Prospect: information for the patient

Radelumin 2000MBq/ml injectable solution

PSMA-1007 (18F)

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section4 includes information on how to report these adverse effects.

Read this prospect thoroughly before this medicine is administered to you, because it contains important information for you.

-Keep this prospect, as you may need to refer to it again.

-If you have any questions, consult your doctor or the nuclear medicine physician overseeing the procedure.

-If you experience adverse effects, consult your doctor or the nuclear medicine physician, even if they are not listed in this prospect. See section4.

1.What is Radelumin and how is it used

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

3.How to use Radelumin

4.Possible adverse effects

5.Storage of Radelumin

6.Contents of the package and additional information

This medication 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 with a protein called prostate-specific membrane antigen (PSMA) in adults with prostate cancer. This is done:

-to find out if prostate cancer has spread to lymph nodes and other tissues outside the prostate before initial curative therapy (e.g., surgical removal of the prostate, radiation therapy)

-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 with PSMA on their surface and makes them visible to the nuclear medicine physician during the PET imaging procedure. This provides valuable information about the patient's disease to their physician and nuclear medicine physician.

The physician who ordered the PET will inform the patient of the results.

The use of Radelumin involves exposure to small amounts of radioactivity. The patient's physician and nuclear medicine physician have considered that the benefit of this procedure with the radiopharmaceutical outweighs the risk of radiation exposure.

This medication should be administered under the responsibility of a physician with specialized training in nuclear medicine.

Do not use Radelumin

-if you are allergic to PSMA-1007 (18F) or to any of the other components of this medication (listed in section6).

Warnings and precautions

Consult with your nuclear medicine doctor before receiving Radelumin if you:

-have kidney or liver problems.

-are on a low-sodium diet or suffer from 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 18years.

Other medications and Radelumin

Inform your nuclear medicine doctor if you are taking, have taken recently, or may need to take any other medication, as they may interfere with image interpretation.

Pregnancy and breastfeeding

This medication is not indicated for use in women.

Driving and operating machinery

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

Radelumin contains sodium, potassium, and ethanol

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

This medication contains up to 1mg of potassium per dose, which is less than 1mmol per dose; essentially «potassium-free».

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

There are strict norms regarding the use, handling, and disposal of radioactive medications.

Radelumin will only be used in specially controlled areas. This medication will only be handled and administered by trained and qualified personnel to use it safely. Those individuals will take special care in the safe use of this medication and will inform you of their actions.

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

The generally recommended dose for 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 an adult weighing 70 kg, 252-308 MBq will be administered.

Administration of Radelumin and procedure performance

Radelumin is administered intravenously in the form of an injection into the vein.

One injection is sufficient to carry out the study your doctor needs.

Procedure duration

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

After Radelumin administration

-Avoid all direct contact with small children and pregnant women during the 12 hours following the injection.

Your nuclear physician will inform you if you should take any other special precautions after receiving the medication. Ask your nuclear physician if you have any doubts.

If you are administered more Radelumin than necessary

It is unlikely that an overdose will occur because you will only receive one Radelumin injection, whose radioactivity has been precisely determined by the nuclear physician in charge of your examination.

However, if an overdose were to occur, the nuclear physician in charge of your examination will take the necessary measures to ensure that your body's exposure to radiation remains at a generally accepted level for nuclear medicine or radiology diagnostic examinations. These measures will vary from patient to patient depending on the clinical condition and the degree of the overdose and may be limited to simple follow-up.

If you have any other doubts about the use of this medication, ask the nuclear physician overseeing the procedure.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

To date, no adverse effects have been reported.

The administration of this radiopharmaceutical involves receiving small amounts of ionizing radiation with a low risk of developing cancer and hereditary defects.

Reporting Adverse Effects

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

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

This medication does not need to be stored by the patient. This medication is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended exclusively for the specialist:

Radelumin should not be used after the expiration date indicated on the label of the sealed container after CAD.

Composition of Radelumin

-The active principle is PSMA-1007 (18F).

-Each milliliter of solution contains 2000MBq of PSMA-1007 (18F) at the time and date of calibration (Cal.).

-The other components are disodium phosphate, dihydrogen potassium phosphate, sodium chloride, potassium chloride, sodium ascorbate, anhydrous ethanol, and water for injection (see section2 "Radelumin contains sodium, potassium, and ethanol").

Appearance of Radelumin and contents of the package

No need to obtain this medication or manipulate the package or vial; the following is only for your information.

Radelumin is a transparent, colorless, or slightly yellowish solution, preserved in a glass vial.

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

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

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

Package size: 1 vial.

Only some package sizes may be marketed.

Marketing Authorization Holder:

ABX advanced biochemical compounds GmbH

Heinrich-Glaeser-Str.10-14

01454 Radeberg

Germany

Manufacturer:Responsible

IRAB S.L.

Dr. Aiguader 88, planta-I

08003 Barcelona

Spain

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

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

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

Local Representative

Institud de Radiofarmacia Aplicada de Barcelona (IRAB)

C/ Doctor Aiguader 88 planta -1, 08003 Barcelona

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

Last review date of this leaflet: February 2025.

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This information is intended solely for healthcare professionals:

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