Diagnostic tests

Ioflupane

Solution for injection.

Ioflupane (123I) 74 MBq/ml at reference time (0.07 - 0.13 µg/ml of ioflupane). 2.5 ml vials contain 185 MBq and 5 ml vials contain 370 MBq ioflupane (123I) (specific activity range 2.5 - 4.5 x 1014 Bq/mmol) at reference time.

This medicinal product is for diagnostic use only. DaTSCAN is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum of patients with clinically uncertain Parkinsonian Syndromes, in order to help differentiate Essential Tremor from Parkinsonian Syndromes related to idiopathic Parkinson's Disease, Multiple System Atrophy and Progressive Supranuclear Palsy. DaTSCAN is unable to discriminate between Parkinson's Disease, Multiple System Atrophy and Progressive Supranuclear Palsy.

DaTSCAN should only be used in patients referred by physicians experienced in the management of movement disorders. Radiopharmaceutical agents should only be used by qualified personnel with the appropriate government authorisation for the use and manipulation of radionuclides within a designated clinical setting.

DaTSCAN is a 5% (v/v) ethanolic solution for intravenous injection and should be used without dilution. Clinical efficacy has been demonstrated across the range 111-185 MBq. Do not exceed 185 MBq and do not use when the activity is below 110 MBq. In the event of overdosage, refer to section 4.9. Patients must undergo appropriate thyroid blocking treatment prior to injection to minimise thyroid uptake of radioactive iodine, for example by oral administration of approximately 120 mg potassium iodide 1-4 hours prior to injection and again 12-24 hours post-injection of DaTSCAN. SPECT imaging should take place between three and six hours post-injection.

Images should be acquired using a gamma camera fitted with a high-resolution collimator and calibrated using the 159keV photopeak and a ± 10% energy window. Angular sampling should preferably be not less than 120 views over 360 degrees. For parallel hole collimators the radius of rotation should be consistent and set as small as possible (typically 11-15 cm). Matrix size and zoom factors should be selected to give a pixel size of 5-7 mm.

A minimum of 500k counts should be collected for optimal images. Normal images are characterised by two symmetrical crescent-shaped areas of equal intensity. Abnormal images are either asymmetric or symmetric with unequal intensity and/or loss of crescent. DaTSCAN is not recommended for use in children or adolescents, as data are not available for these populations.

Not recommended

See adult dosage

DaTSCAN is contra-indicated in pregnancy and in patients with hypersensitivity to iodide or to any of the excipients - Excipients, Acetic acid, sodium acetate, ethanol, water for injections.

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 the appropriate licences of the local competent official organisations. Formal studies have not been carried out in patients with significant renal or hepatic impairment. In the absence of data, DaTSCAN is not recommended in cases of moderate to severe renal or hepatic impairment.

No interaction studies have been carried out in humans. Ioflupane binds to the dopamine transporter. Medicines and drugs that bind to the dopamine transporter with high affinity may therefore interfere with DaTSCAN diagnosis.

These include amphetamine, benztropine, buproprion, cocaine, mazindol, methylphenidate, phentermine and sertraline. Drugs shown during clinical trials not to interfere with DaTSCAN imaging include amantadine, benzhexol, budipine, levodopa, metoprolol, primidone, propranolol and selegiline. Dopamine agonists and antagonists acting on the postsynaptic dopamine receptors are not expected to interfere with DaTSCAN imaging and can therefore be continued if desired. Drugs shown in animal studies not to interfere with DaTSCAN imaging include pergolide.

No serious adverse effects related to DaTSCAN administration have been reported. Common side effects are headache, vertigo and increased appetite. Formication is an uncommon side effect. For each patient, exposure to ionising radiation must be justifiable on the basis of likely benefit. The activity administered must be such that the resulting radiation dose is as low as reasonably achievable bearing in mind the need to obtain the intended diagnostic result.

Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. For diagnostic nuclear medicine investigations, the current evidence suggests that these adverse events will occur with negligible frequency because of the low radiation dose incurred.

Amersham

(POM)

17 August 2009