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.

3 Special populations Elderly No dose adjustment is required in patients aged 65 years and above. Renal impairment There are no data with gallium (68Ga) gozetotide in patients with moderate to severe/end-stage renal impairment. 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 and radiolabelled before administration to the patient. After reconstitution and radiolabelling, gallium (68Ga) gozetotide solution should be administered by slow intravenous injection. Local extravasation resulting in inadvertent radiation exposure to the patient and imaging artefacts should be avoided.

9%) solution for injection to ensure full delivery of the dose. 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.

Instructions regarding the dilution of the gallium (68Ga) gozetotide solution should be followed (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. 1%). 5%). 7 MBq/kg) was evaluated in 1 003 patients with metastatic castration-resistant prostate cancer receiving physician’s discretion for best standard of care (VISION study).

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 System organ class Frequency category Adverse reaction Gastrointestinal disorders Uncommon Nausea Uncommon Constipation Uncommon Vomiting Uncommon Diarrhoea Uncommon Dry mouth General disorders and administration site conditions Common Fatigue Uncommon Injection site reactions1 Uncommon Chills 1 Injection site reactions includes: injection site haematoma, injection site warmth, injection site pruritus 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.

4. For instructions on reconstitution and radiolabelling 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.

Use of computer tomography (CT) or magnetic resonance imaging (MRI) for attenuation correction is recommended. 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. To date no outcome data exist to inform subsequent management of patients with high-risk disease when PSMA PET/CT is utilised for primary staging.

Experience of use of gallium (68Ga) gozetotide PET for selection of patients for PSMA-based therapy is limited to patients with progressive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy, and to selection of patients for treatment with lutetium (177Lu) vipivotide tetraxetan.

Benefit-risk ratio may not be generalisable to other types of PSMA-based therapy and patients with mCRPC with different prior treatments. 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.

1 or to any of the components of the labelled radiopharmaceutical. 4