ENDOLUCINBETA 40 GBq/mL RADIOFARMACEUTICAL PRECURSOR IN SOLUTION

Introduction

Package Leaflet: Information for the Patient

EndolucinBeta 40 GBq/ml Radiopharmaceutical Precursor in Solution

Lutetium Chloride (177Lu)

This medicinal product is subject to additional monitoring. This will allow for the quick identification of new safety information. You can help by reporting any side effects you may experience. The last section of section 4 will provide information on how to report side effects.

Read all of this leaflet carefully before you start receiving the medicinal product combined with EndolucinBeta, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your nuclear medicine doctor who will be supervising the procedure.

• If you experience side effects, consult your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is EndolucinBeta and what is it used for
2. What you need to know before you are given the radiolabelled medicinal product with EndolucinBeta
3. How to use the radiolabelled medicinal product with EndolucinBeta
4. Possible side effects

1. Storage of EndolucinBeta
2. Package Contents and Further Information

1. What is EndolucinBeta and what is it used for

EndolucinBeta is not the final medicinal product and must not be used on its own. It must be used in combination with another medicinal product (carrier medicinal product).

EndolucinBeta is a type of product known as a radiopharmaceutical precursor. It contains the active substance lutetium chloride (177Lu) which emits beta radiation, allowing for a localized radiation effect. This radiation is used to treat certain diseases.

EndolucinBeta must be combined with a carrier medicinal product in a process known as radiolabelling before administration. The carrier medicinal product then takes EndolucinBeta to the site in the body where the disease is located.

These carrier medicinal products have been specifically developed for use with lutetium chloride (177Lu) and may be substances designed to recognize a specific type of cell in the body.

Administration of radiolabelled medicinal products with EndolucinBeta involves exposure to radioactivity. Your doctor and nuclear medicine doctor have considered that the clinical benefit you will receive from the procedure with the radiopharmaceutical outweighs the risks of radiation.

Refer to the package leaflet of the medicinal product that will be radiolabelled with EndolucinBeta.

2. What you need to know before you are given the radiolabelled medicinal product with EndolucinBeta

The radiolabelled medicinal product with EndolucinBeta must not be used

• if you are allergic to lutetium chloride (177Lu) or any of the other ingredients of this medicinal product (listed in section 6).

• if you are pregnant or think you may be pregnant.

Refer to the package leaflet of the medicinal product that will be radiolabelled with EndolucinBeta for more information.

Warnings and Precautions

EndolucinBeta must not be administered directly to patients.

Be particularly careful with the radiolabelled medicinal product with EndolucinBeta:

• if you have kidney problems or bone marrow disease.

Treatment with lutetium (177Lu) labelled ligands may cause the following side effects:

• Reduced red blood cell count (anaemia).
• Reduced platelet count in the blood (thrombocytopenia), which are important for stopping bleeding.
• Reduced white blood cell count (leucopenia, lymphopenia or neutropenia), which are important for protecting the body against infections.

Most of these events are mild and transient. In some patients, a reduction in the number of all three types of blood cells (red blood cells, platelets and white blood cells - pancytopenia) has been described, which may require interruption of treatment.

Because lutetium (177Lu) may sometimes affect your blood cells, your doctor will perform blood tests before starting treatment and at regular intervals during treatment. Talk to your doctor if you experience shortness of breath, bruising, nosebleeds, bleeding gums or if you develop a fever.

During peptide receptor radionuclide therapy of neuroendocrine tumours, the kidneys excrete radiolabelled somatostatin analogues. Therefore, your doctor will perform a blood test to measure kidney function before starting treatment and during treatment.

Treatment with lutetium (177Lu) may cause changes in liver function. Your doctor will perform a blood test to monitor your liver function during treatment.

Radiolabelled medicinal products with lutetium (177Lu) may be administered directly into a vein through a tube called a cannula. Leaks of fluid into the surrounding tissue (extravasation) have been reported. Talk to your doctor if you experience swelling or pain in the arm.

After neuroendocrine tumours are treated with lutetium (177Lu), patients may experience symptoms associated with the release of hormones from tumour cells, known as a carcinoid crisis. Inform your doctor if you feel dizzy or weak or experience flushing or diarrhoea after treatment.

Treatment with lutetium (177Lu) may cause tumour lysis syndrome, due to the rapid destruction of tumour cells. This may cause abnormal blood test results, irregular heartbeats, kidney failure or seizures within a week after treatment. Your doctor will perform blood tests to monitor for this syndrome. Inform your doctor if you experience muscle cramps, muscle weakness, confusion or difficulty breathing.

Refer to the package leaflet of the medicinal product that will be radiolabelled with EndolucinBeta for additional warnings and precautions.

Children and Adolescents

EndolucinBeta must not be used directly in children and adolescents under 18 years of age.

Other Medicinal Products and Radiolabelled Medicinal Products with EndolucinBetaInform your nuclear medicine doctor if you are taking, have recently taken or might take

any other medicinal product, as some medicinal products may interfere with the interpretation of images.

It is not known if lutetium chloride (177Lu) can interact with other medicinal products, as specific studies have not been performed.

Pregnancy and Breast-feeding

You must inform your nuclear medicine doctor before administration of radiolabelled medicinal products with EndolucinBeta if there is any possibility that you may be pregnant, if you have a delayed period or if you are breast-feeding.

In case of doubt, it is important that you consult your nuclear medicine doctor who is supervising the procedure. If you are pregnant

Radiolabelled medicinal products with EndolucinBeta must not be administered if you are pregnant.

If you are breast-feeding

You will be asked to stop breast-feeding.

Please consult your nuclear medicine doctor when you can restart breast-feeding.

Driving and Using Machines

Your ability to drive and use machines may be affected by the medicinal product used in combination with EndolucinBeta. Please read the package leaflet of the medicinal product in question carefully.

3. How to use the Radiolabelled Medicinal Product with EndolucinBeta

There are strict rules for the use, handling and disposal of radiopharmaceuticals. Radiolabelled medicinal products with EndolucinBeta will be used in special controlled areas. This product will only be handled and administered by trained and qualified personnel who are authorized to use it safely. These people 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 radiolabelled medicinal product with EndolucinBeta to be used in your case. This will be the minimum amount necessary to achieve the desired effect, depending on the medicinal product taken with EndolucinBeta and its intended use.

Administration of the Radiolabelled Medicinal Product with EndolucinBeta and Performance of the Procedure

EndolucinBeta must only be used in combination with another medicinal product (carrier medicinal product) that has been specifically developed and authorized for combination with lutetium chloride (177Lu).

Administration will depend on the type of carrier medicinal product. Please read the package leaflet of that medicinal product carefully.

Duration of the Procedure

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

After Administration of the Radiolabelled Medicinal Product with EndolucinBeta, you should

Your nuclear medicine doctor will inform you if you need to take special precautions after administration of the radiolabelled medicinal product with EndolucinBeta. Consult your nuclear medicine doctor if you have any doubts.

If you have been given too much Radiolabelled Medicinal Product with EndolucinBeta

The nuclear medicine doctor will handle the radiolabelled medicinal product with EndolucinBeta under strictly controlled conditions, so it is very unlikely that an overdose will occur. However, in case of overdose or accidental intravenous injection of the unlabelled product, you will receive appropriate treatment that will remove the radionuclide from the body.

If you have any further questions about the use of the radiolabelled medicinal product with EndolucinBeta, consult your nuclear medicine doctor who is supervising the procedure.

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4. Possible Side Effects

As with all medicinal products, the radiolabelled medicinal product with EndolucinBeta may cause side effects, although not everybody gets them.

Dry mouth has been reported in patients with prostate cancer who received treatment with lutetium (177Lu) and this side effect has been transient.

Very common side effects (may affect more than 1 in 10 people):

• Reduced blood cell count (platelets, red or white blood cells)
• Nausea
• Vomiting

Side Effects Reported in Patients Treated for Neuroendocrine Tumours:

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

• Mild and temporary hair loss

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

• Bone marrow cancer (myelodysplastic syndrome)
• Reduced white blood cell count (neutropenia)

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

• Bone marrow cancer (acute myeloid leukaemia)

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

• Carcinoid crisis
• Tumour lysis syndrome (rapid destruction of tumour cells)
• Reduced red blood cell, platelet and white blood cell count (pancytopenia)
• Dry mouth

Cases of bone marrow cancer (myelodysplastic syndrome and acute myeloid leukaemia) have been reported in patients several years after treatment with peptide receptor radionuclide therapy of neuroendocrine tumours labelled with lutetium (177Lu).

After administration of the radiolabelled medicinal product with EndolucinBeta, you will release a certain amount of ionizing radiation (radioactivity) which carries a risk of cancer and genetic defects. In all cases, the radiation risk is outweighed by the potential benefits of administration of the radiolabelled medicinal product.

If you require further information, refer to the package leaflet of the specific medicinal product that will be radiolabelled.

Reporting of Side Effects

If you experience side effects, consult your nuclear medicine doctor, even if they are possible side effects not listed in this leaflet. You can also report them directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. Storage of EndolucinBeta

You will not need to store this medicinal product. The medicinal product 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 for the specialist only.

Keep this medicinal product out of the sight and reach of children.

EndolucinBeta must not be used after the expiry date and time stated on the label after EXP.

EndolucinBeta will be stored in its original packaging which provides protection from radiation.

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6. Package Contents and Further Information

Composition of EndolucinBeta

• Its active substance is lutetium chloride (177Lu). 1 ml of sterile solution contains 40 GBq of lutetium chloride (177Lu) at the date and time of calibration (which corresponds to 10 micrograms of lutetium (177Lu) as lutetium chloride (177Lu)). (GBq: Gigabecquerel is the unit in which radioactivity is measured)
• The other ingredient is hydrochloric acid solution.

Appearance of EndolucinBeta and Package Contents

EndolucinBeta is a radiopharmaceutical precursor in solution. It is presented as a clear and colourless solution in a 2 ml or 10 ml colourless glass vial of type I with a bromobutyl stopper, closed with an aluminium seal.

Each package contains 1 vial, which is placed in a lead container for shielding and packaged in a metal can and outer cardboard box.

The volume of one vial ranges from 0.075-3.75 ml of solution (which corresponds to 3-150 GBq at the date and time of calibration). The volume depends on the amount of medicinal product combined with EndolucinBeta necessary for administration by the nuclear medicine specialist.

Marketing Authorisation Holder and Manufacturer

ITM Medical Isotopes GmbH

Lichtenbergstrasse 1

D-85748 Garching

Germany

Tel: + 49-89-289 139-08

[email protected]

Date of Last Revision of this Leaflet: {Month YYYY}

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

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This information is intended for healthcare professionals only:

The full summary of product characteristics of EndolucinBeta 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 this summary of product characteristics.