Pylclari · 4.3 Contraindications · 1

HOS-099773 · has-adverse-reaction-information · PDF-Seite 6

Summary of safety profile The overall safety profile is based on data from its administration to 797 patients from three clinical studies and spontaneous reporting. In the clinical studies, each patient received a single administration with a median administered activity of 330 MBq. Adverse reactions have been reported during clinical development and are listed below by MedDRA body system organ class. Tabulated list of adverse reactions The frequencies of adverse reactions are defined as follows: 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), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 1: Adverse reactions observed with piflufolastat (18F) MedDRA body system organ class Adverse reactions Frequency Immune system disorders Hypersensitivity Uncommon Metabolism and nutrition disorders Dehydration Uncommon Psychiatric disorders Disorientation Uncommon Nervous system disorders Syncope Not known* Dysgeusia Common Headache Dizziness Uncommon Hyperaesthesia Migraine Eye disorders Visual field defect Uncommon Ear and labyrinth disorders Vertigo Uncommon Gastrointestinal disorders Nausea Not known* Vomiting Skin and subcutaneous tissue Dry skin Uncommon disorders Rash Musculoskeletal and connective Arthralgia Uncommon tissue disorders Muscular weakness 6  Pain in extremity Renal and urinary disorders Dysuria Uncommon General disorders and administration Fatigue Uncommon site conditions Chest discomfo

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HOS-099769 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 3

HOS-099768 · has-indication-information · PDF-Seite 2

This medicinal product is for diagnostic use only. Pylclari 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 initial curative therapy, • To localize recurrence of PCa in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent. 2

HOS-099771 · has-interaction-information · PDF-Seite 5

No interaction studies have been performed. Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of piflufolastat (18F) in prostate cancer. The effect of these therapies on performance of piflufolastat (18F) PET has not been established. Chronic treatment with diuretics does not seem to have any interference with piflufolastat (18F) for interpretation of images. 5

HOS-099772 · has-pregnancy-information · PDF-Seite 6

Pregnancy Piflufolastat (18F) is not intended for use in women. Breast-feeding Piflufolastat (18F) is not intended for use in women. Fertility No studies on fertility have been performed.

HOS-099770 · has-warning-information · PDF-Seite 4

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. Renal impairment Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible. Paediatric population For information on the use in paediatric population, see section 4.2. Patient preparation The patient should be well hydrated before the start of the examination and urged to void before the examination in order to reduce bladder activity and as often as possible during the first hours after the examination in order to reduce radiation exposure. A diuretic expected to act within the uptake time period may be administered to improve interpretation of piflufolastat (18F) PET/CT as it results in less activity depositions in ureters and the bladder. After the procedure Close contact with infants and pregnant women should be restricted during the initial 12 hours following the injection. Interpretation of piflufolastat (18F) images The recommended method for PET images interpretation with piflufolastat (18F) PET/CT is the visual interpretation. Lesions should be considered suspicious if uptake is greater than physiologic uptake in that tissue or greater than adjacent background if no physiologic uptake is expected. Piflufolastat (18F) accumulates in normal tissue where the density of PSMA is high including the lacrimal glands, salivary glands, liver, spleen, and kidneys. Normal organs demonstrate significant variability in the uptake of piflufolastat (18F); however, the impact of tumor burden on normal uptake is minimal and unlikely to be clinically significant. The expression of PSMA can predominantly be found in prostate cancer, but can also be observed in other neoplasms (e.g. renal cell carcinoma, hepatocarcinoma, breast cancer, lung cancer and other malignancies) or non-malignant conditions (e.g hemangioma, ganglia, since they can mimic

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