Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Locametz 25 micrograms kit for radiopharmaceutical preparation
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Gozetotide may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
This medicine is a radiopharmaceutical product for diagnostic use only. Locametz contains a substance called gozetotide. Before use, gozetotide (the powder in the vial) is mixed with a radioactive substance called gallium-68 to make gallium (68Ga) gozetotide solution (this procedure is called radiolabelling). After radiolabelling, gallium (68Ga) gozetotide is used in adult patients to identify prostate cancer lesions that express a protein called prostate-specific membrane antigen (PSMA). By binding to cells that express PSMA, gallium (68Ga) gozetotide makes these parts of the body visible to doctors during a medical imaging procedure called positron emission tomography (PET). The images of your organs obtained with PET allow your doctor to locate abnormal cells or tumours, giving valuable information about your disease. The use of Locametz involves exposure to a small amount 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. If you have any questions about how Locametz works or why this medicine has been prescribed for you, ask your nuclear medicine doctor. 2.
What you need to know before Locametz is used
Locametz must not be used if you are allergic to gozetotide or any of the other ingredients of this medicine (listed in section 6). 1
Warnings and precautions Talk to your nuclear medicine doctor before you receive Locametz 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 Locametz imaging and interpretation. The use of Locametz involves exposure to a small amount of radioactivity. Long-term cumulative radiation exposure contributes to an increased risk of cancer. Your nuclear medicine doctor will explain the necessary radioprotection measures to you (see section 3). Before administration of Locametz you should Drink plenty of water in order to urinate immediately before and as often as possible during the first hours after the examination, in order to eliminate the radiopharmaceutical product from your body. Children and adolescents This medicine should not be given to children or adolescents aged under 18 years because no data are available in this age group. Pregnancy and breast-feeding Locametz is not intended for use in women. All radiopharmaceuticals, including Locametz, have the potential to cause harm to an unborn baby. Driving and using machines It is considered unlikely that Locametz will affect your ability to drive or to use machines. Locametz contains sodium This medicine contains 28.97 mg sodium (main component of cooking/table salt) in each injection. This is equivalent to 1.5% of the recommended maximum daily dietary intake of sodium for an adult. 3.
How to take it
There are strict laws on the use, handling and disposal of radiopharmaceutical products. Locametz will only be used in special controlled areas. This radiopharmaceutical 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 radiopharmaceutical product and will keep you informed of their actions. The nuclear medicine doctor supervising the procedure will decide on the quantity of Locametz 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 is 1.8-2.2 MBq/kg of body weight, ranging from a minimum quantity of 111 MBq up to a maximum quantity of 259 MBq (MBq, megabecquerel, the unit used to express radioactivity). Administration of Locametz and conduct of the procedure After radiolabelling, Locametz is administered by slow intravenous injection. One injection is sufficient to conduct the test that your nuclear medicine doctor needs. You will undergo a PET scan starting 50 to 100 minutes after Locametz administration. Duration of the procedure Your nuclear medicine doctor will inform you about the usual duration of the procedure. After administration of Locametz, you should: drink plenty of water to urinate frequently during the first hours after the examination, in order to eliminate the radiopharmaceutical product from your body.
2
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 Locametz than you should An overdose is unlikely because you will only receive a single dose of Locametz precisely controlled by the nuclear medicine doctor supervising the procedure. However, in the event 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 question on the use of Locametz, 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. Some side effects could be serious
Possible side effects
include the following listed below. If these side effects become serious, tell your nuclear medicine doctor immediately. Common (may affect up to 1 in every 10 people) tiredness (fatigue) Uncommon (may affect up to 1 in every 100 people) nausea constipation vomiting diarrhoea dry mouth a reaction at the site where an injection was given, which may cause some redness, swelling and warmth (injection site reactions) chills This radiopharmaceutical product 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 at: 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 Locametz 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 radiopharmaceutical products 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 after EXP. The expiry date refers to the last day of that month. Before reconstitution, store below 25°C. 3
After reconstitution, store upright below 30°C. Use within 6 hours. 6.
Contents of the pack and other information
What Locametz contains Locametz contains gozetotide. One vial contains 25 micrograms of gozetotide. The other ingredients are: gentisic acid, sodium acetate trihydrate and sodium chloride. See "Locametz contains sodium" in section°2. What Locametz looks like and contents of the pack Locametz is a multidose kit for radiopharmaceutical preparation. It is supplied as one glass vial containing a white freeze-dried powder . For radiolabelling with gallium-68 chloride solution. Gallium-68 is not part of the kit. After reconstitution and radiolabelling, Locametz contains a sterile solution for injection of gallium (68Ga) gozetotide at an activity of up to 1,369 MBq. After reconstitution, the solution obtained also contains hydrochloric acid. Pack size: 1 vial. Marketing Authorisation Holder Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ United Kingdom Manufacturer Advanced Accelerator Applications (Italy) S.R.L. Via Crescentino snc 13040 Saluggia (VC) Italy This leaflet was last revised in March 2024. ———————————————————————————————————————–The following information is intended for healthcare professionals only: The complete SmPC of Locametz 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.
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Frequently asked questions about Locametz 25 micrograms kit for radiopharmaceutical preparation
What is the active substance in Locametz 25 micrograms kit for radiopharmaceutical preparation?
The active substance in Locametz 25 micrograms kit for radiopharmaceutical preparation is gozetotide.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Locametz 25 micrograms kit for radiopharmaceutical preparation, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Locametz 25 micrograms kit for radiopharmaceutical preparation without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: gozetotide
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
This medicinal product is for diagnostic use only.
Locametz, after radiolabelling with gallium-68, is a radioactive diagnostic agent indicated for the identification of prostate-specific membrane antigen (PSMA)-positive lesions by positron emission tomography (PET) in adult patients with prostate cancer.
4.2. Posology and method of administration
This medicinal product should only be administered by trained healthcare professionals with technical expertise in using and handling nuclear medicine imaging agents and only in a designated nuclear medicine facility.
Posology
The recommended dose of gallium (68Ga) gozetotide is 1.8-2.2 MBq/kg of body weight, with a minimum dose of 111 MBq up to a maximum dose of 259 MBq.
Special populations
Elderly
No dose adjustment is required in patients aged 65 years and above (see section 5.2).
Renal impairment / Hepatic impairment
No dose adjustment is required in patients with renal or hepatic impairment (see section 5.2).
Paediatric population
There is no relevant use of Locametz in the paediatric population for the identification of PSMA-positive lesions in prostate cancer.
Method of administration
This medicinal product is for intravenous and multidose use. It should be reconstituted before administration to the patient.
After reconstitution, gallium (68Ga) gozetotide solution should be administered by slow intravenous injection, in order to avoid local extravasation resulting in inadvertent radiation exposure to the patient and imaging artefacts. Accidental extravasation may cause local irritation, due to the acidic pH of the solution. Cases of extravasation should be managed as per institutional guidelines.
The total radioactivity in the syringe should be verified with a dose calibrator immediately before and after administration to the patient. The dose calibrator must be calibrated and comply with international standards (see section 12).
For patient preparation, see section 4.4.
For instructions on reconstitution of the medicinal product before administration, see section 12.
Image acquisition
Gallium (68Ga) gozetotide PET image acquisition should be performed by scanning the whole body starting at mid-thigh and proceeding to skull base. PET images should be acquired 50 to 100 minutes after the intravenous administration of gallium (68Ga) gozetotide solution.
Image acquisition start time and duration should be adapted to the equipment used, the patient and the tumour characteristics, in order to obtain the best image quality possible.
4.3. Contraindications
Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to any of the components of the labelled radiopharmaceutical.
4.4. Special warnings and precautions for use
Individual benefit/risk justification
For each patient, the radiation exposure must be justifiable by the likely benefit. The activity administered should in every case be as low as reasonably achievable to obtain the required diagnostic information.
Radiation risk
Gallium (68Ga) gozetotide contributes to the patient's overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling and reconstitution procedures should be ensured to protect patients and healthcare professionals from unintentional radiation exposure (see sections 6.6 and 12).
Interpretation of gallium (68Ga) gozetotide images
Gallium (68Ga) gozetotide binds to PSMA on the surface of PSMA-expressing cells. Based on the intensity of the signals, PET images obtained with gallium (68Ga) gozetotide indicate the presence of PSMA protein in tissues.
While the uptake of gallium (68Ga) gozetotide reflects the levels of PSMA expression in prostate cancer, gallium (68Ga) gozetotide uptake is not specific to prostate cancer and may occur in other types of cancers, non-malignant processes and normal tissues.
Interpretation of gallium (68Ga) gozetotide PET imaging findings in the context of histopathology and/or other diagnostic procedures is recommended. The diagnostic performance of gallium (68Ga) gozetotide may be affected by serum PSA levels (see section 5.1).
Patient preparation
Patients should be well hydrated prior to gallium (68Ga) gozetotide administration and should be advised to void immediately prior to and frequently during the first hours after image acquisition in order to reduce radiation exposure.
Specific warnings
Sodium content
This medicinal product contains 28.97 mg sodium per injection, equivalent to 1.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
4.5. Interaction with other medicinal products and other forms of interaction
Based on in vitro interaction studies, gallium (68Ga) gozetotide is not expected to have any clinically significant interaction with other medicinal products (see section 5.2). No clinical drug interaction studies were required.
4.6. Fertility, pregnancy and lactation
Pregnancy
Locametz is not indicated for use in females. There are no data on the use of gallium (68Ga) gozetotide in females. Reproductive toxicity studies in animals have not been conducted with gallium (68Ga) gozetotide. However, all radiopharmaceuticals, including gallium (68Ga) gozetotide, have the potential to cause foetal harm.
Breast-feeding
Locametz is not indicated for use in females. There are no data on the effects of gallium (68Ga) gozetotide on the breast-fed newborn/infant or on milk production. Lactation studies have not been conducted in animals with gallium (68Ga) gozetotide.
Fertility
There are no data on the effect of gallium (68Ga) gozetotide on human fertility.
4.7. Effects on ability to drive and use machines
Gallium (68Ga) gozetotide has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of safety profile
Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. As the effective dose is 0.0166 mSv/MBq, with a maximal recommended dose of 259 MBq (4.3 mSv), these adverse reactions are expected to occur with a low probability.
The safety profile of gallium (68Ga) gozetotide was evaluated in 1 003 patients receiving gallium (68Ga) gozetotide at median dose per body weight of 1.9 MBq/kg (range: 0.9-3.7 MBq/kg). Patients underwent PET/CT imaging to establish their eligibility for the VISION clinical study, based on the PSMA expression of their prostate cancer lesions. Gallium (68Ga) gozetotide was concomitantly administered with physician's discretion for best standard of care.
Mild to moderate adverse reactions occurred in patients receiving gallium (68Ga) gozetotide, with the exception of a grade 3 fatigue event (0.1%). No serious adverse reactions occurred in patients receiving gallium (68Ga) gozetotide.
The most common adverse reactions of any grade (incidence ≥0.5%) are fatigue (1.2%), nausea (0.8%), constipation (0.5%) and vomiting (0.5%).
The adverse reactions of any grade in patients receiving gallium (68Ga) gozetotide are shown in Table 1.
Tabulated list of adverse reactions
Adverse reactions (Table 1) are listed by MedDRA system organ class. Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse reaction is based on the following convention (CIOMS III): very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Table 1 Adverse reactions observed with gallium (68Ga) gozetotide in the VISION clinical study
System organ class
Frequency category
Adverse reaction
Gastrointestinal disorders
Uncommon
Nausea
Uncommon
Constipation
Uncommon
Vomiting
Uncommon
Diarrhoea
Uncommon
Dry mouth
General disorders and administration site conditions
Common
Fatigue
Uncommon
Injection site reactions1
Uncommon
Chills
1 Injection site reactions includes: injection site haematoma, injection site warmth
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
In the event of administration of a radiation overdose with gallium (68Ga) gozetotide, the radiation absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by hydration and frequent bladder voiding. It might be helpful to estimate the effective radiation dose that was applied.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- LOCAMETZ 25 micrograme prescriptionGOZETOTIDUM
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- LocametzGozetotidum
- PSMAtraceGozetotidum
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Locametz 25 micrograms kit for radiopharmaceutical preparation. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.