Lutapol

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the patient

LutaPol, radiopharmaceutical precursor, solution

Lutetium (Lu) chloride

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, please consult a nuclear medicine specialist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, please inform the nuclear medicine specialist. See section 4.

Table of contents of the leaflet:

What is LutaPol and what is it used for
Important information before using LutaPol
How to use LutaPol
Possible side effects
How to store LutaPol
Contents of the packaging and other information

1. WHAT IS LUTAPOL AND WHAT IS IT USED FOR

LutaPol is a radiopharmaceutical product intended for therapy only after combination with another medicinal product that targets specific cells in the body. After reaching the target, these cells receive small doses of radiation from the LutaPol product.
The use of lutetium (Lu) labeled drugs is associated with exposure to small doses of radiation. The treating physician and the nuclear medicine specialist have determined that the clinical benefit of the procedure using the radiopharmaceutical product outweighs the risk associated with radiation exposure.
More information on the use and possible side effects of lutetium (Lu) labeled medicinal products is available in the leaflet attached to the packaging of the specific medicinal product intended for labeling.

2. IMPORTANT INFORMATION BEFORE USING LUTAPOL

When not to use LutaPol

if the patient is allergic to lutetium (Lu) chloride or any of the other ingredients of this product (listed in section 6).

Warnings and precautions

Special caution should be exercised when using a radiolabeled drug with LutaPol:
if the patient is pregnant or suspected to be pregnant (see below)
if the patient is breastfeeding.
LutaPol is a radiopharmaceutical product used only after combination with another medicinal product.
It is not intended for direct administration to patients.
Treatment with radiolabeled lutetium (Lu) may lead to the following side effects:

• decrease in red blood cell count (anemia),
• decrease in platelet count in the blood (thrombocytopenia), which plays an important role in stopping bleeding (thrombocytopenia),
• decrease in white blood cell count, which plays an important role in protecting the body against infection (leukopenia, lymphopenia, or neutropenia).

Most of these events are mild and transient. In some patients, a decrease in the number of all three types of blood cells (red blood cells, platelets, and white blood cells - pancytopenia) has been reported, requiring discontinuation of treatment.
Since lutetium (Lu) may sometimes affect blood cells, the doctor will perform blood tests before starting treatment and will perform them at regular intervals during treatment.
Please talk to your doctor if you experience shortness of breath, bluish discoloration, nosebleeds, bleeding from the gums, or fever.
During targeted radioisotope therapy based on somatostatin analogs used to treat neuroendocrine tumors, radiolabeled somatostatin analogs are excreted by the kidneys. Therefore, before starting treatment, the doctor will perform a blood test to check the patient's kidney function.
Treatment with lutetium (Lu) may cause liver function disorders. To monitor liver function during treatment, the doctor will perform a blood test.
After treatment of neuroendocrine tumors with lutetium (Lu), patients may experience symptoms related to the release of hormones from tumor cells, which is called a tumor flare. The patient should inform the doctor if they feel weak or dizzy, or if they experience sudden flushing of the face or diarrhea after treatment.
Treatment with lutetium (Lu) may cause tumor lysis syndrome (TLS) due to the rapid breakdown of tumor cells. This can lead to abnormal blood test results, irregular heart rhythm, kidney failure, or seizures within a week after treatment. The doctor will perform blood tests to monitor the patient for TLS. Please inform the doctor if you experience muscle cramps, muscle weakness, confusion, or shortness of breath.
Radiolabeled products with lutetium (Lu) may be administered directly into the patient's vein through a tube called a cannula. Cases of fluid leakage into the surrounding tissue (extravasation) have been reported. Please tell the doctor if the patient experiences swelling or pain in the arm.

Before administering LutaPol, the patient should:

• drink plenty of water before administration of the radiolabeled drug to urinate as frequently as possible during the first few hours after the procedure.

Children and adolescents

Special precautions should be taken when administering radiolabeled medicinal products to children and adolescents (aged 2 to 16).

LutaPol and other medicines

Please tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No interactions between lutetium (Lu) chloride and other medicines are known, as no relevant clinical trial data are available.

Pregnancy, breastfeeding, and fertility

LutaPol is contraindicated in pregnancy.
Before using the product, please inform the nuclear medicine specialist if:

• there is a suspicion of pregnancy in the patient,
• the patient has not had a menstrual period at the expected time,
• the patient is breastfeeding.

In case of doubts, it is necessary to consult a nuclear medicine specialist.
The doctor will consider an alternative therapy that does not involve ionizing radiation and radiation exposure.
Use of contraception in women and men
Radioisotope therapy and examinations using ionizing radiation may affect the unborn child and cause developmental disorders, so LutaPol should not be used in pregnant women.
It is recommended that female patients of childbearing age use effective contraception during treatment and for several months after the end of treatment, depending on the radiopharmaceutical used.
The nuclear medicine specialist will indicate how long after administration of the lutetium (Lu) labeled radiopharmaceutical the patient should avoid becoming pregnant.
Male patients whose partners are of childbearing age are advised to use effective contraception during treatment and for several months after the last dose of the medicine, depending on the radiopharmaceutical used. The nuclear medicine specialist will indicate how long after administration of the lutetium (Lu) labeled radiopharmaceutical the partner should avoid becoming pregnant.
In case of breastfeeding and the need to administer a radiopharmaceutical, the doctor will recommend stopping breastfeeding.

Before using any medicine, please consult a nuclear medicine specialist.

Driving and using machines

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3. HOW TO USE LUTAPOL

Radiopharmaceutical products can only be administered by authorized personnel. There are strict regulations regarding the use, transfer, and disposal of radiopharmaceutical preparations.
LutaPol is used only in appropriate conditions and only by qualified personnel. These personnel take special precautions to ensure safe use of the product and will keep the patient informed about their actions.

The doctor does not administer LutaPol directly to the patient.

The nuclear medicine specialist supervising the procedure will decide on the dose of the radiolabeled drug with LutaPol to be used in a given case. This will be the smallest dose necessary to achieve the desired result, depending on the labeled drug and its use.

Administration of the radiolabeled drug with LutaPol and performance of the procedure

LutaPol can only be used in combination with another medicinal product that has been specially developed and approved for combination with LutaPol. Only the radiolabeled drug with LutaPol will be administered.

Duration of the procedure

The nuclear medicine specialist will inform the patient about the standard duration of the procedure after administration of the radiolabeled drug with LutaPol.

After administration of the radiolabeled drug with LutaPol

The nuclear medicine specialist will inform the patient about any precautions to be taken after administration of the radiolabeled drug with LutaPol. Please consult the nuclear medicine specialist with any questions.

Administration of a higher dose of the radiolabeled drug with LutaPol than recommended

The radiolabeled drug with LutaPol is administered by the nuclear medicine specialist under strict control, so there is a very small possibility of administration of a higher dose. However, in case of overdose, appropriate treatment will be initiated.
In case of doubts regarding the use of LutaPol, please consult a nuclear medicine specialist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, LutaPol can cause side effects, although not everybody gets them.
In patients with prostate cancer receiving lutetium (Lu) labeled drugs, transient dryness of the mouth has been reported.
Very common side effects (may affect more than 1 in 10 patients) include:

• decrease in blood cell count (platelets, red blood cells, or white blood cells).
• nausea
• vomiting

Side effects reported in patients treated for neuroendocrine tumors

Very common (may affect more than 1 in 10 patients):

• mild, transient hair loss

Common (may affect up to 1 in 10 patients):

• bone marrow cancer (myelodysplastic syndrome)
• decreased white blood cell count (neutropenia)

Uncommon (may affect up to 1 in 100 patients):

• bone marrow cancer (acute myeloid leukemia)

Frequency not known (cannot be estimated from the available data):

• tumor flare
• tumor lysis syndrome (rapid breakdown of tumor cells)
• decrease in red blood cell count, platelet count, and white blood cell count (pancytopenia)
• dry mouth

Cases of bone marrow cancer (myelodysplastic syndrome and acute myeloid leukemia) have been reported several years after targeted radioisotope therapy based on somatostatin analogs labeled with lutetium (Lu) in the treatment of neuroendocrine tumors.
Exposure to ionizing radiation may lead to increased cancer risk (in the case of high radioisotope activities) or genetic disorders.
More information on possible side effects caused by lutetium (Lu) labeled medicinal products is available in the leaflet attached to the packaging of the specific medicinal product intended for labeling.
If the patient experiences any side effects, including any side effects not listed in this leaflet, please inform the nuclear medicine specialist.

Reporting suspected side effects

If you experience any side effects, including any side effects not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel. (22) 49 21 301, Fax (22) 49 21 309, e-mail: [email protected]. Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE LUTAPOL

The patient will not need to store this medicinal product.
Radiopharmaceutical products like LutaPol are stored only by authorized personnel in appropriate conditions. Storage of radiopharmaceutical products is carried out in accordance with local regulations regarding radioactive substances.
The following information is intended only for medical personnel.
The medicine should be stored out of sight and reach of children.
Do not use the product after the expiration date and time stated on the packaging.
Store in the original packaging to protect from radiation.

6. CONTENTS OF THE PACKAGING AND OTHER INFORMATION

What LutaPol contains

The active substance of the product is lutetium (Lu) chloride.
The vial contains, on a given day and at a given time, 0.925-37 GBq of lutetium (Lu) [which corresponds to 1.86-74 micrograms of lutetium (Lu) in the form of lutetium (Lu) chloride].
The other ingredients are hydrochloric acid and water for injections.

What LutaPol looks like and what the packaging contains

Colorless glass vial of type I with a capacity of 2 ml, closed with a rubber stopper and protected with an aluminum cap in a lead shielding container.
Radiopharmaceutical precursor, solution.
Clear, colorless solution.

Marketing authorization holder and manufacturer

National Centre for Nuclear Research, ul. Andrzeja Sołtana 7, 05-400 Otwock, Tel. (22) 718 07 00, Fax (22) 718 03 50, e-mail: [email protected]

Date of last update of the leaflet:

The full Summary of Product Characteristics (SmPC) of LutaPol 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.