Radelumin 1300 Mbq/ml

CHARACTERISTICS OF THE MEDICINAL PRODUCT,

LABELING OF PACKAGING AND PATIENT LEAFLET

CHARACTERISTICS OF THE MEDICINAL PRODUCT

This medicinal product is subject to additional monitoring. This will allow for the rapid identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. To find out how to report adverse reactions, see section 4.8.

1. NAME OF THE MEDICINAL PRODUCT

Radelumin 1300 MBq/ml, solution for injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each milliliter of the solution contains 1300 MBq of Fluoro-PSMA-1007 (F) at the reference time of activity (ART). One 10 ml vial contains from 0.3 to 10 ml of solution, corresponding to an activity of from 390 to 13,000 MBq at the reference time of activity (ART). One 15 ml vial contains from 0.3 to 15 ml of solution, corresponding to an activity of from 390 to 19,500 MBq at the reference time of activity (ART). One 20 ml vial contains from 0.3 to 20 ml of solution, corresponding to an activity of from 390 to 26,000 MBq at the reference time of activity (ART). Fluorine (F) with a half-life of approximately 110 minutes decays to a stable oxygen isotope (O), accompanied by the emission of positron radiation with a maximum energy of 634 keV, followed by the emission of photon radiation with an energy of 511 keV due to the annihilation process. Excipients with known effects Each milliliter of the solution contains 5 mg of sodium, up to 0.1 mg of potassium, and up to 80 mg of ethanol. For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection. Clear, colorless or slightly yellow solution, without visible particles, with a pH between 4.5 and 8.5.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

This medicinal product is intended for diagnostic use only. Radelumin is indicated for the detection of changes with prostate-specific membrane antigen (PSMA) using positron emission tomography (PET) in adult patients with prostate cancer (PCa) in the following clinical situations:

• Initial assessment of the extent of changes in patients with PCa at high risk before undergoing first-line curative therapy,
• Suspected recurrence of PCa in patients with increasing prostate-specific antigen (PSA) levels in serum after first-line curative therapy.

4.2 Posology and method of administration

Radelumin should be administered by appropriately trained medical personnel and only in designated nuclear medicine facilities. Dosage Recommended activity of [F]PSMA-1007 for an adult is 3.6-4.4 MBq/kg body weight (i.e., 252-308 MBq for a 70 kg patient), depending on the type of camera and acquisition mode used. The maximum activity of the injected dose should not exceed 450 MBq. The maximum volume of the injection solution should not exceed 10 ml. Elderly patients No dose modification is required. Renal impairment Radelumin has not been studied in patients with renal impairment. It is considered that there is no need to adjust the dose in patients with renal impairment (see section 5.2). Hepatic impairment Radelumin has not been studied in patients with hepatic impairment. It is considered that there is no need to adjust the dose in patients with hepatic impairment (see section 5.2). Children and adolescents The use of [F]PSMA-1007 is not appropriate in children and adolescents. Method of administration The medicinal product is intended for intravenous administration. The activity of [F]PSMA-1007 should be measured with an activity meter immediately before injection. The recommended maximum volume of Radelumin injection is 10 ml. Instructions for reconstitution of the medicinal product before administration, see section 12. Image acquisition The patient should be placed on their back, with their arms raised above their head, if possible. A computed tomography (CT) or magnetic resonance imaging (MRI) scan should be performed to correct for attenuation and anatomical correlation. The PET scan should be started 90-120 minutes after the end of injection. It is recommended to start recording images from the middle of the thighs and move up to the base of the skull.

4.3 Contraindications

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

4.4 Special warnings and precautions for use

Individual assessment of the benefit-risk ratio For each patient, exposure to radiation must be justified by the likely benefit. In all cases, the lowest possible dose of radiation should be used to obtain the required diagnostic information. To date, there are no data to determine subsequent management of a patient with high-risk disease when a PSMA PET/CT scan was used in the initial assessment of the extent of changes. Interpretation of images obtained using [F]PSMA-1007 Images obtained using [F]PSMA-1007 should be interpreted by nuclear medicine physicians appropriately trained in PET scans using [F]PSMA-1007. The interpretation of images obtained using [F]PSMA-1007 in PET scans should be performed visually. The suspicion of tumor tissue in typical locations for prostate cancer recurrence is based on the uptake value of [F]PSMA-1007 in those locations relative to the background and concurrent evaluation of information from the corresponding CT or MRI scan. Typical patterns of known physiological uptake of PSMA-targeted tracers should be taken into account. Detection of prostate cancer recurrence has been reported in the prostate gland or prostate bed, regional lymph nodes, non-regional lymph nodes, bones, soft tissue, and visceral organs using [F]PSMA-1007. The impact of quantitative/semi-quantitative uptake of [F]PSMA-1007 on image interpretation has not been evaluated. In the case of PET scans using [F]PSMA-1007, errors in image interpretation are possible. Uptake of [F]PSMA-1007 is not specific to prostate cancer and may occur in healthy tissues (see section 5.2), other types of tumors, and non-neoplastic processes, which can lead to false-positive results. Moderate or high physiological uptake of PSMA is noted in the kidneys, lacrimal glands, liver, salivary glands, gallbladder, spleen, and pancreas. False-positive results include other types of tumors (e.g., renal cell carcinoma, hepatocellular carcinoma, breast cancer), benign bone diseases (e.g., Paget's disease), inflammatory processes in activated lymph nodes, benign thyroid diseases, hepatitis, prostatitis, benign prostatic hyperplasia, gliomas, and healing rib fractures. Nerve roots may mimic lymph nodes. Focal non-specific bone uptake has been reported in some cases of [F]PSMA-1007 use without a morphological correlate on CT scan, mainly in the ribs. In cases of non-specific bone uptake, the patient's medical history, laboratory results, and CT correlates should be carefully considered to assess the presence of possible bone metastases. The diagnostic efficacy of [F]PSMA-1007 may depend on serum PSA levels, androgen receptor-targeted therapy, disease extent, and lymph node size (see section 5.1). Changes smaller than 4 mm may be missed due to the limited spatial resolution of PET/CT. In appropriate cases, further investigations, which may include histopathological examination of suspected changes, should be considered. After the examination Within the first 12 hours after injection, close contact with infants and pregnant women should be limited. Special warnings The medicinal product contains up to 50 mg of sodium per administered activity (10 ml), which corresponds to 2.5% of the WHO-recommended maximum daily sodium intake of 2 g for adults. This should be taken into consideration in patients on a controlled sodium diet. The medicinal product contains up to 1 mg of potassium per administered activity (10 ml), which is less than 1 mmol per dose, i.e., the medicinal product is considered "potassium-free". The medicinal product contains up to 800 mg of ethanol per administered activity (8% m/v). This amount in 10 ml of the medicinal product is equivalent to ≤ 20 ml of beer or ≤ 8 ml of wine. This should be taken into consideration in patients with known alcohol dependence.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6 Fertility, pregnancy and lactation

Pregnancy and breastfeeding Radelumin is not indicated for use in women. Fertility No fertility studies have been performed.

4.7 Effects on ability to drive and use machines

Radelumin contains a very small amount of alcohol, which may reduce the ability to drive and use machines in some sensitive individuals.

4.8 Undesirable effects

The safety profile of [F]PSMA-1007 was evaluated in 191 patients with suspected biochemical recurrence of prostate cancer (study ABX-CT-301) and in over 1,000 patients based on literature data. To date, no adverse reactions have been reported. Exposure to ionizing radiation is associated with the induction of tumors and the possibility of congenital malformations. Since the effective dose resulting from the administration of the maximum recommended activity of [F]PSMA-1007 of 450 MBq is 8.6 mSv, the likelihood of these adverse reactions is low. Reporting of suspected adverse reactions After the medicinal product has been placed on the market, it is important to report any suspected adverse reactions. This allows for the continuous monitoring of the benefit-risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C PL-02 222 Warsaw Tel.: + 48 22 49 21 301 Fax: + 48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl. Adverse reactions can also be reported to the marketing authorization holder.

4.9 Overdose

In the event of administration of an excessive dose of radiation with [F]PSMA-1007, the nuclear medicine physician responsible for the examination should take the necessary actions to ensure that the patient's exposure to radiation is maintained at a level generally accepted in diagnostic nuclear medicine or radiological examinations. These actions will vary from patient to patient, depending on their clinical condition and the degree of overdose, and may be limited to routine monitoring. Estimating the effective dose of radiation administered to the patient may be helpful.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Therapeutic category: other diagnostic radiopharmaceuticals, ATC code: V09IX17 Mechanism of action [F]PSMA-1007 is a synthetic peptidomimetic that contains the pharmacophore Glu-NH-CO-NH-Lys of the prostate-specific membrane antigen (PSMA). It binds with high affinity to the enzymatic site of PSMA, which is overexpressed in most prostate cancer cells and, after binding, undergoes internalization. As a result of internalization, there is increased accumulation of [F]PSMA-1007 in prostate cancer cells. Pharmacodynamic effects It appears that at molar concentrations corresponding to the recommended activities of [F]PSMA-1007, there is no pharmacodynamic activity. Clinical efficacy and safety Initial assessment of the extent of changes In a prospective study conducted by Hermsen et al. (Eur J Nucl Med Mol Imaging. 2022; 49(11): 3929-3937) in 99 adult patients (mean age 68.1 ± 6.6 years) with biopsy-proven PCa at intermediate (35/99) and high risk (64/99) who were candidates for extended pelvic lymph node dissection (ePLND), a PET/CT scan with [F]PSMA-1007 was performed. The PET/CT images were evaluated by two independent readers trained in image analysis, and ePLND served as the reference standard for histopathological examination. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of PET/CT imaging with [F]PSMA-1007 for the detection of lymph node metastases, depending on the patient, are presented in Table 1. The mean diameter of lymph nodes not detected by PET/CT but involved by PCa on histopathological examination was 3.5 mm (95% confidence interval 3.0-4.1 mm). In a retrospective study conducted by Sprute et al. (J Nucl Med. 2021; 62(2):208-213) in 96 adult patients (mean age 69.5), a PET/CT scan with [F]PSMA-1007 was performed for staging (87/96) or restaging (9/96), followed by ePLND or salvage lymphadenectomy. Image analysis and correlation with histopathological results were performed by each center individually, and in cases of disagreement, a consensus was reached through analysis by two nuclear medicine physicians from the University Hospital in Heidelberg. Subgroup analyses were performed for different lymph node sizes (all sizes, lymph nodes > 3 mm). The sensitivity, specificity, PPV, and NPV of PET/CT imaging with [F]PSMA-1007 for the detection of lymph node metastases, depending on the patient and the change, are presented in Table 1. Suspected recurrence of PCa Key efficacy data come from 190 patients evaluated in a randomized, open-label, cross-over study ABX-CT-301 conducted at six different centers in France. Patients were adult men and elderly men (mean age 68.7 years, range 49-84) with suspected recurrence of prostate cancer based on increasing PSA levels in serum after initial treatment for localized prostate cancer (primary treatments were prostatectomy with pelvic lymph node dissection (48.7%), prostatectomy (32.8%), and radiotherapy (including external beam radiotherapy and brachytherapy) with or without hormone therapy (16.4%)). The study was an active comparator study: PET/CT scan with [F]PSMA-1007 was compared with PET/CT scan with fluorocholine (F). PET/CT images obtained with the two radiopharmaceuticals for each patient were interpreted by three independent, blinded readers trained in image analysis, and the results were compared with a composite standard of truth (cSOT), while the extent of disease was determined by a panel of experts blinded to both PET and CT images. The diagnostic efficacy of PET and CT scans with [F]PSMA-1007 and fluorocholine (F) was characterized as the detection rate (agreement of positive readings with the cSOT) and is presented in Table 2. The mean detection rate among all readers was 77% for [F]PSMA-1007 and 57% for fluorocholine (F), with a statistically significant difference (odds ratio 2.61; 95% confidence interval 1.97-3.45); p <0.0001). Detection rates ordered by PSA level in serum before the scan are also presented in Table 2.

5.2 Pharmacokinetic properties

Distribution [F]PSMA-1007 is distributed in the bloodstream immediately after administration. In healthy individuals, the blood pool contained an average of 76%, 22%, 12%, and 8% of the administered activity at 2 minutes, 1 hour, 2 hours, and 3 hours after administration, respectively. Uptake in organs [F]PSMA-1007 is taken up by prostate cancer cells preferentially compared to surrounding healthy tissues. One hour after administration, tumor changes become visible, and uptake increases up to 3 hours after administration. The median SUV in prostate cancer changes in patients with biochemical recurrence was approximately 4-40. The highest uptake of [F]PSMA-1007 in non-target organs was noted in the kidneys, salivary glands, lacrimal glands, liver, spleen, gallbladder, and pancreas up to 3 hours after administration (median SUV approximately 5-30). Brain activity is negligible. Elimination Elimination occurs mainly through the hepatobiliary route. In a study by Giesel et al. (Eur J Nucl Med Mol Imaging. 2017; 44(4):678-688), in 3 healthy volunteers, urinary excretion was minimal, and an average of 2.4% of the administered radioactivity was excreted in the urine within 6 hours after injection. No metabolism studies of [F]PSMA-1007 have been performed. Half-life The actual half-life depends primarily on the short physical half-life of fluorine (F), which is approximately 110 minutes, and not on the biological half-life of the carrier molecule.

5.3 Preclinical safety data

Non-clinical data from conventional toxicity studies after single dose administration, pharmacological safety studies, and genotoxicity studies did not reveal any special hazard for humans.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Disodium phosphate Potassium dihydrogen phosphate Sodium chloride Potassium chloride Sodium ascorbate Anhydrous ethanol Water for injections

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products, except for those mentioned in section 12.

6.3 Shelf life

10 hours from the reference time of activity (ART). After first opening The chemical and physical stability of Radelumin 1300 MBq/ml, solution for injection, has been demonstrated after first opening for 10 hours from the reference time of activity. From a microbiological point of view, the product should be used immediately, unless the method of opening, sampling, and dilution precludes the risk of microbial contamination. If the product is not used immediately, the user is responsible for the storage conditions. After first opening, use before the expiry date.

6.4 Special precautions for storage

Do not store above 30°C. Radiopharmaceuticals should be stored in accordance with national regulations for the handling of radioactive materials.

6.5 Nature and contents of container

Radelumin is supplied in glass vials of type I, with a capacity of 10 ml, 15 ml, or 20 ml, closed with rubber stoppers suitable for multiple punctures and sealed with a cap. The product is available in volumes and activities: One 10 ml multidose vial contains from 0.3 to 10 ml of solution, corresponding to an activity of from 390 to 13,000 MBq at the reference time of activity (ART). One 15 ml multidose vial contains from 0.3 to 15 ml of solution, corresponding to an activity of from 390 to 19,500 MBq at the reference time of activity (ART). One 20 ml multidose vial contains from 0.3 to 20 ml of solution, corresponding to an activity of from 390 to 26,000 MBq at the reference time of activity (ART). Multidose vial. Not all pack sizes may be marketed.

6.6 Special precautions for disposal and preparation of the medicinal product

For useGeneral warnings Radiopharmaceuticals should be received, used, and administered only by authorized persons in designated clinical settings. Their receipt, storage, use, transfer, and disposal are subject to legal regulations and/or require appropriate permits issued by the relevant authorities. Radiopharmaceuticals should be prepared in accordance with both radiation protection requirements and pharmaceutical quality requirements. Appropriate precautions should be taken to prepare the product under aseptic conditions. Instructions for dilution of the medicinal product before administration, see section 12. If the vial is damaged at any point during the preparation process, the product should not be used. Administration procedures should be performed in such a way as to minimize the risk of contamination of the medicinal product and exposure of operators to radiation. The use of effective radiation shields is mandatory. The administration of radiopharmaceuticals is associated with the risk of exposure of others to external radiation or contamination from urine, vomit, etc. Therefore, radiation protection measures should be applied in accordance with national regulations. Any unused medicinal product or waste should be disposed of in accordance with local requirements.

7. MARKETING AUTHORIZATION HOLDER

RESPONSIBLE FOR BATCH RELEASE

ABX advanced biochemical compounds - Biomedizinische Forschungsreagenzien GmbH Heinrich-Glaeser-Str. 10-14 01454 Radeberg Germany

8. MARKETING AUTHORIZATION NUMBER

9. DATE OF FIRST AUTHORIZATION

AND DATE OF LAST RENEWAL

Date of first authorization:

10. DATE OF REVISION OF THE TEXT

OF THE SUMMARY OF PRODUCT CHARACTERISTICS

11. DOSIMETRY

Estimated radiation doses to an adult patient after intravenous administration of [F]PSMA-1007 are presented in Table 4. The values were calculated based on human biodistribution data using the OLINDA/EXM software (version 2.1). The effective dose was calculated based on the mass of organs specified in the International Commission on Radiological Protection Publication 103 (ICRP-103). Organ Absorbed dose per unit administered activity (mGy/MBq) Brain 0.0030 Eyes 0.0072 Testes 0.0074 Bone marrow 0.0101 Muscle 0.0103 Whole body 0.0103 Thymus 0.0106 Red bone marrow 0.0121 Rectum 0.0145 Lungs 0.0147 Thyroid 0.0151 Stomach 0.0170 Upper large intestine 0.0176 Esophagus 0.0187 Urinary bladder wall 0.0212 Lower large intestine 0.0239 Heart wall 0.0259 Small intestine 0.0334 Adrenal glands 0.0349 Salivary glands 0.0642 Pancreas 0.0677 Spleen 0.0851 Liver 0.0883 Kidneys 0.1030 Gallbladder wall 0.1400 Effective dose Effective dose (mSv/MBq) (ICRP-103) 0.0191 The effective dose resulting from the administration of the recommended activity of 280 MBq (for a 70 kg adult patient) is approximately 5.3 mSv. The effective dose resulting from the administration of the maximum recommended activity of 450 MBq is approximately 8.6 mSv. For an administered activity of 280 MBq, typical radiation doses to critical organs - gallbladder, kidneys, and liver - are approximately 39 mGy, 29 mGy, and 25 mGy, respectively.

12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

Any unused medicinal product or waste should be disposed of in accordance with local requirements. The medicinal product should be drawn up in aseptic conditions. The vial should not be opened before the stopper has been disinfected. The solution should be drawn up through the stopper using a single-dose syringe with an appropriate protective shield and a single-use, sterile needle or an approved automated injection system. If the vial is damaged, the medicinal product should not be used. Radelumin can be diluted with sodium chloride 9 mg/ml (0.9%) solution immediately before use. Quality control Before administration, the solution should be inspected. Only clear solutions without visible particles should be used.

LABELING OF PACKAGING

INFORMATION TO BE INCLUDED ON THE OUTER PACKAGING

Cap label

1. NAME OF THE MEDICINAL PRODUCT

Radelumin 1300 MBq/ml, solution for injection PSMA-1007 (F) solutio iniectabilis

2. CONTENTS OF ACTIVE SUBSTANCES

[F]PSMA-1007: 1300 MBq/ml {DD/MM/YYYY}{HH:MM}{time zone}

3. LIST OF EXCIPIENTS

Excipients: disodium phosphate, potassium dihydrogen phosphate, sodium chloride, potassium chloride, sodium ascorbate, anhydrous ethanol, and water for injections. For more information on sodium, potassium, and ethanol, see the patient information leaflet.

4. PHARMACEUTICAL FORM AND CONTENTS OF THE PACKAGING

Solution for injection {1 multidose vial (15 ml) code:} {1 multidose vial (20 ml) code:} Volume: {xx.x} ml Activity: {YYYY} MBq {HH:MM} {time zone} {DD/MM/YYYY}

5. METHOD AND ROUTE OF ADMINISTRATION

Read the patient information leaflet carefully before using the medicinal product. Intravenous administration.

6. SPECIAL PRECAUTIONS FOR STORAGE OF THE MEDICINAL PRODUCT

OUT OF THE REACH AND SIGHT OF CHILDREN

Not applicable.

7. OTHER SPECIAL WARNINGS, IF NECESSARY

Radioactive substance

8. EXPIRY DATE

Expiry date (EXP) {HH:MM}{time zone}{DD/MM/YYYY}

9. STORAGE CONDITIONS

Do not store above 30°C.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCT OR WASTE

IF APPROPRIATE

IF APPROPRIATE

Any unused medicinal product or waste should be disposed of in accordance with local requirements.

11. NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER

ABX advanced biochemical compounds - Biomedizinische Forschungsreagenzien GmbH Heinrich-Glaeser-Str. 10-14 01454 Radeberg Germany

12. MARKETING AUTHORIZATION NUMBER

Marketing authorization number:

13. BATCH NUMBER

Batch number (Lot) {variable}

14. GENERAL CATEGORY OF AVAILABILITY

Lz – Medicinal product for use in closed healthcare facilities

15. INSTRUCTIONS FOR USE

Not applicable.

16. INFORMATION PROVIDED IN BRAILLE

Justification for the absence of Braille information has been accepted.

17. UNIQUE IDENTIFIER – 2D BAR CODE

Not applicable.

18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

Not applicable.

MINIMUM INFORMATION TO BE INCLUDED ON SMALL OUTER PACKAGING

IF APPROPRIATE

Small outer packaging (vial)

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

Radelumin 1300 MBq/ml, solution for injection PSMA-1007 (F) solutio iniectabilis Intravenous administration.

2. METHOD OF ADMINISTRATION

Not applicable.

3. EXPIRY DATE

EXP: ART+10 hours.

4. BATCH NUMBER

Lot {variable}

5. CONTENTS OF THE PACKAGING WITH DOSE, VOLUME, OR NUMBER OF UNITS

OF UNITS

Activity: ≤26 GBq (see cap label)

6. OTHER

Radioactive substance Read the instructions before using the medicinal product.

PATIENT INFORMATION LEAFLET

Patient information leaflet included with the packaging: Information for the patient

Radelumin 1300 MBq/ml, solution for injection

PSMA-1007 (F) solutio iniectabilis This medicinal product is subject to additional monitoring. This will allow for the rapid identification of new safety information. You can also help by reporting any side effects you may get. To find out how to report side effects, see section 4.

Read the patient information leaflet carefully before using the medicinal product, as it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your nuclear medicine physician who will be supervising the procedure.
• If you get any side effects, talk to your doctor or nuclear medicine physician. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the patient information leaflet

• 1. What Radelumin is and what it is used for
• 2. Important information before using Radelumin
• 3. How to use Radelumin
• 4. Possible side effects
• 5. How to store Radelumin
• 6. Contents of the packaging and other information

1. What Radelumin is and what it is used for

This medicinal product is a radiopharmaceutical intended for diagnostic use only. Radelumin contains a substance called Fluoro-PSMA-1007 (F). Radelumin is used in a medical imaging procedure called positron emission tomography (PET) to detect certain types of cancer that contain a protein called prostate-specific membrane antigen (PSMA) in adult patients with prostate cancer. This is done to:

• determine if the prostate cancer has spread to the lymph nodes and other tissues outside the prostate gland before undergoing first-line curative therapy (e.g., surgery, radiotherapy)
• identify cancer cells in case of suspected recurrence of prostate cancer in patients who have undergone first-line curative therapy. After administration of Fluoro-PSMA-1007 (F) to the patient, it binds to cells that have PSMA on their surface and makes them visible to the nuclear medicine physician during the medical imaging procedure. This provides valuable information about the patient's disease.

The results of the examination will be communicated by the doctor who ordered the PET scan. The use of Radelumin involves exposure to small amounts of radiation. The doctor and nuclear medicine physician have assessed that the benefits of this examination outweigh the risks of radiation exposure. Radelumin should only be administered by a doctor specializing in nuclear medicine.

2. Important information before using Radelumin

Radelumin must not be used:

• if you are allergic to [F]PSMA-1007 or any of the other ingredients of this medicinal product (listed in section 6).

Warnings and precautions

Before starting treatment with Radelumin, discuss with your nuclear medicine physician if you:

• have kidney or liver problems
• are on a low-sodium diet or are addicted to alcohol (see section "Radelumin contains sodium, potassium, and ethanol").

Children and adolescents

Radelumin is not intended for use in children and adolescents under 18 years of age.

Radelumin and other medicinal products

Tell your nuclear medicine physician about all the medicinal products you are taking or have recently taken, as well as any medicinal products you plan to take, as they may affect the interpretation of the imaging results.

Pregnancy and breastfeeding

Radelumin is not indicated for use in women.

Driving and using machines

It is unlikely that Radelumin will affect your ability to drive or use machines.

Radelumin contains sodium, potassium, and ethanol

The medicinal product contains up to 50 mg of sodium per dose. This corresponds to 2.5% of the WHO-recommended maximum daily sodium intake of 2 g for adults. The medicinal product contains up to 1 mg of potassium per dose, which is less than 1 mmol per dose, i.e., the medicinal product is considered "potassium-free". The medicinal product contains up to 80 mg of ethanol per milliliter (ml), which corresponds to 800 mg per dose (8% m/v). This amount in 10 ml of the medicinal product is equivalent to ≤ 20 ml of beer or ≤ 8 ml of wine.

3. How to use Radelumin

There are strict regulations regarding the use of radiopharmaceuticals, their handling, and disposal. Radelumin will only be used in specially controlled facilities. This medicinal product will be prepared and administered only by trained and qualified personnel. These personnel will take the necessary precautions to ensure the safe use of this medicinal product and will inform the patient about the procedures being performed. The nuclear medicine physician supervising the examination will decide on the dose of Radelumin to be administered to the patient. This will be the smallest amount necessary to obtain the required information. The dose of Radelumin for an adult patient is usually 3.6-4.4 MBq per kilogram of body weight (the abbreviation MBq stands for megabecquerel and corresponds to a multiple of the unit used to express radioactivity - becquerel). This means that an adult patient weighing 70 kg will receive 252-308 MBq.

Administration of Radelumin and the course of the examination

Radelumin is administered by injection into a vein. Usually, one injection is sufficient to perform the necessary imaging examination.

Duration of the examination

The nuclear medicine physician will inform the patient about the typical duration of the examination. The PET scan usually starts approximately 90-120 minutes after the injection of Radelumin.

After administration of Radelumin:

• for 12 hours after injection, the patient should avoid close contact with infants and pregnant women

The nuclear medicine physician will inform the patient if any other special precautions are necessary after administration of this medicinal product. If you have any questions, ask your nuclear medicine physician.

4. Possible side effects

As with any medicinal product, side effects may occur with Radelumin. If you get any side effects, talk to your doctor or nuclear medicine physician. This includes any possible side effects not listed in this leaflet.

5. How to store Radelumin

This medicinal product does not require any special storage conditions.

6. Contents of the packaging and other information

For more information about this medicinal product, contact the marketing authorization holder.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
To date, no side effects have been reported.
This radiopharmaceutical product delivers a small dose of ionizing radiation, which is associated with a low risk of cancer and congenital anomalies.

Reporting side effects

If you experience any symptoms of side effects, including any side effects not listed in this leaflet, please inform your nuclear medicine doctor. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will allow for more information to be collected on the safety of this medicinal product.

5. How to store Radelumin

The patient will not need to store this medicinal product. The storage of this medicinal product is the responsibility of specialists, and the medicinal product is stored in appropriate locations. Radiopharmaceutical products are stored in accordance with national regulations regarding radioactive materials.
Information intended for healthcare professionals only:
Do not use Radelumin after the expiry date stated on the label after the abbreviation "EXP".

6. Contents of the pack and other information

What Radelumin contains

• The active substance of Radelumin is Fluoro-PSMA-1007 (F).
• Each milliliter of solution contains 1300 MBq of Fluoro-PSMA-1007 (F) at the time of reference activity (ART).
• The other ingredients are disodium phosphate, potassium dihydrogen phosphate, sodium chloride, potassium chloride, sodium ascorbate, anhydrous ethanol, and water for injections (see section 2 "Radelumin contains sodium, potassium, and ethanol").

What Radelumin looks like and contents of the pack

The patient will not need to purchase this medicinal product or deal with the packaging or vial; the following information is for informational purposes only.
Radelumin is a clear, colorless or yellowish solution stored in a glass vial.
Radelumin 1300 MBq/ml, solution for injection, vial 10 ml: Each multidose vial contains from 0.3 to 10 ml of solution, corresponding to 390-13 000 MBq at the time of reference activity (ART).
Radelumin 1300 MBq/ml, solution for injection, vial 15 ml: Each multidose vial contains from 0.3 to 15 ml of solution, corresponding to 390-19 500 MBq at the time of reference activity (ART).
Radelumin 1300 MBq/ml, solution for injection, vial 20 ml: Each multidose vial contains from 0.3 to 20 ml of solution, corresponding to 390-26 000 MBq at the time of reference activity (ART).
Pack size: 1 vial.
Not all pack sizes may be marketed.

Marketing authorization holder:

ABX advanced biochemical compounds - Biomedizinische Forschungsreagenzien GmbH
Heinrich-Glaeser-Str. 10-14
01454 Radeberg
Germany
Email: info@abx.de

Manufacturer:

Alliance Medical RP Sp. z o.o.
ul. Szeligowska 3
05-850 Szeligi
Poland
Synektik Pharma Sp z o.o.
ul. Szaserów 128
04-141 Warsaw
Poland
Synektik Pharma Sp. z o.o.
ul. Artwińskiego 3
25-734 Kielce
Poland
Synektik Pharma Sp. z o.o.
ul. Keramzytowa 16
96-320 Mszczonów
Poland
Euro-Pet Positronen Emissions Tomographie Untersuchungszentrum GmbH
Hugstetter Str. 55
79106 Freiburg im Breisgau
Germany
PETNET Solutions S.A.S.
Zac Du Bois Chaland
15 Rue des Pyrenees
91090 Lisses
France
Institut de Radiofarmàcia Aplicada de Barcelona, S.L (IRAB S.L.)
Dr. Aiguader, 88, planta -1
08003 Barcelona
Spain
Alliance Medical RP GmbH
Spessartstr. 9
53119 Bonn
Germany
ABX advanced biochemical compounds - Biomedizinische Forschungsreagenzien GmbH
Heinrich-Glaeser-Str. 10-14
01454 Radeberg
Germany
Radboud Translational Medicine B.V.
Geert Grooteplein 21, route 142
6525 EZ Nijmegen
Netherlands
MVZ – Diagnostisch Therapeutisches Zentrum am Frankfurter Tor GbR
Kadiner Str. 23
10243 Berlin
Germany
Universitätsklinikum Tübingen
Department für Radiologie
Abteilung für Präklinische Bildgebung und Radiopharmazie
Röntgenweg 15-17
72076 Tübingen
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Country

Date of last revision of the leaflet

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Information intended for healthcare professionals only:
The full Summary of Product Characteristics of Radelumin is attached to the packaging of the product as a separate document, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical. See Summary of Product Characteristics.