MIBG (123I) CURIUM PHARMA SPAIN 74 MBq/ml INJECTABLE SOLUTION

Introduction

Prospective: patient information

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

Iobenguane (123I)

Contents of the prospectus:

1. What MIBG (123I) Curium Pharma Spain is and what it is used for
2. What you need to know before starting to use 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. Package contents and additional information

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

This medication is a radiopharmaceutical for diagnostic use only.

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

The radioactive substance can be photographed from outside the body using special cameras that take a scan. This examination shows where the radioactivity is inside the organ and body. This provides the doctor with valuable information 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 adrenal gland tumors and other hormone-producing tumors (called neuroendocrine tumors),
• to detect, plan, and monitor the treatment of neuroblastomas (tumors in the nervous system that mainly affect children),
• to calculate the amount of iobenguane (123I) absorbed by the body before starting treatment with iobenguane,
• to examine how the adrenal glands or heart are functioning.

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

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

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

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

Warnings and precautions

Consult your nuclear medicine doctor before MIBG (123I) Curium Pharma Spainis administered to you

• if you are pregnant or think you may be pregnant,
• if you are breastfeeding,
• if you have reduced kidney function,
• if you have any disease that affects the nervous system, such as Parkinson's disease and similar diseases

Before administration of MIBG (123I) Curium PharmaSpain

• Before MIBG (123I) Curium Pharma Spain is administered to you, your doctor will tell you to take another medication that contains non-radioactive iodine. This medication is 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 its completion.
• your doctor may ask you to stop taking some medications that may interfere with the procedure (see section "Other medications and MIBG (123I) Curium Pharma Spain")

Children and adolescents

Consult your nuclear medicine doctor if you are under 18 years old.

Use of other medications andMIBG (123I) Curium Pharma Spain

Tell your nuclear medicine doctor if you are taking, have recently taken, or may need to take any other medication, as some medications may interfere with the interpretation of the images.

The following medications or substances may particularly influence the procedure:

• Calcium channel blockers (such as diltiazem, nifedipine, verapamil) used to treat high blood pressure and heart disorders
• Tricyclic antihypertensives (such as amitriptyline, imipramine) used to treat depression
• Medications commonly used to treat a stuffy nose or cough (such as phenylephrine, ephedrine, phenylpropanolamine)
• Reserpine and labetalol: medications to treat high blood pressure
• Medications for the treatment of mental disorders with active ingredients whose names almost always end in "azine", such as phenothiazine, such as 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 doctor before this medication is administered to you.

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

In case of doubt, it is essential that you consult your nuclear medicine doctor who supervises the procedure.

If you are pregnant

The nuclear medicine doctor will onlyadminister this medication during pregnancy if the benefit is expected to outweigh the risk.

If you are breastfeeding

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

Driving and using machines

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

MIBG (123I) Curium Pharma Spain contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per vial; i.e., it is essentially "sodium-free".

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

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

The nuclear medicine doctor supervising the procedure will decide the amount of MIBG (123I) Curium Pharma Spain to be used in your case. This will be the minimum amount necessary to obtain the desired information. The generally recommended amount for administration to an adult varies between 110-400 MBq (Megabecquerel, the unit used to express radioactivity).

Use in children and adolescents

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

Administration ofMIBG (123I) Curium PharmaSpain and performance of the procedure

MIBG (123I) Curium Pharma Spain is administered intravenously slowly (injected into a vein over several minutes). You will be constantly monitored during administration because a sudden and severe increase in blood pressure may occur if it is administered too quickly (see section 4).

A single injection is sufficient to perform the procedure your doctor needs.

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

Images are taken between 15 minutes and 24 hours after the injection. The images may be repeated the next day.

Duration of the procedure

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

After administration of MIBG (123I) Curium PharmaSpain:

• You should drink and urinate frequently to eliminate the product from your body,
• Children and adolescents should continue taking non-radioactive iodine to stop the accumulation of radioactivity in the thyroid gland, according to the nuclear medicine doctor's instructions.

The nuclear medicine doctor will inform you if you need to take special precautions after this medication is administered to you. Consult your nuclear medicine doctor if you have any doubts.

If you are given moreMIBG (123I) Curium Pharma Spainthan you should

Overdose is unlikely because you will receive a single, precisely controlled dose of MIBG (123I) Curium Pharma Spain from the nuclear medicine doctor supervising the procedure. However, in case of overdose, you will receive appropriate treatment.

Additionally, the nuclear medicine doctor in charge of the procedure may recommend that you drink plenty of water and urinate frequently to eliminate the traces of radioactivity from your body.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The following side effects may occur with an unknown frequency, during or immediately after the injection, if administered too quickly:

• rapid or irregular heartbeat
• difficulty breathing
• feeling of heat, 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 an hour.

Other side effects that occur with an unknown frequency are:

• Allergic reactions with symptoms such as:
• • difficulty breathing or dizziness,
  • redness,
  • itching, hives,
  • nausea, vomiting,
  • chills

• Headache
• Numbness or tingling in hands and feet
• Local inflammation, pain, and other reactions at the injection site, skin and tissue damage in case of accidental leakage of the medication into the surrounding tissue.

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

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

Administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and genetic defects.

Reporting of side effects

If you experience any side effects, consult your nuclear medicine doctor, even if they are side effects not listed in this prospectus. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

You will not need to store this medication. This medication is stored under the responsibility of the specialist in suitable facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended only for specialists.

Do not use this medication after the expiration date shown on the label after "EXP".

Do not use this medication if you notice visible signs of deterioration.

6. Package contents and additional information

Composition of MIBG (123I) Curium Pharma Spain

• The active substance is iobenguane (123I) as iobenguane sulfate.
• • One milliliter 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 product and package contents

MIBG (123I) Curium Pharma Spain is a clear, colorless or slightly yellowish injectable solution. It is supplied in 10 ml type I glass vials, sealed with a rubber stopper and aluminum 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 authorization holder and manufacturer

Marketing authorization holder:

Curium Pharma Spain S.A.

Avenida Doctor Severo Ochoa, Nº29

28100, Alcobendas, Madrid

Manufacturer:

Curium Netherlands B.V.

Westerduinweg 3

1755 LE Petten

Netherlands

Date of the last revision of this prospectus: June 2023

This information is intended only for healthcare professionals:

The complete technical data sheet of MIBG (123I) Curium Pharma Spain is included as a separate document in 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 technical data sheet.