Patient leaflet - Isoprotrace 10 micrograms kit for Radiopharmaceutical Preparation
1. What Isoprotrace is and what it is used for
This medicine is a radiopharmaceutical product for diagnostic use only.
It contains the substance gozetotide. Before it can be used, the powder in the vial is mixed with a radioactive substance called gallium (68Ga) chloride to make gallium (68Ga) gozetotide (this procedure is called radiolabelling).
After radiolabelling with gallium (68Ga), Isoprotrace is used in a special type of scan called a positron emission tomography (PET) scan to detect specific types of cancer cells with a protein called prostate-specific membrane antigen (PSMA) in patients:
- with prostate cancer who are at high risk of the disease spreading to other parts of the body and who are suitable for treatment which can cure the cancer
- who have received previous treatment for prostate cancer and in whom the cancer is suspected to have returned based on the results from other tests (e.g., prostate specific antigen, PSA).
The use of Isoprotrace involves 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 outweighs the risk due to radiation.
2. What you need to know before you use Isoprotrace
Isoprotrace must not be used
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 Isoprotrace if you have any other type of cancer or any other non-malignant condition, as these could affect the interpretation of the image, or if you have a kidney disease.
Before administration of Isoprotrace
You should drink plenty of water before the start of the examination in order to urinate as often as possible during the first hours after the study to ensure that Isoprotrace is removed as quickly as possible from your body.
Children and adolescents
Isoprotrace is not intended for use in children and adolescents under 18 years of age. Safety and efficacy of gallium (68Ga) gozetotide have not been established in this patient population.
Pregnancy and breast-feeding
Isoprotrace is not intended for use in women. All radiopharmaceuticals, including Isoprotrace, have the potential to cause harm to an unborn baby.
Driving and using machines
It is considered unlikely that Isoprotrace will affect your ability to drive or to use machines.
Isoprotrace contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.
3. How Isoprotrace is used
There are strict laws on the use, handling and disposal of radiopharmaceutical products.
Isoprotrace 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.
The nuclear medicine doctor supervising the procedure will decide on the quantity of Isoprotrace 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 111 to 259 MBq (megabecquerel, the unit used to express radioactivity).
Administration of Isoprotrace and conduct of the procedure
After radiolabelling, Isoprotrace is administered by slow intravenous injection. One single injection is sufficient to perform the examination 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 Isoprotrace, you should
- continue to drink plenty of water so that you remain hydrated and urinate as often as possible to eliminate the medicine from your body
- avoid any close contact with young children and pregnant women for the first 6 hours following 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 Isoprotrace than you should
An overdose is unlikely because you will only receive a single dose of Isoprotrace precisely controlled by the nuclear medicine doctor supervising the procedure. However, in the case of an overdose, you will receive the appropriate treatment. Drinking and emptying your bladder frequently will help remove the radioactivity from your body more quickly.
Should you have any further questions on the use of Isoprotrace, 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:
Uncommon (may affect up to 1 in every 100 people):
- headache
- dizziness
- tingling and numbness of the skin
- feeling sleepy during the day or having trouble sleeping at night
- nausea
- diarrhoea
- difficulty swallowing
- rash
- tiredness
- burning, itching and 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 nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the 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 Isoprotrace 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:
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2° C – 8 °C).
After reconstitution and radiolabelling: Store upright below 25 °C and use within 4 hours.
From a microbiological point of view, unless the method of opening/radiolabelling/dilution, precludes the risk of microbiological contamination, the product should be used immediately. If not used immediately, in use storage times and conditions are the responsibility of the user.
6. Contents of the pack and other information
What Isoprotrace contains
- The active substance is gozetotide. Each vial contains 10 micrograms of gozetotide.
- The other excipients are hydrolysed gelatine, sodium acetate anhydrous and sodium chloride. See section 2 “Isoprotrace contains sodium”.
After radiolabelling, the solution obtained also contains, as excipient, hydrochloric acid.
What Isoprotrace looks like and contents of the pack
The pack consists of 5 multidose glass vials of 10 mL volume in a cardboard box. Each vial contains white or almost white powder.
The radioactive substance is not part of the kit and should be added during the preparation steps before injection.
Marketing Authorisation Holder
Billev Pharma ApS
Slotsmarken 10
2970 Hørsholm
Denmark
Manufacturer
Cilatus Manufacturing Services Limited
Pembroke House
28-32 Pembroke Street Upper
Dublin 2, D02 EK84
Ireland
This leaflet was last revised in February 2025.
---------------------------------------------------------------------------
The following information is intended for healthcare professionals only:
The complete SmPC of Isoprotrace is provided as a separate document in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Please refer to the SmPC.