Patient leaflet - Lumark
B. PACKAGE LEAFLET
Package leaflet: Information for the patient
Lumark 80 GBq/mL radiopharmaceutical precursor solution
Lutetium (177Lu) chloride
Read all of this leaflet carefully before you are given the medicine combined with Lumark because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your nuclear medicine doctor who will supervise the procedure.
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– If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
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1. What Lumark is and what it is used for
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2. What you need to know before the medicine radiolabelled with Lumark is used
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3. How to use the medicine radiolabelled with Lumark
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4. Possible side effects
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5. How to store Lumark
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6. Contents of the pack and other information
1. What Lumark is and what it is used for
Lumark is not a medicine and it is not intended to be used on its own.
Lumark is a so-called radiopharmaceutical precursor. It contains the active substance lutetium (177Lu) chloride.
Lumark is used for radiolabelling medicines, a technique in which medicines are tagged (radiolabelled) with a radioactive form of the element lutetium, known as lutetium (177Lu). These medicines can then be used in medical procedures to carry radioactivity to where it is needed in the body such as sites of tumour cells.
Lumark is only used to radiolabel medicines that have been specifically developed for use with the active substance lutetium (177Lu) chloride.
The use of lutetium (177Lu)-labelled medicines does involve exposure to small amounts of 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 Lumark.
2. What you need to know before the medicine radiolabelled with Lumark is used
The medicine radiolabelled with Lumark must not be used:
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– if you are allergic to lutetium or any of the other ingredients of this medicine (listed in section 6).
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– if you are pregnant or believe you may be pregnant
Warnings and precautions
Treatment with medicine radiolabelled 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 cell (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 experienced 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-177 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 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.
Before administration of Lumark you should
Drink plenty of water before being given the radiolabelled medicine in order to urinate as often as possible during the first few hours after the procedure.
Children and adolescents
Please refer to the package leaflet of the medicine that is to be radiolabelled with Lumark.
Other medicines and medicines radiolabelled with Lumark
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
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advice before you are given medicines radiolabelled with Lumark.
You must inform the nuclear medicine doctor before the administration of medicines radiolabelled with Lumark if there is a possibility you might be pregnant, if you have missed your period or if you are breastfeeding.
When in doubt, it is important to consult your nuclear medicine doctor.
If you are pregnant
Medicines radiolabelled with Lumark must not be administered if you are pregnant.
If you are breast-feeding
You will be asked to stop breast-feeding if you are treated with medicines radiolabelled with Lumark.
Please ask your nuclear medicine doctor when you can resume breast-feeding.
Driving and using machines
The medicines used in combination with Lumark could affect your ability to drive and to use machines. Please read the package leaflet of that medicine carefully.
3. How to use the medicine radiolabelled with Lumark
There are strict laws on the use, handling and disposal of radiopharmaceutical products. Medicines radiolabelled with Lumark will only be used in special, controlled areas. This product will only be handled and given to you by people who are trained and qualified to use it safely. These people will take special care for the safe use of this product and will keep you informed of their actions.
The nuclear medicine doctor supervising the procedure will decide on the quantity of medicine radiolabelled with Lumark to be used in your case. It will be the smallest quantity necessary to achieve the appropriate outcome, depending on the co-administered medicine and its intended use.
Administration of the medicine radiolabelled with Lumark and conduct of the procedure
Lumark must be used only in combination with another medicine which has been specifically developed and authorised for being combined with Lumark. It will only be administered as a combination.
Duration of the procedure
Your nuclear medicine doctor will inform you about the usual duration of the procedure after the administration of the medicine radiolabelled with Lumark.
After administration of the medicine radiolabelled with Lumark has been performed
The nuclear medicine doctor will inform you if you need to take any special precautions after receiving the medicine radiolabelled with Lumark. Contact your nuclear medicine doctor if you have any questions.
If you have been given more medicine radiolabelled with Lumark than you should
Since the medicine radiolabelled with Lumark is handled by a nuclear medicine doctor under strictly controlled conditions, there is only a very small chance of possible overdose. However, in case of an overdose, you will receive the appropriate treatment.
Should you have any further question on the use of Lumark, please ask the nuclear medicine doctor who supervises the procedure.
4. Possible side effects
Like all medicines, the medicine radiolabelled with Lumark 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 (may affect more than 1 in 10 people)
- Reduction in blood cell counts (platelets, red or white blood cells)
- Nausea
- Vomiting
- 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 radiolabelled with Lumark is administered, it will deliver certain amounts of ionising radiation (radioactivity) which carries a small 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 leaflet of the particular medicine to be radiolabelled.
If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet.
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 By reporting side effects you can help provide more information on the safety of this medicine.
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5. How Lumark is stored
You will not have to store this radiopharmaceutical. Storing Lumark is the responsibility of the specialist and will be done 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.
Do not use this medicine after the expiry date and time which are stated on the label after EXP.
Store in the original package to protect from radiation.
6. Contents of the pack and other information
What Lumark contains
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– The active substance is lutetium (177Lu) chloride. Each mL of solution contains 80 GBq lutetium (177Lu) chloride at activity reference time (ART), corresponding to a maximum of 160 microgram of lutetium. The ART is defined as the end of production. (GBq: GigaBecquerel is the unit in which radioactivity is measured).
What Lumark looks like and contents of the pack
Lumark is presented as a sterile, clear, and colourless solution in a colourless type I glass vial of 10 mL, closed with a bromobutylrubber stopper and aluminium overseal.
Each vial contains a volume varying from 0.1 to 5 mL corresponding to an activity ranging from 8 to 400 GBq (at ART). The volume depends on the quantity of medicines combined with Lumark required for administration by the nuclear medicine doctor.
Each pack contains 1 glass vial in a lead cannister placed in a plastic jar.
Marketing Authorisation Holder and Manufacturer
I.D.B. Holland B.V.
Weverstraat 17
5111 PV Baarle-Nassau
The Netherlands
Tel: +31(0)13 5079 558
Fax: +31(0)13 5079 912
Email:
This leaflet was last revised in
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site:
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The following information is intended for healthcare professionals only:
The complete Summary of Product Characteristics (SmPC) of Lumark is provided as a separate document in the pack of the medicinal product, with the objective to provide healthcare professionals with other additional scientific and practical information about the use of this product.
Please refer to the SmPC.
ANNEX IV
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)
Scientific conclusions
Taking into account the PRAC Assessment Report on the PSUR(s) for lutetium (177Lu) chloride, the scientific conclusions of the CHMP are as follows:
In view of available data on extravasation from the literature and the existing warning on extravasation in the summary of product characteristics, and furthermore , considering the risk of radiation nephropathy and appropriate methods to detect renal disease from the literature and spontaneous reports, the PRAC concluded that the product information of products containing lutetium (177Lu) chloride should be amended accordingly. Furthermore, in view of available data on pancytopenia and neutropenia from the literature, studies and from spontaneous reports including in some cases a close temporal relationship and a plausible mechanism of action, and on xerostomia from studies and a plausible mechanism of action, the PRAC considers a causal relationship with lutetium (177Lu) chloride is established and concluded that the product information of products containing lutetium (177Lu) chloride should be amended accordingly.
The CHMP agrees with the scientific conclusions made by the PRAC.
Grounds for the variation to the terms of the marketing authorisation(s)
On the basis of the scientific conclusions for lutetium (177Lu) chloride the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing lutetium (177Lu) chloride is unchanged subject to the proposed changes to the product information.
The CHMP recommends that the terms of the marketing authorisation(s) should be varied.
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