SomaKit TOC · 4.6 Fertility, pregnancy and lactation · 1

HOS-097753 · has-adverse-reaction-information · PDF-Seite 6

Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. As the effective dose is about 4.5 mSv when the maximal recommended activity of 200 MBq is administered, these adverse reactions are expected to occur with a low probability. 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). General disorders and administration site conditions Not known: injection site pain Description of selected adverse reactions Cases in which physiological uptake of gallium (68Ga) edotreotide by splenic tissue has been misdiagnosed as neuroendocrine tumour, leading to unnecessary intervention, have been reported (see section 4.4). 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-097749 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to any of the components of the labelled radiopharmaceutical.

HOS-097748 · has-indication-information · PDF-Seite 2

This medicinal product is for diagnostic use only. After radiolabelling with gallium (68Ga) chloride solution, the solution of gallium (68Ga) edotreotide obtained is indicated for positron emission tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastro- enteropancreatic neuroendocrine tumours (GEP-NET) for localising primary tumours and their metastases.

HOS-097751 · has-interaction-information · PDF-Seite 5

Somatostatin and its analogues are probably competing to bind to the same somatostatin receptors. Therefore, when treating patients with somatostatin analogues, it is preferable to perform imaging with gallium (68Ga) edotreotide the day(s) preceding the next administration of a somatostatin analogue. A long-term exposure to endogenous hypercortisolism may down-regulate somatostatin receptor expression and negatively influence the results of somatostatin receptor imaging with gallium (68Ga) edotreotide. In patients with Cushing syndrome, the normalisation of hypercortisolism should be considered before performing PET with SomaKit TOC. Some evidence exists that glucocorticoids can induce down-regulation of somatostatin subtype 2 receptors (SSTR2). Repeated administration of high doses of glucocorticoids prior to gallium (68Ga) edotreotide administration may cause insufficient SSTR2 expression for adequate visualisation of somatostatin receptor-positive NETs.

HOS-097752 · has-pregnancy-information · PDF-Seite 5

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 her periods are very irregular, etc.), alternative techniques not using ionising radiation (if there are any) should be offered to the patient. Pregnancy No data are available regarding the use of this medicinal product during pregnancy. Radionuclide procedures carried out on pregnant women also involve radiation doses 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. 5 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 12 hours and the expressed feeds discarded. Close contact with infants should be restricted during the initial 12 hours following injection. Fertility No studies were conducted to assess the impact on fertility.

HOS-097750 · has-warning-information · PDF-Seite 3

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 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/Hepatic impairment Careful consideration of the benefit/risk ratio in these patients is required since an increased radiation exposure is possible. Paediatric population For information on use in the paediatric population, see section 4.2. 3 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 examination in order to reduce radiation exposure. Errors of interpretation of gallium (68Ga) edotreotide images PET images with gallium (68Ga) edotreotide reflect the presence of somatostatin receptors in the tissues. The organs with high physiological uptake of gallium (68Ga) edotreotide include spleen, kidneys, liver, pituitary gland, thyroid gland and adrenals. High physiological uptake of gallium (68Ga) edotreotide by the pancreas uncinate process can also be observed. An increased uptake of gallium (68Ga) edotreotide is not specific for GEP-NET. Healthcare professionals should be aware that further imaging or histological and/or other relevant investigations may be required to establish the diagnosis. Due to physiological uptake of gallium (68Ga) edotreotide, splenosis and accessory intrapancreatic spleen may be incidentally detected with somatostatin receptor targeted diagnostics. Cases in which such uptake has been misdiagnosed as neuroendocrine tumours, leading to unnecessary intervention, have been reported. Spleen disorders (e.g. splenectomy, splenosis and accessory intrapancreatic spleen) should therefore be considered as a relevant factor when reporting the outcome of somatostatin receptor targeted diagnostics. Positive results also require evaluating the possibility that another disease, characterised by high local somatostatin receptor concentration

Auszug; vollständigen Abschnitt im Original lesen.