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Safety Information

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Considerations before starting Prolia

Your doctor will take you through the things you need to consider when preparing to take Prolia® (denosumab) and will give you the package leaflet and 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® Package Leaflet.
Should you require a patient reminder card, please speak to your doctor or download a copy here: Patient reminder card.
Blood tests are required prior to every Prolia® injection so it is important to arrange your doctors appointment in plenty of time, to ensure you get all the benefits from your medication.

Things to consider when starting on Prolia®

Do not use Prolia® if:1
  • 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 Package Leaflet)
    • This includes an allergy to latex as the needle cover on the pre-filled syringe contains a derivative of latex
Tell your doctor if you have or have ever had severe kidney problems, kidney failure or have needed dialysis, 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).1
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.
A 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.
Before receiving treatment, tell your doctor or nurse (health care professional) if you:
  • 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 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®
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.
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 the Yellow Card Scheme at http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.
By reporting side effects you can help provide more information on the safety of this medicine. Adverse events should also be reported to Amgen Limited on +44 (0) 1223 436441.
It is important to tell your doctor about any side effects or changes in your condition after you have had your injection.
Check 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.
Prolia® is not recommended for use in pregnant women.1
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