Mozobil
Authorised
This medicine is authorised for use in the European Union
plerixafor
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Mozobil is a medicine used to mobilise blood stem cells from a patient’s bone marrow so that they can be collected and used later for transplantation in the same patient.
Mozobil is used together with the hormone granulocyte-colony stimulating factor (G-CSF) and is only for patients in whom collection of stem cells is difficult.
The patients who are given Mozobil are:
- adults with lymphoma or multiple myeloma (types of blood cancer);
- children from 1 year of age who have lymphoma or solid tumours.
Mozobil contains the active substance plerixafor.
Mozobil is given as an injection under the skin. 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 are 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.
Mozobil is used together with G-CSF. G-CSF is used on its own for 4 days before Mozobil is added. Mozobil is given 6 to 11 hours before the patient’s blood is taken and the stem cells are extracted. It can be used for up to 7 consecutive days. The dose depends on the bodyweight of the patient.
For more information about using Mozobil, see the package leaflet or contact your doctor or pharmacist.
Mozobil is used to 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.
In two main studies involving 298 adults with non-Hodgkin’s lymphoma and 302 adults with multiple myeloma, 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 after transplantation) than patients who received placebo (a dummy treatment). In both studies the patients were also receiving G-CSF.
Among the adults with lymphoma, 59% (89 out of 150) of those receiving Mozobil achieved the target number of stem cells within 4 collection days, compared with 20% (29 out of 148) of the patients receiving placebo. Among the adults with multiple myeloma, 72% (106 out of 148) of those receiving Mozobil achieved the target number of stem cells within 4 collection days, compared with 34% (53 out of 154) of the patients receiving placebo.
In a main study involving 45 children with lymphoma or solid tumours, 80% (24 out of 30) of patients who received Mozobil had at least a doubling of the number of stem cells in the blood, compared with 29% (4 out of 14) patients who received standard mobilisation treatment alone.
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 side effects and restrictions with Mozobil, see the package leaflet.
The European Medicines Agency decided that Mozobil’s benefits are greater than its risks and it can be authorised for use in the EU.
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.
As for all medicines, data on the use of Mozobil is continuously monitored. Side effects reported with Mozobil are carefully evaluated and any necessary action taken to protect patients.
Mozobil received a marketing authorisation valid throughout the EU on 31 July 2009.
Product information
Latest procedure affecting product information:
EMA/N/0000184403
16/07/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Mozobil
- Active substance
- Plerixafor
- International non-proprietary name (INN) or common name
- plerixafor
- Therapeutic area (MeSH)
- Multiple Myeloma
- Hematopoietic Stem Cell Transplantation
- Lymphoma
- Anatomical therapeutic chemical (ATC) code
- L03AX16
Pharmacotherapeutic group
ImmunostimulantsTherapeutic 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.
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