MIBG (123I) Curium Pharma Spain 74 MBq/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

MIBG (123I) Curium Pharma Spain 74 MBq/ml solution for injection

Iobenguane (123I)

Contents of the leaflet:

1. What MIBG (123I) Curium Pharma Spain is and what it is used for
2. What you need to know before using MIBG (123I) Curium Pharma Spain
3. How to use MIBG (123I) Curium Pharma Spain
4. Possible side effects
5. Storage of MIBG (123I) Curium Pharma Spain
6. Contents of the pack and other information

1. What MIBG (123I) Curium Pharma Spain is and what it is used for

This medicine is a radiopharmaceutical for diagnostic use only.

This medicine contains iobenguane (123I), a radioactive substance which, when injected, accumulates in certain organs such as the heart, adrenal glands (located on top of each kidney), and specific tumors.

The radioactive substance can be imaged from outside the body using special cameras that perform a scan. This imaging shows where the radioactivity is located within the organ and body. This provides valuable information to the physician about how that organ is functioning or where a tumor is located.

MIBG (123I) Curium Pharma Spain is used in adults and children:

• to detect specific tumors, such as tumors of the adrenal glands and other hormone-producing tumors (so-called neuroendocrine tumors),
• to detect, plan, and monitor treatment of neuroblastomas (tumors of the nervous system affecting mainly children),
• to calculate the amount of iobenguane (123I) absorbed by the body before starting treatment with iobenguane,
• to assess the function of the adrenal glands or the heart.

The use of MIBG (123I) Curium Pharma Spain involves exposure to small amounts of radiation. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will receive from the radiopharmaceutical procedure outweighs the risk associated with radiation exposure.

2. What you need to know before using MIBG (123I) Curium Pharma Spain

MIBG (123I) Curium Pharma Spain must not be used

• If you are allergic to the active substance or to any of the other components of MIBG (123I) Curium Pharma Spain (listed in section 6).

Warnings and precautions

Consult your nuclear medicine physician before being administered MIBG (123I) Curium Pharma Spain

• if you are pregnant or think you might be pregnant,
• if you are breastfeeding,
• if you have reduced kidney function,
• if you have any disease affecting the nervous system, such as Parkinson's disease or Parkinsonism-like disorders.

Before administration of MIBG (123I) Curium Pharma Spain

• Before receiving MIBG (123I) Curium Pharma Spain, your doctor will instruct you to take another medication containing non-radioactive iodine. This medication is intended to prevent the accumulation of radioactivity in your thyroid gland.
• You should drink plenty of water before starting the procedure to urinate as frequently as possible during the first hours after completion.
• Your doctor may ask you to stop taking certain medications that could interfere with the procedure (see section "Other medicines and MIBG (123I) Curium Pharma Spain").

Children and adolescents

Consult your nuclear medicine physician if you are under 18 years of age.

Use of other medicines and MIBG (123I) Curium Pharma Spain

Inform your nuclear medicine physician if you are taking, have recently taken, or might need to take any other medicines, as some medicines may interfere with image interpretation.

The following medicines or substances may particularly affect the procedure:

• Calcium channel blockers (such as diltiazem, nifedipine, verapamil) used to treat high blood pressure and heart disorders
• Tricyclic antidepressants (such as amitriptyline, imipramine) used to treat depression
• Medicines often used to treat nasal congestion or cough (such as phenylephrine, ephedrine, phenylpropanolamine)
• Reserpine and labetalol: medicines used to treat high blood pressure
• Medicines used to treat mental disorders with active substances whose names almost always end in «azine», such as phenothiazines, e.g., promethazine, levomepromazine, perphenazine
• Cocaine (a drug of abuse)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your nuclear medicine physician before receiving this medicine.

You must inform the nuclear medicine physician before administration of MIBG (123I) Curium Pharma Spain if there is any possibility you might be pregnant, if you have missed a period, or if you are breastfeeding.

In case of doubt, it is important that you consult your nuclear medicine physician supervising the procedure.

If you are pregnant

The nuclear medicine physician will only administer this medicine during pregnancy if the expected benefit outweighs the potential risk.

If you are breastfeeding

The nuclear medicine physician may postpone the procedure until you stop breastfeeding, or may ask you to discontinue breastfeeding. If this is not possible, your doctor may instruct you to interrupt breastfeeding for 3 days and to discard the milk expressed during this period, until radioactivity has been eliminated from your body.

Driving and use of machines

It is considered unlikely that MIBG (123I) Curium Pharma Spain will affect your ability to drive or operate machinery.

MIBG (123I) Curium Pharma Spain contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per vial; this is essentially "sodium-free".

3. How to use MIBG (123I) Curium Pharma Spain

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. MIBG (123I) Curium Pharma Spain will only be used in specially controlled areas. This product will only be handled and administered by trained and qualified personnel who are skilled in its safe use. These individuals will take special care in the safe handling of this product and will inform you of their actions.

The nuclear medicine physician supervising the procedure will determine the amount of MIBG (123I) Curium Pharma Spain to be used in your case. This will be the minimum quantity necessary to obtain the required information. The generally recommended dose for administration in adults ranges between 110–400 MBq (Megabecquerel, the unit used to express radioactivity).

Use in children and adolescents

In children and adolescents, the administered dose will be adjusted according to body weight.

Administration of MIBG (123I) Curium Pharma Spain and performance of the procedure

MIBG (123I) Curium Pharma Spain is administered intravenously as a slow injection (given into a vein over several minutes). You will be continuously monitored during administration because a sudden and severe increase in blood pressure may occur if the injection is given too rapidly (see section 4).

A single injection is sufficient to perform the procedure required by your physician.

After injection of MIBG (123I) Curium Pharma Spain, you may be given an injection of sodium chloride to reduce the risk of injection site pain (see section 4).

Images are acquired between 15 minutes and 24 hours after injection. Imaging may be repeated the following day.

Duration of the procedure

Your nuclear medicine physician will inform you about the usual duration of the procedure.

After administration of MIBG (123I) Curium Pharma Spain:

• You should drink fluids and urinate frequently to help eliminate the product from your body.
• Children and adolescents must continue taking non-radioactive iodine to prevent accumulation of radioactivity in the thyroid gland, according to the instructions provided by the nuclear medicine physician.

The nuclear medicine physician will inform you if you need to take any special precautions after receiving this medicine. Consult your nuclear medicine physician if you have any doubts.

If you are administered more MIBG (123I) Curium Pharma Spain than you should have received

An overdose is unlikely, as you will receive a single dose of MIBG (123I) Curium Pharma Spain that is precisely controlled by the nuclear medicine physician supervising the procedure. However, in the event of an overdose, appropriate treatment will be administered.

Additionally, the nuclear medicine physician in charge of the procedure may recommend that you drink plenty of fluids and urinate frequently to help eliminate residual radioactivity from your body.

If you have any further questions about the use of MIBG (123I) Curium Pharma Spain, please consult the nuclear medicine physician supervising the procedure.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The following adverse effects may occur with unknown frequency, during or immediately after injection, if administered too rapidly:

• fast or irregular heartbeat
• difficulty breathing
• sensation of warmth, more than usual
• temporary high blood pressure. Symptoms may include headache and changes in vision (visual disturbance).
• cramps and abdominal pain

These symptoms should disappear within one hour.

Other adverse effects occurring with unknown frequency are:

• Allergic reactions with symptoms such as:

  • difficulty breathing or dizziness,
  • redness,
  • itching, hives,
  • nausea, vomiting,
  • chills

• Headache

• Tingling or numbness in hands and feet

• Local swelling, pain and other reactions at the injection site, skin and tissue damage in case of accidental leakage of the medicine into surrounding tissue.

If you experience any of these, consult your nuclear medicine physician immediately.

In case of an allergic reaction, you will receive appropriate treatment.

Administration of this radiopharmaceutical involves exposure to a small amount of ionizing radiation, with a very low risk of developing cancer and hereditary defects.

Reporting of adverse effects

If you experience any type of adverse effect, consult your nuclear medicine physician, even if it is an adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of MIBG (123I) Curium Pharma Spain

You will not have to store this medicinal product. This medicine is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.

The following information is intended for the specialist only.

Do not use this medicinal product after the expiry date stated on the label following “EXP”.

Do not use this medicinal product if you notice any visible signs of deterioration.

6. Contents of the container and additional information

Composition of MIBG (123I) Curium Pharma Spain

• The active substance is iobenguane (123I) as iobenguane sulfate.
  • One millilitre contains 74 MBq of iobenguane (123I) and 0.5 mg of iobenguane sulfate.
• The other components are citric acid monohydrate, sodium citrate dihydrate, and water for injectable preparations.

Appearance of the medicinal product and contents of the container

MIBG (123I) Curium Pharma Spain is a clear, colourless or slightly yellow injectable solution. It is supplied in 10 ml Type I glass vials, sealed with a rubber stopper and aluminium overseal.

MIBG (123I) Curium Pharma Spain is supplied in a vial containing 1 ml (74 MBq), 2 ml (148 MBq), 3 ml (222 MBq), 4 ml (296 MBq) or 5 ml (370 MBq).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Curium Pharma Spain S. A.

Avenida Doctor Severo Ochoa, Nº29

28100, Alcobendas, Madrid

Manufacturer:

Curium Netherlands B.V.

Westerduinweg 3

1755 LE Petten

The Netherlands

Date of the most recent review of this summary: June 2023

This information is intended for healthcare professionals only:

The full product information (package leaflet) for MIBG (123I) Curium Pharma Spain is included as a separate document within the product packaging, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the product information.