Gozetotide: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: March 27, 2026🚩 Report this page

Gozetotide

Active ingredient

Sold as Locametz · ILLUCCIX

GB MHRAEU EMA

Drug class: -
Availability: See label
Markets covered: 2
Products on record: 5

Overview

Gozetotide is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	4	March 27, 2026
EU European Union	EMA	1	September 15, 2025

GBUnited Kingdom· MHRA

4 products

Uses

GBOfficial regulatory label· revised March 27, 2026[1]

This medicinal product is for diagnostic use only. After radiolabelling with gallium (68Ga) chloride solution, gallium (68Ga) gozetotide (also known as gallium (68Ga) PSMA-11) is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer in the following clinical settings: • Primary staging of patients with highrisk prostate cancer prior to primary curative therapy.
• Suspected prostate cancer recurrence based on elevated serum prostate-specific antigen (PSA) level, after primary curative therapy.

How to take

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised September 15, 2025[2]

This medicinal product is for diagnostic use only. 4).

How to take

EUOfficial regulatory label

Sources & citations

[1]MHRA (UK) · PL185850048 · revised March 27, 2026
[2]European Medicines Agency · EMEA/H/C/005488 · revised September 15, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised March 27, 2026[1]

Summary of safety profile Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. 5 mSv, these adverse reactions are expected to occur with a low probability. Mild to moderate adverse reactions occurred in patients receiving gallium (68Ga) gozetotide.
The most commonly reported reactions were fatigue, headache, injection site reactions, nausea and rash. Tabulated list of adverse reactions Adverse reactions (Table 1) are listed by MedDRA system organ class and according to the MedDRA convention frequencies: 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:
List of adverse reactions MedDRA system organ class Adverse reactions Frequency Nervous system disorders Headache, dizziness, paraesthesia, insomnia Uncommon Gastrointestinal disorders Nausea, diarrhoea, dysphagia Uncommon Skin and subcutaneous tissue disorders Rash Uncommon General disorders and administration site conditions Fatigue, injection site reactions* Uncommon * Injection site reactions include injection site burning, pruritus and injection site pain.
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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised March 27, 2026[1]

4. Method of administration This medicinal product is administered intravenously as a single injection. It should be reconstituted and radiolabelled before administration to the patient. After reconstitution and radiolabelling, gallium (68Ga) gozetotide solution should be administered by slow intravenous injection.
Local extravasation resulting in inadvertent radiation exposure to the patient and imaging artefacts should be avoided. 9%) solution for injection to ensure full delivery of the dose. 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. Instructions regarding the dilution of the gallium (68Ga) gozetotide solution should be followed (see section 12). For instructions on reconstitution and radiolabelling of the medicinal product before administration, see section 12.
4. Image acquisition Gallium (68Ga) gozetotide is suitable for PET medical imaging. Patients should void immediately prior to image acquisition. The patient should be positioned supine with the arms above the head, as tolerated by the patient.
A CT scan should be obtained for attenuation correction and anatomical correlation. The acquisition must include a whole-body acquisition from the base of the skull to mid- thigh. PET images should be acquired 50 to 100 (ideally 60) minutes after the intravenous administration of gallium (68Ga) gozetotide solution.
Imaging acquisition start time and duration should be adapted according to the equipment used, the patient, and the tumour characteristics in order to obtain the best image quality possible. 1 or to any of the components of the labelled radiopharmaceutical.
4 Special warnings and precautions for use Potential for hypersensitivity or anaphylactic reactions If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and intravenous treatment initiated, if necessary.
To enable immediate action in emergencies, the necessary medicinal products and equipment such as endotracheal tube and ventilator must be immediately available. 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. To date no outcome data exist to inform subsequent management of patients with high risk disease when PSMA PET/CT is utilised for primary staging.
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. 6 and 12). Renal impairment The safety and efficacy of gallium (68Ga) gozetotide have not been studied in patients with renal impairment.

This is not medical advice. Consult a qualified healthcare professional.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised September 15, 2025[2]

Summary of safety profile Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. 3 mSv), these adverse reactions are expected to occur with a low probability. 1%). 5%). 7 MBq/kg) was evaluated in 1 003 patients with metastatic castration-resistant prostate cancer receiving physician’s discretion for best standard of care (VISION study).
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 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, injection site pruritus 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 national reporting system listed in Appendix V.

EUOfficial regulatory label· Warnings and precautions· revised September 15, 2025[2]

4. For instructions on reconstitution and radiolabelling 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.
Use of computer tomography (CT) or magnetic resonance imaging (MRI) for attenuation correction is recommended. 1 or to any of the components of the labelled radiopharmaceutical. 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. To date no outcome data exist to inform subsequent management of patients with high-risk disease when PSMA PET/CT is utilised for primary staging.
Experience of use of gallium (68Ga) gozetotide PET for selection of patients for PSMA-based therapy is limited to patients with progressive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy, and to selection of patients for treatment with lutetium (177Lu) vipivotide tetraxetan.
Benefit-risk ratio may not be generalisable to other types of PSMA-based therapy and patients with mCRPC with different prior treatments. 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.
6 and 12). Interpretation of gallium (68Ga) gozetotide images PET images with gallium (68Ga) gozetotide should be interpreted by visual assessment. Suspicion of malignant lesions is based on gallium (68Ga) gozetotide uptake in comparison with tissue background.
2), other types of cancers and non-malignant processes, potentially leading to false positive findings. Moderate to high physiological PSMA uptake is noted in the kidneys, lacrimal glands, liver, salivary glands and urinary bladder wall.

This is not medical advice. Consult a qualified healthcare professional.