Prospect: information for the patient

Radelumin 1300MBq/ml injectable solution

PSMA-1007 (18F)

This medication 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 medication is administered to you, as 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 Radelumin is and for what it is 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 determine 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 their disease to their doctor and nuclear medicine physician.

The doctor who ordered the PET will inform them of the results.

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

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

Do not use Radelumin

-if you are allergic to PSMA-1007 (18F) or 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 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 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 machines

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

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 guidelines for 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 who will use it safely. These 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 a 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 need to take any other special precautions after receiving the medication. Ask your nuclear physician if you have any doubts.

If you are administered too much Radelumin

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 exams. These measures will vary from patient to patient depending on their clinical status and the degree of overdose and may be limited to simple follow-up.

If you have any other questions 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.

As of the current 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 1300MBq 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 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 1300MBq/mL injectable solution, vial of 10mL: Each multidose vial contains 0.3 to 10mL of solution, corresponding to 390-13000MBq at the date and time of calibration (Cal.).

Radelumin 1300MBq/mL injectable solution, vial of 15mL: Each multidose vial contains 0.3 to 15mL of solution, corresponding to 390-19500MBq at the date and time of calibration (Cal.).

Radelumin 1300MBq/mL injectable solution, vial of 20mL: Each multidose vial contains 0.3 to 20mL of solution, corresponding to 390-26000MBq at the date and time of calibration (Cal.).

Package size: 1 vial.

Only some package sizes may be commercially available.

Marketing Authorization Holder:

ABX advanced biochemical compounds GmbH

Heinrich-Glaeser-Str.10-14

01454 Radeberg

Germany

Responsible for manufacture:

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

Synektik Pharma Sp. z o.o.

ul. Szaserów 128

04-141 Warszawa

Poland

ABX GmbH

Heinrich-Glaeser-Str. 10-14

01454 Radeberg

Germany

Radboud Translational Medicine B.V.

Geert Grooteplein 21, route 142, 6525 EZ

Nijmegen

Netherlands

Synektik Pharma Sp. z o.o.

ul. Artwinskiego 3

25-734 Kielce

Poland

Synektik Pharma Sp. z o.o.

ul. Keramzytowa 16

96-320 Mszczonów

Poland

MVZ – DTZ 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

Local Representative:

Institut 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:June 2024.

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This information is intended solely for healthcare professionals:

The complete technical dossier of 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 dossier.