What is it and how is it used?
Scintimun is a medicine containing an antibody (besilesomab) used to target specific cells called granulocytes (a type of white blood cells involved in the inflammation process) in your body. Scintimun is used for the preparation of a radioactive solution for injection of technetium( 99mTc)- besilesomab. Technetium( 99mTc) is a radioactive element allowing the organs where besilesomab accumulates to be seen using a special camera.
This medicine is for diagnostic use only.
After injection into your vein, your doctor can perform pictures (scans) of your organs that give more information about the detection of sites of inflammation and/or infection.
What do you have to consider before using it?
Do not use Scintimun:
- if you are allergic (hypersensitive) to besilesomab, to antibody from mouse origin or any other antibodies, to any of the other ingredients of Scintimun (see section 6) or to sodium pertechnetate ( 99mTc) solution.
- if you have a positive response to a test detecting human anti-mouse antibodies (HAMA test). Ask your doctor if you are not sure.
- if you are pregnant.
Take special care with Scintimun:
If any of these conditions are applicable to you, you should inform your doctor:
- if you had previously been administered Scintimun, because you should only be administered Scintimun once in your lifetime. If you are not sure if you have been given this before, please let your doctor know.
- if you previously had a scintigraphy with technetium in the last 2 days.
- if you have a tumoral pathology involving a secretion of carcino embryonic antigen (CEA) which could interfere with this investigation.
- if you have any blood disease.
The use of Scintimun involves the administration of a small amount of radioactivity. Because technetium( 99m Tc)-besilomab is administered by trained personnel, there are no precautions which are your responsibility. Because there are strict laws covering the handling, the use and disposal
of radioactivity, technetium( 99mTc)-besilomab is always used in a hospital or a similar setting. It is always handled by trained and qualified people.
In order to obtain images of best quality and to reduce the radiation exposure of your bladder, you should drink sufficient amounts and empty your bladder prior to and after the scintigraphic examination.
Because you could emit radiation especially harmful to young children during the first 12 hours after the injection, you may be told to avoid close contact with young children during this period of time.
This product is not recommended for use in patient below 18 years of age.
Scintimun should not be used for the diagnosis of diabetic foot infection.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any medicines, including medicines obtained without a prescription.
Medicines reducing inflammation and medicines affecting the production of your blood cells (such as corticosteroids or antibiotics) may affect the results of your examination.
Pregnancy
You must not be given Scintimun if you are pregnant.
Ask your doctor or pharmacist for advice before taking any medicine.
You must tell your doctor if you have missed a period or if there is any chance you may be pregnant. Investigations in nuclear medicine may involve a risk to the unborn.
Breast-feeding
If you are breast feeding you may be told to stop breast-feeding for 3 days after your injection and the expressed milk should be discarded. If you wish you can express and store your breast milk before your injection. This will protect your child from the radiation that may be present in your breast milk. However you may be told to avoid close contact with your child during the first 12 hours after the injection.
Important information about some of the ingredients of Scintimun:
If you have an intolerance to some sugars (for example fructose, sorbitol), tell your doctor before you are given Scintimun.
How is it used?
Your doctor will decide on the amount of technetium( 99mTc)- besilesomab to be used in your case. This will be the minimum amount necessary for the scan to be clear enough to provide the required information.
The recommended activity administered intravenously is between 400 to 800 MBq (MegaBecquerel or MBq is a unit used to measure radioactivity).
A single injection into a vein in your arm is sufficient to provide your doctor with the information needed.
You will then need to wait a few hours whilst the radioactive product is taken up by your body. Scans are usually taken 3 to 6 hours after injection and can be repeated after 24 hours.
If you are given more Scintimun than you should:
Because injection is prepared as a single dose by the hospital personnel, under strictly controlled conditions it is very unlikely you will be given too much. However, if this does occur, you will be asked to drink plenty of water and to take laxatives to increase the elimination of the product from your body.
If you have any further questions on the use of this product, ask your doctor.
What are possible side effects?
Like all medicines, Scintimun can cause side effects, although not everybody gets them.
About 14 out of 100 patients having this injection have been found to produce antibodies in their blood reacting against the antibody present in Scintimun. This may increase the risk of allergic reactions in case of repeated administration of Scintimun. Therefore you should not receive Scintimun a second time.
In case of allergic reaction you will receive appropriate treatment from your doctor.
Possible side effects are listed in the order of their frequency below:
Very common (may affect more than 1 user in 10):
Development of human anti-mouse antibodies reacting against the antibody in Scintimun (antibody of the mouse cells) with a risk of allergic reaction
Common (may affect between 1 in 10 and 1 in 100 users):
Low blood pressure
Uncommon (may affect between 1 in 100 and 1 in 1,000 users):
Allergic reaction, including swelling of the face, hives (urticaria)
Rare (may affect between 1 in 1,000 and 1 in 10,000 users):
- Serious allergic reaction which causes difficulty in breathing or dizziness
- Muscle or joint pain
Any radioactive material may cause cancer or hereditary defects, but the frequency of these adverse reactions is not known.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist and the specialist in nuclear medicine who performed the investigation.
How should it be stored?
Keep out of the reach and sight of children.
Do not use Scintimun after the expiry date which is stated on the labels after EXP.
Store in a refrigerator (2°C – 8°C). Keep the vial in the outer carton in order to protect from light. Do not store the reconstituted and radiolabelled product above 25°C and use within 3 hours after labelling.
You will not have to get or store this medicine. The qualified staff of the nuclear medicine center where this investigation is performed, will do this.
What is it?
Scintimun is a kit for the preparation of a radioactive solution for injection. It contains the active substance besilesomab.
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.
How has it been studied?
The company that makes Scintimun will make sure that all doctors who are expected to use it are provided with a letter explaining the risks associated with the medicine.
Further information
The European Commission granted a marketing authorisation valid throughout the European Union for Scintimun to CIS bio international on 11 January 2010. The marketing authorisation is valid for five years, after which it can be renewed.
Name
Scintimun1 mg kit for radiopharmaceutical preparation
Composition
Each vial of Scintimun contains 1 mg of besilesomab.
Besilesomab is an anti-granulocyte monoclonal antibody (BW 250/183), produced in murine cells.
The radionuclide is not part of the kit.
Excipients:
Each vial of Scintimun contains 2 mg of sorbitol.
One ml of the labelled solution contains less than 4 mg of sodium.
For a full list of excipients, see section 6.1.
Pharmaceutical Form
Kit for radiopharmaceutical preparation
Scintimun: white powder
Solvent for Scintimun: white powder
