Radelumin 2000 Mbq/ml

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: Information for the patient

Radelumin 2000 MBq/ml, solution for injection

PSMA-1007 (F) solution for injection
This medicinal product is subject to additional monitoring. This will allow for quick identification of new safety information. The user of the medicinal product can also help by reporting any adverse reactions that occur after taking the medicinal product. To find out how to report adverse reactions, see section 4.

You should carefully read the contents of the leaflet before taking the medicinal product, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any questions, you should consult a nuclear medicine doctor who will be supervising the procedure.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or nuclear medicine doctor. See section 4.

Table of contents of the leaflet

• 1. What is Radelumin and what is it used for
• 2. Important information before taking Radelumin
• 3. How to take Radelumin
• 4. Possible adverse reactions
• 5. How to store Radelumin
• 6. Contents of the packaging and other information

1. What is Radelumin and what is it used for

This medicinal product is a radiopharmaceutical product intended solely for diagnostic purposes.
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 adults with prostate cancer. The purpose of this procedure is:

• to determine whether prostate cancer has spread to the lymph nodes and other tissues outside the prostate before starting treatment with the intention of curing the disease (e.g., surgery to remove the prostate, radiation therapy)
• to identify cancer cells in cases where prostate cancer is suspected to have recurred in patients who have received initial treatment with the intention of curing the disease. After administering Fluoro-PSMA-1007 (F) to the patient, it binds to cells that have PSMA on their surface, making them visible to the nuclear medicine doctor during the medical imaging procedure. This provides valuable information about the patient's disease.

The doctor who ordered the PET scan will inform the patient about the results of the examination.
Taking Radelumin results in exposure to small doses of radiation. The doctor and nuclear medicine doctor have evaluated that the benefits of this examination using a radiopharmaceutical product outweigh the risk of radiation exposure.
The administration of this medicinal product should be carried out by a doctor specializing in nuclear medicine.

2. Important information before taking Radelumin

Radelumin should not be taken:

• if the patient is 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, the patient should discuss this with their nuclear medicine doctor if they:

• have kidney or liver problems
• are on a low-sodium diet or are dependent on 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

The patient should inform their nuclear medicine doctor about all medicinal products they are currently taking or have recently taken, as well as any medicinal products they plan to take, as they may affect the interpretation of the imaging results.

Pregnancy and breastfeeding

This medicinal product is not indicated for use in women.

Driving and using machines

It is unlikely that Radelumin will affect the patient's ability to drive or use machines.

Radelumin contains sodium, potassium, and ethanol

The medicinal product 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 intake of sodium in the diet for adults.
The medicinal product contains up to 1 mg of potassium per dose, which is less than 1 mmol per dose, making it a "potassium-free" medicinal product.
The medicinal product contains up to 80 mg of alcohol (ethanol) per milliliter (ml), which corresponds to 800 mg per dose (8% m/v). The amount of alcohol in a 10 ml dose of this medicinal product is equivalent to less than 20 ml of beer or 8 ml of wine.

3. How to take Radelumin

There are strict regulations regarding the use, handling, and disposal of radiopharmaceutical products.
Radelumin will only be administered in specially controlled areas. This medicinal product will be prepared and administered only by trained and qualified personnel in the safe use of this medicinal product. 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 doctor 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 usual dose administered to an adult is 3.6-4.4 MBq per kilogram of body weight (MBq is the abbreviation for megabecquerel and corresponds to a multiple of the unit used to express radioactivity - 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 injection into a vein.
Usually, one injection is sufficient to perform the necessary imaging examination.

Duration of the examination

The nuclear medicine doctor will inform the patient about the typical duration of the examination. The PET scan usually starts about 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 small children and pregnant women

The nuclear medicine doctor will inform the patient if any other special precautions need to be taken after administration of this medicinal product. If the patient has any questions, they should consult their nuclear medicine doctor.

Overdose of Radelumin

Overdose is unlikely, as Radelumin is administered only in a single dose, the radioactivity of which is precisely determined by the nuclear medicine doctor performing the examination.
However, in the event of an overdose, the nuclear medicine doctor performing the examination will take the necessary steps to ensure that the patient's exposure to radiation remains at a level generally accepted in nuclear medicine diagnostics or radiological examinations.
These measures will vary depending on the patient's clinical condition and the degree of overdose and may be limited to simple monitoring.
If the patient has any further doubts about the use of this medicinal product, they should consult their nuclear medicine doctor.

4. Possible adverse reactions

Like all medicinal products, Radelumin can cause adverse reactions, although not everybody gets 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 cancer and congenital anomalies.

Reporting adverse reactions

If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their nuclear medicine doctor. Adverse reactions 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.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions will allow for the collection of more information on the safety of the 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 it is stored in appropriate facilities. 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 of the outer packaging after the abbreviation "EXP".

6. Contents of the packaging and other information

What Radelumin contains

• The active substance of Radelumin is Fluoro-PSMA-1007 (F).
• Each milliliter of the solution contains 2000 MBq of Fluoro-PSMA-1007 (F) at the time of the activity reference (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 what the packaging contains

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 2000 MBq/ml, solution for injection, 10 ml vial: Each multidose vial contains from 0.3 to 10 ml of solution, corresponding to 600-20,000 MBq at the time of the activity reference (ART).
Radelumin 2000 MBq/ml, solution for injection, 15 ml vial: Each multidose vial contains from 0.3 to 15 ml of solution, corresponding to 600-30,000 MBq at the time of the activity reference (ART).
Radelumin 2000 MBq/ml, solution for injection, 20 ml vial: Each multidose vial contains from 0.3 to 20 ml of solution, corresponding to 600-40,000 MBq at the time of the activity reference (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: [email protected]

Manufacturer:

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

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 other additional scientific and practical information regarding the administration and use of this radiopharmaceutical product. See Summary of Product Characteristics.