Patient Information Leaflet

Locametz25microgramskit for radiopharmaceutical preparation

gozetotida

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section4 includes information on how to report these adverse effects.

Please read the entire leaflet carefully before you are administered this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to refer to it again.
• If you have any questions, consult your nuclear medicine doctor who will oversee the procedure.
• If you experience any adverse effects, consult your nuclear medicine doctor,even if they are not listed in this leaflet.

What is Locametz

This medication is a radioactive agent for diagnostic use only.

Locametz contains a substance called gozetotide. Before it can be used, the gozetotide (the powder from the vial) is combined with a radioactive substance called gallium-68 to produce a solution of gallium (68Ga)-gozetotide (this procedure is known as radioactive labeling).

How is Locametz used

After radioactive labeling 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 prostate cancer has spread to lymph nodes and other tissues outside the prostate before initial curative therapy (e.g., surgery to remove the prostate, radiation therapy)
• to identify cancer cells when there is suspicion of prostate cancer recurrence in patients who have received initial curative therapy
• to determine if patients with metastatic progressive prostate cancer resistant to castration can be suitable for receiving PSMA-directed treatment

How Locametz works

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

The use ofgallium (68Ga)-gozetotideinvolves exposure to radiation. Your physician and nuclear medicine physician have considered that the clinical benefit you will obtain from the procedure with the radioactive agent outweighs the risk of radiation.

If you have any doubts about how Locametz works or why you have been prescribed this medication, consult your nuclear medicine physician.

You should not receive Locametz

• if you are allergic to gozetotide or any of the other components of this medication (listed in section6).

Warnings and precautions

Before receiving Locametz, talk to your nuclear medicine doctor ifyou have any other type of cancer, as this circumstance 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 section3).

Before the administration ofLocametzyou 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 hours after administration.

Children and adolescents

This medication should not be administered to children or adolescents under 18years because 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 operating machinery

It is considered unlikely that Locametz will affect your ability to drive and operate machinery.

Locametzcontains sodium

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

There are strict guidelines for 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 to use it safely. Those individuals will take special care in the safe use of this radiopharmaceutical and will inform you of their actions.

The nuclear medicine physician overseeing the procedure will decide on the amount of Locametz to be used in your case. This will be the minimum amount necessary to obtain the desired information.

The recommended dose for an adult is typically 1.8-2.2 MBq (megabecquerelios, the unit used to express radiactivity) per kilogram of body weight, with a minimum dose of 111 MBq and a maximum of 259 MBq.

Administration of Locametz and procedure

After reconstitution and radiolabeling, Locametz is administered as a slow injection into a vein. 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 of the typical duration of the procedure.

After receiving Locametz, you should

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

Your nuclear medicine physician will inform you if any special precautions are necessary after receiving this medication. Consult with your nuclear medicine physician if you have any questions.

If you have been administered more Locametz than you should

A Locametz overdose is unlikely because you will only receive a single, precisely controlled dose administered by the nuclear medicine physician overseeing 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 physician overseeing the procedure.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The adverse effects listed below may be severe. If you experience any of these effects, inform your nuclear physician.

Frequent(may affect up to 1in every 10people)

• fatigue (tiredness)

Infrequent(may affect up to 1in every 100people)

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

This radiopharmaceutical emits low levels of ionizing radiation associated with a lower risk of cancer and hereditary anomalies.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your nuclear physician, even if it is a possible adverse effect not listed in this prospectus. You may also report them directly through the national notification system included in theAppendix V.Reporting adverse effects can help provide more information about the safety of this medication.

This medication does not need to be stored by the patient. This medication 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 solely for the specialist:

• Locametz should not be used after the expiration date appearing on the packaging and on the label after EXP.The expiration date is the last day of the month indicated.
• Before reconstitution, store below 25°C.
• After reconstitution and radioactive marking, store in a vertical position below 30°C. Use within the next 6hours.

Composition of Locametz

• The active principle is gozetotide. A vial contains 25 micrograms of gozetotide.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 kit for radiopharmaceutical preparation that contains a vial of white lyophilized powder (powder for injection).

Gallium-68 is not part of the 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.

Size of the pack: 1 vial.

Marketing authorisation holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Responsible person

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

Via Crescentino snc

13040 Saluggia (VC)

Italy

You can request more information about this medicinal product by contacting the local representative of the marketing authorisation holder:

Last update of this leaflet

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu

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