LOCAMETZ 25 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION

Introduction

Patient Information Leaflet

Locametz25microgramsradio-pharmaceutical preparation kit

gozetotida

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your nuclear medicine doctor who will be supervising the procedure.
• If you get any side effects, talk to your nuclear medicine doctor, even if you think they are not serious.

Contents of the pack:

1. What is Locametz and what is it used for
2. What you need to know before you are given Locametz
3. How Locametz is given
4. Possible side effects
5. Storage of Locametz
6. Contents of the pack and other information

1. What is Locametz and what is it used for

What is Locametz

This medicine is a radiopharmaceutical for diagnostic use only.

Locametz contains a substance called gozetotida. Before it can be used, the gozetotida (powder in the vial) is combined with a radioactive substance called gallium-68 to produce a solution of gallium (68Ga)-gozetotida (this procedure is called 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 with a protein called prostate-specific membrane antigen (PSMA) in adults with prostate cancer. This is done:

• to find out if the prostate cancer has spread to the lymph nodes and other tissues outside the prostate, before initial curative therapy (e.g. therapy that involves surgical removal of the prostate, radiotherapy)
• to identify cancer cells when there is a suspicion of recurrence of prostate cancer in patients who have received initial curative therapy
• to find out if patients with metastatic castration-resistant prostate cancer may be suitable for PSMA-targeted treatment

How Locametz works

When given to the patient, the gallium (68Ga)-gozetotida binds to cancer cells that have PSMA on their surface and makes them visible to the nuclear medicine doctor during the PET imaging procedure. This provides valuable information about the disease to the doctor and the nuclear medicine doctor.

The use of gallium (68Ga)-gozetotida involves exposure to radioactivity. The doctor and the nuclear medicine doctor have considered that the clinical benefit you will get from the procedure with the radiopharmaceutical outweighs the risk of radiation.

If you have any questions about how Locametz works or why it has been prescribed for you, ask your nuclear medicine doctor.

2. What you need to know before you are given Locametz

Locametz must not be given to you

• if you are allergic to gozetotida or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before receiving Locametz, tell your nuclear medicine doctor 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 doctor will explain the necessary radiation protection measures (see section 3).

Before administration of Locametz, you must

• Drink plenty of water to stay hydrated and urinate just before starting the PET imaging procedure, and as frequently as possible during the first few hours after administration.

Children and adolescents

This medicine must not be given to children or adolescents under 18 years because there are no data available for 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

It is considered unlikely that Locametz will affect your ability to drive and use machines.

Locametz contains sodium

This medicine contains 28.97 mg of sodium (the main component of cooking/table salt) per injection. This is equivalent to 1.5% of the maximum recommended daily intake of sodium for an adult.

3. How Locametz is given

There are strict rules for the use, handling, and disposal of radiopharmaceuticals. Locametz will only be used in special controlled areas. This radiopharmaceutical will only be handled and administered by trained and qualified personnel who are authorized to use it safely. These people will take special care in the safe use of this radiopharmaceutical and will inform you of their actions.

The nuclear medicine doctor 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 desired information.

The recommended amount to be administered is usually 1.8-2.2 MBq (megabecquerel, the unit used to express radioactivity) per kilogram of body weight, with a minimum of 111 MBq and a maximum of 259 MBq.

Administration of Locametz and performance of the procedure

After reconstitution and radiolabelling, Locametz is administered as a slow injection into a vein. You will undergo a PET scan between 50 and 100 minutes after receiving Locametz.

Duration of the procedure

Your nuclear medicine doctor will inform you of the usual duration of the procedure.

After administration of Locametz, you should

• Continue to drink plenty of water to stay hydrated and urinate as frequently as possible to eliminate the radiopharmaceutical from your body.

Your nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine. If you have any questions, ask your nuclear medicine doctor.

If you have been given too much Locametz

An overdose of Locametz is unlikely because you will only receive a single dose that is precisely controlled by the nuclear medicine doctor supervising the procedure. However, in the event of an overdose, you will receive the necessary treatment. You may be asked to drink and urinate frequently to eliminate the radiopharmaceutical from your body.

If you have any other questions about the use of Locametz, ask the nuclear medicine doctor supervising the procedure.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects include the following listed below. If these side effects become serious, inform your nuclear medicine doctor.

Common(may affect up to 1 in 10 people)

• fatigue

Uncommon(may affect up to 1 in 100 people)

• nausea
• constipation
• vomiting
• diarrhea
• dry mouth
• reactions at the injection site, such as bruising, itching, and warmth
• chills

This radiopharmaceutical emits low levels of ionizing radiation associated with a minor risk of cancer and genetic abnormalities.

Reporting of side effects

If you experience any side effects, talk to your nuclear medicine doctor, even if you think they are not serious. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Locametz

You will not need to store this medicine. This medicine is stored under the responsibility of the specialist in suitable facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended for healthcare professionals only:

• Locametz should not be used after the expiry date stated on the packaging and label after EXP. The expiry date is the last day of the month stated.
• Before reconstitution, store below 25°C.
• After reconstitution and radiolabelling, store upright below 30°C. Use within 6 hours.

6. Contents of the pack and other information

Composition of Locametz

• The active substance is gozetotida. One vial contains 25 micrograms of gozetotida. The other ingredients are: gentisic acid, sodium acetate trihydrate, and sodium chloride (see "Locametz contains sodium" in section 2).

Appearance and pack contents of Locametz

Locametz is a multidose radiopharmaceutical preparation kit that contains a vial of white lyophilized powder (powder for solution for injection).

Gallium-68 is not part of the preparation kit.

After reconstitution and radiolabelling, Locametz contains a sterile solution for injection of gallium (68Ga)-gozetotida with an activity of up to 1369 MBq.

After reconstitution, the solution for injection of gallium (68Ga)-gozetotida also contains hydrochloric acid.

Pack size: 1 vial.

Marketing authorisation holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Advanced Accelerator Applications (Italy) S.R.L.

Via Crescentino snc

13040 Saluggia (VC)

Italy

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision 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

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This information is intended for healthcare professionals only:

The full summary of product characteristics of Locametz is included as a separate document in the product packaging, with the aim of providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the summary of product characteristics.