Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - endolucinbeta

Document Subject

Generated Narrative: MedicinalProductDefinition mp69ec9f0e9f354651ce97ae4316b8e482

identifier: http://ema.europa.eu/identifier/2 mL vial: EU/1/16/1105/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: EndolucinBeta 40 GBq/mL radiopharmaceutical precursor, solution

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-69ec9f0e9f354651ce97ae4316b8e482

identifier: http://ema.europa.eu/identifier/2 mL vial: EU/1/16/1105/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - endolucinbeta

Attesters

What is in this leaflet

1. What EndolucinBeta is and what it is used for
2. What you need to know before the medicine radiolabelled with EndolucinBeta is used
3. How the medicine radiolabelled with EndolucinBeta is used
4. Possible side effects
5. How EndolucinBeta is stored
6. Contents of the pack and other information

EndolucinBeta is not a medicine and it is not intended to be used on its own. It has to be used in combination with other medicines (carrier medicines).

EndolucinBeta is a type of product called a radiopharmaceutical precursor. It contains the active substance Lutetium (177Lu) chloride which gives off beta-radiation, allowing a localised radiation effect. This radiation is used to treat certain diseases.

EndolucinBeta has to be combined with a carrier medicine in a process called radiolabelling before administration. The carrier medicine then takes the EndolucinBeta to the disease site in the body.

These carrier medicines have been specially developed for use with Lutetium (177Lu) chloride and may be substances that have been designed to recognise a particular type of cell in the body.

The use of a medicine radiolabelled with EndolucinBeta does involve exposure to radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation.

Please refer to the Package Leaflet of the medicine that is to be radiolabelled with EndolucinBeta.

The medicine radiolabelled with EndolucinBeta must not be used

• if you are allergic to Lutetium (177Lu) chloride or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or believe you may be pregnant.

Please refer to the Package Leaflet of the medicine that is to be radiolabelled with EndolucinBeta for additional information.

Warnings and precautions EndolucinBeta is not to be administered directly to patients. Take special care with the medicine that is radiolabelled with EndolucinBeta:

• if you have renal impairment or bone marrow disease.

Treatment with Lutetium (177Lu) may lead to the following side effects:

• a reduced number of red blood cells (anaemia);
• a reduced number of platelets in the blood (thrombocytopenia) which are important to stop bleeding;
• a reduced number of white blood cells (leukopenia, lymphopenia or neutropenia) which are important for protecting the body against infection.

Most of these events are mild and only temporary. A reduced number of all 3 types of blood cells (red blood cells, platelets, and white blood cells - pancytopenia), requiring treatment discontinuation has been described in some patients.

Because Lutetium (177Lu) can sometimes affect your blood cells, your doctor will do blood tests before you start and at regular intervals during treatment. Talk to your doctor if you experience shortness of breath, bruising, nose bleeds, bleeding from your gums, or if you develop a fever.

During peptide-receptor radionuclide therapy for neuroendocrine tumours, radiolabelled somatostatin analogues are excreted by the kidneys. Your doctor will therefore take a blood test to measure your kidney function before you start and during treatment.

Treatment with Lutetium (177Lu) may cause disturbances of liver function. Your doctor will take a blood test to monitor your liver function during treatment.

Lutetium (177Lu)-labelled medicines may be administered directly into your vein through a tube known as a cannula. There have been reports of leakage of the fluid into the surrounding tissue (extravasation). Tell your doctor if you experience any swelling or pain in your arm.

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

Treatment with Lutetium (177Lu) may cause tumour lysis syndrome, due to the rapid breakdown of tumour cells. This may result in abnormal blood test results, irregular heartbeat, kidney failure or seizures within a week of treatment. Your doctor will perform blood tests to monitor you for this syndrome. Tell your doctor if you have muscle cramping, muscle weakness, confusion, or shortness of breath.

Please refer to the Package Leaflet of the medicine that is to be radiolabelled with EndolucinBeta for additional warnings and precautions.

Children and adolescents EndolucinBeta is not to be used directly in childrens and adolescent patients under 18 years old.

Other medicines and medicines radiolabelled with EndolucinBeta Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines since they may interfere with the procedure. It is not known whether Lutetium (177Lu) chloride may interact with other medicines as specific studies have not been carried out.

Pregnancy and breast-feeding You must inform the nuclear medicine doctor before the administration of medicines radiolabelled with EndolucinBeta if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding.

When in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.

If you are pregnant Medicines radiolabelled with EndolucinBeta must not be administered if you are pregnant.

If you are breast-feeding You will be asked to stop breast-feeding. Please ask your nuclear medicine doctor when you can resume breast-feeding.

Driving and using machines There could be effects on your ability to drive and to use machines due to the medicine used in combination with EndolucinBeta. Please read the package leaflet of that medicine carefully.

There are strict laws on the use, handling and disposal of radiopharmaceuticals. Medicines radiolabelled with EndolucinBeta will only be used in special controlled areas. This medicine will only be handled and given to you by people who are trained and qualified to use it safely. These persons will take special care for the safe use of this medicine and will keep you informed of their actions.

The nuclear medicine doctor supervising the procedure will decide on the quantity of a medicine radiolabelled with EndolucinBeta to be used in your case. It will be the smallest quantity necessary to achieve the appropriate outcome, depending on the medicine you take with EndolucinBeta and what it is used for.

Administration of the medicine radiolabelled with EndolucinBeta and conduct of the procedure EndolucinBeta must be used only in combination with another medicine (carrier medicine) which has been specifically developed and authorised for being combined with Lutetium (177Lu) chloride. The administration will depend on the type of the carrier medicine. Please read the Package Leaflet of that medicine.

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

After administration of the medicine radiolabelled with EndolucinBeta The nuclear medicine doctor will inform you if you need to take any special precautions after receiving the medicine radiolabelled with EndolucinBeta. Contact your nuclear medicine doctor if you have any questions.

If you have been given more medicine radiolabelled with EndolucinBeta than you should Since the medicine radiolabelled with EndolucinBeta is handled by a nuclear medicine doctor under strictly controlled conditions, there is only a very small chance of possible overdose. However, in the case of an overdose or an inadvertent intravenous injection of the unlabelled product, you will receive appropriate treatment that will remove the radionuclide from the body.

Should you have any further questions on the use of the medicine radiolabelled with EndolucinBeta, ask your nuclear medicine doctor who supervises the procedure.

Like all medicines, the medicine radiolabelled with EndolucinBeta can cause side effects, although not everybody gets them.

Dry mouth has been reported among patients with prostate cancer receiving treatment with Lutetium (177Lu) and has been temporary.

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

• Reduction in blood cell counts (platelets, red or white blood cells)
• Nausea
• Vomiting

Side effects reported among patients treated for neuroendocrine tumours:

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

• Mild temporary hair loss

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

• Bone marrow cancer (myelodysplastic syndrome)
• A reduced number of white blood cells (neutropenia)

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

• Bone marrow cancer (acute myeloid leukaemia)

Not known (frequency cannot be estimated from the available data):

• Carcinoid crisis
• Tumour lysis syndrome (rapid breakdown of tumour cells)
• A reduced number of red blood cells, platelets, and white blood cells (pancytopenia)
• Dry mouth

Bone marrow cancer (myelodysplastic syndrome and acute myeloid leukaemia) has been reported in patients several years after treatment with Lutetium (177Lu) peptide receptor radionuclide therapy for neuroendocrine tumours.

After the medicine radiolablelled with EndolucinBeta is administered, it will deliver certain amounts of ionising radiation (radioactivity) which can induce a certain risk of cancer and development of hereditary defects. In all cases, the risk of the radiation is outweighed by the potential benefit of receiving the radiolabelled medicine.

For more information, refer to the Package Peaflet of the particular medicinal product to be radiolabelled.

Reporting of side effects If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects 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 medicine.

You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate premises. Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials.

The following information is intended for the specialist only:

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

EndolucinBeta must not be used after the expiry date and time which is stated on the label after EXP. EndolucinBeta will be stored in the original package that provides protection from radiation.

This medicine does not require any special temperature storage conditions.

What EndolucinBeta contains

• The active substance is Lutetium (177Lu) chloride. 1 mL sterile solution contains 40 GBq Lutetium (177Lu) chloride on the activity reference time (ART), corresponding to 10 micrograms of Lutetium (177Lu) (as chloride). (GBq: GigaBecquerel is the unit in which radioactivity is measured).
• The other ingredient is hydrochloric acid, diluted.

What EndolucinBeta looks like and contents of the pack EndolucinBeta is a radiopharmaceutical precursor, solution. It is presented as a clear and colourless solution in a colourless type I glass 2 mL or 10 mL vial with a V-shaped and flat bottom, respectively, with a bromobutyl stopper, closed with an aluminium seal. Each pack contains 1 vial placed into a lead container for protective shielding and packed in a metallic can and an outer carton.

The volume of one vial ranges from 0.075 3.75 mL solution (corresponding to 3 150 GBq at activity reference time). The volume depends on the quantity of medicine combined with EndolucinBeta required for administration by the nuclear medicine doctor.

Marketing Authorisation Holder and Manufacturer ITM Medical Isotopes GmbH Lichtenbergstrasse 1 D-85748 Garching Germany Tel: + 49-89-289 139-info@itm.ag

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: