Theralugand
Authorised
This medicine is authorised for use in the European Union
lutetium (177Lu) chloride
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Theralugand is a solution containing a radioactive form of lutetium (177Lu) that is used for radiolabelling other medicines. Radiolabelling is a technique where a substance is labelled with a radioactive compound. Once the substance is radiolabelled with Theralugand, it then carries the radioactivity to where it is needed in the body (for example, the site of a tumour) to either treat a disease or obtain images to locate or diagnose an illness.
Theralugand is never given directly to a patient.
Theralugand contains the active substance lutetium (177Lu) chloride and is used to radiolabel medicines that have been specifically developed for use with lutetium (177Lu) chloride.
Theralugand is only to be used by specialists who have experience in radiolabelling. Radiolabelling of a medicine takes place in a laboratory setting. The radiolabelled medicine is then given to the patient according to the instructions in that medicine’s summary of product characteristics (SmPC).
When a medicine is radiolabelled with Theralugand, the medicine will carry the radioactive part of Theralugand, lutetium (177Lu), to the particular site in the body or type of cell in the body that is targeted by the medicine. Lutetium (177Lu) will then emit a type of radiation known as beta-minus, which is used for treatment, as well as a small amount of radiation called gamma radiation, which is used for imaging. The amount of Theralugand used for radiolabelling depends on the medicine to be radiolabelled and its intended use.
The company presented information from published clinical studies on the potential uses of Theralugand. Some of the data presented showed the usefulness of 177Lu in radiolabelling medicines for treating neuroendocrine tumours and prostate cancer, used together with imaging techniques to detect the site and spread of tumours.
For the full list of side effects and restrictions with Theralugand, see the package leaflet.
The side effects depend largely on the medicine that has been radiolabelled with Theralugand. Information on the side effects and restrictions with medicines radiolabelled with Theralugand can be found in the respective package leaflets.
Theralugand itself is radioactive and so the use of medicines radiolabelled with Theralugand may carry a risk of developing cancer and hereditary defects. The doctor will ensure that the risks linked to the radioactive exposure are lower than the risks from the disease itself.
The most common side effects (which may affect more than 1 in 10 people) include anaemia (low levels of red blood cells), thrombocytopenia (low levels of blood platelets), leucopenia (low levels of white blood cells), lymphopenia (low levels of lymphocytes, a particular type of white blood cell), nausea (feeling sick), vomiting and hair loss.
Theralugand must not be used in women who are known to be or may be pregnant, and when pregnancy has not been ruled out.
The European Medicines Agency decided that Theralugand’s benefits for radiolabelling medicines are greater than its risks and it can be authorised for use in the EU. As Theralugand is not intended for use on its own, its benefits and risks will also be assessed independently when added to a medicine.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Theralugand have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Theralugand are continuously monitored. Suspected side effects reported with Theralugand are carefully evaluated and any necessary action taken to protect patients.
Theralugand received a marketing authorisation valid throughout the EU on 22.11.2024
Product information
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Theralugand
- Active substance
- lutetium (177Lu) chloride
- International non-proprietary name (INN) or common name
- lutetium (177Lu) chloride
- Therapeutic area (MeSH)
- Radionuclide Imaging
- Anatomical therapeutic chemical (ATC) code
- V10X
Pharmacotherapeutic group
Other therapeutic radiopharmaceuticalsTherapeutic indication
Theralugand is a radiopharmaceutical precursor, and it is not intended for direct use in patients. It is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with lutetium (177Lu) chloride.
News on Theralugand
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