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" 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. This results in an increase in breakdown of bone by the osteoclasts, which can lead to a loss of bone density. Bone loss is particularly rapid for the first ten years after the menopause and it may lead to the development of osteoporosis \u2013 a condition in which the bones become weak and brittle and break (fracture) more easily.  Osteoporosis can also occur in men, particularly in men having treatment for prostate cancer. The treatments work by reducing the amount of testosterone in the blood, which has a similar effect on bone in men to reduced oestrogen levels in women.  Denosumab works by recognising and binding to a specific protein that normally activates the osteoclasts. By binding to this protein, denosumab stops it from activating the osteoclasts. This prevents the development, activity and survival of the osteoclasts and so stops them from breaking down bone. This helps to keep the bones strong and less likely to break.  In postmenopausal women, this medicine has been shown to reduce the risk of spinal, non-spinal and hip fractures. In men, this medicine has been shown to reduce the risk of spinal fractures. How is Prolia given?  Prolia is given by injection under the skin of the thigh, abdomen or upper arm, once every six months.  Important information about Prolia   As this medicine slows bone breakdown, it prevents calcium being reabsorbed from the bones into the blood. This can cause the amount of calcium in your blood to fall to a low level. Your doctor will usually ask you to take calcium and vitamin D supplements to prevent this and may want you to have regular blood tests to monitor the level of calcium in your blood. You should tell your doctor if you experience symptoms of low calcium levels, which may include muscle spasms, twitches or cramps, and numbness or tingling in the fingers, toes or around the mouth. This medicine may cause serious infections of the skin, abdomen, bladder or ear. Tell your doctor immediately if you experience any of the following symptoms, as they may suggest that you have developed an infection that needs treating: fever, chills, redness or swelling of skin, most commonly on the legs, severe abdominal pain or pain passing urine.  Treatment with denosumab has been associated with a rare condition called osteonecrosis of the jaw. Most of these cases have been in cancer patients, however some have occured in people being treated for osteoporosis. The risk may be increased by poor oral hygiene, dental problems such as tooth decay or poorly fitting dentures, teeth extractions and oral surgery. For this reason, your doctor may want you to have a dental examination and, if necessary, appropriate preventive dentistry, before you start treatment with this medicine. Discuss this with your doctor. It is important to look after your mouth and teeth as much as possible while you are receiving this medicine. You should have regular check-ups with your dentist and get advice straight away if you have any problems with your mouth or teeth (eg loose teeth, pain, swelling, non-healing sores or discharge) during treatment. When you see a dentist during treatment, make sure they know you are having treatment with this medicine. Invasive dental procedures such as tooth extraction or surgery should be avoided if possible.  Unexpected fractures of the thigh bone (femur) have been reported on rare occasions in people being treated with Prolia injections. These fractures have occured with little or no trauma to the thigh. For this reason, while you are having treatment with this medicine you should tell your doctor if you get any new or unusual pain in your thighs, hips or groin, so this can be investigated. These symptoms could be an early indication of a possible fracture.  Prolia should be used with caution in   Smokers. 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. Very common (affect more than 1 in 10 people)  Pain in the extremities, muscles or joints.  Common (affect between 1 in 10 and 1 in 100 people)   Urinary tract infections. Upper respiratory tract infections.  Nerve pain that travels from the back into the buttock and back of leg (sciatica).   Cataracts. Constipation.  Abdominal pain. Rash.  Eczema.  Uncommon (affect between 1 in 100 and 1 in 1000 people)  Infection and inflammation of connective tissue, commonly the skin, of the legs (cellulitis) \u2013 see important information section above.   Diverticulitis. Ear infection.   Rare (affect between 1 in 1000 and 1 in 10,000 people)  Low level of calcium in the blood (hypocalcaemia - see important information section above). Osteonecrosis of the jaw (see important information section above). Unexpected thigh fracture (see important information section above). Allergic reaction to the medicine.  The side effects listed above may not include all of the side effects reported by the medicine&amp;#039;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. If you think you have experienced a side effect from a medicine or vaccine you should check the patient information leaflet. This lists the known side effects and what to do if you get them. You can also get advice from your doctor, nurse or pharmacist. If they think it&amp;#039;s necessary they&amp;#039;ll report it for you. You can also report side effects yourself using the yellow card website: www.mhra.gov.uk/yellowcard. 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.  Other medicines containing the same active ingredient   Xgeva injection. This brand contains a higher dose of denosumab than Prolia. It is licensed for treating bone cancer that can&amp;#039;t be treated with surgery and for reducing bone damage in people with cancers that have spread to the bone.  Further reading For background information about our medicine factsheets, including the references used to produce them, click here. Last updated 20.07.2015 "^^<http://www.w3.org/2001/XMLSchema#string>
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