Skip to main content

This website is intended for patients who have been prescribed Evenity®▼ (romosozumab) and have signed up to the support programme.
Information placed on this digital platform is not intended as a substitute for consultation with your doctor.

Important Safety Information

Important Information for patients and their caregivers

Evenity helps strengthen bones and helps reduce the risk of breaking bones. Like all medicines, there is a risk of developing side effects. Please read this page and the Evenity package leaflet for further information.

What you need to know before you use Evenity

Do not use Evenity if

  • You are allergic to romosozumab or any of the other ingredients of this medicine
  • You have low levels of calcium in the blood (hypocalcaemia). Your doctor will be able to tell you if your levels are too low
  • You have a history of heart attack or stroke

If you are not sure, talk to your doctor or pharmacist before using Evenity.

Warnings and precautions

Heart attack and stroke
Heart attack and stroke have been reported in people receiving Evenity.
Seek medical attention straight away if you get:

  • Chest pain, shortness of breath
  • Headache, numbness, or weakness in your face, arms, or legs, difficulty talking, changes in vision, loss of balance

Your doctor will carefully evaluate the risk of cardiovascular problems before he/she lets you start treatment with Evenity. Tell your doctor if you know that you have an increased risk of cardiovascular problems such as established cardiovascular disease, high blood pressure, high blood fat levels, diabetes, smoking or kidney problems.

Low levels of calcium in the blood
Evenity may cause low levels of calcium in your blood.
Tell your doctor if you notice:

  • Spasms, twitches, or cramps in your muscles
  • Numbness or tingling in your fingers, toes or around your mouth

Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood before you start your treatment and while you take Evenity. Take calcium and vitamin D as your doctor tells you to.

Tell your doctor if you have or have ever had severe kidney problems, kidney failure or have needed dialysis as this may increase your risk of getting low blood calcium if you do not take calcium supplements.

Serious allergic reactions
Serious allergic reactions can happen to people who use Evenity.
Seek medical attention straight away if you get:

  • Swelling of the face, mouth, throat, hands, feet, ankles, lower legs (angioedema), or hives
  • Acute skin eruption showing multiple round, red/pink spots with a blistering or crusting centre (erythema multiforme)
  • Difficulty in swallowing or breathing

Problems with your mouth, teeth or jaw
A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported rarely (may affect up to 1 in 1,000 people) in patients receiving Evenity. ONJ can also occur after stopping treatment. It is important to try to prevent ONJ developing, as it may be a painful condition that can be difficult to treat. In order to reduce the risk of developing ONJ, there are some precautions you should take.

Before receiving Evenity, tell your doctor or nurse if you:

  • Have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction
  • Do not receive routine dental care or have not had a dental check-up for a long time
  • Are a smoker (as this may increase the risk of dental problems)
  • Have previously been treated with a bisphosphonate (used to treat or prevent bone disorders, such as osteoporosis)
  • Are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
  • Have cancer

Your doctor may ask you to undergo a dental examination before you start treatment with Evenity.

Contact your doctor and dentist immediately if you get any problems with your mouth or teeth such as:

  • Loose teeth;
  • Pain or swelling;
  • Mouth sores that do not heal;
  • Pus discharge.

Unusual thigh bone fractures
People who have used Evenity rarely developed unusual fractures of the thigh bone caused by little or no trauma. These fracture types are often preceded by warning signs of thigh or groin pain for several weeks before the fracture occurs. It is not known whether Evenity caused these unusual fractures. Tell your doctor or pharmacist if you get any new or unusual pains in your hip, groin or thigh.

Other medicines and Evenity
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Seek medical attention straight away if you get any of the following possible
symptoms of heart attack or stroke (uncommon: may affect up to 1 in 100 people):

  • Chest pain, shortness of breath
  • Headache, numbness, or weakness in your face, arms, or legs, difficulty talking, changes in vision, loss of balance

Seek medical attention straight away if you get the following symptoms of a
serious allergic reaction (rare: may affect up to 1 in 1,000 people):

  • Swelling of the face, mouth, throat, hands, feet, ankles, lower legs (angioedema), or hives
  • Acute skin eruption showing multiple round, red/pink spots with a blistering or crusting centre (erythema multiforme)
  • Difficulty in swallowing or breathing

Tell your doctor if you notice the following symptoms of low levels of calcium in
the blood (hypocalcaemia) (uncommon: may affect up to 1 in 100 people):

  • Spasms, twitches, or cramps in your muscles
  • Numbness or tingling in your fingers, toes or around your mouth

Other side effects may include:

Very common side effects (may affect more than 1 in 10 people):

  • Common cold
  • Joint pain

Common side effects (may affect up to 1 in 10 people):

  • Rash, inflammation of the skin
  • Headache
  • Sinusitis
  • Neck pain
  • Muscle spasms
  • Redness or pain around the site where the injection was given

Uncommon side effects (may affect up to 1 in 100 people):

  • Hives (urticaria)
  • Cataract

Reporting of side effects

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting side effects you may get. By reporting side effects you can help provide more information on the safety of this medicine.

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.

You can also report side effects directly via http://www.mhra.gov.uk/yellowcard . Adverse events should also be reported to UCB Pharma Ltd via UCBCares® on + 44 (0) 1753 777 100 or 0800 279 3177 (freephone).