Metaiodobenziloguanidina 131 I (mibg- 131 I) do terapii

Package Leaflet: Information for the User

Metajodobenzyloguanidyna- I (MIBG- I) for therapy,

• 370 – 740 MBq/ml, solution for injection

Jobenguan (I)

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

• Keep this package 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 package leaflet, they should inform their doctor. See section 4.

Table of Contents of the Package Leaflet:

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

1. WHAT IS METAJODOBENZYLOGUANIDYNA- I (MIBG- I) FOR THERAPY AND

WHAT IS IT USED FOR

Metajodobenzyloguanidyna- I (MIBG- I) for therapy 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 therapeutic purposes.
Iodine [I] is a short-lived radioisotope with a half-life of 8.04 days.
Metajodobenzyloguanidyna- I (MIBG- I) for therapy is a radiopharmaceutical used in
cancer therapy. Therapeutically, MIBG- I is used to treat disseminated metastatic lesions of malignant pheochromocytoma, paraganglioma, neuroblastoma,
ganglioneuromas, and sometimes medullary thyroid cancer.

2. IMPORTANT INFORMATION BEFORE USING

METAJODOBENZYLOGUANIDYNA- I (MIBG- I) FOR THERAPY

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

If the patient is allergic to jobenguan (I)or any of the other ingredients of this medicine
(listed in section 6).
An absolute contraindication to the use of the preparation is:

• 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

cancer-related bone pain that does not respond to other treatments,

• renal failure requiring dialysis therapy.

A relative contraindication is:

• 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, so it should not be administered to premature infants
or newborns.

Warnings and precautions

Due to the risk of radiation exposure, 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 may need to be hospitalized due to the need to comply with radiological protection regulations.
Administering 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.
To reduce the radiation dose absorbed by the bladder, it is recommended to drink a bit more fluid than average (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 therapy with food and drink

No special precautions are recommended.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor before using this medicine.
An absolute contraindication to the use of the preparation is pregnancy and breastfeeding.
Before taking the medicine, the patient should inform the nuclear medicine specialist if:

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

In the case 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 be followed. After treatment, it is recommended to avoid pregnancy for 1 year.
Breastfeeding should be discontinued after administration of the first dose of the radiopharmaceutical due to the potential risk to the child's health. Breastfeeding can be resumed when the radiation dose that the child could receive during breastfeeding and during contact with the mother is within the legally established norms.

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 THERAPY

This medicine should always be used according to the doctor's recommendations. In case of doubts, consult a doctor.
Recommended dose:
Metajodobenzyloguanidyna- I (MIBG- I) for therapy is a preparation for intravenous administration in
doses of varying radioactive activity.
In cancer therapy using MIBG- I, the recommended single dose is approximately

• 3.7 GBq. The therapeutic dose should be diluted with physiological saline to a volume of about 50 ml and administered intravenously over 1.5-2 hours. The recommended dose is the same for adults and children. The activity of the radiopharmaceutical administered to patients should always be considered in relation to its diagnostic and therapeutic values.

Method of administration

Metajodobenzyloguanidyna- I (MIBG- I) for therapy is a preparation for intravenous administration under
the control of specialized personnel.
During administration of the medicine, the rules of safety at work in conditions of exposure to ionizing radiation should be strictly followed.

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 the nuclear medicine specialist. 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 nuclear medicine specialist

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

The radiopharmaceutical Metajodobenzyloguanidyna- I (MIBG- I) for therapy belongs to preparations
administered under strict medical control only in Nuclear Medicine Departments, by qualified personnel, so the risk of accidental administration is extremely low.
The preparation is supplied in doses of 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 and therapeutic values. This applies in particular to therapeutic doses, which may have serious side effects.
Administration of the medicine may cause: nausea, vomiting, flushing, radiation injury, hypothyroidism or hyperthyroidism, bone marrow suppression, anemia, thrombocytopenia, neutropenia, leukemia, secondary malignant tumors, increased susceptibility to infections.
In the case of therapeutic doses, the non-serious side effects resulting from the administration of the preparation are also overlaid with the effects resulting from radiotoxicity.
Exposure to ionizing radiation may lead to an increased incidence of cancer or genetic defects.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the package leaflet, the doctor should be informed. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will allow for the collection of more information on the safety of the medicine.

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

The medicine should be stored out of sight and reach of children.
The patient will not need to store this medicinal product.
Radiopharmaceuticals 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 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 2 hours at a temperature below 25°C. Transport should be carried out in dry ice.
Follow the recommendations for safety at work in exposure to ionizing radiation.
Metajodobenzyloguanidyna- I (MIBG- I) for therapy, solution for injection should be administered within 4 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 therapy preparation contain

• The active substance of the medicine is meta-jodo( I)benzyloguanidine sulfate with an activity of 370 - 740 MBq/ml.
• Other ingredients of the medicine are: sodium metabisulfite, copper (II) sulfate pentahydrate, sodium acetate trihydrate, acetic acid, benzyl alcohol, sodium chloride, water for injections

What does the Metajodobenzyloguanidyna- I (MIBG- I) for therapy preparation look like and what does the package 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.
A certificate of activity is attached to each source.

Marketing authorization holder and manufacturer

National Center for Nuclear Research
ul. Andrzeja Sołtana 7
05-400 Otwock
Tel: 22 718 07 00
Fax: 22 718 03 50
e-mail: polatom@polatom.pl

Date of approval of the package leaflet:

The Full Product Characteristics (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 on the administration and use of this radiopharmaceutical.