Locametz · 4.3 Contraindications · 1

HOS-099749 · has-adverse-reaction-information · PDF-Seite 5

Summary of safety profile Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. As the effective dose is 0.0166 mSv/MBq, with a maximal recommended dose of 259 MBq (4.3 mSv), these adverse reactions are expected to occur with a low probability. Mild to moderate adverse reactions occurred in patients receiving gallium (68Ga) gozetotide, with the exception of a grade 3 fatigue event (0.1%). The most common adverse reactions are fatigue (1.2%), nausea (0.8%), constipation (0.5%) and vomiting (0.5%). 5 Tabulated list of adverse reactions The safety profile of gallium (68Ga) gozetotide at median dose per body weight of 1.9 MBq/kg (range: 0.9-3.7 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 Uncommon Nausea Uncommon Constipation Gastrointestinal disorders Uncommon Vomiting Uncommon Diarrhoea Uncommon Dry mouth Common Fatigue General disorders and administration site Uncommon Injection site reactions1 conditions Uncommon Chills 1 Injection s

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HOS-099745 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to any of the components of the labelled radiopharmaceutical. 3

HOS-099744 · has-indication-information · PDF-Seite 2

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).

HOS-099747 · has-interaction-information · PDF-Seite 5

Based on in vitro interaction studies, gallium (68Ga) gozetotide is not expected to have any clinically significant interaction with other medicinal products (see section 5.2). No interaction studies have been performed.

HOS-099748 · has-pregnancy-information · PDF-Seite 5

Pregnancy Locametz is not indicated for use in females. There are no data on the use of gallium (68Ga) gozetotide in females. Reproductive toxicity studies in animals have not been conducted with gallium (68Ga) gozetotide. However, all radiopharmaceuticals, including gallium (68Ga) gozetotide, have the potential to cause foetal harm. Breast-feeding Locametz is not indicated for use in females. There are no data on the effects of gallium (68Ga) gozetotide on the breast-fed newborn/infant or on milk production. Lactation studies have not been conducted in animals with gallium (68Ga) gozetotide. Fertility There are no data on the effect of gallium (68Ga) gozetotide on human fertility.

HOS-099746 · has-warning-information · PDF-Seite 4

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. Safe handling, reconstitution and radiolabelling procedures should be ensured to protect patients and healthcare professionals from unintentional radiation exposure (see sections 6.6 and 12). Interpretation of gallium (68Ga) gozetotide images PET images with gallium (68Ga) gozetotide should be interpreted by visual assessment. Suspicion of malignant lesions is based on gallium (68Ga) gozetotide uptake in comparison with tissue background. Gallium (68Ga) gozetotide uptake is not specific to prostate cancer and may occur in normal tissues (see section 5.2), other types of cancers and non-malignant processes, potentially leading to false positive findings. Moderate to high physiological PSMA uptake is noted in the kidneys, lacrimal glands, liver, salivary glands and urinary bladder wall. False positive findings include, but are not limited to, renal cell carcinoma, hepatocellular carcinoma, breast cancer, lung cancer, benign bone diseases (e.g. Paget’s disease), pulmonary sarcoidosis/granulomatosis, gliomas, meningiomas, paragangliomas and neurofibromas. Ganglia can mimic lymph nodes. The diagnostic performance of gallium (68Ga) gozetotide may be affected by serum PSA levels, androgen-receptor-targeting treatments, disease stage and size of malignant lymph nodes (see section 5.1). Gallium (68Ga) gozetotide PET images should be interpreted only by readers trained in the interpre

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