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LOCAMETZ 25 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION

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About the medicine

How to use LOCAMETZ 25 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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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.

Doctor consultation

Not sure if this medicine is right for you?

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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.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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:

België/Belgique/Belgien

Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11

Lietuva

SIA Novartis Baltics Lietuvos filialas

Tel: +370 5 269 16 50

Text in Bulgarian language with contact information of Novartis Bulgaria Eood including phone number

Luxembourg/Luxemburg

Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11

Ceská republika

Novartis s.r.o.

Tel: +420 225 775 111

Magyarország

Novartis Hungária Kft.

Tel.: +36 1 457 65 00

Danmark

Novartis Sverige AB

Tel: +46 8 732 32 00

Malta

Novartis Pharma Services Inc.

Tel: +356 2122 2872

Deutschland

Novartis Pharma GmbH

Tel: +49 911 273 0

Nederland

Novartis Pharma B.V.

Tel: +31 88 04 52 111

Eesti

SIA Novartis Baltics Eesti filiaal

Tel: +372 66 30 810

Norge

Novartis Sverige AB

Tlf: +46 8 732 32 00

Ελλáδα

ΒΙΟΚΟΣΜΟΣ ΑΕΒΕ

Τηλ: +30 22920 63900

or

Novartis (Hellas) A.E.B.E.

Τηλ: +30 210 281 17 12

Österreich

Novartis Pharma GmbH

Tel: +43 1 86 6570

España

Advanced Accelerator Applications Ibérica, S.L.U.

Tel: +34 97 6600 126

Polska

Advanced Accelerator Applications Polska Sp. z o.o.

Tel.: +48 22 275 56 47

France

Advanced Accelerator Applications

Tél: +33 1 55 47 63 00

Portugal

Novartis Farma - Produtos Farmacêuticos, S.A.

Tel: +351 21 000 8600

Hrvatska

Novartis Hrvatska d.o.o.

Tel. +385 1 6274 220

România

Novartis Pharma Services Romania SRL

Tel: +40 21 31299 01

Ireland

Novartis Ireland Limited

Tel: +353 1 260 12 55

Slovenija

Novartis Pharma Services Inc.

Tel: +386 1 300 75 50

Ísland

Novartis Sverige AB

Sími: +46 8 732 32 00

Slovenská republika

Novartis Slovakia s.r.o.

Tel: +421 2 5542 5439

Italia

Novartis Farma S.p.A.

Tel: +39 02 96 54 1

Suomi/Finland

Novartis Sverige AB

Puh/Tel: +46 8 732 32 00

Κúπρος

ΒΙΟΚΟΣΜΟΣ ΑΕΒΕ

Τηλ: +30 22920 63900

or

Novartis Pharma Services Inc.

Τηλ: +357 22 690 690

Sverige

Novartis Sverige AB

Tel: +46 8 732 32 00

Latvija

SIA Novartis Baltics

Tel: +371 67 887 070

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.

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Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

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Frequently Asked Questions

Is a prescription required for LOCAMETZ 25 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION?
LOCAMETZ 25 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in LOCAMETZ 25 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION?
The active ingredient in LOCAMETZ 25 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION is gallium (68Ga) gozetotide. This information helps identify medicines with the same composition but different brand names.
Who manufactures LOCAMETZ 25 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION?
LOCAMETZ 25 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION is manufactured by Novartis Europharm Limited. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of LOCAMETZ 25 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether LOCAMETZ 25 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to LOCAMETZ 25 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION?
Other medicines with the same active substance (gallium (68Ga) gozetotide) include ILLUCCIX 25 MICROGRAMS RADIOPHARMACEUTICAL PREPARATION KIT, ISOPROTRACE 10 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION, ADREVIEW 74 MBq/ml INJECTABLE SOLUTION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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