Metaiodobenziloguanidina 131 I (mibg- 131 I) do diagnostiki

Package Leaflet: Information for the User

Metajodobenzyloguanidyna- I (MIBG- I) for diagnostic purposes,

• 10 – 37 MBq/ml, solution for injection

Read the package leaflet carefully before using the medicine because it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a specialist in nuclear medicine
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, inform the specialist in nuclear medicine. See section 4.

Table of Contents of the Leaflet:

• 1. What is Metajodobenzyloguanidyna- I (MIBG- I) for diagnostic purposes and what is it used for?
• 2. Important information before using Metajodobenzyloguanidyna- I (MIBG- I) for diagnostic purposes.
• 3. How to use the Metajodobenzyloguanidyna- I (MIBG- I) for diagnostic purposes preparation.
• 4. Possible side effects.
• 5. How to store the Metajodobenzyloguanidyna- I (MIBG- I) for diagnostic purposes preparation.
• 6. Contents of the package and other information.

1. WHAT IS METAJODOBENZYLOGUANIDYNA- I (MIBG- I) FOR DIAGNOSTIC

PURPOSES AND WHAT IS IT USED FOR

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

• isotopic diagnostics (detection, localization, assessment of the degree of advancement, control after treatment) of neuroendocrine tumors. These include: pheochromocytoma, neuroblastoma, ganglioneuroma, medullary thyroid carcinoma.
• examining the uptake and retention of MIBG (I) in order to determine indications and plan treatment with high activities of MIBG (I)
• evaluating the response to treatment by examining the uptake and number of MIBG (I) accumulation foci.
• confirming the neuroendocrine nature of tumors of uncertain origin.

2. IMPORTANT INFORMATION BEFORE USING

METAJODOBENZYLOGUANIDYNA- I (MIBG- I) FOR DIAGNOSTIC PURPOSES

When not to use Metajodobenzyloguanidyna- I (MIBG- I) for diagnostic purposes?

If the patient is allergic to MIBG (I) or any of the other components of this medicine (listed in section 6). Absolute contraindications to the use of the preparation include:

• hypersensitivity to the active substance or to any of the excipients,
• confirmed, suspected or unruled pregnancy,
• breastfeeding,
• short expected survival time of the patient (less than 3 months), except for patients with tumor bone pain that does not respond to other treatments,
• renal failure requiring dialysis therapy.

Relative contraindications include:

• rapidly progressing renal failure,
• progressive bone marrow damage and/or impaired renal function due to previous treatment,
• bone marrow 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 should not be administered to premature infants or newborns.

Warnings and precautions

Due to the risk of radiation contamination, caution should be exercised when treating patients with radioactive iodine who:

• may not follow the recommendations of medical staff,
• have urinary incontinence.

Some patients receiving high activities of iodine-131 isotope may need to be hospitalized due to the need to comply with radiological protection regulations. The administration of drugs containing radioactive isotopes poses a risk of exposure to external ionizing radiation or contamination caused by urine stains, vomiting, etc. to other people. Therefore, basic hygiene rules should be followed. In order to reduce the radiation dose absorbed by the bladder, it is recommended to drink a slightly larger than average amount of fluids (about 1-1.5 liters per day more) and to empty the bladder more frequently after administration of the medicine.

Metajodobenzyloguanidyna- I (MIBG- I) for diagnostic purposes and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

• Nifedipine (calcium channel blocker) - causes prolonged retention of MIBG

The following may decrease 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 its derivatives, imipramine and its derivatives, doxepin, amoxapine and loxapine.

The following may inhibit MIBG accumulation:

• antihypertensive drugs acting through blockade of adrenergic neurons (betanidine, debrisoquine, bretylium and guanethidine).
• antidepressants, such as maprotiline and trazodone. The use of these drugs should be discontinued before starting treatment

The above factors indicate that the doctor should be aware of the patient's medical history

Metajodobenzyloguanidyna- I (MIBG- I) for diagnostic purposes with food and drink

No special precautions are recommended.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, consult your doctor before using this medicine. Absolute contraindications to the use of the preparation include pregnancy and breastfeeding. Before taking the medicine, inform the specialist in nuclear medicine if:

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

In the event of the need to administer radiopharmaceuticals to women of childbearing age, it should be ensured that the woman is not pregnant. The rule of administering iodine-131 up to the tenth day after menstruation, or after obtaining a negative pregnancy test result, should apply. After treatment, it is recommended to avoid pregnancy for 1 year. In the event of the need to administer a radiopharmaceutical to a breastfeeding woman, breastfeeding should be discontinued.

Driving and using machines

No effect on the ability to drive and use machines has been described.

3. HOW TO USE THE METAJODOBENZYLOGUANIDYNA- I (MIBG- I) FOR

DIAGNOSTIC PURPOSES PREPARATION

This medicine should always be used according to the doctor's recommendations. In case of doubts, consult a doctor. The recommended dose: (MIBG- I) is a preparation for intravenous administration in doses of varying radioactive activity, different in diagnostics and different in therapy. The dosage depends on the type of examination. The recommended dose in adults is 40 – 80 MBq (1.2-2.2 mCi). The dose used in children is determined based on the child's weight or body surface area. The dose of the medicine is determined by a specialist in nuclear medicine. This activity should be determined individually for each patient. It will be the minimum dose necessary to obtain the expected diagnostic information.

Method of administration

For diagnostic examinations, the radiopharmaceutical is administered intravenously slowly, over approximately 30 seconds. MIBG I, solution for injection is administered only in appropriate clinical conditions and only by properly qualified personnel. These persons take special precautions to ensure safe use of the medicine and will be informed about their actions.

Use of a higher than recommended dose of the medicine

Overdose is almost impossible, because the dose of the product administered to the patient is strictly controlled by a specialist in nuclear medicine. However, in the event of an overdose, the doctor will use appropriate treatment. In case of any doubts related to the use of the medicine, consult a specialist in nuclear medicine

If the Metajodobenzyloguanidyna- I (MIBG- I) for diagnostic purposes preparation was administered by mistake

The radiopharmaceutical Metajodobenzyloguanidyna- I (MIBG- I) for diagnostic purposes belongs to preparations administered under strict medical supervision only 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 considered in relation to its diagnostic value. The preparation is supplied as a solution in vials with a known activity, which makes it easier for the doctor to control the dose to be administered to the patient. In the event of administration of an excessive amount of radioactive substance, the risk of radiation exposure can be reduced by administering larger amounts of fluids.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. The activity of the radiopharmaceutical dose administered 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 harmless symptoms of allergic reactions. Exposure to ionizing radiation may lead to increased incidence of cancer or genetic defects.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, inform your doctor. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Medical Devices and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE THE METAJODOBENZYLOGUANIDYNA- I (MIBG- I) FOR

DIAGNOSTIC PURPOSES PREPARATION
The medicine should be stored out of sight and reach of children. The patient will not need to store this medicinal product. Radiopharmaceutical products are stored only by authorized persons in appropriate clinical conditions. Storage of radiopharmaceuticals is carried out in accordance with local regulations regarding radioactive substances. The following information is intended only for medical personnel. Do not use the product after the expiry date stated on the packaging. The medicine should be stored in the original packaging at a temperature below

• 15°C in a shield ensuring radiation safety in accordance with the Atomic Law. Protect from light. After thawing, store for 4 hours at a temperature below 25°C. Transport should be carried out in dry ice. Metajodobenzyloguanidyna- I (MIBG- I) for diagnostic purposes, solution for injection should be administered within 9 days of the production date. Unused product or material waste should be disposed of in accordance with the requirements of regulations regarding radioactive materials.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What does the Metajodobenzyloguanidyna- I (MIBG- I) for diagnostic purposes preparation contain

• The active substance of the medicine is metajodobenzyloguanidyna- I sulfate with an activity of 10 - 37 MBq/ ml.
• Other components of the medicine are: metajodobenzyloguanidyna- I sulfate, sodium pyrosulfite, copper (II) sulfate pentahydrate, sodium acetate trihydrate, acetic acid, benzyl alcohol, sodium chloride, water for injections.

What does the Metajodobenzyloguanidyna- I (MIBG- I) for diagnostic purposes medicine look like and what does the packaging contain

The MIBG- I solution is supplied in 10 ml glass vials with the possibility of multiple sterile sampling. The vial is closed with a rubber stopper and an aluminum cap and placed in a lead shielding container. The outer transport packaging is a metal box with filling.

Responsible entity and manufacturer

National Center for Nuclear Research
ul. Andrzeja Sołtana 7
05-400 Otwock
Tel: 22 7180700
Fax: 22 7180350
e-mail: polatom@polatom.pl

Date of approval of the leaflet:

The Full Characteristic of the Medicinal Product (ChPL) is attached as a separate document to the packaging of the product, in order to provide healthcare professionals with additional, scientific and practical information regarding the administration and use of this radiopharmaceutical.