LUTENCA 40 GBq/mL RADIOPHARMACEUTICAL PRECURSOR IN SOLUTION

Introduction

Package Leaflet: Information for the Patient

Lutenca 40 GBq/ml Radiopharmaceutical Precursor in Solution

lutetium chloride (177Lu)

Read all of this leaflet carefully before you start receiving the combined medication with Lutenca, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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 effect not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Lutenca and what is it used for
2. What you need to know before you are given the radiolabeled medication with Lutenca
3. How to use the radiolabeled medication with Lutenca
4. Possible side effects
5. Storage of Lutenca
6. Package Contents and Additional Information

1. What is Lutenca and what is it used for

Lutenca is not a final medication and should not be used alone. It must be used in combination with other medications (carrier medications).

Lutenca is a type of product called a radiopharmaceutical precursor. It contains the active ingredient lutetium chloride (177Lu) which emits beta radiation, allowing for localized radiation effects. This radiation is used to treat certain diseases.

Lutenca must be combined with a carrier medication in a process called radiolabeling before administration. The carrier medication then carries Lutenca to the site of the disease in the body.

These carrier medications 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 radiolabeled medications with Lutenca 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.

Consult the package leaflet of the medication that will be radiolabeled with Lutenca.

2. What you need to know before you are given the radiolabeled medication with Lutenca

The radiolabeled medication with Lutenca must not be used

• if you are allergic to lutetium chloride (177Lu) or any of the other components of this medication (listed in section 6),
• if you are pregnant or think you may be pregnant.

Consult the package leaflet of the medication that will be radiolabeled with Lutenca for more information.

Warnings and Precautions

Lutenca must not be administered directly to patients.

Be careful with the radiolabeled medication with Lutenca:

• if you have kidney failure or bone marrow disease.

Treatment with lutetium (177Lu) can cause the following side effects:

• reduction in the number of red blood cells (anemia);
• reduction in the number of platelets in the blood (thrombocytopenia), which are important for stopping bleeding,
• reduction in the number of white blood cells (leukopenia, 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 requires discontinuation of treatment.

Because lutetium (177Lu) can 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 for neuroendocrine tumors, the kidneys excrete radiolabeled somatostatin analogs. Therefore, your doctor will perform a blood test to measure kidney function before starting treatment and during treatment.

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

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

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

Treatment with lutetium (177Lu) can cause tumor lysis syndrome, due to the rapid destruction of tumor cells. This can 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 have muscle cramps, muscle weakness, confusion, or difficulty breathing.

Consult the package leaflet of the medication that will be radiolabeled with Lutenca for additional warnings and precautions.

Children and Adolescents

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

Other Medications and Radiolabeled Medications with Lutenca

Inform 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 procedure.

It is not known if lutetium chloride (177Lu) can interact with other medications, as no specific studies have been conducted.

Pregnancy and Breastfeeding

You must inform your nuclear medicine doctor before administration of radiolabeled medications with Lutenca 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 important that you consult your nuclear medicine doctor who is supervising the procedure.

If you are pregnant

Radiolabeled medications with Lutenca must not be administered if you are pregnant.

If you are breastfeeding

You will be asked to interrupt breastfeeding.

Please consult your nuclear medicine doctor when you can resume breastfeeding.

Driving and Using Machines

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

3. How to use the radiolabeled medication with Lutenca

There are strict rules for the use, handling, and disposal of radiopharmaceuticals. Radiolabeled medications with Lutenca will be used in special controlled areas. This medication 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 medication and will inform you of their actions.

The nuclear medicine doctor supervising the procedure will decide the amount of radiolabeled medication with Lutenca to be used in your case. This will be the minimum amount necessary to achieve the desired effect, depending on the medication taken with Lutenca and its intended use.

Administration of the radiolabeled medication with Lutenca and performance of the procedure

Lutenca must only be used in combination with another medication (carrier medication) that has been specifically developed and authorized for combination with lutetium chloride (177Lu). Administration will depend on the type of carrier medication. Please read the package leaflet of that medication carefully.

Duration of the procedure

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

After administration of the radiolabeled medication with Lutenca

Your nuclear medicine doctor will inform you if you need to take special precautions after receiving the radiolabeled medication with Lutenca. Consult your nuclear medicine doctor if you have any questions.

If you have been given too much radiolabeled medication with Lutenca

The nuclear medicine doctor will handle the radiolabeled medication with Lutenca under closely controlled conditions, so it is very unlikely that an overdose will occur. However, in case of overdose or accidental intravenous injection of the unmarked product, you will receive appropriate treatment to eliminate the radionuclide from the body.

If you have any further questions about the use of the radiolabeled medication with Lutenca, consult your nuclear medicine doctor who is supervising the procedure.

4. Possible side effects

Like all medications, the radiolabeled medication with Lutenca can cause side effects, although not everyone will experience 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):

• reduction 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 people):

• mild and temporary hair loss

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

• bone marrow cancer (myelodysplastic syndrome)
• reduction in the number of white blood cells (neutropenia)

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

• bone marrow cancer (acute myeloid leukemia)

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

• carcinoid crisis
• tumor lysis syndrome (rapid destruction of tumor cells)
• reduction in the number of red blood cells, platelets, and white blood cells (pancytopenia)
• dry mouth

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

After administration of the radiolabeled medication with Lutenca, it will release a certain amount of ionizing radiation (radioactivity) which carries a risk of cancer and some congenital defects. In all cases, the risk of radiation is outweighed by the potential benefits of administering the radiolabeled medication.

If you want more information, consult the package leaflet of the specific medication that will be radiolabeled.

Reporting side effects

If you experience side effects, consult your nuclear medicine doctor, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Lutenca

You will not need to store this medication. The 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 the specialist:

Keep this medication out of the sight and reach of children.

Lutenca must not be used after the expiration date and time stated on the label

Lutenca will be stored in its original packaging, which provides protection against radiation.

This medication does not require any special storage temperature.

6. Package Contents and Additional Information

Composition of Lutenca

• The active ingredient is lutetium chloride (177Lu).

1 ml of sterile solution contains 40 GBq of lutetium chloride (177Lu) at the calibration date and time, which corresponds to 10 micrograms of lutetium (177Lu) (in the form of chloride).

(GBq: The Gigabecquerel is the unit in which radioactivity is measured).

• The other ingredient is hydrochloric acid, diluted.

Appearance of Lutenca and Package Contents

Lutenca is a radiopharmaceutical precursor in solution. It is presented as a clear and colorless solution in a 3 ml or 10 ml colorless glass vial with a bromobutyl stopper and sealed with an aluminum cap. Each package contains 1 vial, which is placed in a lead container for shielding.

The volume of a vial ranges from 0.025 - 5 ml of solution. The volume depends on the amount of medication combined with Lutenca necessary for administration by the nuclear medicine specialist.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Monrol Europe S.R.L

Str. Gradinarilor, nr.1, Pantelimon,

077145, Ilfov county,

Romania

Phone: +40 21 367 48 01

Fax: +40 21 311 75 84

Manufacturer

Monrol Bulgaria Ltd

Lulin District,

128 Bansko Shose Str.,

Sofia 1331, Bulgaria

Phone: + 359 2 824 12 13

Fax: +359 2 824 12 89

This medication is authorized in the Member States of the European Economic Area under the following names:

France: Lutenca

Italy: Lutenca

Portugal: Lutenca

Spain: Lutenca

Sweden: Lutenca

Date of last revision of this leaflet: October 2023

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

This information is intended only for healthcare professionals:

The complete technical data sheet for Lutenca is included as a separate document in the product packaging, with the aim of providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult this technical data sheet.