Quadramet
samarium [153Sm] lexidronam pentasodium
Samarium (153Sm) lexidronam pentasodium.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or your pharmacist.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Quadramet is and what it is used for
What you need to know before you take Quadramet
How to take Quadramet
Possible side effects
How to store Quadramet
Contents of the pack and other information
Quadramet is a medicinal product for therapeutic use only.
This radiopharmaceutical is used for the treatment of bone pain due to your disease. Quadramet has a high affinity for skeletal tissue. Once injected it concentrates in bone lesions.
Because Quadramet contains small amounts of a radioactive element, samarium-153, radiations are delivered locally to the bone lesions, allowing to develop the palliative action on bone pain.
If you are allergic to ethylene diamine tetramethylene phosphonic acid (EDTMP) or similar phosphonate compounds or any of the other ingredients of this medicine (listed in section 6),
If you are pregnant,
If you have received chemotherapy or hemibody field external radiation therapy in a preceding period of 6 weeks.
Talk to your doctor before taking Quadramet.
Your doctor will take blood samples weekly for at least 8 weeks to check your platelets, white and red blood cell counts which may slightly decrease due to the therapy.
During 6 hours following the injection of Quadramet, your physician will encourage you to drink and void as often as possible. He will decide at which time you will be authorised to leave the nuclear medicine department.
In the case of urine incontinence or urinary obstruction you will get a urine catheter for about 6 hours. For the other patients the urine should be collected for at least 6 hours.
If your renal function is decreased, the amount of product will be adapted.
Quadramet is not recommended for use in children below 18 years of age.
Tell your doctor if you are taking or have recently taken or might take any other medicines.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor for advice before taking this medicine.
Quadramet must not be administered to pregnant women.
If Quadramet administration to a breastfeeding woman is deemed necessary, breastfeeding should be stopped.
Your doctor will want to carry out a special scan before administering Quadramet to ascertain whether you are likely to benefit from Quadramet.
One single dose of 37 megabecquerel (Becquerel is the unit in which radioactivity is measured) of
Quadramet per kilogram of body weight is to be injected.
If you have the impression that the effect of Quadramet is too strong or too weak, talk to your doctor or pharmacist.
Quadramet is to be administered by slow injection into a vein.
This medicinal product is not intended to be injected on a regular or continuous basis. The
administration can however be repeated after 8 weeks following injection, subject to the evolution of your disease.
You will be authorised to leave the nuclear medicine department after a dosimetric follow-up (generally within 6 hours following Quadramet injection).
Quadramet being supplied as a single-dose vial, an accidental overdose is unlikely to occur. Radiation dose to the body can be limited by increasing fluid intake and frequent voiding of urine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The undesirable effects due to Quadramet administration are linked with a decrease of red and white blood cells, and platelets. Cases of bleeding have been reported, some of which have been serious.
This is the reason why your blood counts will be monitored strictly for a few weeks following Quadramet injection.
You may exceptionally feel a slight increase in bone pain a few days after Quadramet injection. You should not be alarmed at this; in such case, your pain medicine will be slightly increased. This effect is moderate and brief and will disappear after some hours.
Adverse drug reactions such as nausea, vomiting, diarrhoea and sweating were reported. Hypersensitivity reactions including rare cases of anaphylactic reaction have been reported after
Quadramet administration.
In rare cases, the following undesirable effects have been observed: neuralgia, coagulation disorders, cerebrovascular accidents. These effects were deemed to be related to the progression of the disease.
If you experience back pain or sensory abnormalities, please inform your physician as soon as possible.
If you get any side effects, talk to your doctor or pharmacist. 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.
Keep this medicine out of the sight and reach of children.
Do not use Quadramet after the expiry date which is stated on the label. Quadramet expires 1 day from the activity reference time stated on the label.
Store at –10°C to –20°C in a freezer in its original packaging.
Quadramet should be used within 6 hours of thawing. After thawing, do not freeze again.
The product label includes the appropriate storage conditions and the expiry date for the batch of product. Hospital personnel will ensure that the product is stored correctly and not administered to you after the stated expiry date.
Storage procedures should be in accordance with national regulations for radioactive materials.
The active substance is samarium (153Sm) lexidronam pentasodium.
Each ml of solution contains 1.3 GBq Samarium (153Sm) lexidronam pentasodium at the reference date (corresponding to 20-80 µg/ml of samarium per vial).
The other ingredients are total EDTMP (as EDTMP.H2O), calcium-EDTMP sodium salt (as Ca), total sodium (as Na), water for injections.
Quadramet is a solution for injection.
This medicinal product is a clear, colourless to light amber solution which is packed in a 15 ml colourless European Pharmacopoeia Type I drawn glass vial closed with Teflon-coated chlorobutyl/natural rubber stopper and aluminium flip-off overseal.
Each vial contains 1.5 ml (2 GBq at reference) to 3.1 ml (4 GBq at reference) of solution for injection.
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The complete SmPC of Quadramet is provided as a separate document in the product package, with the objective to provide healthcare professionals with other additional scientific and practical
information about the administration and use of this radiopharmaceutical.
Please refer to the SmPC (SmPC should be included in the box)