Leitlinien & Arzneimittelsicherheit

HOS-084086 · has-adverse-reaction-information · PDF-Seite 5

The following undesirable effects are recognised for DaTSCAN: Tabulated summary of adverse reactions The frequencies of adverse reactions are defined as follows: 5 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) and not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Immune system disorders Not known: Hypersensitivity Metabolism and nutrition disorders Uncommon: Appetite increased Nervous system disorders Common: Headache Uncommon: Dizziness, formication (paraesthesia), dysgeusia Ear and labyrinth disorders Uncommon: Vertigo Skin and subcutaneous tissue disorders Not known: Erythema, pruritus, rash, urticaria, hyperhidrosis Respiratory, thoracic and mediastinal disorders Not known: Dyspnea Gastrointestinal disorders Uncommon: Nausea, dry mouth Not known: Vomiting Vascular disorders Not known: Blood pressure decreased General disorders and administration site conditions Uncommon: Injection site pain (intense pain or burning sensation following administration into small veins) Not known: Feeling hot Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. As the effective dose is 4.63 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.

HOS-084082 · has-contraindication-information · PDF-Seite 3

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Pregnancy (see section 4.6).

HOS-084081 · has-indication-information · PDF-Seite 2

This medicinal product is for diagnostic use only. DaTSCAN is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum: • In adult patients with clinically uncertain Parkinsonian Syndromes, for example those with early symptoms, 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. • In adult patients, to help differentiate probable dementia with Lewy bodies from Alzheimer’s disease. DaTSCAN is unable to discriminate between dementia with Lewy bodies and Parkinson’s disease dementia.

HOS-084084 · has-interaction-information · PDF-Seite 5

No interaction studies have been performed in humans. Ioflupane binds to the dopamine transporter. Medicines that bind to the dopamine transporter with high affinity may therefore interfere with DaTSCAN diagnosis. These include amfetamine, bupropion, cocaine, codeine, dexamfetamine, methylphenidate, modafinil, and phentermine. Selective serotonin reuptake inhibitors (SSRIs), such as sertraline, may increase or decrease ioflupane binding to the dopamine transporter. Serotonin-norepinephrine reuptake inhibitors (SNRIs), such as venlafaxine, may decrease ioflupane binding to the dopamine transporter especially in patients on higher doses. Medicines shown during clinical trials not to interfere with DaTSCAN 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 DaTSCAN imaging and can therefore be continued if desired. Medicinal products shown in animal studies not to interfere with DaTSCAN imaging include pergolide.

HOS-084085 · has-pregnancy-information · PDF-Seite 5

Women of childbearing potential Where it is necessary to administer radioactive medicinal products to women of childbearing potential, information should always be sought about pregnancy. Any woman who has missed a period should be assumed pregnant until proven otherwise. Where uncertainty exists, it is important that radiation exposure should be the minimum consistent with achieving satisfactory imaging. Alternative techniques which do not involve ionising radiation should be considered. Pregnancy Animal reproductive toxicity studies have not been performed with this product. Radionuclide procedures carried out on pregnant women also involve radiation doses to the foetus. Administration of 185 MBq of ioflupane (123I) results in an absorbed dose to the uterus of 3.0 mGy. DaTSCAN is contraindicated in pregnancy (see section 4.3). Breastfeeding It is not known whether ioflupane (123I) is excreted in human milk. Before administering a radioactive medicinal product to a breast-feeding mother, consideration should be given as to whether the investigation could be reasonably delayed until the mother has ceased breast-feeding and as to whether the most appropriate choice of radiopharmaceutical has been made, bearing in mind the secretion of radioactivity 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.

HOS-084083 · has-warning-information · PDF-Seite 3

If hypersensitivity reactions occur, the administration of the medicinal product must be discontinued immediately and, if necessary, intravenous treatment initiated. Resuscitative medicinal products and equipment (e.g. endotracheal tube and ventilator) have to be readily available. 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. 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 dose is as low as reasonably achievable bearing in mind the need to obtain the intended diagnostic result. 3 The patient should be well hydrated before and after the examination and urged to void as often as possible during the first 48 hours after the procedure in order to minimise radiation exposure. 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. 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. Interpretation of DaTSCAN Images DaTSCAN 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 DaTSCAN uptake in the striatum is compared with uptake in a reference region and ratios are compared against an age adjusted healthy subjects

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