What is it and how is it used?
An antibody is a natural substance made by the body which binds to foreign substances to help remove them from your body. You produce many different kinds of antibodies.
LeukoScan (sulesomab) is a special kind of antibody which binds to the surface of certain kinds of blood cells called leukocytes. It is produced in mice and purified so that it can be used in humans. When it is combined to the radioactive technetium isotope and injected into your vein, it finds an abnormal accumulation of white blood cells and attaches to them. One to eight hours later after the injection you will be placed on a special table and pictures will be taken with standard nuclear cameras. This helps your doctor make a diagnosis and evaluate the extent of your illness. The doctor does this by using a special imaging camera that reveals areas of radioactivity to see where the infections are located. This medicine is for diagnostic use only.
LeukoScan is used to determine the presence of infections in long bones. Shortly after mixing the LeukoScan with the radioactive technetium isotope, the doctor will inject it into your vein. One to eight hours later you will be placed on a special table and pictures will be taken with standard nuclear cameras to see where the infections are located.
LeukoScan is an antibody fragment which is linked to a radioactive substance called technetium. LeukoScan is used in patients with suspected infection of the bone called osteomyelitis. The antibody is able to bind to the surface of white blood cells which infiltrate the area of infection. When the radioactive antibody binds to the white blood cells, your doctor can determine where the infection is located by using a special imaging camera that reveals areas of radioactivity. The doctor can also determine how much disease there is. This will help the doctor determine whether there is infection in the bone and what kind of treatment to use.
What do you have to consider before using it?
You should not use LeukoScan 0.31 mg, sulesomab,powder for solution for injection
- If you know that you are allergic (hypersensitive) to sulesomab or any protein which comes from a mouse, tell your doctor. You must then not be given LeukoScan.
Take special care with LeukoScan
- It is possible to have a serious allergic reaction to LeukoScan. Therefore, you doctor should keep you under close observation for a short time after he has given you this medicine.
- If you have ever received LeukoScan or another product made from a mouse antibody, your doctor should take a sample of blood for testing to be sure that you have not developed an allergy to it.
- If the prepared solution of LeukoScan appears discoloured or contains particles, it should not be used.
Using other medicines
No interactions with other medicines have been described to date.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Using Leukoscan with food and drink
No studies effects of food/drink have been performed.
Pregnancy and breast-feeding
Pregnancy
- You should not be given LeukoScan if you are pregnant.
Breast-feeding
- If you are breast feeding, you should stop breast feeding your baby for at least 24 hours after you have been given LeukoScan.
Use of radiopharmaceutical agents
- Radiopharmaceutical agents should be used only by qualified personnel with appropriate government authorisation for the use and manipulation of radionuclides.
- This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings. Its receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licenses of local competent official organisations.
- Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements. Appropriate aseptic precautions should be taken, complying with the requirements of Good Manufacturing Practices (GMP) for pharmaceuticals.
- After use, the container should be disposed of as radioactive waste.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.
Important information about some ingredients of LeukoScan
If you have been told that you have an intolerance to some sugars, inform your doctor before you are given this medicine.
How is it used?
Dosage
You will receive a single dose of 0.25 mg of LeukoScan. It will contain the radioactive technetium isotope in an amount called 740-1110 MBq.
Method and/or route(s) of administration
Your doctor will prepare the LeukoScan and the radioactive isotope technetium in a volume of 1.5 ml. 0.25 mg of LeukoScan will be labelled with 740-1110 MBq of technetium. This material will then be injected into your vein. This dose of radioactivity is safe and will be gone from the body in about 24 hours.
Frequency of administration
LeukoScan is prepared for a single injection. If your doctor decides to give it to you again after several weeks or several months, your blood should be tested first to see if you have developed an allergy to LeukoScan.
If you take more LeukoScan than you should
The maximum amount of LeukoScan that can be administered has not been determined. Patients have been given four times the amount you will receive with no adverse reactions.
In the unlikely event of the administration of a radiation overdose with LeukoScan, the absorbed dose to the patient may be reduced by increased oral or intravenous intake of fluids to promote excretion of the radiolabel.
If you stop using LeukoScan
LeukoScan is prepared for a single injection.
If you have any further questions on the use of this product, ask your doctor.
What are possible side effects?
Like all medicines, LeukoScan can cause side effects, although not everybody gets them.
Some side effects, although not common, have been reported. These include a small increase in the number of certain white blood cells called eosinophils (but without any apparent symptoms) and rash.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
How should it be stored?
Keep out of the reach and sight of children.
Expiry date and storage conditions
Kit - 48 months. Store in a refrigerator (2°C-8°C). Do not freeze.
Reconstituted and radiolabelled material - 4 hours. Do not store above 25°C. Do not refrigerate or freeze.
After use, the container should be disposed of as radioactive waste.
What is it?
LeukoScan is a vial containing a powder to be made into a solution for injection. The powder contains the active substance sulesomab.
What is it 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 it 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 it 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 it 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 benefits has it 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?
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 it 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.
Further information
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
LeukoScan 0.31 mg, powder for solution for injection
Composition
Each 3 ml vial contains 0.31 mg sulesomab (IMMU-MN3 murine Fab′-SH antigranulocyte monoclonal antibody fragments) for the preparation of 99mTc labelled LeukoScan. The kit does not include the radioisotope.
Excipients:
Sucrose (37.8 mg)
For a full list of excipients, see section 6.1.
Pharmaceutical Form
Powder for solution for injection.
