentations SV = svenska 2009-07-21 2014-01-22
Temodal : EPAR - All Authorised presentations SV = svenska 2009-07-21 2014-01-22
Temodal : EPAR - All Authorised presentations SV = svenska 2009-07-21 2014-01-22
Temodal : EPAR - All Authorised presentations SV = svenska 2009-07-21 2014-01-22
Temodal : EPAR - All Authorised presentations SV = svenska 2009-07-21 2014-01-22
Temodal : EPAR - All Authorised presentations SV = svenska 2009-07-21 2014-01-22
Temodal : EPAR - All Authorised presentations SV = svenska 2009-07-21 2014-01-22
Temodal : EPAR - All Authorised presentations SV = svenska 2009-07-21 2014-01-22
Temodal : EPAR - All Authorised presentations SV = svenska 2009-07-21 2014-01-22
Temodal : EPAR - All Authorised presentations SV = svenska 2009-07-21 2014-01-22
Temodal : EPAR - All Authorised presentations SV = svenska 2009-07-21 2014-01-22
Temodal : EPAR - All Authorised presentations SV = svenska 2009-07-21 2014-01-22
Temodal : EPAR - All Authorised presentations SV = svenska 2009-07-21 2014-01-22
Temodal : EPAR - All Authorised presentations SV = svenska 2009-07-21 2014-01-22
Temodal : EPAR - All Authorised presentations SV = svenska 2009-07-21 2014-01-22
Temodal : EPAR - All Authorised presentations SV = svenska 2009-07-21 2014-01-22
Temodal : EPAR - All Authorised presentations SV = svenska 2009-07-21 2014-01-22
Temodal : EPAR - All Authorised presentations SV = svenska 2009-07-21 2014-01-22
Temodal : EPAR - All Authorised presentations SV = svenska 2009-07-21 2014-01-22

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Temodal hard capsules is indicated for the treatment of:

  • adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and subsequently as monotherapy treatment;
  • 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.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Temodal : EPAR - Procedural steps taken before authorisation SV = svenska 2005-12-12  
Temodal : EPAR - Scientific Discussion SV = svenska 2005-12-12  

Authorised

This medicine is approved for use in the European Union

More information on Temodal