Somakit Toc 40 micrograms kit for radiopharmaceutical preparation

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

SomaKit TOC 40 micrograms radiopharmaceutical preparation kit

edotreotide

Read the entire leaflet carefully before you are given this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your nuclear medicine physician who will supervise the procedure.
• If you experience any adverse reactions, consult your nuclear medicine physician, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What SomaKit TOC is and what it is used for
2. What you need to know before you are given SomaKit TOC
3. How SomaKit TOC is administered
4. Possible adverse effects
5. How to store 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 intended solely for diagnostic use. 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 known as radiolabelling).

Gallium (68Ga)-edotreotide contains a small amount of radioactivity. After intravenous injection, it enables the physician to visualize specific areas of the body during an imaging test called positron emission tomography (PET). This medical procedure produces images of organs to help locate abnormal cells or tumors, providing valuable information about the disease.

Administration of SomaKit TOC involves exposure to small amounts of radiation. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will receive from this radiopharmaceutical procedure outweighs the radiation risk.

2. What you need to know before SomaKit TOC is administered

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 SomaKit TOC is administered, speak with the nuclear medicine physician:

• if you experience any signs of an allergic reaction (listed in section 4) after a 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 scan;
• if you have other medical conditions, such as high levels of cortisol in the body (Cushing's syndrome), inflammation, thyroid disease, other types of tumors (of the pituitary, lung, brain, breast, immune system, thyroid, adrenal glands, or other), or spleen disease (including prior trauma or surgery affecting the spleen). These conditions may be visible and may affect the interpretation of images. Therefore, your physician may perform additional scans and tests to confirm findings on gallium (68Ga)-edotreotide imaging;
• if you have been recently vaccinated. Swollen lymph nodes due to vaccination may become visible during gallium (68Ga)-edotreotide imaging;
• if you are taking other medicines, such as somatostatin analogs or glucocorticoids, which may interact with SomaKit TOC;
• if you are pregnant or think you might be;
• if you are breastfeeding.

The nuclear medicine physician will discuss whether you need to take any other special precautions before or after receiving SomaKit TOC.

Before administration of SomaKit TOC

You should drink plenty of water before starting the procedure and urinate frequently during the first few hours after completion, to ensure 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

Inform your nuclear medicine physician if you are taking, have recently taken, or might need to take any other medicines, including somatostatin analogs or glucocorticoids (also called corticosteroids), as some medicines may interfere with image interpretation. If you are taking somatostatin analogs, you may be asked to discontinue treatment for a short period of time.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your nuclear medicine physician before receiving this medicine.

You must inform the nuclear medicine physician before administration of SomaKit TOC if there is any possibility you might be pregnant, if you have missed a period, or if you are breastfeeding.

If in doubt, it is important to consult the nuclear medicine physician supervising the procedure.

There is no available information regarding the safety and efficacy of using this medicine during pregnancy. During pregnancy, tests will only be performed if essential, when the probable benefit clearly outweighs the potential risks to the mother and fetus.

If you are breastfeeding, the nuclear medicine physician may postpone the medical procedure until you have stopped breastfeeding, or may instruct you not to breastfeed and to discard breast milk until radioactivity has cleared from your body (12 hours after administration of SomaKit TOC).

Ask your nuclear medicine physician when you can resume breastfeeding.

Driving and using machines

SomaKit TOC is considered 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; essentially “sodium-free”.

3. How SomaKit TOC is administered

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. SomaKit TOC will only be used in specially controlled areas. This medicine will only be handled and administered by trained and qualified personnel who are skilled in its safe use. These individuals will take special care in the safe handling of this medicine and will inform you of their actions.

The nuclear medicine physician supervising the procedure will determine the amount of SomaKit TOC to be used in your case. This amount will be the minimum necessary to obtain the required information.

The recommended dose for administration in adults is generally 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 required by your physician.

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

Duration of the procedure

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

After receiving SomaKit TOC, you should:

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

The nuclear medicine physician will inform you if you need to take any special precautions after receiving this medicine. Consult your nuclear medicine physician if you have any doubts.

If you have been given more SomaKit TOC than you should have received

An overdose is unlikely, as you will receive a single precisely controlled dose of SomaKit TOC determined by the supervising nuclear medicine physician. However, in the event of an overdose, appropriate treatment will be given. Drinking fluids and urinating frequently will help eliminate the radioactive substance from your body more quickly.

If you have any further questions about the use of SomaKit TOC, ask the nuclear medicine physician supervising the procedure.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

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

• Itching near the injection site

The spleen is an organ located in the abdomen (belly). Some people are born with an additional spleen (an accessory spleen). Additional splenic tissue may also be found in the abdomen after surgery or trauma to the spleen (this is known as splenosis). Gallium (68Ga)-edotreotide may cause an accessory spleen or splenosis to become visible during medical imaging. There have been reports in which this has been mistaken for a tumor. Therefore, your doctor may perform additional scans and tests to confirm the results of gallium (68Ga)-edotreotide imaging (see section 2).

Administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation, with a very low risk of developing cancer and hereditary defects.

Reporting of side effects

If you experience any type of adverse effect, consult your nuclear medicine physician, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of SomaKit TOC

You will not be required to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.

The following information is intended for specialists 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 after “EXP”.

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

Keep in the original packaging to protect from light.

SomaKit TOC must be used within 4 hours after radiolabelling. Do not store at temperatures above 25 °C after radiolabelling.

Do not use SomaKit TOC if signs of deterioration are observed.

Medicines must not be disposed of via wastewater or household waste. Before discarding any radioactive product, wait until the level of radioactivity has decreased sufficiently. This will help protect the environment.

6. Contents of the pack and other information

Contents of SomaKit TOC

• The active substance is edotreotide. Each vial for injectable solution 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 reagent kit for the preparation of a radiopharmaceutical, containing:

• One glass vial with black easy-open closure (flip-off) containing a white powder.
• One cyclic olefin polymer vial with yellow easy-open closure (flip-off) containing a clear, colourless solution.

The radioactive substance is not included in the kit and must be added during the preparation steps prior to injection.

Marketing Authorization 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

More information about this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu

This information is intended for healthcare professionals only:

The full Summary of Product Characteristics for SomaKit TOC is included as a separate document in the medicine's packaging, providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the Summary of Product Characteristics.