Denosumab (Prolia, Xgeva)
This page tells you about the biological therapy drug denosumab and its possible side effects. There are sections about
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. It is also used to slow down bone damage in people who have giant cell tumour of the bone (a non cancerous type of bone tumour).
Prolia can reduce the risk of spinal fractures in men who have weakened bones due to hormone therapy for prostate cancer.
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 and strengthens the bone.
You have denosumab as an injection just below the skin (subcutaneously).
You have Xgeva every 4 weeks. If you have giant cell tumour of the bone you have an extra dose 1 week and 2 weeks after the first dose.
You have Prolia every 6 months.
You have blood tests before starting treatment and regularly during your treatment. The tests check your levels of calcium and other chemicals in the blood.
We've listed the side effects associated with denosumab below. You can use the links to find out more about each side effect. Where there is no link, please go to our cancer drug side effects section or use the search box at the top of the page.
You may have a few side effects. They may be mild or more severe. A side effect may get better or worse through your course of treatment. Or more side effects may develop as the course goes on. This depends on
- How many times you've had the drug before
- Your general health
- The amount of the drug you have (the dose)
The side effects may be different if you are having denosumab with other drugs.
Tell your doctor or nurse straight away if any of the side effects get severe.
More than 10 in every 100 people have one or more of these effects.
- Breathlessness (occurs with Xgeva)
- Diarrhoea (with Xgeva)
- Bone, joint or muscle pain that is sometimes severe
- Arm or leg pain (with Prolia)
Between 1 and 10 in every 100 people have one or more of these.
- Low calcium levels – you will need to take a calcium and vitamin D supplement unless your blood calcium levels are high. Low calcium levels can cause muscle spasms or cramps, twitching, and numbness or tingling in your fingers or toes or around your mouth. Let your doctor or nurse know straight away if you have this
- Infections such as urine, chest, ear or skin infections (occurs with Prolia) – tell your doctor if you have a temperature, feel generally unwell, have pain passing urine, get short of breath, or have earache
- A rash, which may be itchy and become sore (with Prolia)
- Sweating more than usual (with Xgeva)
- Back pain or sciatica (with Prolia) – let your doctor or nurse know if you have any pain, numbness or tingling in your back or legs
- Constipation (with Prolia)
- Clouding of the eye (cataract) with Prolia
- Fertility – you may not be able to become pregnant or father a child after this treatment. Talk to your doctor before starting treatment if you think you may want to have a baby in the future. Men may be able to store sperm before starting treatment
- Pain and sores in the mouth (with Xgeva)
- Dead cells in part of the jaw (osteonecrosis) that may lead to loss of teeth – it is important to have a dental check up before you start treatment and tell your dentist that you are having denosumab
Fewer than 1 in 100 people have these but tell your doctor or nurse straight away if you have them.
- A swollen, red area of skin that feels hot and tender (cellulitis)
- An allergic reaction, causing wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, and a rash or itchy skin
- A split in the wall of the back passage (diverticulitis) causing a high temperature, sickness and tummy (abdominal) pain
- Thigh bone fractures, causing sudden, sharp pain in the hip, groin or thigh
Talk to your doctor, pharmacist or nurse about all your side effects so they can help you manage them. They can give you advice or reassure you. Your nurse will give you a contact number to ring if you have any questions or problems. If in doubt, call them.
Tell your doctor about any other medicines you are taking, including vitamins, herbal supplements and over the counter remedies. Some drugs can react together.
Pregnancy and contraception
This drug may harm a baby developing in the womb. It is important not to become pregnant or father a child while you are having treatment and for at least 5 months afterwards. Talk to your doctor or nurse about effective contraception before starting treatment.
Do not breastfeed during this treatment because the drug may come through in the breast milk.
Denosumab contains a type of sugar called sorbitol. If you have an intolerance to some sugars, ask your doctor if denosumab is safe for you to take.
This page does not list all the very rare side effects of this treatment that are very unlikely to affect you. For further information look at the Electronic Medicines Compendium website at www.medicines.org.uk.
If you have a side effect not mentioned here that you think may be due to this treatment you can report it to the Medicines Health and Regulatory Authority (MHRA) at www.mhra.gov.uk.
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