Cuprymina · 4.6 Fertility, pregnancy and lactation · 1

HOS-095862 · has-adverse-reaction-information · PDF-Seite 5

Adverse reactions following the intravenous administration of Copper-64-labelled medicinal products prepared by radiolabelling with Cuprymina, will be dependent on the specific medicinal product being used. Such information is supplied in the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled. For each patient, exposure to ionising radiation must be justifiable on the basis of likely clinical 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 result. The radiation dose to the patient resulting from exposure after administration may result in higher incidence of cancer and mutations. In all cases, it is necessary to ensure that the risks of the radiation are less than from the disease itself. Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. 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-095858 · has-contraindication-information · PDF-Seite 3

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Established or suspected pregnancy or when pregnancy has not been excluded (see section 4.6). For information on contraindications to particular Copper-64-labelled medicinal products prepared by radiolabelling with Cuprymina refer to the Summary of Product Characteristics/package leaflet of each particular medicinal product to be radiolabelled.

HOS-095857 · has-indication-information · PDF-Seite 2

Cuprymina is a radiopharmaceutical precursor. It is not intended for direct use in patients. This medicinal product must be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide.

HOS-095860 · has-interaction-information · PDF-Seite 4

No interactions studies of Copper-64 chloride with other medicinal products have been performed. The possible use of chelating therapies could interfere with the use of Copper-64-labelled medicinal products. For information concerning interactions associated with the use of Copper-64-labelled medicinal products refer to the Summary of Product Characteristics/package leaflet of the radiolabelled medicinal product.

HOS-095861 · has-pregnancy-information · PDF-Seite 4

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. Before the use of Copper-64-labelled medicinal products, pregnancy should be excluded using an adequate/validated test. Pregnancy The use of Copper-64-labelled medicinal products is contraindicated during established or suspected pregnancy or when pregnancy has not been excluded (see section 4.3). 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 the choice of the most appropriate radiopharmaceuticals, bearing in mind the secretion of activity in breast milk. If the administration is considered necessary, a breast-feeding mother should be advised to stop breast-feeding. The duration of stopping will depend on the particular radiolabelled medicinal product. Further information concerning the use of Copper-64-labelled medicinal products in pregnancy and breast-feeding is specified in the Summary of Product Characteristics of the medicinal product to be radiolabelled. Fertility According to literature reports, it may be considered that both spermatogenetic and genetic damage in male test is are unlikely at the dose of 1,000 MBq. Further information concerning the effect on fertility of the use of Copper-64-labelled medicinal products is specified in the Summary of Product Characteristics of the medicinal product to be radiolabelled.

HOS-095859 · has-warning-information · PDF-Seite 3

Individual benefit/risk justification Cuprymina is not to be administered directly to the patient but must be used for the radiolabelling of carrier molecules, such as monoclonal antibodies, peptides or other substrates. General warnings Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings. Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation. Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements. Appropriate aseptic precautions should be taken. For information concerning special warnings and special precautions for use of Copper-64-labelled medicinal products refer to the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled. It must be considered that the radiolabelled medicinal product emits high intensity Auger electrons. Regarding the dose for a person in close contact with the patient, this is entirely due to the gamma rays (Cuprymina emits 2 gamma rays at 511.0 Kev and 1,345.77 Kev), because β+ and β- emissions have no role due to their very short range. The Copper-64 gamma dose constant is 3.6 x 10-5 mSv x MBq-1 x h at a distance of 1 meter. Assuming the worst case that the whole maximum activity (2,770 MBq) is injected to the patient and Copper-64 is labelled to a molecule with infinite biological half-life (no disposal by the patient) the person is continuously exposed at a distance of 2 meters. With these assumptions the estimated dose for a person in close contact with the patient is 0.46 mSv, which is less than one half of the limit of not exposed people (1 mSv/year). Special precautions for relatives, carers and hospital staff are provided in section 6.6. Disappearance of radioactivity Considering that each MBq of Copper-64 causes a dose rate of 9 nSv/h (at a distance of 2 meters) and that the maximum injected activity is of 2,770 MBq, the initial dose rate is 24,930 nSv/h. Assuming that the environmental background value is of 150 nSv/h, and requiring that the dose rate due to Copper-64 is lower than the environmental background the condition of negligible radioactivity in the patient is reached, in practice, 4 days after injection (dose rate 132 nSv/h) as shown in table 1. 3 Table 1 – Cond

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