What is Prolia?
Prolia is a solution for injection containing the active substance denosumab. It is available in pre-filled syringes or vials, both containing 60 mg of denosumab.
What is Prolia used for?
Prolia is indicated for the treatment of osteoporosis (a disease that makes bones fragile) in post-menopausal women and with a greater risk of bone fractures. Prolia reduces the risk of fractures to the spine and other parts of the body, including the hip.
Prolia is also used to treat bone loss in men undergoing prostate cancer treatment which increases the risk of fractures. Prolia reduces the risk of spinal fractures.
The medicine can only be obtained with a prescription.
How is Prolia used?
Prolia is given once every six months as a 60 mg subcutaneous injection in the thigh, in the abdomen (belly) or on the back of the arm. During treatment with Prolia, your doctor must make sure that the patient takes calcium and vitamin D supplements. Prolia can be given by people who have been adequately instructed in giving injections.
How does Prolia work?
The active substance in Prolia, denosumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) designed to recognize and bind to a specific structure (the antigen) in the body. Denosumab was designed to bind to an antigen called RANKL, involved in the activation of osteoclasts, the cells that participate in the breakdown of bone tissue in the body. By binding to RANKL and blocking it, denosumab reduces the formation and activity of osteoclasts. This reduces bone loss and maintains bone strength, lowering the likelihood of fracture risk.
What studies have been carried out on Prolia?
The effects of Prolia were first tested in experimental models before being studied in humans.
Prolia has been compared with placebo (a dummy treatment) in two main studies involving a total of 8, 000 women with postmenopausal osteoporosis. In the first of these studies, the main measure of effectiveness was the number of women who suffered new spinal fractures over three years. The study also looked at the number of women who suffered fractures in other parts of the body, including the hip. In the second study, women received treatment for breast cancer and were considered at high risk of suffering fractures. The main measure of effectiveness was the alteration of bone density (measurement of bone strength) in the lumbar spine (lower) after one year of treatment.
Furthermore, Prolia was compared with placebo in a main study involving 1, 468 men who were treated for prostate cancer and who were at greater risk of having fractures. The main efficacy parameter was the change in bone density of the lumbar spine after two years. Furthermore, in this study, the number of patients who suffered backbone fractures over three years was observed.
What benefit has Prolia shown during the studies?
Prolia was more effective than placebo in reducing fractures in women with postmenopausal osteoporosis. After three years, 2% of the women who received Prolia reported a new spine fracture after three years, compared with 7% of the women treated with placebo. Furthermore, Prolia was more effective in reducing the number of women who suffered fractures in other parts of the body, including the hip. In women with breast cancer who took Prolia, there was also a higher bone density in the lower spine after one year.
In men undergoing treatment for prostate cancer, Prolia was more effective than placebo in treating bone loss. After two years, an increase in bone density in the lumbar spine was recorded in men taking Prolia, which was 7% higher than those given placebo. Furthermore, after three years, the risk of new bone fractures in the spine was lower in patients receiving Prolia.
What are the risks associated with Prolia?
The most common side effects associated with Prolia (seen in between 1 and 10 patients in 100) are urinary tract infection (infection to the structures that carry urine such as the bladder), upper respiratory tract infection (colds), sciatica (long pain). the nerve on the back of the thighs), cataracts (opacity of the lens in the eye), constipation, rash and pain in the arms or legs. Cataracts have been observed mainly in men undergoing treatment for prostate cancer. For the full list of all side effects reported with Prolia, see the Package Leaflet.
Prolia should not be used in people who may be hypersensitive (allergic) to the active substance or to any of the other ingredients. It must not be given to people with hypocalcaemia (with low levels of calcium in the blood).
Why has Prolia been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Prolia's benefits are greater than its risks and recommended that it be given marketing authorization.
More information on Prolia
On February 20th, 2010, the European Commission granted a marketing authorization for Prolia, valid throughout the European Union, to Amgen Europe BV. The marketing authorization is valid for five years, after which it can be renewed.
For the full EPAR of Prolia click here. For more information on Prolia therapy, read the package leaflet (also part of the EPAR).
Last update of this summary: 01-2010.
