SOMAKIT TOC 40 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION

Introduction

Package Leaflet: Information for the User

SomaKit TOC 40micrograms radiopharmaceutical preparation kit

edotreotide

Read all of this leaflet carefully before you start using 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 experience any side effects, talk to your nuclear medicine doctor, even if they are not listed in this leaflet. See section 4.

Contents of the pack

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

1. What SomaKit TOC is and what it is used for

This medicine is a radiopharmaceutical for diagnostic use only. It contains the active substance edotreotide. Before it can be used, the powder in the vial is mixed with a radioactive substance called gallium chloride (Ga68) to produce gallium (68Ga)-edotreotide (this process is called radiolabelling).

Gallium (68Ga)-edotreotide contains a small amount of radioactivity. After injection into a vein, it allows the doctor to visualize certain areas of the body during an imaging test called positron emission tomography (PET). This medical procedure provides images of the organs to help locate abnormal cells or tumors, obtaining valuable information about the disease.

Administration of SomaKit TOC involves receiving small amounts of radioactivity. Your doctor and nuclear medicine doctor have considered that the clinical benefit you will get from the procedure with the radiopharmaceutical outweighs the risk of radiation.

2. What you need to know before you use SomaKit TOC

Do not use SomaKit TOC

• If you are allergic to edotreotide or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Before you are given SomaKit TOC, talk to your nuclear medicine doctor:

• if you have experienced any signs of an allergic reaction (listed in section 4) after previous administration of SomaKit TOC;
• if you have kidney or liver problems (renal or hepatic disease);
• if you are under 18 years of age;
• if you show signs of dehydration before and after the examination;
• if you have other conditions, such as a high level of cortisol in the body (Cushing's syndrome), inflammation, thyroid disease, another type of tumor (of the pituitary gland, lung, brain, breast, immune system, thyroid, adrenal glands, or other type) or spleen disease (including previous trauma or surgery that affects the spleen). Such conditions may be visible and affect the interpretation of the images. Therefore, your doctor may perform additional tests and examinations to confirm the findings in the images with gallium (68Ga)-edotreotide.
• if you have been vaccinated recently. Inflamed lymph nodes due to vaccination may become visible during imaging with gallium (68Ga)-edotreotide;
• if you have taken other medicines, such as somatostatin analogues or glucocorticoids, that may interact with SomaKit TOC;
• if you are pregnant or think you may be pregnant;
• if you are breast-feeding.

Your nuclear medicine doctor will discuss with you whether you need to take any special precautions before or after using SomaKit TOC.

Before administration of SomaKit TOC

You should drink plenty of water before starting the procedure to urinate frequently during the first few hours after its completion, to ensure that your body eliminates SomaKit TOC as quickly as possible.

Children and adolescents

This medicine is not recommended for patients under 18 years of age, as its safety and efficacy have not been established in this patient population.

Other medicines and SomaKit TOC

Tell your nuclear medicine doctor if you are taking, have recently taken, or might take any other medicines, including somatostatin analogues or glucocorticoids (also called corticoids), as some medicines may interfere with the interpretation of the images. If you are taking somatostatin analogues, you may be asked to stop treatment for a short period of time.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your nuclear medicine doctor for advice before using this medicine.

You must inform your nuclear medicine doctor before administration of SomaKit TOC if there is any possibility that you may be pregnant, if you have a delayed period, or if you are breast-feeding.

In case of doubt, it is important that you consult your nuclear medicine doctor who supervises the procedure.

No information is available on the safety and efficacy of using this medicine during pregnancy. During pregnancy, only essential tests will be performed when the expected benefit is clearly greater than the potential risks to the mother and fetus.

If you are breast-feeding, your nuclear medicine doctor may postpone the medical procedure until you are no longer breast-feeding or ask you not to breast-feed and discard the milk until the radioactivity has disappeared from your body (12 hours after administration of SomaKit TOC).

Ask your nuclear medicine doctor when you can restart breast-feeding.

Driving and using machines

SomaKit TOC is unlikely to affect your ability to drive or use machines.

SomaKit TOC contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially "sodium-free".

3. How to use SomaKit TOC

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

The nuclear medicine doctor supervising the procedure will decide what amount of SomaKit TOC should be used in your case. This will be the minimum amount necessary to obtain the desired information.

The recommended amount for administration to an adult is 100 MBq to 200 MBq (megabecquerels, the unit used to express radioactivity).

Administration of SomaKit TOC and performance of the procedure

After radiolabelling, SomaKit TOC is administered by intravenous injection.

A single injection is sufficient to perform the test that your doctor needs.

After the injection, you will be offered a drink and asked to urinate immediately before performing the test.

Duration of the procedure

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

After administration of SomaKit TOC, you should:

• avoid close contact with children and pregnant women for 12 hours after the injection
• urinate frequently to eliminate the medicine from your body.

Your nuclear medicine doctor will inform you if you need to take special precautions after being given this medicine. If you have any doubts, consult your nuclear medicine doctor.

If you have been given more SomaKit TOC than you should

Overdose is unlikely because you will receive a single, precisely controlled dose of SomaKit TOC by your nuclear medicine doctor. However, in case of overdose, you will receive appropriate treatment. Drinking and urinating frequently will help you eliminate the radioactive substance from your body more quickly.

If you have any further questions on the use of SomaKit TOC, ask your nuclear medicine doctor.

4. Possible side effects

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

Although no side effects have been reported, there is a potential risk of allergic reactions (hypersensitivity) with SomaKit TOC. Symptoms may include: flushing, skin redness, swelling, itching, nausea, and difficulty breathing. In case of an allergic reaction, the medical staff will provide you with the appropriate treatment.

Frequency not known (cannot be estimated from the available data):

• Itching near the injection site

The spleen is an organ located in the abdomen (belly). Some people are born with an extra spleen (an accessory spleen). You can also find extra spleen tissue in the abdomen after surgery or trauma to the spleen (this is called splenosis). Gallium (68Ga)-edotreotide may make an accessory spleen or splenosis visible during medical imaging. There have been reports where this has been mistaken for a tumor. Therefore, your doctor may perform additional tests and examinations to confirm the results of the images with gallium (68Ga)-edotreotide (see section 2).

Administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and genetic disorders.

Reporting of side effects

If you experience any side effects, talk to your nuclear medicine doctor, even if they are not listed in this leaflet. 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 SomaKit TOC

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.

Keep this medicine out of the sight and reach of children.

Do not use SomaKit TOC after the expiry date stated on the carton. The expiry date is the last day of the month stated.

Store in a refrigerator (between 2°C and 8°C).

Keep in the original packaging to protect from light.

SomaKit TOC should be used within 4 hours of radiolabelling. Do not store above 25°C after radiolabelling.

Do not use SomaKit TOC if you notice signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Before disposing of a radioactive product, wait until the level of radioactivity has decreased adequately. These measures will help protect the environment.

6. Contents of the pack and other information

Contents of SomaKit TOC

• The active substance is edotreotide. Each vial of powder for solution for injection contains 40 micrograms of edotreotide.
• The other components are: 1,10-phenanthroline, gentisic acid, mannitol, formic acid, sodium hydroxide, water for injections.

After radiolabelling, the resulting solution also contains hydrochloric acid.

Appearance of SomaKit TOC and contents of the pack

SomaKit TOC 40 micrograms is a radiopharmaceutical preparation kit that contains:

• A glass vial with a black flip-off cap that contains a white powder.
• A polyolefin vial with a yellow flip-off cap that contains a clear, colorless solution.

The radioactive substance is not part of the kit and will be added during the preparation steps prior to injection.

Marketing authorisation holder:

Advanced Accelerator Applications

8-10 Rue Henri Sainte-Claire Deville

92500 Rueil-Malmaison

France

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 SomaKit TOC is included as a separate document in the package of the medicine, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the summary of product characteristics.