Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
lutetium (177Lu) oxodotreotide
Advanced Accelerator Applications
V10XX04
lutetium (177Lu) oxodotreotide
Other therapeutic radiopharmaceuticals
Neuroendocrine Tumors
Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP‑NETs) in adults.
Revision: 10
Authorised
2017-09-26
42 B. PACKAGE LEAFLET 43 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LUTATHERA 370 MBQ/ML SOLUTION FOR INFUSION lutetium ( 177 Lu) oxodotreotide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or other healthcare professional who will supervise the procedure. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Lutathera is and what it is used for 2. What you need to know before Lutathera is used 3. How Lutathera is used 4. Possible side effects 5. How Lutathera is stored 6. Contents of the pack and other information 1. WHAT LUTATHERA IS AND WHAT IT IS USED FOR WHAT LUTATHERA IS Lutathera contains lutetium ( 177 Lu) oxodotreotide. This medicine is a radiopharmaceutical product for therapy only. WHAT LUTATHERA IS USED FOR Lutathera is used for the treatment of adults with certain tumours (gastroenteropancreatic neuroendocrine tumours), which cannot be completely removed from your body by surgery, have spread in your body (metastatic) and do not respond any more to your current treatment. HOW LUTATHERA WORKS The tumour needs to have somatostatin receptors on the surface of its cells in order for the medicine to be effective. Lutathera binds with these receptors and emits radioactivity directly into the tumour cells, causing their death. The use of Lutathera involves exposure to amounts of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation. 2. WHAT YOU NEED TO KNOW BEFORE LUTATHERA IS USED LUTATHERA MUST NOT BE USED - if you are allergic to lutetium ( 177 Lu) oxodotreotide or any of the other ingredients of this medicine (listed in section 6). - if you are pregnant, think you Læs hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Lutathera 370 MBq/mL solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One mL of solution contains 370 MBq of lutetium ( 177 Lu) oxodotreotide at the date and time of calibration. The total amount of radioactivity per single-dose vial is 7 400 MBq at the date and time of infusion. Given the fixed volumetric activity of 370 MBq/mL at the date and time of calibration, the volume of the solution in the vial ranges between 20.5 and 25.0 mL in order to provide the required amount of radioactivity at the date and time of infusion. Physical characteristics Lutetium-177 has a half-life of 6.647 days. Lutetium-177 decays by β - emission to stable hafnium-177 with the most abundant β - (79.3%) having a maximum energy of 0.498 MeV. The average beta energy is approximately 0.13 MeV. Low gamma energy is also emitted, for instance at 113 keV (6.2%) and 208 keV (11%). Excipient with known effect Each mL of solution contains up to 0.14 mmol (3.2 mg) of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion. Clear, colourless to slightly yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well-differentiated (G1 and G2), somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Important safety instructions Lutathera should be administered only by persons authorised to handle radiopharmaceuticals in designated clinical settings (see section 6.6) and after evaluation of the patient by a qualified physician. Patient identification Before starting treatment with Lutathera, somatostatin receptor imaging (scintigraphy or positron emission tomography [PET]) must confirm the overexpression of these receptors in the tumour tissue with the tumour uptake at least as high as normal liver uptake. 3 Posology _Adults _ Læs hele dokumentet