STAMICIS 1 mg KIT FOR RADIOPHARMACEUTICAL PREPARATION

Introduction

Package Leaflet: Information for the Patient

STAMICIS 1 mgkit for radiopharmaceutical preparation EFG

Tetrafluoroborate of [Tetrakis (2-methoxy-2-methylpropyl-1 isocyanide) copper(I)]

Read this package leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your nuclear medicine doctor, who is supervising the procedure.
• If you experience side effects, ask your nuclear medicine doctor, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is STAMICIS and what is it used for
2. What you need to know before you start using STAMICIS
3. How to use STAMICIS
4. Possible side effects
   1. Storage of STAMICIS
   2. Package contents and further information

1. What is STAMICIS and what is it used for

This medicine is a radiopharmaceutical for diagnostic use only.

STAMICIS contains a substance called tetrafluoroborate of [tetrakis (2-methoxy-2-methylpropyl-1 isocyanide) copper(I)] which is used to study the function and blood flow (myocardial perfusion) of the heart by generating an image of it (scintigraphy), for example to detect heart attacks (myocardial infarction) or when a disease causes a decrease in blood supply (ischemia) to the heart muscle (or part of it). STAMICIS is also used in the diagnosis of breast abnormalities along with other diagnostic methods when the results are not conclusive. STAMICIS may also be used to locate the position of overactive parathyroid glands (glands that secrete the hormone that controls blood calcium levels).

After injecting STAMICIS, it accumulates temporarily in certain parts of the body. This radiopharmaceutical contains a small amount of radioactivity that can be detected from outside the body using special cameras. Your nuclear medicine doctor will then obtain an image (scintigraphy) of the affected organ, which can provide your doctor with valuable information about the structure and function of that organ or about the location, for example, of a tumor.

The administration of STAMICIS involves receiving a small amount of radioactivity. Your doctor and nuclear medicine doctor have considered that the clinical benefit you will obtain from the examination with the radiopharmaceutical outweighs the risk of radiation.

2. What you need to know before you start using STAMICIS

Do not use STAMICIS

• if you are allergic to Tetrafluoroborate of [tetrakis (2-methoxy-2-methylpropyl-1 isocyanide) copper(I)] or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor before you start using STAMICIS

• If you are pregnant or think you may be pregnant.
• If you are breast-feeding.
• If you have kidney or liver disease.
• If you have an abnormal heart rhythm, chest pain when your heart works harder during exercise, and you need a stress test.

Consult your nuclear medicine doctor if you are in any of the above situations. The nuclear medicine doctor will indicate if you need to take any special precautions after using this medicine. If you have any doubts, consult your nuclear medicine doctor.

Before the administration of STAMICIS, you should:

• Fast for at least 4 hours if the medicine is to be used to obtain images of the heart.
• Drink plenty of water before starting the examination so that you urinate as frequently as possible during the first hours after the examination.

Children and adolescents

If you are under 18 years old, consult your nuclear medicine doctor.

Using STAMICIS with other medicines

Certain medicines, foods, and drinks may negatively affect the results of the planned study. Therefore, it is recommended that you talk to your specialist to indicate which foods and medicines you should not take before the examination and when you can take them again after it.

Tell your nuclear medicine doctor if you are taking, have recently taken, or may need to take any other medicine, as they may interfere with the interpretation of the images.

In particular, tell your nuclear medicine doctor if you are taking

• medicines that may affect heart function or blood flow.
• medicines called proton pump inhibitors, used to reduce stomach acid production, such as omeprazole, esomeprazole, lansoprazole, rabeprazole, pantoprazole, dexlansoprazole.

Before taking any medicine, talk to your nuclear medicine doctor.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your nuclear medicine doctor before using this medicine. In case of doubt, it is important that you consult your nuclear medicine doctor, who will supervise the procedure.

If you are pregnant:

Your nuclear medicine doctor will administer this medicine during pregnancy only if the expected benefit outweighs the risks.

If you are breast-feeding:

Consult your nuclear medicine doctor, who will indicate that you should interrupt breast-feeding until the radioactivity has disappeared from your body, which takes about 24 hours. The milk extracted during this period should be discarded. Your doctor will indicate when you can restart breast-feeding.

Driving and using machines

It is unlikely that STAMICIS will affect your ability to drive or use machines.

STAMICIS contains sodium

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

3. How to use STAMICIS

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

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

The generally recommended amount for administration to an adult varies depending on the test to be performed and ranges from 150 to 1600 MBq (Megabecquerels, the unit used to express radioactivity).

Use in children and adolescents

In children and adolescents, the amount to be administered will be adjusted according to their body weight.

Administration of STAMICIS and performance of the procedure

STAMICIS is administered into a vein in the arm or foot (intravenous administration).

One or two injections are sufficient to perform the procedure that your doctor needs.

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

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

The ready-to-use solution will be injected into a vein before obtaining the scintigraphy. The images will be obtained within 5 to 10 minutes or up to 6 hours after the injection, depending on the procedure.

In the case of a cardiac study, two injections may be necessary, one at rest and another under stress (for example, during physical exercise or pharmacological stress). The two injections will be administered with an interval of at least two hours and a total dose not exceeding 1600 MBq (1-day protocol). A 2-day protocol is also possible.

For scintigraphy to detect breast abnormalities, an injection of 700-1000 MBq is administered into a vein in the arm opposite the affected breast or into a vein in the foot.

To locate the position of overactive parathyroid glands, the administered activity varies between 400 and 900 MBq, depending on the methods used.

If the medicine is to be used to obtain images of the heart, you will be asked not to eat anything for at least four hours before the test. After the injection, but before obtaining the image (scintigraphy), you will be asked to ingest a low-fat meal, if possible, or to drink one or two glasses of milk, in order to reduce the radioactivity of your liver and to improve the image.

Duration of the procedure

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

After the administration of STAMICIS, you should:

• avoid direct contact with small children and pregnant women during the 24 hours after the injection.
• urinate frequently to eliminate the product from your body.

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

If you have been administered more STAMICIS than you should

Overdose is unlikely because you will receive a precisely controlled single dose of STAMICIS by the nuclear medicine doctor supervising the procedure. However, in case of overdose, you will receive the appropriate treatment. In particular, the nuclear medicine doctor in charge of the procedure may recommend that you drink plenty of water to facilitate the elimination of STAMICIS from the body.

If you have any further questions about the use of this medicine, ask the nuclear medicine doctor supervising the procedure.

4. Possible side effects

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

Rarely, allergic reactions have occurred, accompanied by difficulty breathing, extreme fatigue, dizziness (usually within 2 hours after administration), subcutaneous swelling that can occur in areas such as the face and limbs (angioedema) and obstruct the airways, or reactions that led to a dangerous decrease in blood pressure (hypotension) and heart rate (bradycardia). Doctors are aware of this risk and have emergency treatment available in case it occurs. Rare cases of local skin reactions have also been observed, accompanied by itching, hives, rash, swelling, and redness. If you experience any of these side effects, consult your nuclear medicine doctor immediately.

The following are other possible side effects, listed by frequency:

This radiopharmaceutical will administer small amounts of ionizing radiation associated with the risk of cancer and genetic defects.

Reporting of side effects

If you experience any side effects, consult your nuclear medicine doctor, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of STAMICIS

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.

Do not use STAMICIS after the expiry date stated on the carton after EXP.

6. Package contents and further information

Composition of STAMICIS

• The active substance is Tetrafluoroborate of [tetrakis (2-methoxy-2-methylpropyl-1 isocyanide) copper(I)]. Each vial contains 1 mg of tetrafluoroborate of [Tetrakis (2-methoxy-2-methylpropyl-1 isocyanide) copper(I)].
• The other components are tin(II) chloride dihydrate, L-cysteine hydrochloride monohydrate, sodium citrate, and mannitol.

Appearance of the product and package contents

STAMICIS is a kit for radiopharmaceutical preparation.

STAMICIS is a powder that must be dissolved in a solution and combined with radioactive technetium before use as an injectable. Once the radioactive substance pertecnetate (99mTc) sodium is added to the vial, technetium (99mTc) sestamibi is formed. This solution is ready for injection.

Package size: 5 vials.

Marketing authorization holder and manufacturer

CIS bio international

B.P. 32

91192 GIF-SUR-YVETTE CEDEX

FRANCE

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Curium Pharma Spain, S.A.

Avda. Dr. Severo Ochoa, 29

28100-Alcobendas

Phone: 91 4841989

Date of last revision of this package leaflet:April 2024.

Other sources of information

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

The complete technical data sheet of STAMICIS is included in a document attached to the package leaflet, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the technical data sheet [the technical data sheet must be included in the package].