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Prolia^® (denosumab) - information for patients

About Prolia^®

Prolia^® (denosumab) is used to treat:¹

Osteoporosis in women after the menopause (postmenopausal) and men who have an increased risk of fracture (broken bones), reducing the risk of spinal, non-spinal and hip fractures.
Bone loss that results from a reduction in hormone (testosterone) level caused by surgery or treatment with medicines in patients with prostate cancer.
Bone loss that results from long-term treatment with glucocorticoids in patients who have an increased risk of fracture.

Prolia^® contains denosumab, a protein (monoclonal antibody) that interferes with the action of another protein, in order to treat bone loss and osteoporosis.¹

There are cells in your body that remove old bone (osteoclasts), and other cells that rebuild bone (osteoblasts).
Normally the process of bone formation and resorption is balanced.
After the menopause in women, bone-removing cells cause you to lose bone at a rate that is too fast. This can leave you with thinner, weaker bones and put you at risk for breaking a bone.
Men also experience bone loss, which can lead to osteoporosis, but this tends to occur later in life.
Bone loss can also occur in patients receiving glucocorticoids.

Treatment with Prolia® makes bone stronger and less likely to break.¹

To get the most benefit from your treatment in reducing the risk of fractures, it is important to use Prolia® for as long as your doctor prescribes it for you. Do not stop your treatment without contacting your doctor.¹

Why am I being prescribed Prolia^®

As we get older, our risk of bone breaks and fractures increases. Osteoporosis causes your bones to become brittle and more fragile so that a fall or even mild stresses such as bending over or coughing can cause a fracture.³ Lifestyle changes and keeping active can help to prevent falling. Food supplements, such as calcium and vitamin D, and drug treatments, such as Prolia^®, can strengthen bones which can reduce your risk of a fracture.²

Prolia^® is used to help improve bone strength and help reduce the risk of fractures in women with osteoporosis after the menopause. You may not see any changes or feel any different in yourself when you are taking it, but Prolia^® can reduce your risk of fractures.²

Treatment with Prolia^® increases bone mass and can be beneficial in men with osteoporosis who are at high risk of fracture and in prostate cancer patients who have suffered bone loss due to testosterone level reduction caused by surgery or treatment with medicines. Also, treatment with Prolia^® can be benefical in patients with bone loss that results from long-term treatment with glucocorticoids in patients who have an increased risk of fracture.²

Your doctor will have considered your medical history and circumstances, as well as information available before deciding to prescribe Prolia^®. This might have included clinical trials demonstrating:²

The ability of Prolia^® to reduce bone loss and gradually restore bone mass
The ability of Prolia^® to reduce the risk of fracture
The side effect profile of Prolia^®

References:

Prolia^® (denosumab) Patient Information Leaflet.
Prolia^® (denosumab) Summary of Product Characteristics.
Kanis, J. et al. Re: BMJ 2015;350:h2088.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. Side effects can be reported directly to the Health Products Regulatory Authority (HPRA) using the available methods via www.hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine. Side effects should also be reported to Amgen Limited on +44 (0) 1223 436441 or Freephone 1800 535 160.

Please report any potential quality issue with the Amgen product you have received, by calling us on +44 (0) 1223 436441 or Freephone 1800 535 160 and providing us with the details. Please ensure that you keep your packaging, so we are able to identify your product more easily.

For a list of possible side effects, please see

Patient Information Leaflet (PIL)

Prolia® (denosumab) - information for patients About Prolia®

Prolia® (denosumab) is used to treat:1

Prolia® contains denosumab, a protein (monoclonal antibody) that interferes with the action of another protein, in order to treat bone loss and osteoporosis.1

Treatment with Prolia® makes bone stronger and less likely to break.1