Country: European Union
Language: English
Source: EMA (European Medicines Agency)
gozetotide
Novartis Europharm Limited
V09I
gozetotide
Diagnostic radiopharmaceuticals
Radionuclide Imaging
This medicinal product is for diagnostic use only. Locametz, after radiolabelling with gallium 68, is indicated for the detection of prostate specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in adults with prostate cancer (PCa) in the following clinical settings:Primary staging of patients with high risk PCa prior to primary curative therapy,Suspected PCa recurrence in patients with increasing levels of serum prostate specific antigen (PSA) after primary curative therapy,Identification of patients with PSMA positive progressive metastatic castration resistant prostate cancer (mCRPC) for whom PSMA targeted therapy is indicated (see section 4.4).
Revision: 2
Authorised
2022-12-09
26 B. PACKAGE LEAFLET 27 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LOCAMETZ 25 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION gozetotide This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 nuclear medicine doctor who will supervise the procedure. - If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Locametz is and what it is used for 2. What you need to know before Locametz is used 3. How Locametz is used 4. Possible side effects 5. How Locametz is stored 6. Contents of the pack and other information 1. WHAT LOCAMETZ IS AND WHAT IT IS USED FOR WHAT LOCAMETZ IS This medicine is a radiopharmaceutical product for diagnostic use only. Locametz contains a substance called gozetotide. Before use, gozetotide (the powder in the vial) is coupled with a radioactive substance called gallium-68 to make gallium ( 68 Ga) gozetotide solution (this procedure is called radiolabelling). WHAT LOCAMETZ IS USED FOR After radiolabelling with gallium-68, Locametz is used in a medical imaging procedure called positron emission tomography (PET) to detect specific types of cancer cells with a protein called prostate-specific membrane antigen (PSMA) in adults with prostate cancer. This is done: - to find out whether prostate cancer has spread to lymph nodes and other tissues outside the prostate, before primary curative therapy (e.g. therapy involving surgical removal of the prostate, radiation therapy) - to identify cancer cells when recurrence of prostate cancer is suspected in patients who have received primary cu Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Locametz 25 micrograms kit for radiopharmaceutical preparation 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The vial contains 25 micrograms of gozetotide. The radionuclide is not part of the kit. Excipient with known effect The vial contains 28.97 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Kit for radiopharmaceutical preparation One vial of white lyophilised powder (powder for solution for injection). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Locametz, after radiolabelling with gallium-68, is indicated for the detection of prostate-specific membrane antigen (PSMA)-positive lesions with positron emission tomography (PET) in adults with prostate cancer (PCa) in the following clinical settings: • Primary staging of patients with high-risk PCa prior to primary curative therapy, • Suspected PCa recurrence in patients with increasing levels of serum prostate-specific antigen (PSA) after primary curative therapy, • Identification of patients with PSMA-positive progressive metastatic castration-resistant prostate cancer (mCRPC) for whom PSMA-targeted therapy is indicated (see section 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This medicinal product should only be administered by trained healthcare professionals with technical expertise in using and handling nuclear medicine imaging agents and only in a designated nuclear medicine facility. Posology The recommended dose of gallium ( 68 Ga) gozetotide is 1.8-2.2 MBq/kg of body weight, with a minimum dose of 111 MBq up to a maximum dose of 259 MBq. 3 _Special populations_ _Elderly_ No dose adjustment is required in patients aged 65 Read the complete document