EndolucinBeta® (n.c.a. Lu-177)

EndolucinBeta^® is a radiopharmaceutical precursor, and it is not intended for direct use in patients. It is to be used only for the radiolabeling of targeting molecules that have been specifically developed and authorized for radiolabeling with Lu-177.
Pharmaceutical Company: ITM Medical Isotopes GmbH, Lichtenbergstr. 1, 85748 Garching, Germany. Name of the medicinal product: EndolucinBeta® 40 GBq/mL radiopharmaceutical precursor, solution, Active substance: Lutetium (177Lu ) chloride. Composition: 1 mL of solution contains 40 GBq Lutetium (177Lu) chloride on activity reference time (ART), corresponding to 10 micrograms of 177Lu (as chloride). Excipients: Hydrochloric acid, diluted. Therapeutic indications: EndolucinBeta® is a radiopharmaceutical precursor and 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 177Lu chloride. Contraindications: Hypersensitivity to the active substance or to any of the excipients, established or suspected pregnancy or when pregnancy has not been excluded. For information on contraindications to particular 177Lu-labelled medicinal products prepared by radiolabelling with EndolucinBeta®, refer to the Summary of Product Characteristics (SmPC)/Package Leaflet of the particular medicinal product to be radiolabelled. Undesirable effects: Adverse reactions following the administration of a 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 SmPC/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. See also detailed tabular listing of contraindications acc. to SmPC. Warning(s).: Keep out of sight and reach of children. Radioactive. See also detailed warnings and information on contraindications acc. to SmPC. Note: Prescription only. Status of the information.: 02/2021