What is LeukoScan?
LeukoScan is a vial containing a powder that is made up into a solution for injection. The active ingredient contained in the powder is sulesomab.
What is LeukoScan used for?
LeukoScan is not used alone but must undergo radioactive marking before use. Radioactive marking is a technique whereby a substance is marked (marked) with a radioactive compound. LeukoScan is radiolabelled by mixing it with a solution of radioactive technetium (99mTc).
This radiolabelled medicine is used for diagnostic purposes. LeukoScan is used to identify the site and extent of infections or inflammations in patients with suspected osteomyelitis (bone infection), including patients suffering from diabetic foot ulcers.
The medicine can only be obtained with a prescription.
How is LeukoScan used?
Treatment with radiolabeled LeukoScan should be performed and administered only by personnel authorized to use radioactive drugs. The radioactive solution is administered as an intravenous injection, while a scintigraphy is performed between 1 and 8 hours later. Scintigraphy is a scanning method that uses a special camera (gamma camera) capable of detecting radioactivity. Since LeukoScan has not been studied in patients aged less than or equal to 21 years, doctors will have to carefully evaluate the risks and benefits of using it before administering it to patients 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) designed to recognize and bind to a specific structure (called an antigen) found in certain cells of the body. Sulesomab was designed to bind to the antigen called NCA90, present on the surface of granulocytes (a type of white blood cell).
When LeukoScan is radiolabelled, technetium-99 (99mTc), a radioactive compound, binds to sulesomab. When the radiolabelled medicine is injected to the patient, the monoclonal antibody carries the radioactivity to the target antigen located on the granulocytes. Since numerous granulocytes accumulate on the site of an infection, radioactivity will accumulate where the infection exists and can be detected through special scanning techniques such as scintigraphy or SPECT (single photon emission computed tomography).
What studies have been carried out on LeukoScan?
LeukoScan has been studied in two main studies. The first study analyzed the LeukoScan used in the detection of osteomyelitis in 102 patients with diabetic foot ulcers. The second study analyzed the use of LeukoScan in 130 patients with suspected long bone osteomyelitis. Of these 232 patients, 158 had also undergone a scan with a traditional scintigraphic technique (in which the patient is injected with a solution of his own radiolabelled white blood cells with an adequate radioactive marker). The main measure of the effectiveness of the medicine was the comparison of the diagnosis made with LeukoScan with that carried out through histopathology and microbial culture of bone biopsy (a procedure that requires a bone sample to be taken and grown in the laboratory to determine if it is suffering from an infection).
What benefit has LeukoScan shown during the studies?
Based on the results of the two studies, LeukoScan proved to be equally effective in the diagnosis of bone infections than in the biopsy and culture technique. LeukoScan is more effective than the standard technique of radiolabelled white blood cells, with a higher sensitivity (88% detection of infections with LeukoScan, compared to 73% identified with the radiolabelled white blood cell technique).
What is the risk associated with LeukoScan?
Rare side effects are eosinophilia (increase in eosinophils, a type of white blood cell) and rash. For a complete list of all the side effects related to LeukoScan, see the package leaflet.
LeukoScan should not be used in patients who may be hypersensitive (allergic) to sulesomab, mouse protein or any other ingredient in the medicine. The medicine should not be used during pregnancy.
Why has LeukoScan been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of LeukoScan outweigh the risks in determining the location and extent of bone infections / inflammations in patients with suspected osteomyelitis, including patients suffering from diabetic foot ulcers. It therefore recommends that the marketing authorization be assigned to LeukoScan.
More information about LeukoScan:
On February 14, 1997, the European Commission issued a marketing authorization for LeukoScan to Immunomedics GmbH, valid throughout the European Union. The marketing authorization was renewed on February 14, 2002 and February 14, 2007.
The full EPAR for LeukoScan can be found here.
Last update of this summary: 02-2007.
