Radelumin 2000 mbq/ml

Package leaflet: Information for the patient

Radelumin 2000 MBq/ml, solution for injection
PSMA-1007 ( F) solutio iniectabilis
This medicinal product will be subject to additional monitoring. This will allow rapid
identification of new safety information. Patients can also help by reporting any adverse reactions that occur after administration of the medicine. For information on how to report adverse reactions – see section 4.
Please read this leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult the nuclear medicine physician who will supervise the procedure.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or the nuclear medicine physician. See section 4.

Table of contents of the 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 package and other information

1. What Radelumin is and what it is used for

This medicine is a radiopharmaceutical product intended solely for diagnostic use.
Radelumin contains a substance called Fluoro-PSMA-1007 ( F). Radelumin is used in an imaging procedure known as positron emission tomography (PET) to detect certain types of cancer expressing a protein called prostate-specific membrane antigen (PSMA) in adults with prostate cancer. This procedure aims to:

• Determine whether prostate cancer has spread to lymph nodes and other tissues beyond the prostate gland prior to initiating first-line curative therapy (e.g. therapy involving surgical removal of the prostate gland, radiotherapy)
• Identify cancer cells in cases of suspected recurrence of prostate cancer in patients who have previously received first-line curative therapy. After administration of Fluoro-PSMA-1007 ( F) to the patient, it binds to cells expressing PSMA on their surface, making them visible to the nuclear medicine physician during the PET imaging procedure. This enables the referring physician and the nuclear medicine physician to obtain valuable information about the patient's disease.

The results of the scan will be communicated by the physician who ordered the PET examination.
Administration of Radelumin results in exposure to low doses of radiation. Your referring physician and the nuclear medicine physician have determined that the benefits of this diagnostic procedure using a radiopharmaceutical outweigh the risks associated with radiation exposure.
Administration of this medicine should be supervised by a physician specialized in nuclear medicine.

2. Important information before using Radelumin

Radelumin must not be used:

• if the patient is allergic to [F]PSMA-1007 or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Radelumin, please discuss with the nuclear medicine physician if the patient:

• has kidney or liver problems
• is on a low-sodium diet or is alcohol-dependent (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 with other medicines
Inform the nuclear medicine physician about all medicines currently taken or recently used, as well as any medicines the patient intends to take, because they may affect the interpretation of imaging results.
Pregnancy and breastfeeding
This medicine is not indicated for use in women.
Driving and using machines
It is unlikely that Radelumin will affect the ability to drive or operate machinery.
Radelumin contains sodium, potassium and ethanol
This medicine contains up to 50 mg of sodium (the main component of table salt) per dose. This corresponds to 2.5% of the maximum recommended daily dietary sodium intake for adults.
This medicine contains up to 1 mg of potassium per dose, which is less than 1 mmol per dose, meaning the medicine is considered "potassium-free".
This medicine contains up to 80 mg of alcohol (ethanol) per millilitre (ml), equivalent to 800 mg per dose (8% m/v). The amount of alcohol in a 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 governing the use, handling, and disposal of radiopharmaceuticals.
Radelumin will be administered only in specially controlled facilities. This medicinal product will be prepared and administered exclusively by trained and qualified personnel experienced in its safe use. These individuals will take all 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 determine the dose of Radelumin to be administered to the patient. This will be the smallest amount required to obtain the necessary diagnostic information.

The administered dose for an adult is usually 3.6–4.4 MBq per kg of body weight (MBq stands for megabecquerel and represents a multiple of the unit used to express radioactivity—the becquerel). This means that an adult weighing 70 kg will receive 252–308 MBq.

Administration of Radelumin and the course of the examination
Radelumin is administered by intravenous injection.
Typically, a single injection is sufficient to perform the required imaging procedure.

Duration of the examination
The nuclear medicine physician will inform the patient about the expected duration of the examination. The PET scan usually begins approximately 90–120 minutes after the injection of Radelumin.

After administration of Radelumin:

• For 12 hours after the injection, the patient should avoid close contact with young children and pregnant women.

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

Administration of a higher than recommended dose of Radelumin
Overdose is unlikely, as Radelumin is administered only as a single dose, the radioactivity of which is precisely determined by the nuclear medicine physician conducting the examination.

However, in the event of an accidental overdose, the supervising nuclear medicine physician will take all necessary steps to ensure that the patient's radiation exposure remains within levels generally accepted in nuclear medicine diagnostics or radiological examinations. These measures will vary depending on the individual patient, clinical condition, and extent of overdose, and may range from simple monitoring to more specific interventions.

If you have any further doubts regarding the use of this medicinal product, please consult the nuclear medicine physician supervising the examination.

4. Possible adverse reactions

Like all medicines, this medicinal product can cause adverse reactions, although not everyone experiences them.
No adverse reactions have been reported to date.
This radiopharmaceutical product delivers a small dose of ionizing radiation, which is associated with a low risk of developing cancer and congenital abnormalities.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform the nuclear medicine physician. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration 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.
Reporting adverse reactions enables continued monitoring of the medicine's safety and helps provide more information on its safe use.

5. How to store Radelumin

The patient will not be required to store this medicine. Storage of this medicine is the responsibility of specialists, and the medicine is stored in appropriate locations. Radiopharmaceutical products are stored in accordance with national regulations concerning radioactive materials.
Information intended solely for healthcare professionals:
Do not use Radelumin after the expiry date stated on the label of the shield container following the abbreviation "EXP".

6. Contents of the pack and other information

What Radelumin contains

• The active substance is Fluoro-PSMA-1007 ( F).
• Each millilitre of solution contains 2000 MBq of Fluoro-PSMA-1007 ( F) at the activity reference time (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 medicine or handle the packaging or vial; the information below is provided for informational purposes only.
Radelumin is a clear, colourless or slightly yellow solution stored in a glass vial.
Radelumin 2000 MBq/ml, solution for injection, 10 ml vial: Each multidose vial contains between 0.3 and 10 ml of solution, corresponding to 600–20,000 MBq at the activity reference time (ART).
Radelumin 2000 MBq/ml, solution for injection, 15 ml vial: Each multidose vial contains between 0.3 and 15 ml of solution, corresponding to 600–30,000 MBq at the activity reference time (ART).
Radelumin 2000 MBq/ml, solution for injection, 20 ml vial: Each multidose vial contains between 0.3 and 20 ml of solution, corresponding to 600–40,000 MBq at the activity reference time (ART).
Pack size: 1 vial.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
ABX advanced biochemical compounds - Biomedizinische Forschungsreagenzien GmbH
Heinrich-Glaeser-Str. 10-14
01454 Radeberg
Germany
Email: [email protected]

Manufacturer:
Alliance Medical RP Sp. z o.o.
ul. Szeligowska 3
05-850 Szeligi
Poland
VOXEL S.A.
ul. Wrocławska 1-3
30-006 Kraków
Poland
Alliance Medical RP Berlin GmbH
Max-Planck-Str. 4
12489 Berlin
Germany
ABX advanced biochemical compounds – Biomedizinische Forschungsreagenzien GmbH
Heinrich-Glaeser-Str. 10-14
01454 Radeberg
Germany
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
ITEL Telecomunicazioni S.r.l.
Via A. Labriola zona industriale SNC
70037 Ruvo di Puglia (BA)
Italy
SPARKLE S.r.l.
Contrada Calò snc
73042 Casarano (LE)
Italy
Radboud Translational Medicine B.V.
Geert Grooteplein 21, route 142
6525 EZ Nijmegen
The Netherlands
Advanced Accelerator Applications Molecular Imaging France S.A.S. Marseille
Bat Cerimed
27 Boulevard Jean Moulin
13005 Marseille
France
Seibersdorf Labor GmbH
2444 Seibersdorf
Austria
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
Advanced Accelerator Applications 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
Marchioninistr. 67
81377 Munich
Germany
Krankenhausbetriebsgesellschaft Bad Oeynhausen mbH
Georgstr. 11
32545 Bad Oeynhausen
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
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 Molecular Imaging France
126 Rocade Sud
62660 Beuvry
France
Advanced Accelerator Applications (Portugal) Unipessoal Lda.
Rua Fonte Das Sete Bicas 170
4460-283 Matosinhos
Portugal
Congregazione Poveri Servi Della Divina Provvidenza-Casa Buoni Fanciulli-Istituto Don Calabria
Via Don Angelo Sempreboni 5
37024 Negrar
Italy
Universitätsklinikum Leipzig AöR
Stephanstr. 9a
04103 Leipzig
Germany
Advanced Accelerator Applications Molecular Imaging France
14 Rue Gustave Eiffel
10430 Rosieres-Pres-Troyes
France
Universitätsklinikum Würzburg AöR
Oberdürrbacher Str. 6
97080 Würzburg
Germany

This medicinal product is authorised for marketing in the European Economic Area under the following names:

Information intended exclusively for medical professionals:

The full Product Information leaflet for Radelumin is included in the product packaging as a separate document, providing additional scientific and practical information for medical professionals on the administration and use of this radiopharmaceutical. See the Product Information leaflet.