LeukoScan

sulesomab

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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 their 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 of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

What is LeukoScan?

LeukoScan is a vial containing a powder to be made into a solution for injection. The powder contains the active substance sulesomab.

What is LeukoScan used for?

LeukoScan is not used on its own, but must be radiolabelled before use. Radiolabelling is a technique where a substance is tagged (labelled) with a radioactive compound. LeukoScan is radiolabelled by mixing it with a solution of radioactive technetium (99mTc).

This radiolabelled medicine is for diagnostic use. LeukoScan is used to find the site and extent of infection or inflammation in patients with suspected osteomyelitis (bone infection), including patients with diabetic foot ulcers.

The medicine can only be obtained with a prescription.

How is LeukoScan used?

Radiolabelled LeukoScan treatment should only be handled and given by someone who is authorised to use radioactive medicines. The radiolabelled solution is given as an intravenous injection, and a scintigraphy is carried out 1 to 8 hours later. Scintigraphy is a scanning method that uses a special camera (gamma camera) that can detect radioactivity. Because LeukoScan has not been studied in patients aged 21 years or younger, doctors should carefully weigh the benefits and the risks of its use before administering it to a patient in this age group.

How does LeukoScan work?

The active substance in LeukoScan, sulesomab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found in certain cells in the body. Sulesomab has been designed to target an antigen called NCA90, which is present on the surface of granulocytes (a type of white blood cell).

When LeukoScan is radiolabelled, the radioactive compound technetium-99 (99mTc) becomes attached to sulesomab. When the radiolabelled medicine is injected into the patient, the monoclonal antibody carries the radioactivity to the target antigen on the granulocytes. As large numbers of granulocytes gather at the site of an infection, the radioactivity will accumulate where there is an infection, and it can be detected using special scanning techniques, such as scintigraphy or SPECT (single photon emission computed tomography).

How has LeukoScan been studied?

LeukoScan has been studied in two main studies. The first investigated LeukoScan in the detection of osteomyelitis in 102 patients with diabetic foot ulcers. The second study investigated LeukoScan in 130 patients with suspected long bone osteomyelitis. Among these 232 patients, 158 had also undergone a scan using a standard scintigraphy technique (when the patient receives a specially prepared injection of their own white blood cells radiolabelled with a suitable radioactive marker). The main measure of effectiveness was the comparison of the diagnosis made using LeukoScan imaging with the diagnosis from bone biopsy histopathology and microbial culture (when a bone sample is taken and grown in a laboratory to see if it is carrying an infection).

What benefit has LeukoScan shown during the studies?

When the results of both studies were looked at together, LeukoScan was shown to be as effective in diagnosing bone infections as the biopsy and culture technique. LeukoScan was more effective than the standard technique of radiolabelled white blood cells, with a higher sensitivity (detection of 88% of the infections with LeukoScan, compared to 73% with the radiolabelled white blood cells).

What is the risk associated with LeukoScan?

Rare side effects are eosinophilia (increase in eosinophils, a type of white blood cells) and facial rash. For the full list of all side effects reported with LeukoScan, see the Package Leaflet.

LeukoScan should not be used in people who may be hypersensitive (allergic) to sulesomab, mouse proteins, or any of the other ingredients. It should not be used in pregnant women.

Why has LeukoScan been approved?

The Committee for Medicinal products for Human Use (CHMP) decided that LeukoScan’s benefits are greater than its risks for determining the location and extent of infection/inflammation in bone in patients with suspected osteomyelitis, including patients with diabetic foot ulcers. They recommended that LeukoScan be given marketing authorisation.

Other information about LeukoScan:

The European Commission granted a marketing authorisation valid throughout the European Union, for LeukoScan to Immunomedics GmbH on 14 February 1997. The marketing authorisation was renewed on 14 February 2002 and 14 February 2007.

Name Language First published Last updated
LeukoScan : EPAR - Summary for the public BG = bălgarski 13/08/2007  
LeukoScan : EPAR - Summary for the public ES = español 13/08/2007  
LeukoScan : EPAR - Summary for the public CS = čeština 13/08/2007  
LeukoScan : EPAR - Summary for the public DA = dansk 13/08/2007  
LeukoScan : EPAR - Summary for the public DE = Deutsch 13/08/2007  
LeukoScan : EPAR - Summary for the public ET = eesti keel 13/08/2007  
LeukoScan : EPAR - Summary for the public EL = elliniká 13/08/2007  
LeukoScan : EPAR - Summary for the public EN = English 13/08/2007  
LeukoScan : EPAR - Summary for the public FR = français 13/08/2007  
LeukoScan : EPAR - Summary for the public IT = italiano 13/08/2007  
LeukoScan : EPAR - Summary for the public LV = latviešu valoda 13/08/2007  
LeukoScan : EPAR - Summary for the public LT = lietuvių kalba 13/08/2007  
LeukoScan : EPAR - Summary for the public HU = magyar 13/08/2007  
LeukoScan : EPAR - Summary for the public MT = Malti 13/08/2007  
LeukoScan : EPAR - Summary for the public NL = Nederlands 13/08/2007  
LeukoScan : EPAR - Summary for the public PL = polski 13/08/2007  
LeukoScan : EPAR - Summary for the public PT = português 13/08/2007  
LeukoScan : EPAR - Summary for the public RO = română 13/08/2007  
LeukoScan : EPAR - Summary for the public SK = slovenčina 13/08/2007  
LeukoScan : EPAR - Summary for the public SL = slovenščina 13/08/2007  
LeukoScan : EPAR - Summary for the public FI = suomi 13/08/2007  
LeukoScan : EPAR - Summary for the public SV = svenska 13/08/2007  

This EPAR was last updated on 20/09/2011 .

Authorisation details

Product details

Product details for LeukoScan
NameLeukoScan
Agency product numberEMEA/H/C/000111
Active substance

sulesomab

International non-proprietary name (INN) or common name

sulesomab

Therapeutic area Radionuclide ImagingOsteomyelitis
Anatomical therapeutic chemical (ATC) code V04D

Publication details

Publication details for LeukoScan
Marketing-authorisation holder

Immunomedics GmbH

Revision6
Date of issue of marketing authorisation valid throughout the European Union14/02/1997

Contact address:

Immunomedics GmbH
Otto-Röhm-Straße 69
D-64293 Darmstadt
Germany

Product information

Product information

26/02/2008  LeukoScan -EMEA/H/C/000111 -II/0021

Name Language First published Last updated
LeukoScan : EPAR - Product Information SV = svenska 13/08/2007  
LeukoScan : EPAR - Product Information SV = svenska 13/08/2007  
LeukoScan : EPAR - Product Information SV = svenska 13/08/2007  
LeukoScan : EPAR - Product Information SV = svenska 13/08/2007  
LeukoScan : EPAR - Product Information SV = svenska 13/08/2007  
LeukoScan : EPAR - Product Information SV = svenska 13/08/2007  
LeukoScan : EPAR - Product Information SV = svenska 13/08/2007  
LeukoScan : EPAR - Product Information SV = svenska 13/08/2007  
LeukoScan : EPAR - Product Information SV = svenska 13/08/2007  
LeukoScan : EPAR - Product Information SV = svenska 13/08/2007  
LeukoScan : EPAR - Product Information SV = svenska 13/08/2007  
LeukoScan : EPAR - Product Information SV = svenska 13/08/2007  
LeukoScan : EPAR - Product Information SV = svenska 13/08/2007  
LeukoScan : EPAR - Product Information SV = svenska 13/08/2007  
LeukoScan : EPAR - Product Information SV = svenska 13/08/2007  
LeukoScan : EPAR - Product Information SV = svenska 13/08/2007  
LeukoScan : EPAR - Product Information SV = svenska 13/08/2007  
LeukoScan : EPAR - Product Information SV = svenska 13/08/2007  
LeukoScan : EPAR - Product Information SV = svenska 13/08/2007  
LeukoScan : EPAR - Product Information SV = svenska 13/08/2007  
LeukoScan : EPAR - Product Information SV = svenska 13/08/2007  
LeukoScan : EPAR - Product Information SV = svenska 13/08/2007  

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
LeukoScan : EPAR - All Authorised presentations SV = svenska 21/10/2005  

Pharmacotherapeutic group

Diagnostic agents

Therapeutic indication

This medicinal product is for diagnostic use only.

LeukoScan is indicated for diagnostic imaging for determining the location and extent of infection/inflammation in bone in patients with suspected osteomyelitis, including patients with diabetic foot ulcers.

LeukoScan has not been employed to diagnose osteomyelitis in patients with sickle cell anaemia.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
LeukoScan : EPAR - Procedural steps taken before authorisation SV = svenska 21/10/2005  
LeukoScan : EPAR - Scientific Discussion SV = svenska 21/10/2005  

Authorised

This medicine is approved for use in the European Union