Metaiodobenzylguanidine- 123 i (mibg-123 i)

Package leaflet: Information for the user

Metaiodobenzylguanidine- I (MIBG- I), 18.5–370 MBq/ml, solution for injection
Jobenguan ( I)
Please read this leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet. You may need to read it again.
• If you have any doubts, please consult a nuclear medicine specialist physician.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform the nuclear medicine specialist physician immediately. See section 4.

Leaflet contents:

1. What is Metaiodobenzylguanidine- I (MIBG- I) and what is it used for?
2. Important information before use of Metaiodobenzylguanidine- I (MIBG- I).
3. How to use Metaiodobenzylguanidine- I (MIBG- I).
4. Possible adverse reactions.
5. How to store Metaiodobenzylguanidine- I (MIBG- I).
6. Contents of the pack and other information.

1. WHAT IS METAIODOBENZYLGUANIDINE- I (MIBG- I) AND WHAT IS IT USED FOR?

Metaiodobenzylguanidine- I (MIBG- I) is a medicinal product (radiopharmaceutical) intended exclusively for diagnostic use.
Metaiodobenzylguanidine- I (MIBG- I) is a radiopharmaceutical used in scintigraphic localization of tumours embryologically derived from the neural crest. These include chromaffin tumours, phaeochromocytomas, paragangliomas, and ganglioneuromas.
Metaiodobenzylguanidine- I (MIBG- I) is also used for detection, assessment of disease extent, and monitoring of treatment in neuroblastomas.
Metaiodobenzylguanidine- I (MIBG- I) is additionally used for functional imaging of the adrenal medulla (to investigate suspected hyperplasia) and of the myocardium (to assess sympathetic innervation).

2. IMPORTANT INFORMATION BEFORE USING THE MEDICINAL PRODUCT

METAIODOBENZYLOGUANIDINE-123 I (MIBG-123 I)

When must METAIODOBENZYLOGUANIDINE-123 I (MIBG-123 I) not be used?
Do not use if the patient is allergic to iobenguane (123I) or to any of the other ingredients of this medicinal product (listed in section 6).

Warnings and precautions
Thyroid blockade is required prior to administration of MIBG-123I. This can be achieved by administering iodine-containing products, such as Lugol's solution, potassium iodide, or potassium iodate, providing an amount equivalent to 130 mg of iodine per day. Thyroid blockade should begin at least 30 minutes before administration of iobenguane (123I) and continued for 1–2 days thereafter.

Uptake of metaiodobenzylguanidine by chromaffin granules may, theoretically, cause sudden release of norepinephrine, potentially leading to a significant increase in blood pressure. Therefore, continuous monitoring of the patient is required during administration of the medicinal product. Iobenguane (123I) must be administered slowly (over a period of not less than one minute per patient).

Administration of radiopharmaceuticals involves a risk of external ionizing radiation exposure or contamination (e.g. from urine, vomit, etc.) for other persons. Therefore, basic hygiene precautions must be observed.

To reduce radiation dose absorbed by the urinary bladder, increased fluid intake (approximately 1–1.5 litres above normal daily intake) and frequent voiding of the bladder are recommended after administration of the medicinal product.

Interaction of METAIODOBENZYLOGUANIDINE-123 I (MIBG-123 I) with other medicinal products
Inform the physician about all medicinal products currently used or recently used, as well as any medicinal products planned for future use. Medicinal products that may affect uptake of iobenguane should be discontinued under medical supervision, according to the table below:

Meta-iodobenzylguanidine-123 I (MIBG-123 I) and food and drink
No special precautions are recommended.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicinal product.

Before administration of the radiopharmaceutical, the nuclear medicine specialist should be informed if:

• there is suspicion of pregnancy,
• menstruation has not occurred at the expected time,
• the patient is breastfeeding. In case of uncertainty, consultation with the nuclear medicine specialist supervising the procedure is required.

In case of necessity to administer the medicinal product to a woman of childbearing potential, it should be ensured that the woman is not pregnant. The absorbed dose to the uterus following administration of 370 MBq I-MIBG is 3.7 mGy. Doses exceeding 0.5 mGy should be considered potentially harmful to the fetus.

Breastfeeding must be discontinued after administration of the radiopharmaceutical due to the potential risk to the child's health.

Driving and operating machinery
No effects on the ability to drive and operate machinery have been reported.

Meta-iodobenzylguanidine-123 I (MIBG-123 I) contains sodium.
The product contains less than 1 mmol of sodium (23 mg) per vial; at this level, the product may be considered "sodium-free".

3. HOW TO USE THE MEDICINAL PRODUCT METAJODOBENZYLOGUANIDINE- I (MIBG- I)

There are strict regulations regarding the use, transfer, and disposal of radiopharmaceuticals. The medicinal product
Metajodobenzyloguanidyna- I (MIBG- I) is used exclusively under appropriate clinical conditions and only by appropriately qualified personnel. These individuals take special precautionary measures to ensure safe use of the medicinal product and will continuously report on their actions.
The medicinal product is intended for intravenous administration.
The nuclear medicine specialist supervising the procedure determines the dose of the medicinal product to be administered in each individual case. This will be the minimum dose necessary to obtain the required diagnostic information. The recommended dose for adults ranges between 80 and 370 MBq (MBq = megabecquerel, a unit of radioactivity measurement).
Adults: the recommended dose is 80–200 MBq.
In the case of sympathetic innervation imaging of the heart muscle, the proposed dosage is 111–370 MBq for adults and not less than 80 MBq for children.
Use in children and adolescents:
In children and adolescents, the amount of medicinal product to be administered is determined based on the patient's body weight.
Recommended dose:
I- jobenguan is administered according to the following dosing schedule:

• children below 6 months: 4 MBq per kilogram of body weight (maximum 40 MBq)
• children between 6 months and 2 years: 4 MBq per kilogram of body weight (minimum 40 MBq)
• children above 2 years: an appropriate fraction of the adult dose calculated according to the child's body weight, based on the table provided below:

The above recommended dosing regimen should also take into account rules established by
local regulations regarding dosing of radiopharmaceutical products.
There is no specific dosing for elderly patients.
Iobenguane is administered by intravenous infusion or slow intravenous injection. If necessary, the administered volume may be increased by diluting the solution.

Administration of the medicinal product and performance of the examination
Metajodobenzyloguanidyna- I (MIBG- I) is a medicinal product for intravenous administration under the supervision of specialized personnel.
During administration, strict adherence to radiation safety regulations for ionizing radiation is required.
The radiopharmaceutical should be injected slowly intravenously (over no less than 1 minute).

Duration of the procedure
Your doctor will inform you about the standard duration of the procedure.

After administration of Metajodobenzyloguanidyna- I (MIBG- I), you should:

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

Your doctor will inform you about the need to take special precautions after administration of the medicinal product. In case of doubts, please consult your treating physician or a nuclear medicine specialist.

Use of a higher than recommended dose of the medicinal product
Overdose is highly unlikely, as the dose administered to the patient is strictly controlled by a nuclear medicine specialist.
The medicinal product is supplied in vials of known activity, which facilitates accurate dose control for the patient. In the event of an overdose, the physician may initiate appropriate treatment.
Due to renal elimination of the radiopharmaceutical, maintaining adequate diuresis is essential to reduce patient radiation exposure.
In case of any further doubts regarding the use of this medicinal product, please consult a nuclear medicine specialist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicinal product can cause adverse reactions, although not everyone experiences them.
Administration of MIBG-123 I may occasionally cause nausea, urticaria, skin redness, chills, or other non-severe manifestations of allergic reactions.
In case of too rapid injection, during or immediately after its administration, palpitations, dyspnea, sensation of warmth, transient increase in blood pressure, or cramping abdominal pain may occur.
These symptoms usually resolve within one hour.
Exposure to ionizing radiation may increase the risk of developing cancer or may lead to the occurrence of hereditary defects.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 22 49-21-309, e-mail: [email protected].
Adverse reactions can also be reported to the marketing authorization holder.
Reporting of adverse reactions allows further collection of information on the safety of the medicinal product.

5. HOW TO STORE METAIODOBENZYLGUANIDINE-123I (MIBG-123I)

The patient will not be required to store this medicinal product.
Radiopharmaceuticals are stored exclusively by authorized personnel under appropriate clinical conditions. Storage of radiopharmaceuticals must comply with local regulations concerning radioactive substances.
The following information is intended solely for medical personnel.
Do not use this medicinal product after the expiry date stated on the label: Expiry date and time: {DD.MM.YYYY} {HH:MM}

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What the medicinal product contains
Meta-iodobenzylguanidine-123I (MIBG-123I)

• The active substance is iobenguane-123I at a concentration of 18.5–370 MBq/mL.
• The other components of the medicinal product are: sodium pyrosulfite, copper(II) sulfate pentahydrate, sodium acetate trihydrate, acetic acid, benzyl alcohol, sodium chloride, water for injections.

What Metajodobenzyloguanidyna-123I (MIBG-123I) looks like and contents of the pack

MIBG-123I solution is supplied in 10 ml glass vials allowing multiple sterile withdrawals.
The vial is closed with a rubber stopper and an aluminium cap and placed inside a lead shielding container.
The outer transport packaging consists of a metal can with cushioning material.
A certificate of activity is provided with each source.

Marketing Authorisation Holder and Manufacturer
National Centre for Nuclear Research
Andrzeja Soltana 7
05-400 Otwock
Tel: +48 22 7180700
Fax: +48 22 7180350
e-mail: [email protected]

The Summary of Product Characteristics (SmPC) is included as a separate document within the product packaging, providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.