Amyvid · 4.6 Fertility, pregnancy and lactation · 1

HOS-096170 · has-adverse-reaction-information · PDF-Seite 7

Summary of the safety profile The safety profile of Amyvid is based on its administrations to 26,979 subjects in clinical trials. Tabulated list of adverse reactions Adverse reactions observed during clinical studies and post-marketing experience are listed below by frequency category. Frequencies are defined as 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 (frequency cannot be estimated from the available data). System organ class Uncommon Rare Very Rare Immune system Hypersensitivityb disorders Nervous system Headache Dysgeusia disorders Vascular disorders Flushing Gastrointestinal Nausea disorders Skin and subcutaneous Pruritus tissue disorders Urticaria General disorders and Injection site reactiona Infusion site rash administration site conditions a Injection site reaction includes injection site bruising, injection site discomfort, injection site erythema, injection site extravasation, injection site haemorrhage, injection site irritation, injection site paraesthesia, injection site pruritus, injection site pain, infusion site bruising, infusion site extravasation, infusion site reaction, infusion site haematoma, and infusion site pain. 7 b Post-marketing adverse reaction. Frequency assessment based on post-marketing exposures. Symptoms may include rash, erythema, pruritus, facial swelling, tongue oedema, and airway constriction. Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. As the effective dose is 7 mSv when the recommended activity of 370 MBq of florbetapir (18F) is administered, these adverse reactions are expected to occur with 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-096166 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 3

HOS-096165 · has-indication-information · PDF-Seite 2

This medicinal product is for diagnostic use only. Amyvid is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of β-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. Amyvid should be used in conjunction with a clinical evaluation. A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD. For the limitations in the interpretation of a positive scan, see sections 4.4 and 5.1.

HOS-096168 · has-interaction-information · PDF-Seite 6

No in vivo interaction studies have been performed. In vitro binding studies have not shown interference of florbetapir (18F) binding to β-amyloid plaques in the presence of other common medicinal products taken by AD patients.

HOS-096169 · has-pregnancy-information · PDF-Seite 6

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. 6 Pregnancy Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus. Only essential investigations should therefore be carried out during pregnancy, when the likely benefit far exceeds the risk incurred by the mother and foetus. No studies have been conducted in pregnant women. No animal studies have been conducted to investigate the reproductive effects of florbetapir (18F) (see section 5.3). Breast-feeding It is not known whether florbetapir (18F) is excreted in human milk during breast-feeding. 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 breast-feeding, and to what is the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of activity in breast milk. If the administration is considered necessary, breast-feeding should be interrupted for 24 hours and the expressed feeds discarded. Close contact with infants should be restricted during the initial 24 hours following injection. Fertility No studies on fertility have been performed.

HOS-096167 · has-warning-information · PDF-Seite 4

Limitations of use A positive scan does not independently establish a diagnosis of AD or other cognitive disorder since neuritic plaque deposition in grey matter may be present in asymptomatic elderly and some neurodegenerative dementias (Alzheimer’s disease, Lewy body dementia, Parkinson’s disease dementia). For the limitations of use in patients with mild cognitive impairment (MCI), see section 5.1. The efficacy of Amyvid for predicting development of AD or monitoring response to therapy has not been established (see section 5.1). Some scans may be difficult to interpret due to image noise, atrophy with a thinned cortical ribbon, or image blur, which could lead to interpretation errors. For cases in which there is uncertainty about the location of grey matter and of the grey/white matter border on the PET scan, and a co-registered recent CT or MR image is available, the interpreter should examine the fused PET-CT or PET-MR image to clarify the relationship of the PET radioactivity and the grey matter anatomy. Increased uptake has been identified in extracerebral structures such as salivary glands, skin, muscles and bone in some cases (see section 5.2). Examination of sagittal images and co-registered CT or MR images could help to distinguish occipital bone from occipital grey matter. 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 and hepatic impairment Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible. Florbetapir (18F) is excreted primarily through the hepatobiliary system and patients with hepatic impairment have the potential of increased radiation exposure (see section 4.2). Paediatric population For information on the use in the paediatric population, see sections 4.2 or 5.1. Interpretation of Amyvid images Amyvid images should only be interpreted by readers trained in the interpretation of PET images with florbetapir (18F). A negative scan indicates sparse or no density of cortical β-amyloid plaques. A positive scan indicates moderate to frequent density. Image interpretation errors in the estimation of brain β-amyloid neuritic plaque density, including false negatives, have been observed. Review of images should be primarily in the transa

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