Patient Information

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

Iobenguane (123I)

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, the adrenal glands (located at the top of each kidney) and specific tumors.

The radioactive substance can be photographed from the outside of the body, using special cameras that take a scan. This examination shows where the radioactivity is located within the organ and the body. This provides the doctor with valuable information about how the 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 (known as 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 the heart are functioning.

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

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

• If you are allergic to the active ingredient or to 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 Spain is 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 neurological disease, such as Parkinson's disease and similar conditions.

Before administration of MIBG (123I) Curium Pharma Spain

• Before MIBG (123I) Curium Pharma Spain is administered to you, your doctor will instruct you to take another non-radioactive iodine-containing medication. 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 affect 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

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

The following medications or substances may especially 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
• Medications often used to treat stuffy nose or cough (such as phenylephrine, ephedrine, phenylpropanolamine)
• Reserpine and labetalol: medications for treating high blood pressure
• Medications for treating mental disorders with active ingredients whose names almost always end in «azina», such as phenothiazine, such as promethazine, levomepromazine, perphenazine
• Cocaine (a substance of abuse)

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your nuclear medicine doctor before this medication is administered to you.

You should inform your nuclear medicine doctor before the administration of MIBG (123I) Curium Pharma Spain if there is any possibility of pregnancy, if you experience a delay in your period, or if you are breastfeeding.

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

If you are pregnant

Your nuclear medicine doctor will only administer this medication during pregnancy if the expected benefit outweighs the risk.

If you are breastfeeding

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

Driving and operating machines

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

MIBG (123I) Curium Pharma Spain contains sodium

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

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

The nuclear physician overseeing the procedure will decide on the amount ofMIBG (123I) Curium PharmaSpainto be used in your case. This will be the minimum amount necessary to obtain the desired information. The generally recommended dose for an adult varies between 110-400 MBq (MegaBecquerel, the unit used to express radioactivity).

Use in children and adolescents

The dose to be administered will be adjusted according to your body weight in children and adolescents.

Administration ofMIBG (123I) Curium PharmaSpain and procedure performance

MIBG (123I) Curium PharmaSpainis administered intravenously in a slow manner (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 PharmaSpain, it is possible that you will be administered a sodium chloride injection to reduce the risk of pain at the injection site (see section 4).

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

Procedure duration

Your nuclear physician 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 instructions of the nuclear physician.

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

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

A overdose is unlikely because you will receive a single, precisely controlled dose of MIBG (123I) Curium PharmaSpaincontrolled by the nuclear physician overseeing the procedure. However, in the event of an overdose, you will receive the appropriate treatment.

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

If you have any other questions about the use of MIBG (123I) Curium PharmaSpain, ask the nuclear physician overseeing the procedure.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

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

These symptoms should disappear within an hour.

Other adverse 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
• tingling or numbness in hands and feet
• local inflammation, pain, and other reactions at the injection site, tissue damage in case of accidental leakage of the medication into surrounding tissue.

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

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

The administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and hereditary defects.

Reporting Adverse Effects

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

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

This medication does not need to be stored by you. This medication will be stored under the responsibility of the specialist in suitable facilities. Storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended solely for the specialist.

Do not use this medication after the expiration date that appears on the label after “CAD”.

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

Composition of MIBG ( 123 I) Curium Pharma Spain

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

Appearance of the product and content of the packaging

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

MIBG ( 123 I) 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).

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Curium Pharma Spain S. A.

Avenida Doctor Severo Ochoa, Nº29

28100, Alcobendas, Madrid

Responsible for manufacturing:

Curium Netherlands B.V.

Westerduinweg 3

1755 LE Petten

Netherlands

Last review date of this leaflet: June 2023

This information is intended solely for healthcare professionals:

The complete technical data sheet of MIBG ( 123 I) 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 refer to the technical data sheet.