What is it and how is it used?
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.
What do you have to consider before using it?
Do not take QUADRAMET:
- If you are hypersensitive (allergic) to ethylene diamine tetramethylene phosphonic acid (EDTMP) or similar phosphonate compounds,
- If you are pregnant,
- If you have received chemotherapy or hemibody field external radiation therapy in a preceding period of 6 weeks.
Take special care with QUADRAMET:
QUADRAMET is not recommended for use in children below 18 years of age.
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.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription.
Pregnancy and breast-feeding:
QUADRAMET must not be administered to pregnant women.
If QUADRAMET administration to a breastfeeding woman is deemed necessary, breastfeeding should be stopped.
Ask your doctor or pharmacist for advice before taking any medicine.
How is it used?
Your doctor will want to carry out a special scan before administering QUADRAMET to ascertain whether you are likely to benefit from QUADRAMET.
Dosage
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.
Method and route of administration
QUADRAMET is to be administered by slow injection into a vein.
Frequency of administration
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.
Duration of treatment
You will be authorised to leave the nuclear medicine department after a dosimetric follow-up (generally within 6 hours following QUADRAMET injection).
If you take more QUADRAMET than you should
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.
What are possible side effects?
Like all medicines, QUADRAMET can have 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How should it be stored?
Keep out of the reach and sight 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.
What is it?
What is it used for?
QUADRAMET is used to relieve bone pain in patients with multiple painful osteoblastic skeletal metastases (when cancer has spread to the bones). Osteoblastic metastases are a type of bone metastasis where new bone tissue grows rapidly. QUADRAMET is only used in bone metastases that can take up a type of chemical called bisphosphonates, as this means that the metastases will also take up QUADRAMET. Before receiving QUADRAMET patients should have a bone scan using bisphosphonates radiolabelled with technetium-99m [ 99mTc] as markers, to check that their metastases are of the type that QUADRAMET can be used for.
The medicine can only be obtained with a prescription.
How is it used?
QUADRAMET should only be handled and given by someone who is authorised to use radioactive medicines and after full oncological (cancer) evaluation. The dose of QUADRAMET is calculated based on the patient’s body weight to provide a specific dose of radioactivity (37 mega becquerels per kilogram body weight). The medicine is given by slow intravenous injection (into a vein) over one minute. Patients who respond to QUADRAMET generally have relief of their pain within one week of treatment. The pain relief may last for up to four months.
How does it work?
QUADRAMET is a radiopharmaceutical product. Its active substance is samarium [ Sm] lexidronam pentasodium. It is a complex (a type of chemical) made up of a radioactive element, samarium-153 ( Sm), bound to another chemical called ‘ethylene diamine tetra methylene phosphonic acid’ (EDTMP).
When QUADRAMET is injected into a patient, the complex is distributed around the body via the bloodstream. Because EDMTP has a high affinity for bone tissue, it accumulates in the bone, especially in areas of rapid bone growth such as osteoblastic metastases. As a result, the radiation brought by the samarium-153 can act locally and help to relieve the bone pain.
How has it been studied?
QUADRAMET has been studied in 373 patients in three main studies. In two of these, the effectiveness of QUADRAMET was compared with that of placebo (a dummy treatment). The main measure of effectiveness was the reduction of pain. This was measured using various means, such as visual or descriptive scales, analgesic (painkiller) use, and assessment by the doctor.
What benefits has it shown during the studies?
QUADRAMET was effective in providing pain relief from osteoblastic bone metastases, and, where it was compared with placebo, more effective than placebo. In one of the studies, which involved patients with bone metastases from prostate cancer, the patients’ use of opioid analgesics (such as morphine) was also reduced following treatment with QUADRAMET.
What is the risk associated?
The main side effects of QUADRAMET are a reduction in red and white blood cell and platelet counts. The following side effects have also been reported: asthenia (weakness), nausea (feeling sick), vomiting, diarrhoea, peripheral oedema (fluid retention), headaches, hypotension (low blood pressure), dizziness, myasthenia (muscle weakness), confusion and sweating. For the full list of all side effects reported with QUADRAMET, see the Package Leaflet.
QUADRAMET should not be used in people who may be hypersensitive (allergic) to EDTMP or to phosphonates (similar chemical compounds). It should not be used in pregnant women or in patients who have had chemotherapy or hemi-body external radiotherapy in the previous six weeks. QUADRAMET should not be used at the same time as any chemotherapy that affects the bone marrow or at the same time as other bisphosphonate medicines if these can interact with the way QUADRAMET fixes to bone metastases.
Why has it been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that QUADRAMET’s benefits are greater than its risks for the relief of bone pain in patients with multiple painful osteoblastic skeletal metastases. The Committee recommended that QUADRAMET be given marketing authorisation.
Further information
The European Commission granted a marketing authorisation valid throughout the European Union for QUADRAMET to CIS bio international on 5 February 1998. The marketing authorisation was renewed on 5 February 2003 and on 5 February 2008.
This summary was last updated in 12-2007.
Name
QUADRAMET, solution for injection
Composition
Each ml of solution contains 1.3 GBq Samarium [ Sm] lexidronam pentasodium at the reference date (corresponding to 20 to 46 µg/ml of samarium per vial)
Samarium specific activity is approximately 28 – 65 MBq/µg of samarium.
Each vial contains 2-4 GBq at the reference date.
Samarium-153 emits both medium-energy beta particles and an imageable gamma photon, and has a period of 46.3 hours (1.93 days). The primary radiation emissions of samarium-153 are shown in Table 1.
For a full list of excipients, see section 6.1.
Pharmaceutical Form
Solution for injection.
Clear, colourless to light amber solution with pH ranging between 7.0 and 8.5.
