What is QUADRAMET?
QUADRAMET is a solution for injection containing the active ingredient samarium [153Sm] lexidronam pentasodium.
What is QUADRAMET used for?
QUADRAMET is used to reduce bone pain in patients who have skeletal metastases (common bone cancer), multiple painful osteoblasts. Osteoblastic metastases are a type of bone metastasis characterized by rapid growth of bone tissue. QUADRAMET is used only in bone metastases capable of absorbing chemicals called bisphosphonates, since this means that the metastases will also absorb QUADRAMET. Before receiving QUADRAMET, patients should undergo bone scintigraphy using technetium-99m-labeled bisphosphonates as markers [99mTc] to verify that the metastases they present are of the type for which QUADRAMET can be used.
The medicine can only be obtained with a prescription.
How is QUADRAMET used?
QUADRAMET should be handled and administered only by persons authorized to use radioactive drugs and after a complete cancer (tumor) assessment. The dose of QUADRAMET is calculated based on the patient's body weight, in order to provide a specific dose of radioactivity (37 megabecquerels per kilogram of body weight). The medicine is given by slow intravenous injection (into a vein) over one minute. Patients who respond to QUADRAMET therapy generally experience a reduction in pain within one week of treatment. Pain relief can last up to four months.
How does QUADRAMET work?
QUADRAMET is a radiopharmaceutical product. Its active ingredient is samarium [153Sm] lexidronam pentasodium. It is a complex (a type of chemical substance) consisting of a radioactive element, samarium-153 (153Sm), bound to another chemical element, ethylenediaminetetramethylphosphonic acid (EDTMP).
When QUADRAMET is given to a patient by injection, the complex is distributed throughout the body via the bloodstream. EDMTP, having a high affinity for bone tissue, accumulates in bones and especially in areas of rapid bone growth, such as osteoblastic metastases. As a result, radiation carried with samarium-153 can act locally and help alleviate bone pain.
What studies have been carried out on QUADRAMET?
QUADRAMET has been studied in 373 patients during three main studies. In two of these the efficacy of QUADRAMET was compared with that of placebo (a dummy treatment). Pain reduction has been the main measure of effectiveness. This reduction was measured with various tools, including visual or descriptive scales, use of analgesics (painkillers) and physician evaluation.
What benefit has QUADRAMET shown during the studies?
QUADRAMET was effective in determining pain reduction from osteoblastic bone metastases and was more effective when compared with placebo. In one of the studies, which involved patients with bone metastases secondary to prostate cancer, treatment with QUADRAMET also led to a reduction in the use of opioid analgesics (such as morphine) by patients.
What is the risk associated with QUADRAMET?
The main side effects of QUADRAMET are a reduction in the number of white blood cells, red blood cells and platelets. The following side effects have also been reported: asthenia (weakness), nausea, vomiting, diarrhea, peripheral edema (fluid retention), headache, hypotension (low blood pressure), dizziness, myasthenia (muscle weakness), confusion and intense 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 phosphonates (similar chemical compounds). It must not be used in pregnant women or in patients who have undergone chemotherapy or external radiotherapy of a body within six weeks. QUADRAMET should not be used concomitantly with a chemotherapy treatment that has effects on the bone marrow or in conjunction with other bisphosphonate drugs where the latter may interact with the mode of adherence of QUADRAMET to bone metastases.
Why has QUADRAMET been approved?
The Committee for Medicinal Products for Human Use (CHMP) considered that the benefits of QUADRAMET outweigh the risks in the treatment of bone pain in patients presenting with multiple painful osteoblastic skeletal metastases. The Committee recommended the granting of the marketing authorization for QUADRAMET.
More information on QUADRAMET
On 5 February 1998 the European Commission issued a marketing authorization for QUADRAMET, valid throughout the European Union, to CIS bio international. The marketing authorization was renewed on 5 February 2003 and 5 February 2008.
For the full EPAR of QUADRAMET, click here.
Last update of this summary: 12-2007.
