Striascan

Striascan can only be obtained with a prescription and should only be used in patients who have been referred by a doctor with experience in the management of movement disorders or dementia. Striascan is only handled and given by people who have experience in the safe handling of radioactive materials.

Striascan is given by slow injection lasting at least 15 to 20 seconds into an arm vein. A scan is taken 3 to 6 hours after the injection. Between 1 to 4 hours before receiving Striascan, patients must also take another medicine, such as iodine tablets, to prevent the radioactive iodine in Striascan from getting into the thyroid gland.

Resuscitation equipment should be available before Striascan is given, in case the patient has an allergic reaction.

For more information about using Striascan, see the package leaflet or contact your doctor or pharmacist.

The active substance in Striascan, ioflupane (123I), is a radiopharmaceutical. It contains a substance called ioflupane, which is labelled with 123I (iodine 123), a radioactive form of iodine. Ioflupane attaches specifically to structures on nerve cell endings that are responsible for the transport of dopamine.

When Striascan is injected, ioflupane (123I) is distributed by the blood and builds up in the striatum, where it attaches to the structures that transport dopamine. This build-up can be seen using an 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 the dopamine-containing nerve cells in the striatum. If this happens, the amount of Striascan 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.

The European Medicines Agency concluded that, in accordance with EU requirements, Striascan has been shown to be comparable to DaTSCAN. Therefore, the Agency’s view was that, as for DaTSCAN, the benefit of Striascan outweighs the identified risk and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Striascan have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Striascan are continuously monitored. Side effects reported with Striascan are carefully evaluated and any necessary action taken to protect patients.

Striascan received a marketing authorisation valid throughout the EU on 25 June 2019.

Because Striascan is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, DaTSCAN, and do not need to be repeated for Striascan.

As for every medicine, the company provided studies on the quality of Striascan. There was no need for ‘bioequivalence’ studies to investigate whether Striascan is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Striascan is given by injection into a vein, so the active substance is delivered straight into the bloodstream.