Stamicis

Patient Information Leaflet

STAMICIS 1 mg

Kit for radiopharmaceutical preparation
Tetrakis (2-methoxy-isobutyl-isonitrile) copper(I) tetrafluoroborate
Please read 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 questions, ask the nuclear medicine physician who will perform the examination.
• If you experience any side effects, including those not listed in this leaflet, contact the nuclear medicine physician. See section 4.

Contents of this leaflet:

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

1. What STAMICIS is and what it is used for

This medicinal product is a radiopharmaceutical for diagnostic use only.
STAMICIS contains a substance called copper(I) tetrakis(2-methoxy-isobutyl-isonitrile) tetrafluoroborate, which is used to study heart function and blood flow to the heart (myocardial perfusion) by providing an image of the heart (scintigraphy), for example in detecting heart attacks (myocardial infarctions) or when a disease causes reduced blood supply to the heart muscle or part of it (ischemia). STAMICIS is also used in the diagnosis of breast abnormalities, in addition to other diagnostic methods when results are inconclusive. STAMICIS may also be used to locate overactive parathyroid glands (glands that secrete the hormone regulating calcium levels in the blood).
After injection, STAMICIS temporarily accumulates in certain parts of the body. This substance is a radiopharmaceutical containing a small amount of radioactivity, which can be detected from outside the body using special cameras. The nuclear medicine physician will then obtain an image (scintigraphy) of the organ of interest, providing your doctor with important information about the structure and function of that organ or the location, for example, of a tumour.
The use of STAMICIS involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will receive from the radiopharmaceutical procedure outweighs the risk due to radiation exposure.

2. What you need to know before STAMICIS is used

STAMICIS must not be used

• if you are allergic to tetrakis(2-methoxy-isobutyl-isonitrile) copper(I) tetrafluoroborate or to any of the other ingredients of this medicinal product (listed in section 6).

Warnings and precautions
Exercise particular caution with STAMICIS

• if there is a possibility that you are pregnant or if you suspect pregnancy,
• if you are breastfeeding,
• if you have severe liver or kidney disease,
• if you have an abnormal heart rhythm, chest pain when the heart works harder during physical activity, and need to undergo a stress test.

You must inform the nuclear medicine physician if any of these situations apply to you. The nuclear medicine physician will inform you whether any necessary precautions should be taken after using this medicinal product. Please consult the nuclear medicine physician if you have any questions.
Before administration of STAMICIS you must

• fast for at least 4 hours if the product is to be used for imaging of the heart,
• drink plenty of water before the start of the examination to urinate as frequently as possible during the first hour following the study.

Children and adolescents
Please consult the nuclear medicine physician if you are under 18 years of age.
Other medicines and STAMICIS
Many medicines, foods, and beverages can negatively affect the outcome of the planned examination. Therefore, it is recommended to discuss with the physician who ordered the examination which medications should be discontinued before the examination and when they can be taken again. Also inform the nuclear medicine physician if you are currently taking, have recently taken, or might take any other medicine, as it could interfere with the interpretation of the images.
In particular, inform the nuclear medicine physician if you are taking:

• medications that affect heart function and/or blood flow to the heart,
• medicines called proton pump inhibitors: these are used to reduce gastric acid production, such as omeprazole, esomeprazole, lansoprazole, rabeprazole, pantoprazole, dexlansoprazole. Please consult the nuclear medicine physician before taking any medicine.

Pregnancy and breastfeeding
You must inform the nuclear medicine physician before administration of STAMICIS if there is any possibility you may be pregnant, if you have missed a menstrual period, or if you are breastfeeding. In case of doubt, it is important to consult the nuclear medicine physician who will supervise the procedure.
If you are pregnant,
the nuclear medicine physician will administer this medicine during pregnancy only if the expected benefit clearly outweighs the risks.
If you are breastfeeding,
inform the nuclear medicine physician so that appropriate advice can be given regarding interruption of breastfeeding until radioactivity has left your body. This takes approximately 24 hours. Breast milk expressed during this period must be discarded. Ask the nuclear medicine physician when you can resume breastfeeding.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult the nuclear medicine physician before taking this medicine.
Driving and using machines
It is considered unlikely that STAMICIS will affect your ability to drive or operate machinery.
STAMICIS contains sodium
This medicinal product contains less than 1 mmol of sodium (23 mg) per vial, i.e. it is essentially 'sodium-free'.

3. How STAMICIS is used

There are strict regulations governing the use, handling, and disposal of radiopharmaceuticals.
STAMICIS will be used only in designated controlled areas. This product will be handled and
administered by trained and qualified personnel experienced in its safe use. Such personnel will
take all necessary precautions for the safe use of this product and will inform you of their actions.
The nuclear medicine physician supervising the procedure will determine the amount of STAMICIS
to be used in your case. The smallest amount necessary to obtain the required information will be
used.
The recommended dose for administration in adults usually ranges, depending on the type of
examination, between 150 and 1600 MBq (Megabecquerel, the unit used to express radioactivity).

Use in children and adolescents
In children and adolescents, the administered dose will be adjusted according to the child's body
weight.

Administration of STAMICIS and procedure conduct
STAMICIS is administered into a vein in the arm or foot (intravenous administration).
One or two injections are sufficient to perform the examination required by your physician.
After the injection, you will be encouraged to drink fluids and will be asked to urinate immediately
before the scan.
The nuclear medicine physician will inform you if any special precautions are required after using
this medicinal product. Please consult your nuclear medicine physician for any questions.
The ready-to-use solution will be injected intravenously prior to performing the scintigraphy. The
scan may be performed within 5–10 minutes or up to 6 hours after injection, depending on the type
of examination.
For cardiac investigations, two injections may be required—one at rest and one under stress (e.g.,
during physical exercise or pharmacological stress). The two injections will be administered at least
two hours apart, and a total dose exceeding 1600 MBq will not be administered (one-day protocol).
A two-day protocol is also available.
For scintigraphy of breast abnormalities, an injection of 700–1000 MBq is administered into a vein
in the arm opposite to the affected breast or into a vein in the foot.
For localization of hyperactive parathyroid glands, the administered activity ranges between 400 and
900 MBq, depending on the method used.
If the medicinal product is used to acquire images of the heart, you will be asked to fast for at least
4 hours before the examination. After the injection, but before image acquisition (scintigraphy), you
will be asked, if possible, to eat a meal containing some fat or to drink one or two glasses of milk, in
order to reduce radioactivity in the liver and improve image quality.

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

After administration of STAMICIS, you must:

• avoid close contact with young children and pregnant women for the 24 hours following the injection,
• urinate frequently to eliminate the product from your body.

The nuclear medicine physician will inform you if any special precautions are required after
receiving this medicinal product. Please consult your nuclear medicine physician for any questions.

If you are administered more STAMICIS than you should receive
An overdose is extremely unlikely, as you will receive only a precisely controlled dose of STAMICIS
determined by the nuclear medicine physician supervising the procedure. However, in the event of
an overdose, appropriate treatment will be provided. In particular, the physician responsible for the
procedure may recommend that you drink plenty of fluids to facilitate the elimination of STAMICIS
from the body.
If you have any further questions about the use of this medicinal product, please consult the
nuclear medicine physician 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 been observed, possibly including shortness of breath, extreme fatigue,
feeling unwell (usually about 2 hours after administration), swelling under the skin which may occur in areas such as the face and limbs (angioedema), and airway obstruction, or leading to a dangerous drop in blood pressure (hypotension) and slowing of the heart rate (bradycardia). Physicians are aware of this possibility and have emergency treatments available for such cases. Rarely, local skin reactions have also been observed, including itching, hives, rash, swelling, and redness. If you experience any of these effects, consult your nuclear medicine physician immediately.
Other possible side effects are listed below in order of frequency:

This radiopharmaceutical will emit low levels of ionizing radiation associated with minimal risk of cancer and hereditary abnormalities.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or nuclear medicine specialist. You may also report adverse reactions directly through the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How STAMICIS is stored

Do not store this medicinal product. This medicinal product is stored by the specialist under appropriate conditions and under their responsibility. Radiopharmaceuticals must be stored in accordance with national regulations concerning radioactive materials.
The following information is intended for specialists only.
Do not use this medicinal product after the expiry date stated on the container following "EXP.".

6. Package Contents and Other Information

What STAMICIS Contains

• The active substance is tetrakis(2-methoxy-isobutyl-isonitrile) copper(I) tetrafluoroborate. One vial contains 1 mg of tetrakis(2-methoxy-isobutyl-isonitrile) copper(I) tetrafluoroborate.
• The other components are: stannous chloride dihydrate, cysteine hydrochloride monohydrate, sodium citrate, mannitol.

Description of the Appearance of STAMICIS and Package Contents
The product is a kit for the preparation of a radiopharmaceutical.
STAMICIS consists of a powder that must be dissolved in a solution and combined with radioactive technetium prior to use as an injection. Adding the solution containing the radioactive substance sodium pertechnetate ( Tc) to the vial induces the formation of technetium ( Tc) sestamibi. This solution is then ready for injection.
Pack: 5 vials.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Curium Italy S.r.l.
Via Enrico Tazzoli, 6
I-20154 Milan MI
ITALY

Manufacturer
CIS bio international
B.P. 32
91192 GIF-SUR-YVETTE CEDEX
FRANCE

The following information is intended for healthcare professionals only:

The complete Product Characteristics Summary of STAMICIS is provided as a separate document at the end of the package leaflet within the product packaging, with the purpose of offering healthcare professionals additional scientific and practical information on the administration and use of this radiopharmaceutical.
Refer to the Product Characteristics Summary [The Product Characteristics Summary must be included in the package].