What is it and how is it used?
DaTSCAN contains the active substance ioflupane ( I) which is used to help identify (diagnose) conditions in the brain. It belongs to a group of medicines called “radiopharmaceuticals”, which contain a small amount of radioactivity.
When DaTSCAN is injected into an adult, it is carried around the body in the blood. It collects in a small area of your brain. Changes in this area of the brain occur in:
A scan will give your doctor information about any changes in this area of your brain. Your doctor may feel that the scan would help in finding out more about your condition and deciding on possible treatment.
When DaTSCAN is used, you are exposed to small amounts of radioactivity. This exposure is less than in some types of X-ray investigation. Your doctor will always consider the possible risks and benefits of DaTSCAN.
This medicine is used for diagnostic use only. It is used only to identify illness.
What do you have to consider before using it?
Do not use DaTSCAN if:
you are pregnant
Take special care with DaTSCAN
DaTSCAN is not recommended for:
- people with moderate or severe problems with their kidneys or liver
Use in Children
DaTSCAN is not recommended for:
- children aged 0 to 18 years
Taking other medicines
Some medicines may reduce the quality of the picture obtained. The doctor may ask you to stop taking them for a short time before you receive DaTSCAN.
Pregnancy and breast-feeding
Do not use DaTSCAN if you are pregnant or think you may possibly be pregnant. This is because the child may receive some of the radioactivity. Tell your doctor if you think you might be pregnant. Alternative techniques which do not involve radioactivity should be considered.
If you are breast-feeding, your doctor may delay the use of DaTSCAN, or ask you to stop breast-feeding. It is not known whether ioflupane ( I) is passed into breast milk.
Driving and using machines
DaTSCAN has no known influence on the ability to drive and use machines.
Important information about some of the ingredients of DaTSCAN
DaTSCAN contains alcohol (ethanol) 5 % by volume. Each dose contains up to 197 mg alcohol. This is about the same as 5 ml beer, or 2 ml wine. This is harmful for those suffering from alcoholism. To be taken into account in pregnant or breastfeeding women, children and high risk groups such as patients with liver disease or epilepsy. Tell your doctor if any of these apply to you.
How is it used?
There are strict laws on the use, handling and disposal of radioactivity. DaTSCAN will always be used in a hospital or a similar place. It will only be handled and given to you by people who are trained and qualified to use it safely. They should tell you anything you need to do for the safe use of this medicine.
Your doctor will decide the dose that is best for you.
Before you receive DaTSCAN, your doctor will ask you to take some tablets or liquid that contain iodine. These stop the radioactivity building-up in your thyroid gland. It is important that you take the tablets or liquid as the doctor tells you.
DaTSCAN is given to you as an injection, usually into a vein in your arm. The recommended radioactivity given by injection is between 111 to 185 MBq (megabequerel or MBq is a unit used to measure radioactivity). A single injection is enough. The camera pictures are usually taken 3 to 6 hours after the injection of DaTSCAN.
If you get more DaTSCAN than you should
Since DaTSCAN is given by a doctor under controlled conditions, it is unlikely that you will get an overdose. Your doctor will suggest that you drink plenty of fluids to help the body get rid of the medicine. You will need to be careful with the water (urine) that you pass - your doctor will tell you what to do . This is normal practice with medicines like DaTSCAN. Any ioflupane ( I) which remains in your body will naturally lose its radioactivity.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
What are possible side effects?
Like all medicines, DaTSCAN can cause side effects, although not everybody gets them.
The frequency of side effects is:
Common: affects 1 to 10 users in 100
- Headache
Uncommon: affects 1 to 10 users in 1,000
- Increased appetite
- Dizziness
- Taste disturbance
- Nausea
- Dry mouth
- Vertigo
- A brief irritating feeling similar to ants crawling over your skin (formication)
- Intense pain on injection. This has been reported among patients receiving DaTSCAN into a small vein
Not known: frequency cannot be estimated from the available data.
- Hypersensitivity (allergic)
The amount of radioactivity in the body from DaTSCAN is very small. It will be passed out of the body in a few days without need for you to take special precautions.
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.
How should it be stored?
Do not use DaTSCAN after the expiry date, which is stated on the carton and vial after EXP. Hospital staff will ensure that the product is stored and thrown away correctly and not used after the expiry date stated on the label.
What is it?
What is it used for?
DaTSCAN is for diagnostic use only. It is used to detect the loss of nerve cells in an area of the brain called the striatum, specifically the cells that release dopamine, a chemical messenger.
The medicine is used to help in the diagnosis of the following conditions in adults (aged 18 years or over):
The medicine can only be obtained with a prescription.
How is it used?
DaTSCAN should only be used in patients who have been referred by a doctor with experience in the management of movement disorders or dementia. DaTSCAN is only handled and given by people who have experience in the safe handling of radioactive materials.
DaTSCAN is given by slow injection lasting no less than 15 to 20 seconds into an arm vein. A scan is taken three to six hours after the injection. When receiving DaTSCAN, patients must also take another medicine, such as iodine tablets, to prevent their thyroid gland from taking up the iodine contained in DaTSCAN. This is taken one to four hours before DaTSCAN.
Resuscitation equipment should be available before DaTSCAN is given, in case the patient has an allergic reaction.
How does it work?
The active substance in DaTSCAN, ioflupane ( I), is a radiopharmaceutical. It contains a substance called ioflupane, which is labelled with I (iodine-123), a radioactive form of the chemical element iodine. Ioflupane attaches specifically to structures on the surface of nerve cell endings in the striatum that are responsible for the transport of dopamine.
When DaTSCAN is injected, ioflupane ( I) is distributed through the body in the blood and accumulates in the striatum, where it attaches to the structures that transport dopamine. This can be seen using a special imaging technique called single-photon-emission computed tomography (SPECT), which detects the radioactive iodine-123.
In patients with Parkinson’s disease and related diseases, and in patients with dementia with Lewy bodies, there is typically a loss of nerve cells in the striatum containing dopamine. If this happens, the amount of DaTSCAN attaching to these nerve cells is greatly reduced, which can be seen on the scan. This enables diseases related to Parkinson’s disease to be distinguished from essential tremor, and for Lewy body dementia to be distinguished from Alzheimer’s disease.
How has it been studied?
In movement disorders, DaTSCAN has been studied in 254 adults in two main studies. In the studies, images obtained in 45 healthy volunteers were compared with those obtained in 180 patients with Parkinson’s disease or related diseases, and in 29 patients with essential tremor.
In dementia, DaTSCAN has been studied in one main study involving 288 adults who had been diagnosed with dementia with Lewy bodies or Alzheimer’s disease, or another form of dementia.
In all of the studies, the main measure of effectiveness was the accuracy of the diagnosis based on the images from the scan compared with the diagnosis made by a specialist doctor.
What benefits has it shown during the studies?
In movement disorders, DaTSCAN was effective at detecting changes in the brain due to Parkinson’s disease or related diseases. In the larger of the two studies, the sensitivity of DaTSCAN was 97%. This means that the disease identified by the doctor reading the images obtained using DaTSCAN matched the existing diagnosis of the patients in 97% of cases.
In dementia, the sensitivity of DaTSCAN in distinguishing dementia caused by Lewy bodies from other types of dementia ranged from 75 to 80%.
What is the risk associated?
No serious side effects have been reported with DaTSCAN. The most common side effect with DaTSCAN (seen in between 1 and 10 patients in 100) is headache. The risk caused by radioactivity is thought to be very low. For the full list of all side effects reported with DaTSCAN, see the package leaflet.
DaTSCAN should not be used in people who may be hypersensitive (allergic) to ioflupane or any of the other ingredients. It must not be used in women who are pregnant.
Why has it been approved?
The CHMP decided that DaTSCAN’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Further information
The European Commission granted a marketing authorisation valid throughout the European Union for DaTSCAN to GE Healthcare Limited on 27 July 2000. The marketing authorisation is valid for an unlimited period.
This summary was last updated in 04-2011.
Name
DaTSCAN 74 MBq/ml solution for injection
Composition
Excipients:
This medicinal product contains 39.5 g/l ethanol.
For a full list of excipients see section 6.1
Pharmaceutical Form
Solution for injection.
Clear colourless solution.
