RADELUMIN 1300 MBq/mL INJECTABLE SOLUTION
How to use RADELUMIN 1300 MBq/mL INJECTABLE SOLUTION
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Introduction
Package Leaflet: Information for the Patient
Radelumin 1300MBq/ml Solution for Injection
PSMA-1007 (18F)
This medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet includes information on how to report side effects.
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
- Keep this leaflet, you may need to read it again.
- If you have any further questions, ask your doctor or the nuclear medicine doctor supervising the procedure.
- If you get any side effects, talk to your doctor or the nuclear medicine doctor, even if they are not listed in this leaflet. See section 4.
Contents of the Package Leaflet
- What is Radelumin and what is it used for
- What you need to know before you are given Radelumin
- How Radelumin is given
- Possible side effects
- Storage of Radelumin
- Contents of the pack and further information
1. What is Radelumin and what is it 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 with a protein called prostate-specific membrane antigen (PSMA) in adults with prostate cancer. This is done:
- to find out if the prostate cancer has spread to the lymph nodes and other tissues outside the prostate before initial curative therapy (e.g., therapy involving surgical removal of the prostate, radiotherapy)
- to identify cancer cells when there is a suspicion of recurrence of prostate cancer in patients who have received initial curative therapy
When administered to the patient, PSMA-1007 (18F) binds to cancer cells that have PSMA on their surface and makes them visible to your nuclear medicine doctor during the PET imaging procedure. This provides valuable information about your disease to your doctor and nuclear medicine doctor.
The doctor who requested the PET scan will inform you of the results.
The use of Radelumin involves exposure to small amounts of radioactivity. Your doctor and nuclear medicine doctor have considered that the benefit of this procedure with the radiopharmaceutical outweighs the risk of your exposure to radiation.
This medicine should only be administered under the responsibility of a doctor with specialized training in nuclear medicine.
2. What you need to know before you are given Radelumin
Do not use Radelumin
- if you are allergic to PSMA-1007 (18F) or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your nuclear medicine doctor before you are given Radelumin if you:
- have kidney or liver problems.
- are on a low-sodium diet or suffer from alcohol dependence (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.
Other medicines and Radelumin
Tell your nuclear medicine doctor if you are taking, have recently taken, or might take any other medicines, as they may 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 unlikely to affect your ability to drive or use machines.
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 recommended daily intake of sodium for an adult.
This medicine contains up to 1 mg of potassium per dose, which is less than 1 mmol per dose; i.e., it is essentially "potassium-free".
This medicine contains up to 80 mg of alcohol (ethanol) per milliliter (ml), which is equivalent to 800 mg per dose (8% m/v). The amount per 10 ml dose of this medicine is equivalent to less than 20 ml of beer or 8 ml of wine.
3. How Radelumin is given
There are strict rules for 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 to use it safely. These people will take special care in the safe use of this medicine and will inform you of their actions.
The nuclear medicine doctor supervising the procedure will decide the amount of Radelumin to be used in your case. This will be the minimum amount necessary to obtain the desired information.
The recommended dose for administration to an adult is 3.6-4.4 MBq per kilogram of body weight. The MegaBecquerel (MBq) is the unit used to express radioactivity. This means that, for a 70 kg adult, 252-308 MBq will be administered.
Administration of Radelumin and performance of the procedure
Radelumin is administered intravenously in the form of an injection into the vein.
A single injection is sufficient to perform the study that your doctor needs.
Duration of the procedure
Your nuclear medicine doctor will inform you about the usual duration of the procedure. The PET scan will usually start between 90 and 120 minutes after administration of the Radelumin injection.
After administration of Radelumin
- Avoid direct contact with small children and pregnant women for 12 hours after the injection.
Your nuclear medicine doctor will inform you if you need to take any other special precautions after receiving the medicine. Ask your nuclear medicine doctor if you have any questions.
If you are given more Radelumin than you should
It is unlikely that an overdose will occur because you will only receive a single injection of Radelumin, whose radioactivity will have been precisely determined by the nuclear medicine doctor in charge of your examination.
However, if an overdose occurs, the nuclear medicine doctor in charge of your examination will take the necessary measures to ensure that your body's exposure to radiation is maintained at a level generally accepted for diagnostic nuclear medicine or radiology examinations. These measures will vary from patient to patient depending on the clinical condition and the degree of overdose and may be limited to simple monitoring.
If you have any further questions on the use of this medicine, ask the nuclear medicine doctor supervising the procedure.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
To date, no side effects have been reported.
Administration of this radiopharmaceutical involves receiving small amounts of ionizing radiation with a low risk of developing cancer and genetic disorders.
Reporting of side effects
If you experience side effects, inform your nuclear medicine doctor, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Radelumin
You will not need to store this medicine. This medicine is stored under the responsibility of the specialist in suitable facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.
The following information is intended only for the specialist:
Radelumin should not be used after the expiry date stated on the label of the lead-lined container after CAD.
6. Contents of the pack and further information
Composition of Radelumin
- The active substance is PSMA-1007 (18F).
- Each milliliter of solution contains 1300 MBq of PSMA-1007 (18F) at the time and date of calibration (Cal.).
- 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").
Appearance of Radelumin and contents of the pack
You will not need to obtain this medicine or handle the packaging or vial; the following is for your information only.
Radelumin is a clear, colorless or slightly yellowish solution, which is stored in a glass vial.
Radelumin 1300 MBq/mL solution for injection, 10 mL vial: Each multidose vial contains 0.3 to 10 mL of solution, corresponding to 390-13000 MBq at the time and date of calibration (Cal.).
Radelumin 1300 MBq/mL solution for injection, 15 mL vial: Each multidose vial contains 0.3 to 15 mL of solution, corresponding to 390-19500 MBq at the time and date of calibration (Cal.).
Radelumin 1300 MBq/mL solution for injection, 20 mL vial: Each multidose vial contains 0.3 to 20 mL of solution, corresponding to 390-26000 MBq at the time and date of calibration (Cal.).
Pack size: 1 vial.
Not all pack sizes may be marketed.
Marketing authorization 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
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
04-349 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
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Member State | Medicinal Product Name |
France | Radelumin 1300 MBq/mL solution injectable |
Belgium | Radelumin 1300 MBq/mL solution injectable / oplossing voor injectie / Injektionslösung |
Germany | Radelumin 1300 MBq/ml Injektionslösung |
Italy | Radelumin 1300 MBq/mL soluzione iniettabile |
Luxembourg | Radelumin 1300 MBq/ml |
Netherlands | Radelumin 1300 MBq/ml oplossing voor injectie |
Austria | Radelumin 1300 MBq/ml Injektionslösung |
Poland | Radelumin 1300 MBq/ml |
Portugal | Radelumin 1300 MBq/ml solução injetável |
Spain | Radelumin 1300 MBq/mL solución inyectable |
Date of last revision of this leaflet:June 2025.
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This information is intended only for healthcare professionals:
The full summary of product characteristics 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 summary of product characteristics.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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