This information is produced and provided originally by the European Medicines Agency (EMA). We only provide general information and advice from medical professionals should be followed. It is very important to consult more information about the drug, such as side-effects, benefits, indications, approval and so forth. More information concerning the use of this drug is available on the EMA website at www.ema.europa.eu. This information was last updated by EMA in September 2012. It is always important to consult the leaflet information.
Denosumab is the active substance in XgevaTM.
XgevaTM is used to prevent bone complications in adults with a solid tumor that has spread to the bone. These complications include fractures, spinal compression (when the spinal cord is compressed by the bone), or complications requiring radiotherapy or surgery.
The medicine can only be obtained with a prescription.
What is it?
The active substance in XgevaTM, denosumab, is a monoclonal antibody. This is an antibody that has been designed to recognise and attach to a specific structure, called an antigen that is found in the body. Denosumab has been designed to attach to an antigen called RANKL, which is involved in activating osteoclasts, the cells in the body that are involved in breaking down bone tissue. By attaching to and blocking RANKL, denosumab reduces the formation and activity of the osteoclasts. This reduces the loss of bone, making fractures and other serious bone complications less likely to happen.
Does it work?
The effects of XgevaTM were first tested in experimental models before being studied in humans.
XgevaTM was compared with zoledronic acid (another medicine used to prevent bone complications) in three main studies in patients with different types of cancer which had spread to the bone. The first study involved 2,046 patients with breast cancer. The second study involved 1,901 men with prostate cancer which did not respond to hormonal treatment. The third study involved 1,776 patients with advanced solid tumors in various parts of the body, excluding the breast or the prostate, or with multiple myeloma (a cancer of the bone marrow).
All the studies looked at the risk of patients having a first ‘skeletal-related event’ ,such as a fracture, pressure on the spinal cord or the need to receive radiotherapy or surgery, during the study period by measuring how long it took for this event to happen.
XgevaTM was shown to be effective in delaying the patients’ first skeletal-related event. In the first and second studies, XgevaTM reduced the risk of developing a first skeletal-related event by 18% compared with zoledronic acid. In the third study, XgevaTM reduced the risk of developing a first skeletal-related event by 16% compared with zoledronic acid.
Is it safe?
The most common side effects with XgevaTM (seen in more than 1 patient in 10) are dyspnea and diarrhea. For the full list of all side effects reported with XgevaTM, see the package leaflet.
XgevaTM should not be used in people who are allergic to denosumab or any of the other ingredients. It must not be used in people with severe, untreated low blood calcium levels (hypocalcaemia).
This information is based on the Summary for the public of this drug produced by the European Medicines Agency. For more information, click here.
Prolia (brand name)
Xgeva (brand name)