Lumark - Lutetium (177Lu) chloride
What is Lumark - Lutetium (177Lu) chloride and what is it used for?
Lumark contains the radioactive compound Lutetium (177Lu) chloride and is used for the radioactive labeling of other medicines. Radiolabeling is a technique that involves marking (or "labeling) a medicine with a radioactive compound so that the radioactivity can be transported to the part of the body where it is needed, for example to the site of a tumor.
Lumark is not given to patients alone - it is only used to radiolabel medicines that have been specially developed for use with Lumark.
How is Lumark used - Lutetium (177Lu) chloride?
Lumark is to be used only by specialists with experience in radioactive labeling.
Lumark is never given alone. Radiolabeling with Lumark takes place in the laboratory. The radiolabelled medicine is then given to the patient according to the instructions in the product information of the medicine.
How does Lumark - Lutetium (177Lu) chloride work?
The active substance in Lumark, Lutetium (177Lu) chloride, is a radioactive compound that emits predominantly a type of radiation known as beta radiation, with a small amount of gamma radiation. When radiolabelled with Lumark, the medicine transports the radiation to the part of the body where it is needed, to kill cancer cells (in case of therapeutic use) or to obtain images on a screen (in case of diagnostic use).
What benefit has Lumark - Lutetium (177Lu) chloride shown during the studies?
Because the use of Lutetium (177Lu) for radioactive labeling of medicines is well established, the company presented data from the scientific literature. Several published studies have shown the usefulness of Lutetium (177Lu) in the radiolabelling of medicines for diagnosis and treatment of neuroendocrine tumors, a group of tumors that attack hormone-secreting cells in various parts of the body, including the pancreas, intestines, stomach and lungs.
The benefits of Lumark largely depend on the medicine that was used for the radiolabelling.
What are the Risks associated with Lumark - Lutetium (177Lu) chloride?
The side effects of Lumark are highly dependent on the medicine it is used with and are described in the package leaflet of that medicine. Lumark itself is radioactive, therefore, like any other radioactive medicine, its use may carry risks relating to the development of cancer and hereditary defects. However, the amount of Lumark to be used is small and, therefore, these risks are considered low. Physicians should ensure that the expected benefits of using Lumark for patients outweigh the risks from radioactivity.
Medicines radiolabelled with Lumark should not be used in women who are pregnant or of childbearing potential. For the full list of restrictions on the use of Lumark, see the package leaflet. For more information on restrictions that apply to medicines radiolabelled with Lumark, see the package leaflets of those medicines
Why has Lumark - Lutetium (177Lu) chloride been approved?
The Committee for Medicinal Products for Human Use (CHMP) considered that the use of Lutetium (177Lu) for radioactive labeling of medicinal products is well established and well documented in the scientific literature. As with all materials used for radioactive labeling of medicinal products, There is a risk associated with the use of Lumark radiation exposure. The product information for Lumark contains guidance on how to minimize these risks.
The CHMP concluded that Lumark's benefits outweigh its risks and therefore recommended that it be given a Marketing Authorization.
What measures are being taken to ensure the safe and effective use of Lumark - Lutetium (177Lu) chloride?
A risk management plan has been developed to ensure that Lumark is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Lumark, including the appropriate precautions to be followed by healthcare professionals and patients.
Further information can be found in the summary of the risk management plan
More about Lumark - Lutetium (177Lu) chloride
On 19 June 2015, the European Commission issued a "Marketing Authorization" for Lumark, valid throughout the European Union.
For the full version of the EPAR and the summary of Lumark's risk management plan, visit the Agency's website: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Lumark therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist. This summary was last updated 06-2015.
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