ILLUCCIX 25 MICROGRAMS RADIOPHARMACEUTICAL PREPARATION KIT

Introduction

Package Leaflet: Information for the Patient

Illuccix 25micrograms radiopharmaceutical preparation kit

gozetotida

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 nuclear medicine doctor who will be supervising the procedure.
• If you experience any side effects, talk to your doctor or nuclear medicine doctor, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Illuccix and what is it used for
2. What you need to know before you are given Illuccix
3. How Illuccix is given
4. Possible side effects
5. Storage of Illuccix
6. Package contents and further information

1. What is Illuccix and what is it used for

What is Illuccix

This medicine is a radiopharmaceutical for diagnostic use only.

Illuccix contains a substance called gozetotida. 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) gozetotida. This process is called 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 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 treatment (e.g. surgical removal of the prostate, radiotherapy).
• when it is suspected that the prostate cancer has come back, in patients with rising levels of prostate-specific antigen (PSA) in the blood who have received initial curative treatment.
• to find out if patients with metastatic castration-resistant prostate cancer may be suitable for a specific treatment called PSMA-targeted therapy.

How Illuccix works

When given to the patient, the gallium (68Ga) gozetotida binds to cancer cells that have PSMA on their surface and makes them visible to the nuclear medicine doctor during the medical imaging procedure using PET. This provides valuable information about your disease to your doctor and nuclear medicine doctor.

The use of gallium (68Ga) gozetotida involves exposure to small amounts of ionising radiation. Your doctor and nuclear medicine doctor have considered that the clinical benefit you will get from the procedure with the radiopharmaceutical outweighs the risk due to radiation exposure.

2. What you need to know before you are given Illuccix

Illuccix must not be given to you:

• if you are allergic to gozetotida or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Tell your nuclear medicine doctor before you are given Illuccix if you have kidney disease.

Before Illuccix is given to you, you must:

• drink plenty of water to stay hydrated and urinate just before starting the PET imaging procedure, and as often as possible during the first few hours after administration.

Children and adolescents

Talk to your nuclear medicine doctor if you are under 18 years old. Illuccix is not intended for use in children and adolescents under 18 years old.

Other medicines and Illuccix

Tell your nuclear medicine doctor if you are taking, have recently taken or might take:

• any other medicine, as it may interfere with the interpretation of the images.
• furosemide or other medicines to increase urine production.

Pregnancy and breastfeeding

Illuccix is not intended for use in women. All radiopharmaceuticals, including Illuccix, may cause harm to the foetus.

Driving and using machines

It is considered unlikely that Illuccix will affect your ability to drive and use machines.

Illuccix contains sodium

This medicine contains up to 42 mg of sodium (the main component of cooking/table salt) per dose. This is equivalent to 2.1% of the maximum daily intake of sodium recommended by the WHO for an adult.

3. How Illuccix is given

There are strict rules about 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 persons who will use it safely. These persons will take special care in the safe use of this radiopharmaceutical and will keep you informed of their actions.

Your nuclear medicine doctor supervising the procedure will decide the amount of Illuccix to be used in your case. This will be the minimum amount necessary to get the desired information.

The recommended amount to be administered to an adult is usually between 126 and 154 MBq (megabecquerel, the unit used to express radioactivity).

Administration of Illuccix and procedure development

After radiolabelling, gallium (68Ga) gozetotida is administered as a slow injection into a vein. You will undergo a PET scan between 50 and 100 minutes after receiving Illuccix.

A single injection is sufficient to perform the test your doctor needs.

Duration of the procedure

Your nuclear medicine doctor will inform you of the usual duration of the procedure.

After Illuccix is given to you, you must:

• continue to drink plenty of water to stay hydrated and urinate as often as possible to eliminate the radiopharmaceutical from your body.
• avoid close contact with small children and pregnant women for 2 hours after the injection.

Your nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine. Talk to your nuclear medicine doctor if you have any questions.

If you are given more Illuccix than you should

An overdose is unlikely because you will only receive a single dose of Illuccix that is precisely controlled by the nuclear medicine doctor supervising the procedure. However, in case of overdose, you will receive treatment as needed. You may be asked to drink and urinate frequently to eliminate the radiopharmaceutical from your body.

If you have any further questions on the use of Illuccix, ask your nuclear medicine doctor supervising the procedure.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur:

Rare (may affect up to 1 in 1,000 people):

• temporary increase in blood levels of a digestive enzyme (amylase)
• constipation
• feeling of weakness
• bruising, warmth or skin rash at the injection site

This radiopharmaceutical emits low levels of ionising radiation associated with a minor risk of cancer and genetic abnormalities.

Reporting of side effects

If you experience any side effects, talk to your doctor or nuclear medicine doctor, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Illuccix

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 for healthcare professionals only:

• Illuccix must not be used after the expiry date stated on the carton after EXP. The expiry date is the last day of the month shown.
• before reconstitution, store in a refrigerator (between 2°C and 8°C).
• store 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. Package contents and further information

Composition of Illuccix

• the active substance is gozetotida. One vial contains 25 micrograms of gozetotida.
• the other ingredients are: D-mannose, hydrochloric acid, sodium acetate anhydrous and water for injections.

Appearance and package contents of Illuccix

Illuccix is a multidose radiopharmaceutical preparation kit that contains:

• a glass vial containing a white powder;
• a glass vial containing a clear and colourless solution;
• a glass vial used for the radiolabelling of the final medicine;
• a label for the shielding of radiolabelled products.

The radioactive substance is not part of the preparation kit and must be added during the preparation stages before injection.

Marketing authorisation holder and manufacturer

TELIX INNOVATIONS S.A.

Rue de Hermée, 255

4040 Herstal

Belgium

This medicine is authorised in the Member States of the European Economic Area 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 last revision of this leaflet:January 2025

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/)

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This information is intended for healthcare professionals only:

The full summary of product characteristics of Illuccix is included as a separate document in the product packaging, with the aim of providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Refer to the summary of product characteristics.