Locametz 25 micrograms kit for radiopharmaceutical preparation
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Locametz 25 micrograms, kit for radiopharmaceutical preparation
gozetotida
This medicinal product is subject to additional monitoring, which will allow rapid identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is provided at the end of section 4.
Read this entire leaflet carefully before you are administered 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 side effects, consult your nuclear medicine physician, even if they are side effects not listed in this leaflet.
Leaflet contents:
- What Locametz is and what it is used for
- What you need to know before you are administered Locametz
- How Locametz is administered
- Possible side effects
- Storage of Locametz
- Contents of the pack and other information
1. What Locametz is and what it is used for
What Locametz is
This medicine is a radiopharmaceutical for diagnostic use only.
Locametz contains a substance called gozetotide. Before it can be used, gozetotide (the powder in the vial) is combined with a radioactive substance called gallium-68 to produce a solution of gallium (68Ga)-gozetotide (this process is known as radiolabelling).
What Locametz is used for
After radiolabelling with gallium-68, Locametz is used in a medical imaging procedure called positron emission tomography (PET) to detect certain types of cancer cells expressing a protein called prostate-specific membrane antigen (PSMA) in adults with prostate cancer. This is performed:
- to determine whether prostate cancer has spread to lymph nodes and other tissues outside the prostate, prior to initial curative therapy (e.g., therapy involving surgical removal of the prostate, radiotherapy)
- to identify cancer cells when there is suspicion of prostate cancer recurrence in patients who have received initial curative therapy
- to determine whether patients with metastatic castration-resistant prostate cancer may be suitable candidates for PSMA-targeted therapy
How Locametz works
When administered to the patient, gallium (68Ga)-gozetotide binds to cancer cells that express 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 physician and nuclear medicine specialist.
The use of gallium (68Ga)-gozetotide involves exposure to radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will derive from the radiopharmaceutical procedure outweighs the radiation risk.
If you have any questions about how Locametz works or why it has been prescribed for you, consult your nuclear medicine physician.
2. What you need to know before you are given Locametz
Do not be given Locametz
- if you are allergic to gozetotide or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before receiving Locametz, speak with your nuclear medicine physician if you have any other type of cancer, as this may affect the interpretation of the images.
The use of Locametz involves exposure to small amounts of radioactivity. Repeated exposure to radiation may increase the risk of cancer. Your nuclear medicine physician will explain the necessary radiation protection measures to you (see section 3).
Before administration of Locametz you should
- Drink plenty of water to stay hydrated and urinate immediately before starting the PET imaging procedure, and as frequently as possible during the first hours after administration.
Children and adolescents
This medicine should not be given to children or adolescents under 18 years of age, as there are no available data in this age group.
Pregnancy and breastfeeding
Locametz is not indicated for use in women. All radiopharmaceuticals, including Locametz, have the potential to cause harm to the fetus.
Driving and using machines
Locametz is unlikely to affect your ability to drive or operate machinery.
Locametz contains sodium
This medicine contains 28.97 mg of sodium (the main component of table/cooking salt) in each injection. This corresponds to 1.5% of the maximum daily recommended sodium intake for an adult.
3. How Locametz is administered
There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Locametz will only be used in specially controlled areas. This radiopharmaceutical will only be handled and administered by trained and qualified personnel competent in its safe use. These individuals will take particular care in the safe use of this radiopharmaceutical and will inform you about their actions.
The nuclear medicine physician supervising the procedure will decide the amount of Locametz to be used in your case. This will be the minimum amount necessary to obtain the required information.
The recommended administered dose for an adult is 1.8–2.2 MBq (megabecquerels, the unit used to express radioactivity) per kg of body weight, with a minimum dose of 111 MBq and a maximum dose of 259 MBq.
Administration of Locametz and performance of the procedure
After reconstitution and radiolabelling, Locametz is administered as a slow intravenous injection. A PET scan will be performed between 50 and 100 minutes after you have received Locametz.
Duration of the procedure
Your nuclear medicine physician will inform you about the usual duration of the procedure.
After administration of Locametz, you should
- Continue drinking plenty of fluids to stay hydrated and urinate as frequently as possible to help eliminate the radiopharmaceutical from your body.
The nuclear medicine physician will inform you if you need to take any special precautions after receiving this medicine. Consult your nuclear medicine physician if you have any doubts.
If you have been given more Locametz than you should
An overdose of Locametz is unlikely because you will receive only a single dose, precisely controlled by the nuclear medicine physician supervising the procedure. However, in the event of an overdose, appropriate treatment will be given. 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 Locametz, ask the nuclear medicine physician supervising the procedure.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everybody experiences them.
The adverse effects include the following listed below. If these adverse effects become severe, inform your nuclear medicine physician.
Frequent (may affect up to 1 in 10 people)
- fatigue (tiredness)
Uncommon (may affect up to 1 in 100 people)
- nausea
- constipation
- vomiting
- diarrhoea
- dry mouth
- reactions at the injection site, such as bruising, itching, and warmth
- chills
This radiopharmaceutical product emits low amounts of ionizing radiation associated with a minimal risk of cancer and hereditary abnormalities.
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 national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Locametz
This medicinal product does not require storage by the patient. It 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:
- Locametz must not be used after the expiry date stated on the container and label after EXP. The expiry date refers to the last day of the month indicated.
- Before reconstitution, store below 25°C.
- After reconstitution and radiolabelling, store in an upright position below 30°C. Use within 6 hours.
6. Contents of the pack and other information
Composition of Locametz
- The active substance is gozetotide. One vial contains 25 micrograms of gozetotide. The other components are: gentisic acid, sodium acetate trihydrate and sodium chloride (see “Locametz contains sodium” in section 2).
Appearance of Locametz and contents of the pack
Locametz is a multidose reagent kit for radiopharmaceutical preparation containing a vial of white lyophilized powder (powder for injectable solution).
Gallium-68 is not part of the reagent kit.
After reconstitution and radiolabelling, Locametz contains a sterile injectable solution of gallium (68Ga)-gozetotide with an activity of up to 1,369 MBq.
After reconstitution, the injectable solution of gallium (68Ga)-gozetotide also contains hydrochloric acid.
Pack size: 1 vial.
Marketing Authorization Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Manufacturer responsible
Advanced Accelerator Applications (Italy) S.R.L.
Via Crescentino snc
13040 Saluggia (VC)
Italy
More information about this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:
Belgium/Belgium/Belgium Novartis Pharma N.V. Tel/Tel: +32 2 246 16 11 | Lithuania SIA Novartis Baltics Lithuania branch Tel: +370 5 269 16 50 |
| Luxembourg/Luxembourg Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11 |
Czech Republic Novartis s.r.o. Tel: +420 225 775 111 | Hungary Novartis Hungária Kft. Tel.: +36 1 457 65 00 |
Denmark Novartis Sverige AB Tel: +46 8 732 32 00 | Malta Novartis Pharma Services Inc. Tel: +356 2122 2872 |
Germany Novartis Pharma GmbH Tel: +49 911 273 0 | Netherlands Novartis Pharma B.V. Tel: +31 88 04 52 111 |
Estonia SIA Novartis Baltics Estonia branch Tel: +372 66 30 810 | Norway Novartis Sverige AB Tlf: +46 8 732 32 00 |
Greece BIOKOSMOS S.A. Tel: +30 22920 63900 or Novartis (Hellas) S.A. Tel: +30 210 281 17 12 | Austria Novartis Pharma GmbH Tel: +43 1 86 6570 |
Spain Novartis Farmacéutica, S.A. Tel: +34 93 306 42 0 | Poland Advanced Accelerator Applications Polska Sp. z o.o. Tel.: +48 22 275 56 47 |
France Advanced Accelerator Applications Tél: +33 1 55 47 63 00 | Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600 |
Croatia Novartis Hrvatska d.o.o. Tel. +385 1 6274 220 | Romania Novartis Pharma Services Romania SRL Tel: +40 21 31299 01 |
Ireland Novartis Ireland Limited Tel: +353 1 260 12 55 | Slovenia Novartis Pharma Services Inc. Tel: +386 1 300 75 50 |
Iceland Novartis Sverige AB Sími: +46 8 732 32 00 | Slovakia Novartis Slovakia s.r.o. Tel: +421 2 5542 5439 |
Italy Novartis Farma S.p.A. Tel: +39 02 96 54 1 | Finland/Finland Novartis Sverige AB Puh/Tel: +46 8 732 32 00 |
Cyprus BIOKOSMOS S.A. Tel: +30 22920 63900 or Novartis Pharma Services Inc. Tel: +357 22 690 690 | Sweden Novartis Sverige AB Tel: +46 8 732 32 00 |
Latvia SIA Novartis Baltics Tel: +371 67 887 070 |
Date of the most recent review of this leaflet
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
This information is intended for healthcare professionals only:
The full summary of product characteristics for Locametz 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.
Please consult the summary of product characteristics.