Denosumab is used to treat bone loss (osteoporosis) in women who are at high risk for bone fracture after menopause. It is also used to treat bone loss in men who are at high risk for bone fracture. Osteoporosis causes bones to become thinner and break more easily.
What is Prolia used for?
- Treatment of osteoporosis in women who have passed the menopause and in men at high risk of breaking a bone.
- Treatment of bone loss resulting from hormone therapy or surgery for prostate cancer in men at high risk of breaking a bone.
How does Prolia work?
- Prolia injection contains the active ingredient denosumab, which is a type of medicine called a human monoclonal antibody. This medicine is used to prevent the breakdown of bone.
- Bone is not a static structure. It is continually shaped, reformed and rebuilt by cells called osteoblasts and osteoclasts. These cells continuously deposit and remove calcium and phosphorous, stored in a protein network that makes up the structure of the bone. Old bone is broken down by the osteoclasts and new bone is formed by the osteoblasts.
- In menopausal women, blood levels of the female hormone oestrogen start to decrease.
How is Prolia given?
- Prolia is given by injection under the skin of the thigh, abdomen or upper arm, once every six months.
Prolia should be used with caution in
- People with poor oral hygeine, or any current or recent problems with their mouth or teeth.
- People with cancer.
- People with anaemia or blood clotting problems.
- People with infections.
- People with severely decreased kidney function.
- People with an allergy to latex (the needle cover of the pre-filled syringe contains a latex derivative).
- Prolia should not be used in
- People with a low level of calcium in their blood (hypocalcaemia).
- People with rare hereditary problems of fructose intolerance (Prolia contains sorbitol).
- People having treatment with other medicines that contain denosumab, eg people having Xgeva injections to reduce damage from cancer that has spread to the bones.
- This medicine is not recommended for children and adolescents under 18 years of age.
This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction after being given this medicine, inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
- Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- This medicine has not been studied in pregnant women, hence its safety has not been established. It is not recommended for use during pregnancy. If you think you could be pregnant while having treatment with this medicine you should consult your doctor straight away.
- It is not known if this medicine passes into breast milk and its potential effect on the production of breast milk has not been fully studied. It is not recommended for use in breastfeeding mothers. Ask your doctor for further information.
Possible side effects of Prolia
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.
- Pain in the extremities, muscles or joints.
- Urinary tract infections.
- Upper respiratory tract infections.
- Nerve pain that travels from the back into the buttock and back of leg (sciatica).
- Abdominal pain.
- Infection and inflammation of connective tissue, commonly the skin, of the legs (cellulitis).
- Ear infection.
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
- This medicine is not known to affect other medicines. However, it is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while having treatment with this one, to make sure that the combination is safe.