Isoprotrace 10 micrograms radiopharmaceutical preparation kit
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Isoprotrace 10 micrograms reagent kit for radiopharmaceutical preparation
gozetotide
Read the entire leaflet carefully before you start using 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 your nuclear medicine physician, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Isoprotrace is and what it is used for
- What you need to know before you are given Isoprotrace
- How Isoprotrace is administered
- Possible side effects
- How to store Isoprotrace
- Contents of the pack and other information
1. What Isoprotrace is and what it is used for
This medicine is a radiopharmaceutical for diagnostic use only.
It contains a substance called gozetotide. Prior to use, the powder in the vial is mixed with a radioactive substance called gallium chloride (68Ga) to produce gallium (68Ga)-gozetotide (this process is known as radiolabeling).
After radiolabeling with gallium (68Ga), Isoprotrace is used in a special type of imaging diagnostic technique called positron emission tomography (PET) to detect certain types of cancer cells that have a protein called prostate-specific membrane antigen (PSMA) in patients:
- with prostate cancer at high risk of the disease spreading to other parts of the body and who are candidates for curative treatment
- who have previously received treatment for prostate cancer and in whom recurrence of the cancer is suspected, based on results from other tests (e.g., prostate-specific antigen [PSA]).
The use of Isoprotrace involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will obtain from the radiopharmaceutical procedure outweighs the risk from radiation exposure.
2. What you need to know before you are given Isoprotrace
Do not be given Isoprotrace
- if you are allergic to gozetotide or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before starting Isoprotrace, speak with your nuclear medicine physician if you have kidney disease.
Before administration of Isoprotrace
You should drink plenty of water before starting the procedure and urinate frequently during the first hours after completion to ensure that Isoprotrace is eliminated from your body as quickly as possible.
Children and adolescents
Isoprotrace is not indicated for use in children and adolescents under 18 years of age. The safety and efficacy of gallium (68Ga) gozetotide have not been established in this patient population.
Pregnancy and breastfeeding
Isoprotrace is not indicated for use in women. All radiopharmaceuticals, including Isoprotrace, can cause harm to the fetus.
Driving and using machines
Isoprotrace is considered unlikely to affect the ability to drive or use machines.
Isoprotrace contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial; that is, essentially "sodium-free".
3. How Isoprotrace is administered
There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Isoprotrace will only be used in specially controlled areas. This product will only be handled and administered by trained and qualified personnel who are skilled in its safe use. These individuals will take particular care in the safe use of this product and will inform you of their actions.
The nuclear medicine physician supervising the procedure will determine the amount of Isoprotrace to be used in your case. This will be the minimum quantity necessary to obtain the required information.
The recommended dose usually administered to an adult is 111 to 259 MBq (megabecquerels, the unit used to express radioactivity).
Administration of Isoprotrace and performance of the procedure
After radiolabelling, Isoprotrace is administered via slow intravenous injection. 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 typical duration of the procedure.
After administration of Isoprotrace, you should
- continue drinking plenty of water to stay hydrated and urinate as frequently as possible in order to eliminate the medication from your body
- avoid direct contact with young children and pregnant women during the first 6 hours after 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 Isoprotrace than you should
An overdose is unlikely, as you will receive only a single dose of Isoprotrace, precisely controlled by the supervising nuclear medicine physician. However, if an overdose does occur, appropriate treatment will be administered. Drinking fluids and urinating frequently will help eliminate radioactivity from your body more quickly.
If you have any further questions about the use of Isoprotrace, ask the nuclear medicine physician supervising the procedure.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The following adverse effects may occur:
Uncommon (may affect up to 1 in 100 people):
- headache
- dizziness
- tingling and numbness of the skin
- daytime drowsiness or difficulty falling asleep at night
- nausea
- diarrhoea
- difficulty swallowing
- rash
- fatigue
- burning, itching, and pain at the injection site
Administration of this radiopharmaceutical involves exposure to a small amount of ionizing radiation, carrying a very low risk of developing cancer and hereditary defects.
Reporting of adverse effects
If you experience any type of adverse effect, consult 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 Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Conservation of Isoprotrace
You will not be required to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.
The following information is intended for specialists only:
Do not use this medicine after the expiry date stated on the container and label after "EXP". The expiry date refers to the last day of the month indicated.
Store in a refrigerator (2 °C – 8 °C).
After reconstitution and radiolabelling: store in an upright position below 25 °C and use within 4 hours.
From a microbiological standpoint, unless the method of opening, radiolabelling, or dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the duration and conditions of in-use storage are the responsibility of the user.
6. Contents of the pack and other information
Composition of Isoprotrace
-
The active substance is gozetotide. Each vial contains 10 micrograms of gozetotide.
-
The other excipients are: hydrolysed gelatine, anhydrous sodium acetate and sodium chloride. See section 2, “Isoprotrace contains sodium”.
After radiolabelling, the resulting solution also contains hydrochloric acid as an excipient.
Appearance of Isoprotrace and contents of the pack
The pack contains 5 multidose glass vials with a volume of 10 ml in a cardboard box. Each vial contains a white or almost white powder.
The radioactive substance is not part of the kit and must be added during the preparation steps prior to administration.
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
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
NUCLIBER, S.A.
Tel. No. +34 915062940
Date of the most recent review of this leaflet: 02/2025
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
This information is intended for healthcare professionals only:
The full Summary of Product Characteristics for Isoprotrace is included as a separate document in the product package, providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
Please consult the Summary of Product Characteristics.