Safety information

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Your doctor will take you through the things you need to consider when preparing to take Prolia® and will give you the patient reminder card, which contains important safety information you need to be aware of before and during your treatment with Prolia®.
Further Prolia® information is also available in the Prolia® Patient Information Leaflet. Should you require a patient reminder card, please speak to your doctor or download a copy here: Patient reminder card.

Things to consider when starting on Prolia®1

Do not use Prolia® if:

  • You have low calcium levels in the blood (hypocalcaemia)
  • You are allergic to denosumab or any of the other ingredients of this medicine (listed in the Patient Information Leaflet)
Tell your doctor if you have or have ever had severe kidney problems, kidney failure or have needed dialysis, or are taking medicines called glucocorticoids (such as prednisolone or dexamethasone) which may increase your risk of getting low blood calcium if you do not take calcium supplements.
If your doctor has prescribed calcium and/or vitamin D it is important that you take this as instructed during your Prolia® treatment (until advised otherwise by your doctor).
You may have low levels of calcium in your blood while receiving Prolia®. Please tell your doctor immediately if you notice any of the following symptoms: spasms, twitches or cramps in your muscle, and/or numbness or tingling in your fingers, toes or around your mouth, and/or seizures, confusion or loss of consciousness.
Severe low blood calcium levels leading to hospitalisation and even life-threatening reactions has been reported in rare cases. Before each dose and in patients predisposed to hypocalcaemia within two weeks after initial dose, the calcium levels in your blood will therefore be checked (via blood test).
A rare side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported rarely in patients receiving Prolia® for osteoporosis. ONJ can also occur after stopping treatment. In order to reduce the risk of developing ONJ, there are some precautions you should take (please see section below "Before receiving treatment, tell your doctor or nurse").
Whilst being treated with Prolia® you may develop a skin infection with symptoms such as a swollen, red area of skin, most commonly in the lower leg, that feels hot and tender (cellulitis), and possibly with symptoms of fever. Please tell your doctor immediately if you develop any of these symptoms.
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Before receiving treatment, tell your doctor or nurse (healthcare professional) if you:1

  • Have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction.
  • Don't 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).
  • 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 Prolia.®
While being treated, you should maintain good oral hygiene and receive routine dental check-ups. If you wear dentures you should make sure these fit properly. If you are undergoing dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Prolia®.

Contact your doctor immediately in the following situations:1

Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw (ONJ, bone damage in the jaw).
Contact your doctor immediately if you develop a swollen, red area of skin, most commonly in the lower leg, that feels hot and tender (cellulitis), and possibly with symptoms of fever, as these may be symptoms of a skin infection.
Contact your doctor if you experience new or unusual pain in your hip, groin, or thigh as this may be an early indication of a possible fracture of the thigh bone.
Consult your doctor if you experience ear pain, discharge from the ear and/or an ear infection as these could be signs of bone damage in the ear.

It is important to tell your doctor about any side effects or changes in your condition after you have had your injection.
Don't forget to inject Prolia® or make sure that you have been booked in for future injections. The benefits of Prolia® start from the first injection but because the treatment effect does wear off, if you miss an injection you might increase your risk of a fracture. Please consult your doctor on the date for a potential next injection.
Prolia® is not recommended for use in pregnant women.
Tell your doctor or pharmacist if you are taking, or have recently taken or might take any other medicines. It is especially important that you tell your doctor if you are being treated with another medicine containing denosumab.

References:

  1. Prolia® (denosumab) Patient Information Leaflet

Reporting of side effects:

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. Side effects can be reported directly to the Health Products Regulatory Authority (HPRA) using the available methods via www.hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine. Side effects should also be reported to Amgen Limited on +44 (0) 1223 436441 or Freephone 1800 535 160.
Please report any potential quality issue with the Amgen product you have received, by calling us on +44 (0) 1223 436441 or Freephone 1800 535 160 and providing us with the details. Please ensure that you keep your packaging, so we are able to identify your product more easily.
For a list of possible side effects, please see
Patient Information Leaflet (PIL)

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