Denosumab (Prolia, Xgeva)

This page tells you about the biological therapy drug denosumab and its possible side effects. There are sections about

What denosumab is
How denosumab works
How you have denosumab
Occasional side effects
Rare side effects
Important points to remember

Denosumab (pronounced den-oh-sue-mab) is a type of monoclonal antibody. Monoclonal antibodies are a type of biological therapy. They are made in the laboratory. They recognise and find specific proteins on the outside of some cells. Denosumab is also known by its brand names, Xgeva and Prolia.

Xgeva is licensed for use in preventing fractures and other cancer related bone problems in adults with cancer that has spread to the bones.

In healthy bones specialised bone cells constantly break down and replace old tissue. These specialised bone cells are

Osteoclasts, which break down old bone
Osteoblasts, which build new bone

This process is called bone remodelling and is very well controlled. There is a fine balance between the rates of bone breakdown and growth, which keeps bones strong and healthy.

Denosumab works by targeting a protein called RANKL which controls the activity of osteoclasts. This stops bone cells being broken down.

You have denosumab as an injection just below the skin (subcutaneously). You have Xgeva every 4 weeks. You have Prolia every 6 months.

The side effects associated with denosumab are listed below. They may be different if you are having it with other drugs.

Between 1 and 10 in every 100 people have one or more of these.

Infections such as urine, chest, ear or skin infections – tell your doctor if you have a temperature, feel generally unwell, have pain passing urine, get short of breath, or have earache
Cellulitis – a swollen, red area of skin that feels hot and tender
A rash, which may be itchy and become sore
Aching joints
Back pain or sciatica – let your doctor or nurse know if you have any pain, numbness or tingling in your back or legs
Constipation
Muscle and bone pain
Tiredness
Clouding of the eye (cataract)
Fertility – we don’t know exactly how this drug affects fertility so do talk with your doctor before starting treatment if this is important to you

Fewer than 1 in 100 people have these.

Low calcium levels – you will have blood tests to check your calcium levels and you may need to take a calcium and vitamin D supplement
Osteonecrosis of the jaw can be a side effect of taking denosumab – have a dental check up before you start treatment and tell your dentist that you are having denosumab

You won’t get all these side effects and some may be very mild. A side effect may get worse through your course of treatment. Or you may have more side effects as the course goes on. This depends on

How many times you've had a drug before
Your general health
How much of the drug you have (the dose)
Other drugs you are having

Tell your doctor about any other medicines you are taking, including vitamins, herbal supplements, and other over the counter remedies – some drugs can react together.

Talk to your doctor, pharmacist or nurse about all your side effects so they can help you manage them.