Denosumab (Prolia, Xgeva)

Denosumab is a type of targeted drug called a monoclonal antibody. It is also known as Prolia and Xgeva. You pronounce denosumab as den-oh-sue-mab.

It is a treatment for secondary bone cancer (cancer that has spread to the bones). It helps to strengthen the bones and prevent fractures for some types of cancer.

It also helps to slow down bone damage in people who have giant cell tumour of the bone (a non cancerous type of bone tumour).

How does denosumab work?

In healthy bones, specialised 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.

How do you have denosumab?

You have denosumab as an injection just below the skin (subcutaneously) usually in your thigh, abdomen or upper arm.

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Transcript

Nurse: This is a short film showing you how to give an injection just under your skin. This is called a subcutaneous or sub cut injection. This does not replace what your doctors and nurses tell you, so always follow their advice.

Voiceover: Subcutaneous injections may be part of your cancer treatment. Or, you may need them to prevent side effects of treatment, such as blood clots after surgery. Or to help control cancer symptoms, such as pain or sickness.

Most injections come in prefilled syringes.

Nurse: So, today I am going to show you how to give a subcutaneous injection. I am going to start by giving it into a practice cushion and then you can have a go at giving one yourself. Before you start, you need to get your equipment together. What you are going to need is an alcohol wipe to clean your skin, some cotton wool, a prefilled syringe and a sharps bin. It is important that you wash your hands with soap and water and dry them thoroughly before you start. Check that you have got the correct drug and that it is in date.

You can give the injection into the back of your arm, your tummy, your thigh or the outer part of your bottom. It is important that you vary where you give the injection. So it may be that you give it one day in your tummy and the next in your thigh.

So you start by cleaning the skin with the alcohol wipe and allowing it to air dry. Then you take the cover off the needle and pinch the skin up and hold it a bit like a pen and in an upright position, in a quick dart like motion pop it straight down into the skin. Then you press the plunger right to the end, quickly pull the needle out, dab it with cotton wool, pop the needle into the sharps bin. And then you need to wash your hands again.

So here’s what you are going to need. If you start by checking the drug and the expiry date. And then with the alcohol wipe give your skin a clean. That’s it give it a few seconds for the air to dry it. Okay, and then if you want to pick up the syringe and take the cover off the needle. Then pinch your skin up and at a ninety degree angle gently push the needle in...then press the plunger...and then quickly remove it... dab your skin with the cotton wool and put the syringe in the sharps bin.

How often do you have denosumab?

You have denosumab as cycles of treatment. This means that you have the drug and then a rest to allow your body to recover.

How often you have denosumab depends on the dose and whether you have Prolia or Xgeva.

You have Prolia every 6 months.

You usually 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.

Tests

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.

Your doctor usually asks you to see a dentist before and regularly during this treatment to check the condition of your mouth and teeth.

What are the side effects of denosumab?

Side effects can vary from person to person. They also depend on what other treatment you are having.

When to contact your team

Your doctor, nurse, or pharmacist will go through the possible side effects. They will monitor you closely during treatment and check how you are at your appointments. Contact your advice line as soon as possible if:

you have severe side effects
your side effects aren’t getting any better
your side effects are getting worse

Early treatment can help manage side effects better.

We haven't listed all the side effects here. Remember it is very unlikely that you will have all of these side effects, but you might have some of them at the same time.

Common side effects

These side effects happen in more than 10 in 100 people (more than 10%). You might have one or more of them. They include:

Low level of calcium in the blood

Low calcium levels in the blood can cause painful muscle spasms, cramps or muscle twitching. You might also get numbness or tingling in your feet, hands or around your mouth.

You usually have calcium and vitamin d supplements to take while you're on denosumab.

Shortness of breath

You might find it difficult to breath or get your breath. Contact your advice line or tell your doctor or nurse.

Diarrhoea

Contact your advice line if you have diarrhoea. For example, in one day you have 2 or more loose bowel movements than usual. If you have a stoma Open a glossary item , you might have more output than normal. Your doctor may give you anti diarrhoea medicine to take home with you after treatment.

Try to eat small meals and snacks regularly. It’s best to try to have a healthy balanced diet if you can. You don’t necessarily need to stop eating foods that contain fibre. But if your diet is normally very high in fibre, it might help to cut back on high fibre foods such as beans, nuts, seeds, dried fruit, bran and raw vegetables.

Drink plenty to try and replace the fluid lost. Aim for 8 to 10 glasses per day.

Pain

You might have muscle and or bone pain. You might also have pain in your arms and legs. Let your doctor or nurse know so they can advise you on how to reduce it.

Occasional side effects

These side effects happen in between 1 and 10 out of every 100 people (between 1 and 10%). You might have one or more of them. They include:

damage to your jaw bone - signs include ongoing jaw pain, swelling, numbness, heavy feeling in the jaw and loosing of teeth. Contact your advice line or tell your doctor or nurse straight away
if you are having denosumab because your cancer has spread to the bones there is a small chance you might develop another type of cancer
low levels of phosphate in the blood - if you are feeling tired, have sore muscles, lose your appetite, feel irritable or confused contact your advice line or tell your doctor or nurse straight away
you might need to have a tooth taken out
you might sweat more

Other occasional side effects of Prolia

infections such as urine or lung infections
pain or tingling that moves through your hip and down your leg (sciatica)
constipation and tummy (abdominal) pain
skin problems such as a rash and dry, itchy skin
hair loss

Rare side effects

These side effects happen in fewer than 1 in 100 people (fewer than 1%). You might have one or more of them. They include:

if you are having denosumab for giant cell tumour of the bone you might have high levels of calcium in the blood after you stop treatment
a rash skin or sores in the mouth
new or unusual pain in your hip, groin or thigh this could be a fracture of your thigh bone
allergic reaction that can cause a rash, shortness of breath, redness or swelling of the face and dizziness - some allergic reactions can be life threatening, tell your nurse or doctor if you notice any of these symptoms

Other side effects

There isn't enough information to work out how often this side effect might happen.

damage to the bones in the ear - signs are ear pain, discharge from the ear with or without an infection. Contact your advice line or tell your doctor or nurse straight away if you have any of these symptoms

What else do I need to know

Other medicines, food and drink

Cancer drugs can interact with medicines, herbal products, and some food and drinks. We are unable to list all the possible interactions that may happen. An example is grapefruit or grapefruit juice which can increase the side effects of certain drugs.

Tell your healthcare team about any medicines you are taking. This includes vitamins, herbal supplements and over the counter remedies. Also let them know about any other medical conditions or allergies you may have.

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 with this drug and for at least 5 months afterwards. Talk to your doctor or nurse about effective contraception before starting treatment.

Fertility

It is not known whether this treatment affects fertility Open a glossary item in people. Talk to your doctor before starting treatment if you think you may want to have a baby in the future.

Breastfeeding

It is not known whether this drug comes through into the breast milk. Doctors usually advise that you don’t breastfeed during this treatment.

Treatment for other conditions

If you are having tests or treatment for anything else, always mention your cancer treatment. For example, if you are visiting your dentist.

More information about this treatment

For further information about this treatment and possible side effects go to the electronic Medicines Compendium (eMC) website. You can find the patient information leaflet on this website.

You can report any side effect you have to the Medicines Health and Regulatory Authority (MHRA) as part of their Yellow Card Scheme.