Mozobil

plerixafor

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This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Mozobil?

Mozobil is a solution for injection that contains the active substance plerixafor.

What is Mozobil used for?

Mozobil is used to help to collect haematopoietic stem cells (cells in the bone marrow that can develop into different types of blood cells) for transplantation. It is used in 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. 

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?

Treatment with Mozobil 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.

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.

How has Mozobil been studied?

The effects of Mozobil were first tested in experimental models before being studied in humans.

Mozobil has been compared with placebo (a dummy treatment) in two main studies involving 298 adults with a type of lymphoma called non-Hodgkin’s lymphoma and 302 adults with multiple myeloma. All of the patients were also receiving G-CSF. 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 stems cells collected and in whom the stems cells were successfully engrafted (started growing and producing normal blood cells).

What benefit has Mozobil shown during the studies?

Mozobil was more effective than placebo at mobilising stems cells from the bone marrow into the blood. Among the patients with lymphoma, 60% of those receiving Mozobil achieved the target number of stems 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). In both studies, there were more patients who received Mozobil that achieved the target number of stem cells and in whom the stems cells were successfully engrafted.

What is the risk associated with Mozobil?

The most common side effects with Mozobil (seen in 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 reported with Mozobil, see the package leaflet. 

Mozobil should not be used in people who may be hypersensitive (allergic) to plerixafor or any of the other ingredients.

Why has Mozobil been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Mozobil’s benefits are greater than its risks for use in combination with G-CSF 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. The Committee recommended that Mozobil be given marketing authorisation.

Other information about Mozobil

The European Commission granted a marketing authorisation valid throughout the European Union for Mozobil to Genzyme Europe B.V. on 31 July 2009.

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

This EPAR was last updated on 09/10/2014 .

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.

Revision9
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

22/09/2014  Mozobil -EMEA/H/C/001030 -PSUV/21

Name Language First published Last updated
Mozobil : EPAR - Product Information SV = svenska 20/08/2009 12/06/2014
Mozobil : EPAR - Product Information SV = svenska 20/08/2009 12/06/2014
Mozobil : EPAR - Product Information SV = svenska 20/08/2009 12/06/2014
Mozobil : EPAR - Product Information SV = svenska 20/08/2009 12/06/2014
Mozobil : EPAR - Product Information SV = svenska 20/08/2009 12/06/2014
Mozobil : EPAR - Product Information SV = svenska 20/08/2009 12/06/2014
Mozobil : EPAR - Product Information SV = svenska 20/08/2009 12/06/2014
Mozobil : EPAR - Product Information SV = svenska 20/08/2009 12/06/2014
Mozobil : EPAR - Product Information SV = svenska 20/08/2009 12/06/2014
Mozobil : EPAR - Product Information SV = svenska 20/08/2009 12/06/2014
Mozobil : EPAR - Product Information SV = svenska 20/08/2009 12/06/2014
Mozobil : EPAR - Product Information SV = svenska 20/08/2009 12/06/2014
Mozobil : EPAR - Product Information SV = svenska 20/08/2009 12/06/2014
Mozobil : EPAR - Product Information SV = svenska 20/08/2009 12/06/2014
Mozobil : EPAR - Product Information SV = svenska 20/08/2009 12/06/2014
Mozobil : EPAR - Product Information SV = svenska 20/08/2009 12/06/2014
Mozobil : EPAR - Product Information SV = svenska 20/08/2009 12/06/2014
Mozobil : EPAR - Product Information SV = svenska 20/08/2009 12/06/2014
Mozobil : EPAR - Product Information SV = svenska 20/08/2009 12/06/2014
Mozobil : EPAR - Product Information SV = svenska 20/08/2009 12/06/2014
Mozobil : EPAR - Product Information SV = svenska 20/08/2009 12/06/2014
Mozobil : EPAR - Product Information SV = svenska 20/08/2009 12/06/2014
Mozobil : EPAR - Product Information SV = svenska 20/08/2009 12/06/2014
Mozobil : EPAR - Product Information SV = svenska 20/08/2009 12/06/2014
Mozobil : EPAR - Product Information SV = svenska 20/08/2009 12/06/2014

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 SV = svenska 20/08/2009 09/10/2014
Mozobil : EPAR - All Authorised presentations SV = svenska 20/08/2009 09/10/2014
Mozobil : EPAR - All Authorised presentations SV = svenska 20/08/2009 09/10/2014
Mozobil : EPAR - All Authorised presentations SV = svenska 20/08/2009 09/10/2014
Mozobil : EPAR - All Authorised presentations SV = svenska 20/08/2009 09/10/2014
Mozobil : EPAR - All Authorised presentations SV = svenska 20/08/2009 09/10/2014
Mozobil : EPAR - All Authorised presentations SV = svenska 20/08/2009 09/10/2014
Mozobil : EPAR - All Authorised presentations SV = svenska 20/08/2009 09/10/2014
Mozobil : EPAR - All Authorised presentations SV = svenska 20/08/2009 09/10/2014
Mozobil : EPAR - All Authorised presentations SV = svenska 20/08/2009 09/10/2014
Mozobil : EPAR - All Authorised presentations SV = svenska 20/08/2009 09/10/2014
Mozobil : EPAR - All Authorised presentations SV = svenska 20/08/2009 09/10/2014
Mozobil : EPAR - All Authorised presentations SV = svenska 20/08/2009 09/10/2014
Mozobil : EPAR - All Authorised presentations SV = svenska 20/08/2009 09/10/2014
Mozobil : EPAR - All Authorised presentations SV = svenska 20/08/2009 09/10/2014
Mozobil : EPAR - All Authorised presentations SV = svenska 20/08/2009 09/10/2014
Mozobil : EPAR - All Authorised presentations SV = svenska 20/08/2009 09/10/2014
Mozobil : EPAR - All Authorised presentations SV = svenska 20/08/2009 09/10/2014
Mozobil : EPAR - All Authorised presentations SV = svenska 20/08/2009 09/10/2014
Mozobil : EPAR - All Authorised presentations SV = svenska 20/08/2009 09/10/2014
Mozobil : EPAR - All Authorised presentations SV = svenska 20/08/2009 09/10/2014
Mozobil : EPAR - All Authorised presentations SV = svenska 20/08/2009 09/10/2014
Mozobil : EPAR - All Authorised presentations SV = svenska 20/08/2009 09/10/2014
Mozobil : EPAR - All Authorised presentations SV = svenska 20/08/2009 09/10/2014
Mozobil : EPAR - All Authorised presentations SV = svenska 20/08/2009 09/10/2014

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 (see section 4.2).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Mozobil : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 15/04/2010 09/10/2014

Initial marketing-authorisation documents

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

Authorised

This medicine is approved for use in the European Union