Romosozumab

(Brand name: Evenity®)

Romosozumab (also known as Evenity®) is a new injectable drug treatment for some women with osteoporosis. It may be suitable if you’ve already broken a bone due to osteoporosis and are at high risk of breaking another.

Romosozumab works by speeding up the cells that build bone (osteoblasts), and slowing down the cells that break down bone (osteoclasts). This helps to prevent bone loss. It can help strengthen your bones and reduce your risk of breaking more bones.

Who can have romosozumab?

Romosozumab may be suitable if you are a woman and you:

• have been through the menopause, and
• have broken a bone due to osteoporosis, and
• have a high risk of breaking another bone.

It is only licensed for use in women in the UK. This means that if you're a man with osteoporosis, you're very unlikely to be offered romosozumab.

Romosozumab can be used as a first drug treatment for osteoporosis. It can also be used if you’ve already tried other drug treatments and are still breaking bones.

In practice, romosozumab will usually only be offered to post-menopausal women who've had one or more spinal fractures, or whose risk of breaking another bone is likely to be high because of very low bone density or several other risk factors.

Where is romosozumab available?

Romosozumab is a new treatment, so it may not yet be available everywhere.

In England and Wales, romosozumab was approved for use on the NHS in May 2022. This means it should be available in most places, for women who have been through the menopause and have broken a bone due to osteoporosis in the last two years, meaning they are at high risk of breaking another.

In Scotland, it is available on the NHS for women who have been through the menopause and have broken a bone due to osteoporosis in the last two years.

In Northern Ireland, the Department of Health has endorsed the guidance used in England and Wales. This means you should be able to get romosozumab if your doctor thinks it is suitable for you.

It's worth bearing in mind that GPs won't usually prescribe romosozumab, so you'll probably need to see a specialist at a hospital. If your referral is likely to be delayed, your GP may recommend starting you on a different drug treatment, to help protect your bones while you wait.

When is romosozumab not suitable?

You won't be able to have romosozumab if you have:

• a history of heart attack or stroke
• a low blood calcium level (hypocalcaemia) – you’ll need to increase your intake of calcium and vitamin D before you can start romosozumab.

Pregnancy and breast-feeding
Romosozumab is only licensed for use in women who have been through the menopause. It hasn’t been tested in pregnant or breast-feeding women. This means we don’t yet know whether it might affect a child in the womb or while being breast-fed. If you’re pregnant or breast-feeding, ask your doctor about treatments that may be suitable for you.

Men with osteoporosis
Romosozumab is only licensed for use in women, as there hasn’t been enough research to show it is safe and works well in men. Occasionally, a doctor may agree to prescribe a medication outside its licence – known as ‘off-label’ use. But in practice, you probably won’t be able to have romosozumab if you’re a man.

What does treatment involve?

Romosozumab involves giving yourself two injections just under the skin, once a month for 12 months. You’ll have a total dose of 210mg per month (105mg in each injection).

You’ll be given instructions and shown how to give yourself the injections. If you can’t do them yourself, a family member or carer can do them for you.

You should do your two injections together each month – one straight after the other. You can give them into your stomach area (abdomen) or your thigh. It’s best to choose a different part of the body for each injection. If this isn’t possible, don’t give both injections in the exact same place.

You can also have the injections in the outer area of your upper arm, but only if someone else does this for you.

It’s important to have enough calcium and vitamin D while you’re on romosozumab. Your doctor may prescribe calcium and vitamin D supplements before and during your treatment, to make sure you are getting enough.

How long will my treatment last?

You’ll be on romosozumab for one year. It will help to reduce your risk of broken bones during this time.

What will happen when I stop having romosozumab?

When you finish your course of romosozumab, your doctor will talk to you about starting a different treatment for osteoporosis, such as a bisphosphonate. The benefits of romosozumab start to wear off when you stop taking it. So if you don’t start another treatment, your bones will become weaker and you’ll become more likely to break another bone.

We don’t yet know how quickly the risk of breaking bones increases when you stop taking romosozumab. It’s important to discuss this with your healthcare professional before starting treatment – particularly if you already know a bisphosphonate drug treatment won’t be suitable for you afterwards.

If you're prescribed romosozumab

Get all the information you need

Find out about your treatment options so that you can be fully involved in decisions and know what to expect. Talk to your doctor about your medication, its side effects and any risks. You can read more about these below.

It’s important to read the information in the patient information leaflet that comes with your treatment. You can also read more detailed information in our fact sheet.

Discuss what will happen when you stop romosozumab

It's important to discuss your future treatment plan before starting romosozumab. When you finish your one-year course of romosozumab, the benefits will start to wear off unless you start another treatment straight away. Your doctor will want to make sure you understand this before they prescribe romosozumab.

Know how to lower your risk of side effects and other problems

Like all treatments, romosozumab can cause side effects, but these aren’t very common. They can include:

• joint pain
• headache
• cold-like symptoms.

If you do get side effects, they shouldn't last for long. The best thing to do is speak to your doctor or pharmacist.

Other possible health risks

Some research suggests that romosozumab might increase your risk of heart attack or stroke. Because of this, you're unlikely to be offered romosozumab if you've already had a heart attack or stroke. 

Romosozumab can, very rarely, cause some other serious health problems.

• Osteonecrosis of the jaw – this is where the mouth fails to heal quickly, usually following dental treatment.
• Atypical (unusual) thigh bone fracture – this is an unusual and rare type of thigh bone fracture that can occasionally happen, even with little or no force.

Content reviewed: March 2021

(updated September 2022)