Radelumin 2000 MBq/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Radelumin 2000MBq/ml solution for injection

PSMA-1007 (18F)

This medicinal product is subject to additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is included at the end of section 4.

Read all of this leaflet carefully before you are given this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or the nuclear medicine physician supervising the procedure.
• If you experience any adverse reactions, consult your doctor or the nuclear medicine physician, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Radelumin is and what it is used for
2. What you need to know before being given Radelumin
3. How Radelumin is administered
4. Possible adverse reactions
5. How to store Radelumin
6. Contents of the pack and other information

1. What Radelumin is and what it is used for

This medicine is a radiopharmaceutical for diagnostic use only.

Radelumin contains a substance called PSMA-1007 (18F). Radelumin is used in a medical imaging procedure called positron emission tomography (PET) to detect certain types of cancer cells expressing a protein known as prostate-specific membrane antigen (PSMA) in adults with prostate cancer. This is performed:

• to determine whether prostate cancer has spread to lymph nodes and other tissues outside the prostate prior to initial curative therapy (e.g., therapy involving surgical removal of the prostate, radiotherapy)
• to identify cancer cells when there is suspicion of prostate cancer recurrence in patients who have received initial curative therapy

When administered to the patient, PSMA-1007 (18F) binds to cancer cells expressing PSMA on their surface, making them visible to the nuclear medicine physician during the PET imaging procedure. This provides valuable information about the disease to your physician and nuclear medicine specialist.

The physician who ordered the PET scan will inform you of the results.

The use of Radelumin involves exposure to small amounts of radioactivity. Your physician and the nuclear medicine physician have determined that the benefit of this procedure with the radiopharmaceutical outweighs the risk associated with radiation exposure.

This medicine must be administered under the supervision of a physician with specialized training in nuclear medicine.

2. What you need to know before starting to use Radelumin

Do not use Radelumin

• if you are allergic to PSMA-1007 (18F) or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your nuclear medicine physician before you are given Radelumin if you:

• have kidney or liver problems.
• are on a low-sodium diet or have alcohol dependence (see the 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.

Other medicines and Radelumin

Inform your nuclear medicine physician if you are taking, have recently taken, or might need to take any other medicines, as they could interfere with the interpretation of the images.

Pregnancy and breastfeeding

This medicine is not indicated for use in women.

Driving and using machines

Radelumin is considered unlikely to affect your ability to drive or operate machinery.

Radelumin contains sodium, potassium and ethanol

This medicine contains up to 50 mg of sodium (main component of table/cooking salt) per dose. This is equivalent to 2.5% of the maximum daily recommended sodium intake for an adult.

This medicine contains up to 1 mg of potassium per dose, which is less than 1 mmol per dose; therefore, it is essentially "potassium-free".

This medicine contains up to 80 mg of alcohol (ethanol) per milliliter (ml), amounting to 800 mg per dose (8% m/v). The amount in each 10 ml dose of this medicine is equivalent to less than 20 ml of beer or 8 ml of wine.

3. How to use Radelumin

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals.

Radelumin will only be used in special controlled areas. This medicine will only be handled and administered by trained and qualified personnel who are skilled in its safe use. These individuals will take special care in the safe use of this medicine and will inform you of their actions.

The nuclear medicine physician supervising the procedure will decide the amount of Radelumin to be used in your case. This will be the minimum quantity necessary to obtain the desired information.

The generally recommended dose for administration in an adult is 3.6–4.4 MBq per kg of body weight. The megabecquerel (MBq) is the unit used to express radioactivity. This means that for a 70 kg adult, a dose of 252–308 MBq will be administered.

Administration of Radelumin and performance of the procedure

Radelumin is administered intravenously as an injection into the vein.

One injection is sufficient to carry out the study required by your physician.

Duration of the procedure

Your nuclear medicine physician will inform you about the usual duration of the procedure. PET imaging will typically begin between 90 and 120 minutes after administration of the Radelumin injection.

After administration of Radelumin

• Avoid direct contact with young children and pregnant women for 12 hours following the injection.

The nuclear medicine physician will inform you if you need to take any other special precautions after receiving the medicine. Ask your nuclear medicine physician if you have any questions.

If you are given more Radelumin than you should

An overdose is unlikely because you will receive only one injection of Radelumin, with radioactivity precisely determined by the nuclear medicine physician in charge of your examination.

However, if an overdose occurs, the nuclear medicine physician in charge of your examination will take necessary measures to ensure that your body's radiation exposure remains within levels generally accepted for diagnostic procedures in nuclear medicine or radiology. These measures will vary from patient to patient depending on clinical status and the extent of the overdose, and may be limited to simple monitoring.

If you have any further questions about the use of this medicine, ask the nuclear medicine physician supervising the procedure.

4. Possible adverse effects

Like all medicines, this medicinal product may produce adverse effects, although not everyone will experience them.

To date, no adverse effects have been reported.

Administration of this radiopharmaceutical involves exposure to small amounts of ionizing radiation, with a low risk of developing cancer and hereditary defects.

Reporting of adverse effects

If you experience any adverse effects, inform the nuclear medicine physician, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Radelumin

You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.

The following information is intended exclusively for the specialist:

Radelumin must not be used after the expiry date stated on the label of the shielded container after EXP.

6. Contents of the pack and other information

Composition of Radelumin

• The active substance is PSMA-1007 (18F).
• Each mL of solution contains 2000 MBq of PSMA-1007 (18F) at the time and date of calibration (Cal.).
• The other components 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").

Appearance of Radelumin and contents of the pack

You will not have to obtain or handle this medicine or its container; the following is for informational purposes only.

Radelumin is a clear, colourless or slightly yellowish solution, supplied in a glass vial.

Radelumin 2000 MBq/mL solution for injection, 10 mL vial: Each multidose vial contains 0.3 to 10 mL of solution, corresponding to 600–20000 MBq at the date and time of calibration (Cal.).

Radelumin 2000 MBq/mL solution for injection, 15 mL vial: Each multidose vial contains 0.3 to 15 mL of solution, corresponding to 600–30000 MBq at the date and time of calibration (Cal.).

Radelumin 2000 MBq/mL solution for injection, 20 mL vial: Each multidose vial contains 0.3 to 20 mL of solution, corresponding to 600–40000 MBq at the date and time of calibration (Cal.).

Pack size: 1 vial.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder:

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

Manufacturer:

IRAB S.L.
Dr. Aiguader 88, planta-I
08003 Barcelona
Spain

Advanced Accelerator Applications Molecular Imaging Iberica S.L.U.
C/ Josep Anselm Clavé 100
08950 Esplugues De Llobregat
Spain (Barcelona)

Advanced Accelerator Applications Molecular Imaging Iberica S.L.U.
Ctra Madrid Cartagena Sn
El Palmar
30120 Murcia
Spain

Advanced Accelerator Applications (Portugal) Unipessoal Lda.
Rua das 7 Bicas no. 170, Fração B
4460-188 Senhora da Hora
Portugal

Advanced Accelerator Applications Molecular Imaging France
126 Rocade Sud
62660 Beuvry
France

EURO-PET GmbH
Hugstetter Str. 55
79106 Freiburg im Breisgau
Germany

PETNET Solutions S.A.S.
15 Rue des Pyrenees
91090 Lisses
France

Alliance Medical RP GmbH
Spessartstr. 9
53119 Bonn
Germany

Alliance Medical RP Sp. z o.o.
ul. Szeligowska 3
05-850 Szeligi
Poland

ITEL Telecomunicazioni S.r.l.
Via A. Labriola zona industriale SNC
70037 Ruvo di Puglia (BA)
Italy

AAA Molecular Imaging France S.A.S. Marseille
Bat Cerimed
27 Boulevard Jean Moulin
13005 Marseille
France

SPARKLE S.r.l.
Contrada Calò snc
73042 Casarano (LE)
Italy

ABX GmbH
Heinrich-Glaeser-Str. 10-14
01454 Radeberg
Germany

Radboud Translational Medicine B.V.
Geert Grooteplein 21, route 142, 6525 EZ
Nijmegen
The Netherlands

Seibersdorf Labor GmbH
2444 Seibersdorf
Austria

AAA Molecular Imaging France S.A.S. Saint Cloud
3 Rue Charles Lauer
92210 Saint-Cloud
France

Advanced Accelerator Applications Germany GmbH
Saime-Genc-Ring 18
53121 Bonn
Germany

Advanced Accelerator Applications Germany GmbH
Marchioninistrasse 67
81377 München
Germany

Advanced Accelerator Applications Molecular Imaging Italy S.r.l.
Viale Dell'Industria Snc
86077 Pozzilli
Italy

Advanced Accelerator Applications Molecular Imaging Italy S.r.l.
Via Piero Maroncelli 40
47014 Meldola
Italy

Congregazione Poveri Servi Della Divina Provvidenza-Casa Buoni Fanciulli-Istituto Don Calabria
Via Don Angelo Sempreboni 5
37024 Negrar
Italy

Universitätsklinikum Tübingen
Department für Radiologie
Abteilung für Präklinische Bildgebung und Radiopharmazie
Röntgenweg 15-17
72076 Tübingen
Germany

BIONT, a.s.
Karloveská 63
842 29 Bratislava
Slovakia

Krankenhausbetriebsgesellschaft Bad Oeynhausen mbH
Georgstr. 11
32545 Bad Oeynhausen
Germany

Universitätsklinikum Leipzig AöR
Stephanstr. 9a
04103 Leipzig
Germany

VOXEL S.A.
ul. Wroclawska 1-3
30-006 Kraków
Poland

Advanced Accelerator Applications Molecular Imaging France
14 Rue Gustave Eiffel
10430 Rosieres-Pres-Troyes
France

Alliance Medical RP Berlin GmbH
Max-Planck-Str. 4
12489 Berlin
Germany

Universitätsklinikum Würzburg AöR
Oberdürrbacher Str. 6
97080 Würzburg
Germany

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

Date of the last review of this leaflet: October 2025.

This information is intended for healthcare professionals only:

The summary of product characteristics for Radelumin is included as a separate document in the product packaging, to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical. See the summary of product characteristics.