EndolucinBeta - Lutetium (177Lu) chloride

What is EndolucinBeta - Lutetium (177Lu) chloride used for and what is it used for?

EndolucinBeta contains the radioactive lutetium compound (177Lu) chloride and is used for the radiolabelling of other medicines. Radioactive marking is a technique used to mark (or label) medicines with radioactive compounds so that they can carry radioactivity to the areas of the body where it is needed, such as a tumor site.

EndolucinBeta should only be used to perform radioactive marking of medicines developed specifically for use with EndolucinBeta.

How is EndolucinBeta - Lutetium (177Lu) chloride used?

EndolucinBeta should only be used by specialists with experience in radioactive marking.

EndolucinBeta is never supplied directly to the patient. Radiolabelling with EndolucinBeta takes place in the laboratory. The radiolabelled medicine is subsequently administered to the patient according to the instructions in the product information of the medicine itself.

How does EndolucinBeta - Lutetium (177Lu) chloride work?

The active ingredient in EndolucinBeta, Lutetium (177Lu) chloride, is a radioactive compound that predominantly emits a type of radiation known as beta radiation, with a small amount of gamma radiation. A medicine radiolabelled with EndolucinBeta is administered to transport radiation where necessary inside the body, in order to destroy cancer cells (if used as a treatment) or to obtain images on a screen (if used to make a diagnosis).

What benefit has EndolucinBeta - Lutetium (177Lu) chloride shown during the studies?

Numerous published studies have demonstrated the usefulness of Lutetium (177Lu) for the radiolabelling of medicines, in order to diagnose and treat neuroendocrine tumors. These represent a group of tumors that attack hormone-secreting cells in various parts of the body, including pancreas, intestine, stomach and lungs. The benefits of EndolucinBeta depend largely on the medicine that was used for radiolabelling.

What are the risks associated with EndolucinBeta - Lutetium (177Lu) chloride?

The side effects of EndolucinBeta depend largely on the medicine with which it is used and are described in the package leaflet of the medicine in question. In itself EndolucinBeta is radioactive, so, like any other radioactive medicine, its use can involve the risk of developing cancer and hereditary defects. However, the amount of EndolucinBeta to be used is small and therefore these risks are considered low. Your doctor needs to make sure that the expected benefits of using EndolucinBeta for patients are greater than the risks of radioactivity.

Medications radiolabelled with EndolucinBeta should not be used in women who are or could be pregnant. For the full list of restrictions related to the use of EndolucinBeta, see the package leaflet. For more information on the limitations that specifically apply to endolucinBeta-labeled medicines, see the package leaflets of the medicines in question.

Why has EndolucinBeta - Lutetium (177Lu) chloride been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that the use of Lutetium (177Lu) for the radiolabelling of medicinal products is well documented in the scientific literature. As with all materials used for the radiolabelling of medicinal products, exposure to radiation associated with the use of EndolucinBeta involves risks. The EndolucinBeta product information contains information on how to minimize these risks.

The CHMP considered that EndolucinBeta's benefits are greater than its risks and recommended that it be given marketing authorization.

What measures are being taken to ensure the safe and effective use of EndolucinBeta - Lutetium (177Lu) chloride?

Recommendations and precautions for the safe and effective use of EndolucinBeta by healthcare professionals and patients have been included in the summary of product characteristics and the package leaflet.

Other information on EndolucinBeta - Lutetium (177Lu) chloride

For the full EPAR of EndolucinBeta, consult the website of the Agency: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with EndolucinBeta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

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