LOCAMETZ

Patient Information Leaflet

Locametz 25 micrograms kit for radiopharmaceutical preparation

gozetotide
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while receiving this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before you are given this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your supervising nuclear medicine physician.
• If you experience any side effect, including those not listed in this leaflet, inform your nuclear medicine physician. See section 4.

Contents of this leaflet

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

1. What Locametz is and what it is used for

What Locametz is
This medicinal product is a radiopharmaceutical for diagnostic use only.
Locametz contains a substance called gozetotide. Prior to use, gozetotide (the powder contained in the vial) is combined with a radioactive substance called gallium-68 to obtain gallium ( Ga) gozetotide solution (this process is known as labelling).

What Locametz is used for
After labelling with gallium-68, Locametz is used in a medical imaging procedure called positron emission tomography (PET) to detect specific types of cancer cells expressing a protein called prostate-specific membrane antigen (Prostate-Specific Membrane Antigen, PSMA) in adults with prostate cancer. This is done:

• to determine whether prostate cancer has spread to lymph nodes and other tissues outside the prostate, prior to primary curative therapy (e.g. therapy involving surgical removal of the prostate, radiotherapy)
• to identify cancer cells when recurrence of prostate cancer is suspected in patients who have received primary curative therapy
• to determine whether patients with metastatic castration-resistant progressive prostate cancer may be suitable candidates for a specific treatment known as PSMA-targeted therapy.

How Locametz works
When administered to the patient, gallium ( Ga) gozetotide binds to tumour cells expressing PSMA on their surface, making them visible to the nuclear medicine physician during the PET imaging procedure. This provides valuable information to the physician and nuclear medicine specialist about the patient's disease.
The use of gallium ( Ga) gozetotide involves exposure to small amounts of radioactivity. The physician and nuclear medicine specialist have determined that the clinical benefit obtained from the radiopharmaceutical procedure outweighs the risk associated with radiation exposure.
If you have any questions about how Locametz works or why this medicine has been prescribed for you, please consult your nuclear medicine physician.

2. What you need to know before using Locametz

Locametz must not be used

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

Warnings and precautions
Please consult the nuclear medicine physician before receiving Locametz if you have any other type of cancer, as this may affect image interpretation.
The use of Locametz involves exposure to a small amount of radioactivity. Repeated exposure to radiation may increase the risk of cancer. The nuclear medicine physician will explain the necessary radiation protection measures to you (see section 3).
Before Locametz is administered to you, you must

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

Children and adolescents
This medicinal product must not be administered to children or adolescents under 18 years of age, as data are not available in this age group.
Pregnancy and breastfeeding
Locametz is not intended for use in women. All radiopharmaceuticals, including Locametz, may potentially cause harm to the fetus.
Driving and operating machinery
It is unlikely that Locametz will affect your ability to drive or operate machinery.
Locametz contains sodium
This medicinal product contains 28.97 mg of sodium (the main component of table salt) per injection. This corresponds to 1.5% of the maximum daily recommended dietary intake for an adult.

3. How to use Locametz

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Locametz will
be used only in specially controlled areas. This radiopharmaceutical will be handled and administered only
by trained and qualified personnel who are skilled in its safe use. These individuals will pay
particular attention to the safe use of this radiopharmaceutical and will inform you about the procedures
followed.
The nuclear medicine physician supervising the procedure will determine the amount of Locametz to
be used in your case. You will be given the minimum amount necessary to obtain the required
information.
The usually recommended administered amount for an adult is 1.8–2.2 MBq
(megabecquerel, the unit of measurement used to express radioactivity) per kg of body weight, with
a minimum amount of 111 MBq and a maximum amount of 259 MBq.
Administration of Locametz and conduct of the procedure
After reconstitution and labeling, Locametz is administered by slow intravenous injection.
You will undergo a PET scan starting from 50 to 100 minutes after receiving Locametz.
Duration of the procedure
The nuclear medicine physician will inform you about the usual duration of the procedure.
After administration of Locametz, you must

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

The nuclear medicine physician will inform you if you need to take any other special precautions after
receiving this medicine. If you have any questions, contact the nuclear medicine physician.
If you have been given more Locametz than you should have
Since you will receive only a single dose carefully controlled by the nuclear medicine physician
responsible for the procedure, an overdose of Locametz is unlikely. However, in case of
overdose, you will receive appropriate treatment. You may be asked to drink fluids and urinate
frequently to eliminate the radiopharmaceutical from the body.
If you have any further questions about the use of Locametz, consult the nuclear medicine physician responsible
for the procedure.

4. Possible side effects

Like all medicines, this medicinal product can cause side effects, although not everybody gets them.
The side effects include those listed below. If these side effects become severe, inform the nuclear medicine physician.

Common (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
• injection site reactions such as bruising, itching, and warmth (injection site reactions)
• chills

This radiopharmaceutical will emit low levels of ionising radiation, associated with a minimal risk of cancer and heritable abnormalities.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to the nuclear medicine physician. You may also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Locametz

This medicinal product must not be stored by the user. It is stored under the responsibility of a specialist in suitable premises. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive products.
The following information is intended for specialists only:

• Locametz must not be used after the expiry date stated on the carton and label after "Exp.". The expiry date refers to the last day of that month.
• Before reconstitution, store below 25°C.
• After reconstitution and labelling, store in an upright position at a temperature below 30°C. Use within 6 hours.

6. Contents of the pack and other information

What Locametz contains

• 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).

Description of the appearance of Locametz and contents of the pack
Locametz is a multidose kit for radiopharmaceutical preparation containing one vial of white lyophilized powder (powder for injectable solution).
Gallium-68 is not part of the kit.
After reconstitution and radiolabelling, Locametz contains a sterile injectable solution of gallium ( Ga) gozetotide with an activity of up to 1,369 MBq.
After reconstitution, the injectable solution of gallium ( Ga) gozetotide also contains hydrochloric acid.
Pack: 1 vial.

Marketing Authorization 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Sverige AB Novartis Pharma Services Inc.
Tel: +46 8 732 32 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Sverige AB
Tel: +372 66 30 810 Tlf: +46 8 732 32 00

Ελλάδα Österreich
ΒΙΟΚΟΣΜΟΣ ΑΕΒΕ Novartis Pharma GmbH
Τηλ: +30 22920 63900 Tel: +43 1 86 6570
or
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Novartis Sverige AB Novartis Slovakia s.r.o.
Sími: +46 8 732 32 00 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Sverige AB
Tel: +39 02 96 54 1 Puh/Tel: +46 8 732 32 00

Κύπρος Sverige
ΒΙΟΚΟΣΜΟΣ ΑΕΒΕ Novartis Sverige AB
Τηλ: +30 22920 63900 Tel: +46 8 732 32 00
or
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

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

The following information is intended for healthcare professionals only:

The full Product Characteristics Summary (SmPC) of Locametz is provided as a
separate document in the medicinal product's packaging, aimed at providing healthcare professionals
with additional scientific and practical information on the administration and use of this
radiopharmaceutical.
Refer to the SmPC.