Patient leaflet - Illuccix 25 micrograms kit for Radiopharmaceutical Preparation

1. What Illuccix is and what it is used for

What Illuccix is

This medicine is a radiopharmaceutical product for diagnostic use only.

Illuccix contains a substance called gozetotide. Before it can be used, a pharmacist or your physician will mix the product with a radioactive substance called gallium-68 to make gallium (⁶⁸Ga) gozetotide. This procedure 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 specific types of cancer cells with a protein called prostate-specific membrane antigen (PSMA) in adults with prostate cancer. This is done:

to help detect and locate cancerous cells when recurrence of prostate cancer is suspected in patients who have received primary curative therapy.
to find out whether the patients with metastatic prostate cancer may be suitable for a specific therapy targeting the cancerous cells through the prostate-specific membrane antigen (PSMA) protein.

How Illuccix works

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

The use of gallium (⁶⁸Ga) gozetotide does involve exposure to small amounts of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical product outweights the risk due to radiation exposure.

2. What you need to know before Illuccix is used

Do not use Illuccix:

if you are allergic to gozetotide 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 Illuccix if you:

have any other type of cancer or any other non-malignant condition, as these could affect the interpretation of the image. Your nuclear medicine doctor will take into account your serum level of PSA for illuccix imaging and interpretation.

Before administration of Illuccix you should:

drink plenty of water so that you remain hydrated and urinate immediately before the PET medical imaging procedure, and as often as possible during the first hours after the 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 aged under 18 years.

Other medicines and Illuccix

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

any other medicines since they may interfere with the interpretation of the images.
furosemide or any medicinal products used to increase urination.

Pregnancy and breast-feeding

This medicine is not for use in women.

Driving and using machines

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

Illuccix contains sodium

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

3. How Illuccix is used

There are strict laws on the use, handling and disposal of radiopharmaceutical products. Illuccix will only be used in special controlled areas. This product will only be handled and given to you by people who are trained and qualified to use it safely. These persons will take special care for the safe use of this product and will keep you informed of their actions. 70 mm

The nuclear medicine doctor supervising the procedure will decide on the quantity of Illuccix to be used in your case. It will be the smallest quantity necessary to get the desired information.

The quantity to be administered usually recommended for an adult ranges from 126 to 154 MBq (megabecquerel, the unit used to express radioactivity).

Administration of Illuccix and conduct of the procedure

After radiolabelling, gallium (⁶⁸Ga) gozetotide is administered as a slow injection into a vein. You will undergo a PET scan starting 50 to 100 minutes after you have received Illuccix.

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

Duration of the procedure

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

After administration of Illuccix, you should:

continue to drink plenty of water so that you remain hydrated and urinate as often as possible to eliminate the product from your body. - avoid any close contact with young children and pregnant women for 2 hours after the injection;

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

If you have been given more Illuccix than you should

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

Should you have any further questions on the use of Illuccix, please ask the nuclear medicine doctor who supervises the procedure.

4. Possible side effects

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

The following side effects can occur:

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

temporarily increased blood level of a digestive enzyme (amylase) - constipation
feeling weak
warmth where the injection site is given

Side effects of which the frequency is not known:

pain at the injection site

This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities.

Reporting of side effects

If you get any side effects, talk to your treating physician/nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How Illuccix is stored

You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate premises. Storage of radiopharmaceuticals will be in accordance with national regulations on radioactive materials.

The following information is intended for the specialist only. - Illuccix must not be used after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. - before reconstitution, store in a refrigerator (2°C – 8°C). - store in the original packaging in order 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

What Illuccix contains

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

What Illuccix looks like and contents of the pack

Illuccix is a multidose kit for radiopharmaceutical preparation containing: - a glass vial containing a white powder;

a glass vial containing a clear and colourless solution; - an empty glass vial used to radiolabel the final medication; - label for radiolabelled product shielding.

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

TELIX PHARMACEUTICALS (UK) LIMITED

St Mary’s Court, The Broadway

Amersham

Buckinghamshire

United Kingdom

HP7 0UT

Manufacturer

TELIX INNOVATIONS S.A.

Rue de Hermée, 255

4040 Herstal

Belgium

This leaflet was last revised in 05/2026.

Other sources of information

Detailed information on this medicine is available on the website of Medicines & Healthcare products Regulatory Agency (MHRA) (https://www. gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency).

-----------------------------------------------------------------------------The following information is intended for healthcare professionals only:

The complete SmPC of Illuccix is provided as a separate document in the product package, with the objective of providing healthcare professionals with additional scientific and practical information about the administration and use of this radiopharmaceutical.

Please refer to the SmPC.

Prescription needed?	Yes, prescription-only medicine (POM)
Active substance	Gozetotide
Strength	25 micrograms
Pharmaceutical form	Kit for radiopharmaceutical preparation One vial of powder for solution for injection: the vial contains a white lyophilised powder. One vial of solvent: the vial contains a clear, colourless solution. One empty vial: the vial is sterile, vacuum sealed and used for the radiolabelling of the kit. For radiolabelling with gallium (68Ga) chloride solution. pH (after reconstitution and radiolabelling): 4.0 – 5.0
How is it taken	Intravenous
Excipients	Powder for solution for injection, D-Mannose, Solvent, Water for injections, Sodium acetate anhydrous, Hydrochloric acid
Pack sizes	1 kit
Is it available?	Listed as available (NHS Dictionary of Medicines and Devices – not a record of current supplies)
Shelf life	Kit: 2 years. After radiolabelling: 2 hours. Do not store above 25 °C nor freeze the solution after radiolabelling. From a microbiological point of view, once reconstituted and radiolabelled, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Storage	Before reconstitution, store in a refrigerator (2°C – 8°C). Store in the original package in order to protect from light. For storage conditions after reconstitution and radiolabelling of the medicinal product, see section 6.3. Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.
Drug group (ATC)	Diagnostic radiopharmaceuticals, other diagnostic radiopharmaceuticals for tumour detection
Additional monitoring	Yes ▼ – new safety information is collected quickly. Report any side effect to the Yellow Card scheme.
Marketing authorisation	PL 57676/0001 (first authorised 12 February 2025)
Marketing authorisation holder	TELIX PHARMACEUTICALS (UK) LIMITED

Illuccix 25 micrograms kit for radiopharmaceutical preparation – patient leaflet, side effects, dosage