Metaiodobenzylguanidine 131 i (mibg-131 i) for diagnosis

Package leaflet: Information for the user

Metajodobenzyloguanidyna 131 I (MIBG- 131 I) do diagnostyki,
10 – 37 MBq/ml, solution for injection
Please read all of this leaflet carefully before the medicine is administered, as it contains
important information for the patient.

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

Leaflet contents:

1. What is Metajodobenzyloguanidyna 131 I (MIBG- 131 I) do diagnostyki and what is it used for?
2. Important information before use of Metajodobenzyloguanidyna 131 I (MIBG- 131 I) do diagnostyki.
3. How to use Metajodobenzyloguanidyna 131 I (MIBG- 131 I) do diagnostyki.
4. Possible side effects.
5. How to store Metajodobenzyloguanidyna 131 I (MIBG- 131 I) do diagnostyki.
6. Contents of the pack and other information.

1. WHAT IS METAJOODOBENZYLOGUANIDINE 131 I (MIBG- 131 I) FOR DIAGNOSTIC USE AND WHAT IS IT USED FOR?

Metajodobenzyloguanidyna 131 I (MIBG- 131 I) do diagnostyki is a radiopharmaceutical
containing the active substance, radioactive iodine-131 isotope. The preparation is
administered intravenously in doses of varying radioactivity for diagnostic purposes.
Iodine [131I] is a short-lived radioisotope with a half-life of 8.04 days.
Metajodobenzyloguanidyna 131 I (MIBG- 131 I) do diagnostyki is a radiopharmaceutical
used in oncological diagnostics. It is indicated for:

• Radionuclide diagnostics (detection, localization, assessment of disease extent, post-treatment monitoring) of neuroendocrine tumours, particularly: pheochromocytoma, neuroblastoma, carcinoid tumour, medullary thyroid carcinoma.
• Assessment of uptake and retention of iobenguane (131I) to determine indications and plan treatment with high-activity iobenguane (131I).
• Evaluation of treatment response by assessing uptake and number of iobenguane (131I)-accumulating foci.
• Confirmation of the neuroendocrine nature of tumours of uncertain origin.

2. IMPORTANT INFORMATION BEFORE USE

METAIODOBENZYLGUANIDINE- I (MIBG- I) FOR DIAGNOSTIC USE
When not to use metaiodobenzylguanidine- I (MIBG- I) for diagnostic use?
If the patient is allergic to ioflupane ( I) or to any of the other components of this
medicinal product (listed in section 6).
Absolute contraindications to the use of the product are:

• hypersensitivity to the active substance or to any of the excipients,
• confirmed, suspected or not excluded pregnancy,
• breastfeeding,
• short expected survival time (less than 3 months), except in patients with tumour-related bone pain refractory to other treatments,
• renal failure requiring dialysis.

Relative contraindications are:

• rapidly progressing renal failure,
• progressive bone marrow damage and/or impaired renal function due to prior treatment,
• bone marrow tissue damage,
• unacceptable medical risk associated with the need for patient isolation,
• severe cases of urinary incontinence.

The product contains benzyl alcohol: 10 mg/ml, therefore it must not be administered to premature infants or newborns.
Warnings and precautions
Due to the risk of radioactive contamination, caution must be exercised when treating patients with radioactive iodine:

• who may not comply with instructions from medical personnel,
• with urinary incontinence.

Some patients receiving high activities of iodine-131 isotope may require hospitalization due to the need to comply with radiation protection regulations.
Administration of medicinal products containing radioactive isotopes poses a risk of external ionizing radiation exposure or contamination from urine stains, vomit, etc., to other individuals. For this reason, basic hygiene principles must be observed.
To reduce radiation dose absorbed by the urinary bladder, it is recommended to drink slightly more fluids than usual (approximately 1–1.5 litres more per day) and to empty the bladder more frequently after administration of the medicinal product.
Metaiodobenzylguanidine- I (MIBG- I) for diagnostic use and other medicinal products
Inform the physician about all medicinal products currently or recently taken by the patient, as well as any medicinal products the patient plans to take.

• Nifedipine (calcium channel blocker) – causes prolonged retention of ioflupane

The following may reduce uptake:

• antihypertensive drugs: reserpine, labetalol, calcium channel blockers (diltiazem, nifedipine, verapamil)
• sympathomimetic drugs (present in nasal decongestants, such as phenylephrine, ephedrine or phenylpropanolamine)
• cocaine
• tricyclic antidepressants such as amitriptyline and derivatives, imipramine and derivatives, doxepin, amoxapine and loxapine.

The following may inhibit accumulation of ioflupane:

• antihypertensive agents acting via blockade of adrenergic neurons (bethanidine, debrisoquine, bretylium and guanethidine).
• antidepressants such as maprotiline and trazodone. The use of these drugs should be discontinued prior to initiation of treatment.

The above factors indicate that the physician should be fully aware of the patient's medical history.
Metaiodobenzylguanidine- I (MIBG- I) for diagnostic use with 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 physician before using this medicinal product.
Pregnancy and breastfeeding are absolute contraindications to the use of this medicinal product.
Before administration of the medicinal product, the nuclear medicine specialist must be informed if:

• there is suspicion of pregnancy in a woman,
• menstruation has not occurred at the expected time,
• the woman is breastfeeding. In case of doubt, consultation with a nuclear medicine specialist supervising the examination is required.

When administration of radiopharmaceuticals to women of reproductive age is necessary, it must be ensured that the woman is not pregnant. Administration of iodine-131 should occur either within the first 10 days after menstruation or after a negative pregnancy test result. After treatment, pregnancy should be avoided for 1 year.
If administration of a radiopharmaceutical to a breastfeeding woman is necessary, breastfeeding must be discontinued.
Driving and operating machinery
No effects on the ability to drive and operate machinery have been reported.

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

I) FOR DIAGNOSTICS
This medicine should always be used exactly as prescribed by the physician. In case of doubt, consult your doctor.

Recommended dose:
(MIBG- I) is a radiopharmaceutical for intravenous administration with different radioactive activities used for diagnostics and therapy, respectively.
The dosage depends on the type of examination. The recommended dose for adults is 40–80 MBq (1.2–2.2 mCi). The dose for children is determined based on the child's body weight or body surface area.
The dose is determined by a nuclear medicine specialist. This activity should be individually adjusted for each patient and should be the minimum necessary to obtain the required diagnostic information.

Method of administration
For diagnostic examinations, the radiopharmaceutical is administered slowly intravenously over approximately 30 seconds.
MIBG I, solution for injection, must be administered exclusively under appropriate clinical conditions and only by appropriately qualified personnel. These individuals will take special precautionary measures to ensure safe use of the medicine and will continuously monitor their actions.

Administration of a higher than recommended dose of the medicine
Overdose is almost impossible because the administered dose is strictly controlled by a nuclear medicine specialist. However, in the event of an overdose, the physician will initiate appropriate treatment.

If you have any doubts regarding the use of the medicine, consult a nuclear medicine specialist.

If the medicinal product Metajodobenzyloguanidyna- I (MIBG- I) for diagnostics has been administered by mistake
The radiopharmaceutical metaiodobenzylguanidine- I (MIBG- I) for diagnostics is a product administered exclusively under strict medical supervision in Nuclear Medicine Departments by qualified personnel; therefore, the risk of accidental administration is extremely low.

The activity of the radiopharmaceutical dose administered to patients should always be evaluated in relation to its diagnostic value.

The product is supplied as a solution in vials of known activity, which facilitates dose control by the physician prior to administration to the patient. In the event of accidental administration of an excessive amount of radioactive substance, radiation exposure risk may be reduced by increasing fluid intake.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The administered dose activity of the radiopharmaceutical given to patients should always be considered in relation to its diagnostic value.
Administration of the medicine may cause: nausea, rash, itching, urticaria, erythema or other benign manifestations of allergic reactions.
Exposure to ionizing radiation may lead to an increased risk of cancer or may lead to the development of hereditary defects.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform a doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C,
02-222 Warszawa,
tel.: + 48 22 49 21 301,
fax: + 48 22 49 21 309,
e-mail: [email protected].
By reporting adverse reactions, additional information on the safety of using the medicine can be collected.

5. HOW TO STORE METAIODOBENZYLOGUANIDINE-131 I (MIBG-131 I) FOR DIAGNOSTIC USE

(MIBG- I) FOR DIAGNOSTICS
Keep the medicinal product out of the sight and reach of children.
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 the product after the expiry date stated on the packaging.
The medicinal product should be stored in its original packaging at a temperature below

• 15°C, shielded with radiation protection in accordance with the provisions of the Atomic Law. Protect from light. After thawing, store for up to 4 hours at a temperature below 25°C. Transport should be carried out using dry ice. Metaiodobenzylguanidine-131 I (MIBG-131 I) for diagnostics, solution for injection, should be administered within 9 days from the date of production. Unused product or waste material must be disposed of in accordance with regulations governing radioactive materials.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Metaiodobenzylguanidine- I (MIBG- I) for diagnostics contains

• The active substance is meta-iodobenzylguanidine-131 I sulfate with an activity of 10 - 37 MBq/mL.
• The other constituents are: meta-iodobenzylguanidine sulfate, sodium pyrosulfite, copper(II) sulfate pentahydrate, sodium acetate trihydrate, acetic acid, benzyl alcohol, sodium chloride, water for injections.

What Metaiodobenzylguanidine- I (MIBG- I) for diagnostics looks like and contents of the pack
The MIBG-131 I solution is supplied in 10 mL glass vials allowing multiple sterile withdrawals.
The vial is closed with a rubber stopper and aluminum cap and placed inside a lead shielding container.
The outer transport packaging is a metal can with cushioning material.
Marketing Authorization Holder and Manufacturer
National Centre for Nuclear Research
Andrzeja Sołtana 7
05-400 Otwock
Tel: 22 7180700
Fax: 22 7180350
e-mail: [email protected]
The complete Product Information (SmPC) is provided as a separate document included in the product packaging, intended to provide healthcare professionals with additional scientific and practical information regarding administration and use of this radiopharmaceutical.