Mozobil

plerixafor

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This is a summary of the European public assessment report (EPAR) for Mozobil. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Mozobil.

For practical information about using Mozobil, patients should read the package leaflet or contact their doctor or pharmacist.

What is Mozobil and what is it used for?

Mozobil is a medicine used to help collecting haematopoietic stem cells (cells in the bone marrow that can develop into different types of blood cells) for transplantation. It is used in adult patients with lymphoma or multiple myeloma (types of blood cell cancer) for autologous transplantation (when the patient’s own cells are used in the transplant). It is only used in patients in whom collection of stem cells is difficult. Mozobil contains the active substance plerixafor.

Because the number of patients that need mobilisation and collection of haematopoietic stem cells for transplantation is low, the condition is considered ‘rare’, and Mozobil was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 20 October 2004.

How is Mozobil used?

Mozobil is available as a solution for injection. The medicine can only be obtained with a prescription and treatment should only be started and supervised by a doctor who has experience in treating cancer or blood disorders. After the patient has been given Mozobil, the patient’s stem cells need to be extracted from the blood and stored before transplantation. Because of this, treatment should be carried out in collaboration with a specialised centre that has experience with this type of procedure and can monitor the stem cells correctly.

Mozobil is used together with a hormone called granulocyte colony-stimulating factor (G-CSF). G-CSF is used on its own for four days before Mozobil is added. Mozobil is given as an injection under the skin, six to 11 hours before each session when the patient’s blood is taken and the stem cells are extracted. It can be used for up to seven consecutive days. The dose depends on the bodyweight of the patient.

For further information, see the package leaflet.

How does Mozobil work?

Mozobil is used to help dislodge (‘mobilise’) the stem cells from the bone marrow so they can be released into the blood. The active substance in Mozobil, plerixafor, works by blocking the activity of a protein called the ‘CXCR4 chemokine receptor’. This protein normally helps to keep stem cells within the bone marrow. By blocking its activity, Mozobil allows the stem cells to be released into the blood, so that they can be collected.

What benefits of Mozobil have been shown in studies?

In two main studies, more patients who received Mozobil achieved the target number of stem cells and had successful engraftment of stem cells (the cells started growing and producing normal blood cells) compared with patients who received placebo (a dummy treatment). The studies involved 298 adults with a type of lymphoma called non-Hodgkin’s lymphoma and 302 adults with multiple myeloma. In both studies the patients were also receiving G-CSF and the main measure of effectiveness was the number of patients in whom a target number of stem cells could be collected from the blood within two or four collection days. The studies also looked at the number of patients with a target number of stem cells collected and in whom the stem cells were successfully engrafted.

Among the patients with lymphoma, 60% of those receiving Mozobil achieved the target number of stem cells within four collection days (89 out of 150), compared with 20% of the patients receiving placebo (29 out of 148). Among the patients with multiple myeloma, 72% of those receiving Mozobil achieved the target number of stem cells (106 out of 148), compared with 34% of the patients receiving placebo (53 out of 154).

What are the risks associated with Mozobil?

The most common side effects with Mozobil (which may affect more than 1 patient in 10) are diarrhoea, nausea (feeling sick) and reactions at the site of injection. For the full list of all side effects and restrictions with Mozobil, see the package leaflet.

Why is Mozobil approved?

The European Medicines Agency decided that Mozobil’s benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Mozobil?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mozobil have been included in the summary of product characteristics and the package leaflet.

Other information about Mozobil

The European Commission granted a marketing authorisation valid throughout the European Union for Mozobil on 31 July 2009.

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

Name Language First published Last updated
Mozobil : EPAR - Summary for the public BG = bălgarski 2009-08-20 2017-10-12
Mozobil : EPAR - Summary for the public ES = español 2009-08-20 2017-10-12
Mozobil : EPAR - Summary for the public CS = čeština 2009-08-20 2017-10-12
Mozobil : EPAR - Summary for the public DA = dansk 2009-08-20 2017-10-12
Mozobil : EPAR - Summary for the public DE = Deutsch 2009-08-20 2017-10-12
Mozobil : EPAR - Summary for the public ET = eesti keel 2009-08-20 2017-10-12
Mozobil : EPAR - Summary for the public EL = elliniká 2009-08-20 2017-10-12
Mozobil : EPAR - Summary for the public EN = English 2009-08-20 2017-10-12
Mozobil : EPAR - Summary for the public FR = français 2009-08-20 2017-10-12
Mozobil : EPAR - Summary for the public IT = italiano 2009-08-20 2017-10-12
Mozobil : EPAR - Summary for the public LV = latviešu valoda 2009-08-20 2017-10-12
Mozobil : EPAR - Summary for the public LT = lietuvių kalba 2009-08-20 2017-10-12
Mozobil : EPAR - Summary for the public HU = magyar 2009-08-20 2017-10-12
Mozobil : EPAR - Summary for the public MT = Malti 2009-08-20 2017-10-12
Mozobil : EPAR - Summary for the public NL = Nederlands 2009-08-20 2017-10-12
Mozobil : EPAR - Summary for the public PL = polski 2009-08-20 2017-10-12
Mozobil : EPAR - Summary for the public PT = português 2009-08-20 2017-10-12
Mozobil : EPAR - Summary for the public RO = română 2009-08-20 2017-10-12
Mozobil : EPAR - Summary for the public SK = slovenčina 2009-08-20 2017-10-12
Mozobil : EPAR - Summary for the public SL = slovenščina 2009-08-20 2017-10-12
Mozobil : EPAR - Summary for the public FI = suomi 2009-08-20 2017-10-12
Mozobil : EPAR - Summary for the public SV = svenska 2009-08-20 2017-10-12
Mozobil : EPAR - Summary for the public HR = Hrvatski 2009-08-20 2017-10-12

This EPAR was last updated on 24/10/2017 .

Authorisation details

Product details

Product details for Mozobil
NameMozobil
Agency product numberEMEA/H/C/001030
Active substance

plerixafor

International non-proprietary name (INN) or common name

plerixafor

Therapeutic area Multiple MyelomaHematopoietic Stem Cell TransplantationLymphoma
Anatomical therapeutic chemical (ATC) code L03AX16
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 Mozobil
Marketing-authorisation holder

Genzyme Europe B.V.

Revision14
Date of issue of marketing authorisation valid throughout the European Union31/07/2009

Contact address:

Genzyme Europe B.V.
Gooimer 10
NL-1411 DD Naarden
The Netherlands

Product information

Product information

19/10/2017  Mozobil -EMEA/H/C/001030 -II/0032

Name Language First published Last updated
Mozobil : EPAR - Product Information HR = Hrvatski 2009-08-20 2017-10-24
Mozobil : EPAR - Product Information HR = Hrvatski 2009-08-20 2017-10-24
Mozobil : EPAR - Product Information HR = Hrvatski 2009-08-20 2017-10-24
Mozobil : EPAR - Product Information HR = Hrvatski 2009-08-20 2017-10-24
Mozobil : EPAR - Product Information HR = Hrvatski 2009-08-20 2017-10-24
Mozobil : EPAR - Product Information HR = Hrvatski 2009-08-20 2017-10-24
Mozobil : EPAR - Product Information HR = Hrvatski 2009-08-20 2017-10-24
Mozobil : EPAR - Product Information HR = Hrvatski 2009-08-20 2017-10-24
Mozobil : EPAR - Product Information HR = Hrvatski 2009-08-20 2017-10-24
Mozobil : EPAR - Product Information HR = Hrvatski 2009-08-20 2017-10-24
Mozobil : EPAR - Product Information HR = Hrvatski 2009-08-20 2017-10-24
Mozobil : EPAR - Product Information HR = Hrvatski 2009-08-20 2017-10-24
Mozobil : EPAR - Product Information HR = Hrvatski 2009-08-20 2017-10-24
Mozobil : EPAR - Product Information HR = Hrvatski 2009-08-20 2017-10-24
Mozobil : EPAR - Product Information HR = Hrvatski 2009-08-20 2017-10-24
Mozobil : EPAR - Product Information HR = Hrvatski 2009-08-20 2017-10-24
Mozobil : EPAR - Product Information HR = Hrvatski 2009-08-20 2017-10-24
Mozobil : EPAR - Product Information HR = Hrvatski 2009-08-20 2017-10-24
Mozobil : EPAR - Product Information HR = Hrvatski 2009-08-20 2017-10-24
Mozobil : EPAR - Product Information HR = Hrvatski 2009-08-20 2017-10-24
Mozobil : EPAR - Product Information HR = Hrvatski 2009-08-20 2017-10-24
Mozobil : EPAR - Product Information HR = Hrvatski 2009-08-20 2017-10-24
Mozobil : EPAR - Product Information HR = Hrvatski 2009-08-20 2017-10-24
Mozobil : EPAR - Product Information HR = Hrvatski 2009-08-20 2017-10-24
Mozobil : EPAR - Product Information HR = Hrvatski 2009-08-20 2017-10-24

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
Mozobil : EPAR - All Authorised presentations HR = Hrvatski 2009-08-20 2014-10-09
Mozobil : EPAR - All Authorised presentations HR = Hrvatski 2009-08-20 2014-10-09
Mozobil : EPAR - All Authorised presentations HR = Hrvatski 2009-08-20 2014-10-09
Mozobil : EPAR - All Authorised presentations HR = Hrvatski 2009-08-20 2014-10-09
Mozobil : EPAR - All Authorised presentations HR = Hrvatski 2009-08-20 2014-10-09
Mozobil : EPAR - All Authorised presentations HR = Hrvatski 2009-08-20 2014-10-09
Mozobil : EPAR - All Authorised presentations HR = Hrvatski 2009-08-20 2014-10-09
Mozobil : EPAR - All Authorised presentations HR = Hrvatski 2009-08-20 2014-10-09
Mozobil : EPAR - All Authorised presentations HR = Hrvatski 2009-08-20 2014-10-09
Mozobil : EPAR - All Authorised presentations HR = Hrvatski 2009-08-20 2014-10-09
Mozobil : EPAR - All Authorised presentations HR = Hrvatski 2009-08-20 2014-10-09
Mozobil : EPAR - All Authorised presentations HR = Hrvatski 2009-08-20 2014-10-09
Mozobil : EPAR - All Authorised presentations HR = Hrvatski 2009-08-20 2014-10-09
Mozobil : EPAR - All Authorised presentations HR = Hrvatski 2009-08-20 2014-10-09
Mozobil : EPAR - All Authorised presentations HR = Hrvatski 2009-08-20 2014-10-09
Mozobil : EPAR - All Authorised presentations HR = Hrvatski 2009-08-20 2014-10-09
Mozobil : EPAR - All Authorised presentations HR = Hrvatski 2009-08-20 2014-10-09
Mozobil : EPAR - All Authorised presentations HR = Hrvatski 2009-08-20 2014-10-09
Mozobil : EPAR - All Authorised presentations HR = Hrvatski 2009-08-20 2014-10-09
Mozobil : EPAR - All Authorised presentations HR = Hrvatski 2009-08-20 2014-10-09
Mozobil : EPAR - All Authorised presentations HR = Hrvatski 2009-08-20 2014-10-09
Mozobil : EPAR - All Authorised presentations HR = Hrvatski 2009-08-20 2014-10-09
Mozobil : EPAR - All Authorised presentations HR = Hrvatski 2009-08-20 2014-10-09
Mozobil : EPAR - All Authorised presentations HR = Hrvatski 2009-08-20 2014-10-09
Mozobil : EPAR - All Authorised presentations HR = Hrvatski 2009-08-20 2014-10-09

Pharmacotherapeutic group

Immunostimulants

Therapeutic indication

Mozobil is indicated in combination with granulocyte-colony-stimulating factor to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma whose cells mobilise poorly.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Mozobil : EPAR - Public assessment report HR = Hrvatski 2009-08-20  
Committee for medicinal products for human use, summary of positive opinion for Mozobil HR = Hrvatski 2009-05-29  

Authorised

This medicine is approved for use in the European Union