Metaiodobenzylguanidine 131 i (mibg-131 i) for therapy

Package leaflet: Information for the user

Metajodobenzyloguanidyna 131 I (MIBG- 131 I) do terapii,
370 – 740 MBq/ml, solution for injection
Jobenguan ( 131 I)
Please read this leaflet carefully before use as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, 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 immediately. See section 4.

Leaflet contents:

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

1. WHAT IS METAJODOBENZYLOGUANIDYNA 131 I (MIBG- 131 I) DO TERAPII AND FOR WHAT PURPOSE IS IT USED?

Metajodobenzyloguanidyna 131 I (MIBG- 131 I) do terapii is a radiopharmaceutical containing the active substance, radioactive iodine-131. The medicinal product is administered intravenously in doses of varying radioactivity for therapeutic purposes.
Iodine-131 is a short-lived radioisotope with a half-life of 8.04 days.
Metajodobenzyloguanidyna 131 I (MIBG- 131 I) do terapii is a radiopharmaceutical used in cancer therapy. Therapeutically, MIBG- 131 I is indicated for the treatment of disseminated metastatic lesions in malignant forms of pheochromocytoma, paraganglioma, neuroblastoma, carcinoids, and occasionally medullary thyroid carcinoma.

2. IMPORTANT INFORMATION BEFORE USE

METAIODOBENZYLGUANIDINE-131 I (MIBG-131 I) FOR THERAPY
When not to use metaiodobenzylguanidine-131 I (MIBG-131 I) for therapy?
If the patient is allergic to iofenguan (131I) or to any of the other components of this medicinal product (listed in section 6).
Absolute contraindications are:

• hypersensitivity to the active substance or to any of the excipients,
• confirmed, suspected or not excluded pregnancy,
• breastfeeding,
• short expected survival time of the patient (less than 3 months), except in patients with

untreatable bone cancer pain,

• renal failure requiring dialysis therapy.

Relative contraindications are:

• rapidly progressing renal failure,
• progressive bone marrow damage and/or impaired renal function due to previous treatment,
• bone marrow tissue damage,
• unacceptable medical risk associated with the necessity of 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:

• patients who may not comply with medical staff instructions,
• patients 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 radiopharmaceuticals poses a risk of exposure to external ionizing radiation or contamination (e.g. 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, increased fluid intake (approximately 1–1.5 litres more per day than usual) and frequent bladder emptying are recommended after administration of the medicinal product.
Metaiodobenzylguanidine-131 I (MIBG-131 I) for therapy and other medicines
Inform the physician about all medicines currently used or recently used, as well as any medicines the patient intends to take.
The following medicines may affect retention or reduce uptake of iofenguan:

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

Reduced uptake may be caused by:

• 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.

Inhibition of iofenguan accumulation may be caused by:

• antihypertensive drugs acting via blockade of adrenergic neurons (betanidine, debrisoquine, bretylium and guanethidine)
• antidepressants such as maprotiline and trazodone.

Administration of these drugs should be discontinued prior to starting therapy.
The above factors indicate that the physician should be fully aware of the patient's medical history.
Metaiodobenzylguanidine-131 I (MIBG-131 I) for therapy 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 plans to have a child, she should consult a physician before using this medicinal product.
Pregnancy and breastfeeding are absolute contraindications for the use of this medicinal product.
Before administration of the medicinal product, the nuclear medicine specialist must be informed if:

• pregnancy is suspected 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 procedure 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 follow the rule of being given within the first 10 days after menstruation or after a negative pregnancy test result. After treatment, pregnancy should be avoided for 1 year.
Breastfeeding must be discontinued after the first dose of the radiopharmaceutical due to potential health risks to the infant. Breastfeeding may be resumed when the radiation dose the infant would receive during breastfeeding and contact with the mother remains within legally defined limits.
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 THERAPY

(MIBG- I) FOR THERAPY
This medicinal product must always be used in accordance with the instructions given by the physician.
In case of doubts, consult your doctor.

Recommended dose:
Metaiodobenzylguanidine- I (MIBG- I) for therapy is a preparation intended for intravenous administration, with varying levels of radioactive activity.
In oncological 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 both adults and children.
The radioactivity of the radiopharmaceutical administered to patients should always be considered in relation to its diagnostic and therapeutic value.

Method of administration
Metaiodobenzylguanidine- I (MIBG- I) for therapy is intended for intravenous administration under the supervision of specialized personnel.
During administration, strict adherence to safety procedures for working with ionizing radiation is required.

Administration of a higher than recommended dose
Overdose is nearly impossible, as the dose administered to the patient is strictly controlled by a nuclear medicine specialist physician. However, in the event of an overdose, the physician will initiate appropriate treatment.
If you have any doubts regarding the use of this medicinal product, please consult a nuclear medicine specialist physician.

If Metaiodobenzylguanidine- I (MIBG- I) for therapy has been accidentally administered
The radiopharmaceutical Metaiodobenzylguanidine- I (MIBG- I) for therapy belongs to preparations administered under strict medical supervision exclusively in Nuclear Medicine Departments by qualified personnel; therefore, the risk of accidental administration is extremely low.
The product is supplied in doses of known activity, which facilitates the physician’s control over the dose to be administered to the patient. In the event of accidental administration of an excessive amount of radioactive substance, radiation exposure risk may be reduced by administering increased 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 and therapeutic value. This particularly applies to therapeutic doses, which may cause serious side effects.

Administration of the medicine may cause: nausea, vomiting, transient skin flushing, radiation injury, hypothyroidism or hyperthyroidism, bone marrow suppression, anaemia, thrombocytopenia (low platelet count), neutropenia, leukaemias, secondary malignant tumours, increased susceptibility to infections.

In the case of therapeutic doses, the above-mentioned non-serious side effects resulting from administration of the preparation are accompanied by effects resulting from radiotoxicity. Exposure to ionizing radiation may lead to an increased risk of developing cancer or may result in hereditary defects.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your 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 Warsaw,
tel.: + 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 helps to provide more information on the safe use of the medicine.

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

(MIBG- I) FOR THERAPY
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 regarding radioactive substances.
The following information is intended solely for medical personnel.
Do not use the product after the expiry date stated on the container.
The medicinal product should be stored below -15°C in a shielded container providing radiation protection, in accordance with the Atomic Law regulations. Protect from light. After thawing, store for up to 2 hours below 25°C. Transport should be carried out using dry ice.
Follow recommendations concerning safety precautions when working with ionizing radiation.
Metajodobenzyloguanidyna- I (MIBG- I) for therapy, solution for injection, should be administered within 4 days from the date of production.
Any unused product or waste material must be disposed of in accordance with regulations governing radioactive materials.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Metajodobenzyloguanidyna-131 I (MIBG-131 I) for therapy contains

• The active substance is meta-iodo[131I]benzylguanidine sulfate with an activity of 370–740 MBq/ml.
• 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-131 I (MIBG-131 I) for therapy 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 an aluminium seal, and placed inside a lead shielding container. The outer transport packaging is a metal can with cushioning material. A certificate of activity is attached to each source.

Marketing Authorisation Holder and Manufacturer
National Centre for Nuclear Research
Andrzeja Sołtana 7
05-400 Otwock
Tel: +48 22 718 07 00
Fax: +48 22 718 03 50
e-mail: [email protected]

The full Product Information (SmPC) is provided as a separate document inside the product packaging, intended to provide healthcare professionals with additional scientific and practical information regarding administration and use of this radiopharmaceutical.