Mepact

mifamurtide

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This is a summary of the European public assessment report (EPAR) for Mepact. 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 Mepact.

What is Mepact?

Mepact is a powder that is made up into a suspension for infusion (drip into a vein). It contains the active substance mifamurtide.

What is Mepact used for?

Mepact is used to treat high-grade non-metastatic osteosarcoma (a type of bone cancer) in patients aged between two and 30 years. ‘High-grade’ means that the cancer is of a severe type, and ‘non-metastatic’ means that it is at an early stage and has not spread far within the body. Mepact is used with other anticancer medicines after the cancer has been removed by surgery.

Because the number of patients with osteosarcoma is low, the disease is considered ‘rare’, and Mepact was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 21 June 2004.

The medicine can only be obtained with a prescription.

How is Mepact used?

Mepact treatment should be started and supervised by a specialised doctor who has experience in diagnosing and treating osteosarcoma.

The dose of Mepact depends on the patient’s height and weight. It should be given twice a week for 12 weeks, and then once a week for 24 weeks. Mepact is given as a slow infusion lasting an hour. It must not be given as a bolus injection (all at once).

How does Mepact work?

The active substance in Mepact, mifamurtide, is an immunomodulator. It works by activating macrophages and monocytes (types of white blood cell that form part of the immune system). The precise way that mifamurtide works in osteosarcoma is not fully understood, but it is thought to cause the white blood cells to release chemicals that kill the cancerous cells.

How has Mepact been studied?

Mepact has been studied in one main study involving 678 patients aged between one and 31 years with high-grade non-metastatic osteosarcoma. After surgery to remove the cancer, all of the patients were given various combinations of anticancer medicines. Half of the patients were also given Mepact. The study compared patients who were given Mepact with those who were not. The main measure of effectiveness was the number of patients who survived without the disease coming back. The patients were followed up for up to 10 years.

What benefit has Mepact shown during the studies?

Mepact, used with other anticancer medicines, increased how long patients survived without their disease coming back: 68% of the patients receiving Mepact (231 out of 338) survived without the disease coming back, compared with 61% of the patients who did not receive it (207 out of 340). The risk of dying was also reduced by 28% in patients receiving Mepact.

What is the risk associated with Mepact?

The most common side effects with Mepact (seen in more than 1 patient in 10) are anaemia (low red-blood-cell counts), loss of appetite, headache, dizziness, tachycardia (rapid heartbeat), hypertension (high blood pressure), hypotension (low blood pressure), dyspnoea (difficulty breathing), tachypnoea (rapid breathing), cough, vomiting, diarrhoea, constipation, abdominal pain (stomach ache), nausea, hyperhidrosis (excessive sweating), myalgia (muscle pain), arthralgia (joint pain), back pain, pain in extremity (the arms and legs), fever, chills, fatigue (tiredness), hypothermia (low body temperature), general pain, malaise (feeling unwell), asthenia (weakness) and chest pain. For the full list of all side effects reported with Mepact, see the package leaflet.

Mepact should not be used in people who may be hypersensitive (allergic) to mifamurtide or any of the other ingredients. It must not be used at the same time as ciclosporin or other calcineurin inhibitors (medicines that reduce the activity of the immune system), or high doses of non-steroidal anti-inflammatory drugs (NSAIDs; used to treat pain and inflammation).

Why has Mepact been approved?

The CHMP decided that Mepact’s benefits are greater than its risks when used with other anticancer medicines and recommended that it be given marketing authorisation.

Other information about Mepact

The European Commission granted a marketing authorisation valid throughout the European Union for Mepact on 6 March 2009. The marketing authorisation is valid for five years, after which it can be renewed.

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

Name Language First published Last updated
Mepact : EPAR - Summary for the public BG = bălgarski 2009-05-06 2013-10-01
Mepact : EPAR - Summary for the public ES = español 2009-05-06 2013-10-01
Mepact : EPAR - Summary for the public CS = čeština 2009-05-06 2013-10-01
Mepact : EPAR - Summary for the public DA = dansk 2009-05-06 2013-10-01
Mepact : EPAR - Summary for the public DE = Deutsch 2009-05-06 2013-10-01
Mepact : EPAR - Summary for the public ET = eesti keel 2009-05-06 2013-10-01
Mepact : EPAR - Summary for the public EL = elliniká 2009-05-06 2013-10-01
Mepact : EPAR - Summary for the public EN = English 2009-05-06 2013-10-01
Mepact : EPAR - Summary for the public FR = français 2009-05-06 2013-10-01
Mepact : EPAR - Summary for the public IT = italiano 2009-05-06 2013-10-01
Mepact : EPAR - Summary for the public LV = latviešu valoda 2009-05-06 2013-10-01
Mepact : EPAR - Summary for the public LT = lietuvių kalba 2009-05-06 2013-10-01
Mepact : EPAR - Summary for the public HU = magyar 2009-05-06 2013-10-01
Mepact : EPAR - Summary for the public MT = Malti 2009-05-06 2013-10-01
Mepact : EPAR - Summary for the public NL = Nederlands 2009-05-06 2013-10-01
Mepact : EPAR - Summary for the public PL = polski 2009-05-06 2013-10-01
Mepact : EPAR - Summary for the public PT = português 2009-05-06 2013-10-01
Mepact : EPAR - Summary for the public RO = română 2009-05-06 2013-10-01
Mepact : EPAR - Summary for the public SK = slovenčina 2009-05-06 2013-10-01
Mepact : EPAR - Summary for the public SL = slovenščina 2009-05-06 2013-10-01
Mepact : EPAR - Summary for the public FI = suomi 2009-05-06 2013-10-01
Mepact : EPAR - Summary for the public SV = svenska 2009-05-06 2013-10-01
Mepact : EPAR - Summary for the public HR = Hrvatski 2009-05-06 2013-10-01

This EPAR was last updated on 22/02/2016 .

Authorisation details

Product details

Product details for Mepact
NameMepact
Agency product numberEMEA/H/C/000802
Active substance

mifamurtide

International non-proprietary name (INN) or common name

mifamurtide

Therapeutic area Osteosarcoma
Anatomical therapeutic chemical (ATC) code L03AX15
Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Mepact
Marketing-authorisation holder

Takeda France SAS

Revision12
Date of issue of marketing authorisation valid throughout the European Union06/03/2009

Contact address:

Takeda France SAS
Immeuble Pacific
11-13 cours Valmy
92800 Puteaux
France

Product information

Product information

17/12/2015  Mepact -EMEA/H/C/000802 -IAIN/0040/G

Name Language First published Last updated
Mepact : EPAR - Product Information HR = Hrvatski 2009-05-06 2016-02-22
Mepact : EPAR - Product Information HR = Hrvatski 2009-05-06 2016-02-22
Mepact : EPAR - Product Information HR = Hrvatski 2009-05-06 2016-02-22
Mepact : EPAR - Product Information HR = Hrvatski 2009-05-06 2016-02-22
Mepact : EPAR - Product Information HR = Hrvatski 2009-05-06 2016-02-22
Mepact : EPAR - Product Information HR = Hrvatski 2009-05-06 2016-02-22
Mepact : EPAR - Product Information HR = Hrvatski 2009-05-06 2016-02-22
Mepact : EPAR - Product Information HR = Hrvatski 2009-05-06 2016-02-22
Mepact : EPAR - Product Information HR = Hrvatski 2009-05-06 2016-02-22
Mepact : EPAR - Product Information HR = Hrvatski 2009-05-06 2016-02-22
Mepact : EPAR - Product Information HR = Hrvatski 2009-05-06 2016-02-22
Mepact : EPAR - Product Information HR = Hrvatski 2009-05-06 2016-02-22
Mepact : EPAR - Product Information HR = Hrvatski 2009-05-06 2016-02-22
Mepact : EPAR - Product Information HR = Hrvatski 2009-05-06 2016-02-22
Mepact : EPAR - Product Information HR = Hrvatski 2009-05-06 2016-02-22
Mepact : EPAR - Product Information HR = Hrvatski 2009-05-06 2016-02-22
Mepact : EPAR - Product Information HR = Hrvatski 2009-05-06 2016-02-22
Mepact : EPAR - Product Information HR = Hrvatski 2009-05-06 2016-02-22
Mepact : EPAR - Product Information HR = Hrvatski 2009-05-06 2016-02-22
Mepact : EPAR - Product Information HR = Hrvatski 2009-05-06 2016-02-22
Mepact : EPAR - Product Information HR = Hrvatski 2009-05-06 2016-02-22
Mepact : EPAR - Product Information HR = Hrvatski 2009-05-06 2016-02-22
Mepact : EPAR - Product Information HR = Hrvatski 2009-05-06 2016-02-22
Mepact : EPAR - Product Information HR = Hrvatski 2009-05-06 2016-02-22
Mepact : EPAR - Product Information HR = Hrvatski 2009-05-06 2016-02-22

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
Mepact : EPAR - All Authorised presentations HR = Hrvatski 2009-05-06 2014-01-10
Mepact : EPAR - All Authorised presentations HR = Hrvatski 2009-05-06 2014-01-10
Mepact : EPAR - All Authorised presentations HR = Hrvatski 2009-05-06 2014-01-10
Mepact : EPAR - All Authorised presentations HR = Hrvatski 2009-05-06 2014-01-10
Mepact : EPAR - All Authorised presentations HR = Hrvatski 2009-05-06 2014-01-10
Mepact : EPAR - All Authorised presentations HR = Hrvatski 2009-05-06 2014-01-10
Mepact : EPAR - All Authorised presentations HR = Hrvatski 2009-05-06 2014-01-10
Mepact : EPAR - All Authorised presentations HR = Hrvatski 2009-05-06 2014-01-10
Mepact : EPAR - All Authorised presentations HR = Hrvatski 2009-05-06 2014-01-10
Mepact : EPAR - All Authorised presentations HR = Hrvatski 2009-05-06 2014-01-10
Mepact : EPAR - All Authorised presentations HR = Hrvatski 2009-05-06 2014-01-10
Mepact : EPAR - All Authorised presentations HR = Hrvatski 2009-05-06 2014-01-10
Mepact : EPAR - All Authorised presentations HR = Hrvatski 2009-05-06 2014-01-10
Mepact : EPAR - All Authorised presentations HR = Hrvatski 2009-05-06 2014-01-10
Mepact : EPAR - All Authorised presentations HR = Hrvatski 2009-05-06 2014-01-10
Mepact : EPAR - All Authorised presentations HR = Hrvatski 2009-05-06 2014-01-10
Mepact : EPAR - All Authorised presentations HR = Hrvatski 2009-05-06 2014-01-10
Mepact : EPAR - All Authorised presentations HR = Hrvatski 2009-05-06 2014-01-10
Mepact : EPAR - All Authorised presentations HR = Hrvatski 2009-05-06 2014-01-10
Mepact : EPAR - All Authorised presentations HR = Hrvatski 2009-05-06 2014-01-10
Mepact : EPAR - All Authorised presentations HR = Hrvatski 2009-05-06 2014-01-10
Mepact : EPAR - All Authorised presentations HR = Hrvatski 2009-05-06 2014-01-10
Mepact : EPAR - All Authorised presentations HR = Hrvatski 2009-05-06 2014-01-10
Mepact : EPAR - All Authorised presentations HR = Hrvatski 2009-05-06 2014-01-10
Mepact : EPAR - All Authorised presentations HR = Hrvatski 2009-05-06 2014-01-10

Pharmacotherapeutic group

Immunostimulants

Therapeutic indication

Mepact is indicated in children, adolescents and young adults for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection. It is used in combination with postoperative multi-agent chemotherapy. Safety and efficacy have been assessed in studies of patients two to 30 years of age at initial diagnosis.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Mepact : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2010-02-26 2016-02-22
Mepact-H-C-802-A20-22: EPAR - Assessment Report - Article 20 HR = Hrvatski 2012-08-30  

Initial marketing-authorisation documents

Name Language First published Last updated
Mepact : EPAR - Public assessment report HR = Hrvatski 2009-05-06  
Committee for medicinal products for human use, summary of positive opinion for Mepact HR = Hrvatski 2008-12-18