EndolucinBeta · 4.6 Fertility, pregnancy and lactation · 1

HOS-097463 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile Adverse reactions following the administration of a Lutetium (177Lu)-labelled medicinal product prepared by radiolabelling with EndolucinBeta will be dependent on the specific medicinal product being used. Such information will be supplied in the Summary of Product Characteristics/Package Leaflet of the medicinal product to be radiolabelled. Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. The radiation dose resulting from therapeutic exposure 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. Adverse reactions are divided into groups according to the MedDRA convention frequencies: 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). Tabulated list of adverse reactions MedDRA system Very common Common Uncommon Not known organ class Neoplasms Refractory Acute myeloid benign, cytopenia with leukaemia (see malignant and multilineage section 4.4) unspecified dysplasia (including cysts (Myelodysplastic and polyps) syndrome) (see section 4.4) 6  MedDRA system Very common Common Uncommon Not known organ class Blood and Anaemia Neutropenia Pancytopenia lymphatic Thrombo- system disorders cytopenia Leukopenia Lymphopenia Endocrine Carcinoid crisis disorders Metabolism and Tumour lysis nutrition syndrome disorders Gastrointestinal Nausea

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HOS-097459 · 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 Lutetium (177Lu)-labelled medicinal products prepared by radiolabelling with EndolucinBeta, refer to the Summary of Product Characteristics/Package Leaflet of the particular medicinal product to be radiolabelled.

HOS-097458 · has-indication-information · PDF-Seite 3

EndolucinBeta is a radiopharmaceutical precursor, and it is not intended for direct use in patients. It is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with Lutetium (177Lu) chloride.

HOS-097461 · has-interaction-information · PDF-Seite 5

No interaction studies of Lutetium (177Lu) chloride with other medicinal products have been performed. For information concerning interactions associated with the use of Lutetium (177Lu)-labelled medicinal products refer to the Summary of Product Characteristics/Package Leaflet of the medicinal product to be radiolabelled.

HOS-097462 · has-pregnancy-information · PDF-Seite 5

Women of childbearing potential Female patients of reproductive potential should be advised to use contraception during the treatment with medicines labelled with EndolucinBeta and for 7 months after the last dose. 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 177Lu-labelled medicinal products, pregnancy should be excluded using an adequate/validated test. Men of reproductive potential Male patients with female partners of reproductive potential should be advised to use barrier method of contraception (e.g., condom) along with another highly effective contraceptive method during the treatment with medicines labelled with EndolucinBeta and for 4 months after the last dose. Pregnancy The use of Lutetium (177Lu)-labelled medicinal products is contraindicated during established or suspected pregnancy or when pregnancy has not been excluded due to the risk of ionizing radiation to the foetus (see section 4.3). 5 Breast-feeding Before administering radiopharmaceuticals to a mother who is breastfeeding, 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 the administration is considered necessary, breastfeeding should be interrupted and the expressed feeds discarded. Fertility According to literature reports and taking a conservative approach (maximum patient dose of 10 GBq, average labelling yield and no additional measures), it may be considered that 177Lu-labelled medicinal products do not lead to reproductive toxicity including spermatogenetic damage in male testes or genetic damage in male testes or female ovaries. Further information concerning the use of Lutetium (177Lu)-labelled medicinal products concerning fertility is specified in the Summary of Product Characteristics/Package Leaflet of the medicinal product to be radiolabelled.

HOS-097460 · has-warning-information · PDF-Seite 3

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 therapeutic effect. EndolucinBeta is not to be administered directly to the patient, but must be used for the radiolabelling of carrier molecules, such as monoclonal antibodies, peptides, vitamins or other substrates. Renal impairment and haematological disorders Careful consideration of the benefit risk ratio in these patients is required since an increased radiation 3 exposure is possible. It is recommended to perform individual radiation dosimetry assessments of specific organs, which may not be the target organ of therapy. Myelodysplastic syndrome and acute myeloid leukaemia Myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML) have been observed after treatment with Lutetium (177Lu) peptide receptor radionuclide therapy for neuroendocrine tumours (see section 4.8). This should be taken into account when considering the benefit/risk, especially in patients with possible risk factors like prior exposure to chemotherapeutic agents (such as alkylating agents). Myelosuppression Anaemia, thrombocytopenia, leucopenia, lymphopenia, and less commonly neutropenia may occur during radioligand therapy with Lutetium (177Lu). Most events are mild and transient, but in some cases patients have required blood and platelet transfusions. In some patients more than one cell line may be affected and pancytopenia requiring treatment discontinuation has been described. A blood count should be taken at baseline and monitored regularly during treatment, in accordance with clinical guidance. Renal irradiation Radiolabelled somatostatin analogues are excreted by the kidney. Radiation nephropathy has been reported following peptide receptor radionuclide therapy for neuroendocrine tumours using other radioisotopes. Renal function including glomerular filtration rate (GFR) should be assessed at baseline and during treatment and renal protection should be considered, in accordance with clinical guidance of the radiolabelled medicinal product. Hepatotoxicity Cases of hepatotoxicity have been reported in the post-marketing setting and in the literature in patients with liver metastases undergoing treatment with Lutetium (177Lu) peptide receptor radionuclide therapy for neuroendocrine tum

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