Prolia^® (denosumab) - information for patients

Frequently Asked Questions

The list below includes questions frequently asked by existing Prolia^® (denosumab) patients, or those being considered for Prolia^® treatment. If you have any questions about your treatment programme, please discuss these with your doctor.

What is Prolia^® used for?

Prolia^® is licensed for treating:¹

Osteoporosis in women after the menopause (postmenopausal) and men who have an increased risk of fracture (broken bones), reducing the risk of spinal, non-spinal and hip fractures.
Bone loss that results from a reduction in hormone (testosterone) level caused by surgery or treatment with medicines in patients with prostate cancer.
Bone loss that results from long-term treatment with glucocorticoids in patients who have an increased risk of fracture.

What do I need to consider when taking Prolia®?

For complete information on what you need to know before you use Prolia^® please see the Considerations before starting Prolia^® page or the Patient Information Leaflet (PIL).

What do I need to remember?

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 under 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^®.¹ Please refer to the Patient reminder card .
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).¹
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. Side effects should also be reported to Amgen Limited on +44 (0) 1223 436441 or Freephone 1800 535 160.
Don't forget to take Prolia^® as prescribed or please consult your doctor on the date for a potential next injection. Because the treatment effect does wear off, if you miss an injection you might increase your risk of fracture.⁴

Why are calcium and vitamin D important?

Both calcium and vitamin D play a vital role in maintaining strong bones. Calcium supplements ensure your body has the right level of calcium for different functions in your body and vitamin D helps ensure that the calcium you take (through supplements or through your diet) is transferred into the bloodstream.

Prolia^® may lower the calcium levels in your blood. If you have low blood calcium, it may get worse during treatment, so your low blood calcium must be treated before you receive Prolia^®.¹

Where do I get calcium and vitamin D from?

You can get calcium from dairy products such as milk and cheese and you can boost your vitamin D levels through exposure to sunlight. Your doctor may prescribe supplements to increase your calcium and vitamin D.

For more information on what you can do to build healthy bones, please visit the Irish Osteoporosis Society website.

How much calcium and vitamin D do I need?

The amount of calcium and vitamin D you need will depend on your levels to start with, so will be specific to you. Your doctor can measure these levels through single blood tests and will then decide on the correct dose of supplements, and may advise you on maintaining or increasing your levels through lifestyle changes such as diet and exposure to sunlight.

What should I do if I missed my injection?

Administer your injection (if you were trained to do it) or book in for an injection as soon as it is convenient for you and your healthcare provider.¹ The treatment effect of Prolia^® does wear off if treatment is stopped, so it is important you continue to get your injection every six months. If you miss an injection you might increase your risk of a fracture.^2,3

How to remember my injection?

Mark the injection date on your calendar, phone, and/or Prolia^® Passport card to keep a record of the next injection date. You can download the Prolia^® Passport card on the More Resources page. Also, each pack of Prolia^® contains a reminder card, that can be removed from the carton and used to keep a record of the next injection date.

What support services are available to me and to my family?

For more information on what support services are available, please visit the Irish Osteoporosis Society website - www.irishosteoporosis.ie - or ring the National Helpline on 01 637 5050.

References:

Prolia^® (denosumab) Patient Information Leaflet
Kanis, JA et al. Osteoporos Int. 2019;30(1):3–44;
Tsourdi E, et al. Bone. 2017;105:11–7.
Yu E. et al. JBMR. 2020. 35(6):1009–1013.

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)

Prolia® (denosumab) - information for patients Frequently Asked Questions

What is Prolia® used for?