Illuccix 25 micrograms radiopharmaceutical preparation kit
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Illuccix 25 micrograms kit for radiopharmaceutical preparation
gozetotide
Read the entire leaflet carefully before you are given this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your nuclear medicine physician who will supervise the procedure.
- If you experience any adverse reactions, consult the physician in charge of your treatment or your nuclear medicine physician, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Illuccix is and what it is used for
- What you need to know before you are given Illuccix
- How Illuccix is administered
- Possible side effects
- How to store Illuccix
- Contents of the pack and other information
1. What Illuccix is and what it is used for
What Illuccix is
This medicine is a radiopharmaceutical for diagnostic use only.
Illuccix contains a substance called gozetotide. Before it can be used, a pharmacist or your doctor will mix the medicine with a radioactive substance called gallium-68 to produce gallium (68Ga) gozetotide. This procedure is known as radiolabelling.
What Illuccix is used for
After radiolabelling with gallium-68, Illuccix is used in a medical imaging procedure called positron emission tomography (PET) to detect certain types of tumour cells that have a protein called prostate-specific membrane antigen (PSMA) in adults with prostate cancer. This is done:
- to determine whether prostate cancer has spread to lymph nodes and other tissues outside the prostate before initial curative treatment (e.g., surgical removal of the prostate, radiotherapy).
- when recurrence of prostate cancer is suspected in patients with rising levels of serum prostate-specific antigen (PSA) who have received initial curative treatment.
- to determine whether patients with metastatic castration-resistant prostate cancer may be suitable candidates for a specific treatment called PSMA-targeted therapy.
How Illuccix works
When administered to the patient, gallium (68Ga) gozetotide binds to cancer cells that have PSMA on their surface, making them visible to the nuclear medicine physician during the PET imaging procedure. This provides valuable information about your disease to your doctor and the nuclear medicine physician.
The use of gallium (68Ga) gozetotide involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will receive from the radiopharmaceutical procedure outweighs the risk due to radiation exposure.
2. What you need to know before you are given Illuccix
Do not be given Illuccix:
- if you are allergic to gozetotide or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your nuclear medicine physician before you are given Illuccix if you have kidney disease.
Before Illuccix is administered, you must:
- drink plenty of water to stay hydrated and urinate just before starting the PET imaging procedure, and as frequently as possible during the first hours after administration.
Children and adolescents
Speak with your nuclear medicine physician if you are under 18 years of age. Illuccix is not indicated for use in children and adolescents under 18 years of age.
Other medicines and Illuccix
Tell your nuclear medicine physician if you are taking, have recently taken, or might need to take:
- any other medicines, as they may interfere with the interpretation of the images.
- furosemide or other medicines to increase urine production.
Pregnancy and breastfeeding
Illuccix is not indicated for use in women. All radiopharmaceuticals, including Illuccix, can harm the unborn child.
Driving and using machines
Illuccix is considered unlikely to affect your ability to drive or operate machinery.
Illuccix contains sodium
This medicine contains up to 42 mg of sodium (a main component of table/cooking salt) per dose. This is equivalent to 2.1% of the maximum daily sodium intake recommended by the WHO for an adult.
3. How Illuccix is administered
There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Illuccix will only be used in specially controlled areas. This radiopharmaceutical will only be handled and administered by trained and qualified personnel who are skilled in its safe use. These individuals will take special care in the safe use of this radiopharmaceutical and will keep you informed of their actions.
The nuclear medicine physician supervising the procedure will determine the amount of Illuccix to be used in your case. This will be the minimum amount necessary to obtain the desired information.
The recommended administered dose for an adult is between 126 and 154 MBq (megabecquerel, the unit used to express radioactivity).
Administration of Illuccix and procedure performance
After radiolabelling, gallium (68Ga) gozetotide is administered as a slow intravenous injection. A PET scan will be performed between 50 and 100 minutes after you have received Illuccix.
A single injection is sufficient to perform the test required by your physician.
Duration of the procedure
Your nuclear medicine physician will inform you about the usual duration of the procedure.
After receiving Illuccix you should:
- continue drinking plenty of water to stay hydrated and urinate as frequently as possible to eliminate the radiopharmaceutical from your body.
- avoid close contact with young children and pregnant women for 2 hours after the injection.
The nuclear medicine physician will inform you if any special precautions are necessary after receiving this medication. Consult your nuclear medicine physician if you have any doubts.
If you have been given more Illuccix than you should
Overdose is unlikely because you will receive only a single dose of Illuccix, which is precisely controlled by the nuclear medicine physician supervising the procedure. However, in the event of an overdose, treatment will be given as necessary. You may be advised to drink fluids and urinate frequently to help eliminate the radiopharmaceutical from your body.
If you have any further questions about the use of Illuccix, ask the nuclear medicine physician supervising the procedure.
4. Possible adverse effects
Like all medicines, this medicinal product may produce adverse effects, although not everyone experiences them.
The following adverse effects may occur:
Rare (may affect up to 1 in 1,000 people):
- temporary increase in the blood level of a digestive enzyme (amylase)
- constipation
- feeling of weakness
- bruising, warmth, or skin rash at the injection site
This radiopharmaceutical emits low levels of ionizing radiation, which is associated with a minimal risk of cancer and hereditary abnormalities.
Reporting of adverse effects
If you experience any type of adverse effect, consult the doctor in charge of your treatment or your nuclear medicine physician, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish System for Pharmacovigilance of Human Medicinal Products: www.notificaRAM.es.
By reporting adverse effects, you can help provide more information on the safety of this medicinal product.
5. Storage of Illuccix
This medicinal product does not require storage by the user. Illuccix is stored under the responsibility of a specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.
The following information is intended for specialists only.
- Illuccix must not be used after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month indicated.
- Before reconstitution, store in a refrigerator (between 2°C and 8°C).
- Keep in the original packaging to protect from light.
- After reconstitution and radiolabelling, store below 25°C and use within 2 hours. Do not freeze.
6. Contents of the pack and other information
Composition of Illuccix
- The active substance is gozetotide. One vial contains 25 micrograms of gozetotide.
- The other components are: D-mannose, hydrochloric acid, anhydrous sodium acetate, and water for injections.
Appearance of the product and contents of the pack
Illuccix is a multidose reagent kit for radiopharmaceutical preparation containing:
- A glass vial containing a white powder;
- A glass vial containing a clear, colourless solution;
- An empty glass vial used for the radioactive labelling of the final medicinal product;
- A label for shielding radiolabelled products.
The radioactive substance is not part of the reagent kit and must be added during the preparation steps prior to injection.
Marketing Authorization Holder and Manufacturer
TELIX INNOVATIONS S.A.
Rue de Hermée, 255
4040 Herstal
Belgium
This medicinal product is authorized in the European Economic Area Member States under the following names:
Illuccix
Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden
Date of the most recent review of this leaflet: January 2025
Other sources of information
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)
This information is intended for healthcare professionals only:
The Summary of Product Characteristics for Illuccix is included as a separate document in the product packaging, providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
Refer to the Summary of Product Characteristics.