Author: CIS bio international


Long information

What is it?

Scintimun is a kit for the preparation of a radioactive solution for injection. It contains the active substance besilesomab.

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Scintimun 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. Scintimun is radiolabelled by mixing it with a solution of radioactive technetium ( 99mTc).
Scintimun is for diagnostic use only. It is used to locate areas of infection or inflammation in adults with suspected osteomyelitis (bone infection) in the limbs, in combination with other appropriate imaging methods.
Scintimun should not be used to diagnose diabetic foot infection (infection that occurs in the feet of patients with diabetes).
The medicine can only be obtained with a prescription.

How is it used?

Scintimun should only be used in hospitals with a nuclear medicine department and should only be handled by authorised staff.
A radioactive Scintimun solution is made by mixing the powder and solvent provided in the kit and then radiolabelling it with technetium ( 99mTc). The solution is given to the patient as one injection into a vein. The amount of besilesomab injected varies between 0.25 to 1 mg, depending on how much radioactivity is required.
Three to six hours after the injection, the doctor takes pictures of the limbs (scans) to locate the areas in the bones affected by osteomyelitis.

How does it work?

The active substance in Scintimun, besilesomab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in the body. Besilesomab has been designed to attach to an antigen called NCA-95, which is found on the surface of granulocytes, a type of white blood cell involved in inflammation and fighting infection.

How has it been studied?

The effects of Scintimun were first tested in experimental models before being studied in humans. In one main study in 130 patients who had or were suspected to have osteomyelitis in their limbs, Scintimun was compared with a medicine containing white blood cells radiolabelled with technetium ( 99mTc). Both techniques were used in each patient to diagnose and locate osteomyelitis and the images obtained from each patient were then compared. The main measure of effectiveness for Scintimun was based on how much the assessment of the images obtained with Scintimun agreed with that obtained with the radiolabelled white blood cells.

What benefits has it shown during the studies?

Scintimun produced comparable results to the radiolabelled white blood cells when used to diagnose and locate osteomyelitis in limbs. The agreement rate was 83%.

What is the risk associated?

The most common side effect with Scintimun (seen in more than 1 patient in 10) is the production of anti-mouse antibodies. For the full list of all side effects reported with Scintimun, see the Package Leaflet. Scintimun should not be used in people who may be hypersensitive (allergic) to besilesomab, to other mouse antibodies or to any of the other ingredients. Scintimun must not be used in patients who have tested positive for human anti-mouse antibody (HAMA) and must not be used in pregnant women. As for all radioactive substances used in medicine, patients should be exposed to the lowest possible dose of Scintimun.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Scintimun?s benefits are greater than its risks. The Committee recommended that Scintimun be given marketing authorisation.

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