LOCAMETZ

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. 2 MBq/kg of body weight, with a minimum dose of 111 MBq up to a maximum dose of 259 MBq.

2). 2). Paediatric population There is no relevant use of Locametz in the paediatric population for the identification of PSMA-positive lesions in prostate cancer. Method of administration This medicinal product is for intravenous and multidose use.

It should be reconstituted before administration to the patient. After reconstitution, gallium (68Ga) gozetotide solution should be administered by slow intravenous injection, in order to avoid local extravasation resulting in inadvertent radiation exposure to the patient and imaging artefacts.

Accidental extravasation may cause local irritation, due to the acidic pH of the solution. Cases of extravasation should be managed as per institutional guidelines. The total radioactivity in the syringe should be verified with a dose calibrator immediately before and after administration to the patient.

The dose calibrator must be calibrated and comply with international standards (see section 12). For patient preparation, see section

Summary of safety profile Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. 3 mSv), these adverse reactions are expected to occur with a low probability. 7 MBq/kg). Patients underwent PET/CT imaging to establish their eligibility for the VISION clinical study, based on the PSMA expression of their prostate cancer lesions.

Gallium (68Ga) gozetotide was concomitantly administered with physician’s discretion for best standard of care. 1%). No serious adverse reactions occurred in patients receiving gallium (68Ga) gozetotide. 5%). The adverse reactions of any grade in patients receiving gallium (68Ga) gozetotide are shown in Table 1.

Tabulated list of adverse reactions Adverse reactions (Table 1) are listed by MedDRA system organ class. Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

In addition, the corresponding frequency category for each adverse reaction is based on the following convention (CIOMS III): 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).

Table 1 Adverse reactions observed with gallium (68Ga) gozetotide in the VISION clinical study System organ class Frequency category Adverse reaction Uncommon Nausea Uncommon Constipation Uncommon Vomiting Uncommon Diarrhoea Gastrointestinal disorders Uncommon Dry mouth Common Fatigue Uncommon Injection site reactions1General disorders and administration site conditions Uncommon Chills 1 Injection site reactions includes: injection site haematoma, injection site warmth Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

4. For instructions on reconstitution of the medicinal product before administration, see section 12. Image acquisition Gallium (68Ga) gozetotide PET image acquisition should be performed by scanning the whole body starting at mid-thigh and proceeding to skull base.

PET images should be acquired 50 to 100 minutes after the intravenous administration of gallium (68Ga) gozetotide solution. Image acquisition start time and duration should be adapted to the equipment used, the patient and the tumour characteristics, in order to obtain the best image quality possible.

1 or to any of the components of the labelled radiopharmaceutical. 4 Special warnings and precautions for use 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.

Radiation risk Gallium (68Ga) gozetotide contributes to the patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. 6 and 12). Interpretation of gallium (68Ga) gozetotide images Gallium (68Ga) gozetotide binds to PSMA on the surface of PSMA-expressing cells.

Based on the intensity of the signals, PET images obtained with gallium (68Ga) gozetotide indicate the presence of PSMA protein in tissues. While the uptake of gallium (68Ga) gozetotide reflects the levels of PSMA expression in prostate cancer, gallium (68Ga) gozetotide uptake is not specific to prostate cancer and may occur in other types of cancers, non-malignant processes and normal tissues.

Interpretation of gallium (68Ga) gozetotide PET imaging findings in the context of histopathology and/or other diagnostic procedures is recommended. 1). Patient preparation Patients should be well hydrated prior to gallium (68Ga) gozetotide administration and should be advised to void immediately prior to and frequently during the first hours after image acquisition in order to reduce radiation exposure.

1 or to any of the components of the labelled radiopharmaceutical.