ISOPROTRACE

The medicinal product should only be administered by trained healthcare professionals with technical expertise in using and handling nuclear medicine diagnostic 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.

Elderly population No special dosage regimen for elderly patients is required. Paediatric population There is no relevant use of gallium (68Ga) gozetotide in the paediatric population for the identification of PSMA positive lesions in prostate cancer.

The safety and efficacy of gallium (68Ga) gozetotide in children aged 0 to 18 years have not been established. Hepatic impairment The safety and efficacy of gallium (68Ga) gozetotide have not been studied in patients with hepatic impairment.

Renal impairment The safety and efficacy of gallium (68Ga) gozetotide have not been studied in patients with renal impairment. Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients, see section

Summary of safety profile Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. 5 mSv, these adverse reactions are expected to occur with a low probability. Mild to moderate adverse reactions occurred in patients receiving gallium (68Ga) gozetotide.

The most commonly reported reactions were fatigue, headache, injection site reactions, nausea and rash. Tabulated list of adverse reactions Adverse reactions (Table 1) are listed by MedDRA system organ class and according to the MedDRA convention frequencies: 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:

List of adverse reactions MedDRA system organ class Adverse reactions Frequency Nervous system disorders Headache, dizziness, paraesthesia, insomnia Uncommon Gastrointestinal disorders Nausea, diarrhoea, dysphagia Uncommon Skin and subcutaneous tissue disorders Rash Uncommon General disorders and administration site conditions Fatigue, injection site reactions* Uncommon * Injection site reactions include injection site burning, pruritus and injection site pain.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4. Method of administration This medicinal product is administered intravenously as a single injection. 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 instructions on reconstitution and radiolabelling of the medicinal product before administration, see section 12.

4. Image acquisition Gallium (68Ga) gozetotide is suitable for PET medical imaging. Patients should void immediately prior to image acquisition. The patient should be positioned supine with the arms above the head, as tolerated by the patient.

A CT scan should be obtained for attenuation correction and anatomical correlation. The acquisition must include a whole-body acquisition from the base of the skull to mid- thigh. PET images should be acquired 50 to 100 (ideally 60) minutes after the intravenous administration of gallium (68Ga) gozetotide solution.

Imaging acquisition start time and duration should be adapted according 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 Potential for hypersensitivity or anaphylactic reactions If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and intravenous treatment initiated, if necessary.

To enable immediate action in emergencies, the necessary medicinal products and equipment such as endotracheal tube and ventilator must be immediately available. 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.

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). Renal impairment The safety and efficacy of gallium (68Ga) gozetotide have not been studied in patients with renal impairment.

Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients. Hepatic impairment The safety and efficacy of gallium (68Ga) gozetotide have not been studied in patients with hepatic impairment.

Patient preparation There is no need for fasting. Patients are allowed to take all their medications. PSMA- expression may be increased by androgen-deprivation therapy, but the clinical significance is unclear. The patient should be well-hydrated before the start of the examination and urged to void just prior to the image acquisition.

The patient should be urged to void as often as possible during the first hours after the examination in order to reduce radiation. Concomitant administration of loop diuretics can lower the activity of gallium (68Ga) gozetotide in the bladder and ureter and decrease peri-bladder artefacts.

Interpretation of gallium (68Ga) gozetotide images PSMA can be expressed in various cancerous and non-cancerous tissues with a variable intensity. Gallium (68Ga) gozetotide uptake is not specific to prostate cancer and may occur in normal tissues, most notably the kidneys, lacrimal glands, salivary glands, urinary bladder wall, liver as well as in sympathetic ganglia.

Furthermore, gallium (68Ga) gozetotide uptake may occur in other types of cancers and non- malignant processes, potentially leading to false positive findings. , gliomas, thyroid cancer, breast, lung, lymphoma, neuroendocrine tumours, colorectal tumours, primary bone tumours, and many others.

False negative results can occur in prostate cancer, not expressing PSMA receptors at a sufficient level to be detected. This is described in approximately 3-10% of cases. Gallium (68Ga) gozetotide PET images should be interpreted only by readers trained in the interpretation of PET images with gallium (68Ga) gozetotide PET.

Findings on gallium (68Ga) gozetotide PET images should always be interpreted in […]

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