STRIASCAN Solution for injection Ref.[27906] Active ingredients: Ioflupane ¹²³I

Potential for hypersensitivity or anaphylactic reactions

If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and intravenous treatment initiated, if necessary. To enable immediate action in emergencies, the necessary medicinal products and equipment such as endotracheal tube and ventilator must be immediately available.

Individual benefit / risk justification

For each patient, the radiation exposure must be justifiable by the likely benefit. The activity administered should in every case be as low as reasonably achievable to obtain the required diagnostic information.

Renal impairment / Hepatic impairment

Formal studies have not been carried out in patients with significant renal or hepatic impairment. In the absence of data, Striascan is not recommended in cases of moderate to severe renal or hepatic impairment.

Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.

Patient preparation

The patient should be well hydrated before the start of the examination and urged to void as often as possible during the first hours after the examination in order to reduce radiation.

Interpretation of Striascan Images

Striascan images are interpreted visually, based upon the appearance of the striata. Optimum presentation of the reconstructed images for visual interpretation is transaxial slices parallel to the anterior commissure-posterior commissure (AC-PC) line. Determination of whether an image is normal or abnormal is made by assessing the extent (as indicated by shape) and intensity (in relation to the background) of the striatal signal.

Normal images are characterised by two symmetrical crescent-shaped areas of equal intensity. Abnormal images are either asymmetric or symmetric with unequal or reduced intensity and/or loss of crescent.

As an adjunct, visual interpretation may be assisted by semi-quantitative assessment using CE-marked software, where Striascan uptake in the striatum is compared with uptake in a reference region and ratios are compared against an age adjusted healthy subjects' database. The evaluation of ratios, such as the left/right striatum Striascan uptake (symmetry) or caudate/putamen uptake, may further help with the image assessment.

The following precautions should be taken when using semi-quantitative methods:

• Semi-quantification should only be used an adjunct to visual assessment
• Only CE marked software should be used
• Users should be trained in the use of CE marked software by the manufacturer and follow EANM practice guidelines for image acquisition, reconstruction and assessment
• Readers should interpret the scan visually and then perform the semi-quantitative analysis according to manufacturer’s instructions including quality checks for the quantitation process
  • ROI/VOI techniques should be used to compare uptake in the striatum with uptake in a reference region
  • Comparison against an age adjusted healthy subjects database is recommended to account for age-expected decrease in striatal binding
  • The reconstruction and filter settings (including attenuation correction) used can affect the semi-quantitative values. The reconstruction and filter settings recommended by the manufacturer of the CE marked software should be followed and should match those used for semi-quantification of the healthy subjects database.
  • The intensity of the striatal signal as measured by SBR (striatal binding ratio) and asymmetry and caudate to putamen ratio provide objective numerical values corresponding to the visual assessment parameters and can be helpful in difficult to read cases
  • If the semi-quantitative values are inconsistent with the visual interpretation, the scan should be evaluated for appropriate placement of the ROIs /VOIs, correct image orientation and appropriate parameters for image acquisition and attenuation correction should be verified. Some software packages can support these processes to reduce operator-dependent variability
  • Final assessment should always consider both visual appearance and semi-quantitative results

Specific warnings

This medicinal product contains 39.5 g/L (5% volume) ethanol (alcohol), up to 197 mg per dose, equivalent to 5 mL beer or 2 mL wine. Harmful for those suffering from alcoholism. To be taken into account in high-risk groups such as patients with liver disease or epilepsy.

This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.

Precautions with respect to environmental hazard see section 6.6.

No interaction studies have been performed in humans.

Ioflupane binds to the dopamine transporter. Active substances that bind to the dopamine transporter with high affinity may therefore interfere with Striascan diagnosis. These include:

• amfetamine,
• benzatropine,
• bupropion,
• cocaine,
• mazindol,
• methylphenidate,
• phentermine and
• sertraline.

Active substances shown during clinical trials not to interfere with Striascan imaging include:

• amantadine,
• trihexyphenidyl,
• budipine,
• levodopa,
• metoprolol,
• primidone,
• propranolol and
• selegiline.

Dopamine agonists and antagonists acting on the postsynaptic dopamine receptors are not expected to interfere with Striascan imaging and can therefore be continued if desired. Medicinal products shown in animal studies not to interfere with Striascan imaging include pergolide.

Women of childbearing potential

When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant. Any woman who has missed a period should be assumed to be pregnant until proven otherwise. If in doubt about her potential pregnancy (if the woman has missed a period, if the period is very irregular, etc.), alternative techniques not using ionising radiation (if there are any) should be offered to the patient.

Pregnancy

Animal reproductive toxicity studies have not been performed with this product. Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus. Administration of 185 MBq of ioflupane (¹²³I) results in an absorbed dose to the uterus of 2.6 mGy. Striascan is contraindicated in pregnancy (see section 4.3).

Breastfeeding

It is not known whether ioflupane (¹²³I) is excreted in human milk. Before administering radiopharmaceuticals to a mother who is breast-feeding, consideration should be given to the possibility of delaying the administration of radionuclide until the mother has ceased breastfeeding, and to what is the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of activity in breast milk.

If administration is considered necessary, breast-feeding should be interrupted for 3 days and substituted by formula feeding. During this time, breast milk should be expressed at regular intervals and the expressed feeds should be discarded.

Fertility

No fertility studies have been performed. No data are available.

Striascan has no known influence on the ability to drive and use machines.

The following undesirable effects are recognised for ioflupane (123I).

Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. As the effective dose is 4.6 mSv when the maximal recommended activity of 185 MBq is administered these adverse events are expected to occur with a low probability.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.