60 mg Solution for\u00a0injection\u00a0(\u00a0solution for injection\u00a0) in a pre-filled\u00a0syringe.
denosumab<\/p>\n\n\n\n
Prolia contains denosumab, a\u00a0protein\u00a0(a monoclonal\u00a0antibody\u00a0) that inhibits the function of another\u00a0protein\u00a0to counteract the loss of bone mass and treat\u00a0osteoporosis\u00a0(osteoporosis).\u00a0Treatment with Prolia strengthens the bone tissue and reduces the risk of bone fractures.<\/p>\n\n\n\n
Bone is a living\u00a0tissue\u00a0that is constantly renewed.\u00a0Estrogen\u00a0helps keep the bone tissue healthy.\u00a0After menopause, the levels of\u00a0estrogen\u00a0fall, which can lead to skeletal bones becoming thinner and thus fragile.\u00a0This can lead to a condition called\u00a0osteoporosis.\u00a0Men can also suffer from\u00a0osteoporosis, which can be caused by, among other things, aging and\/or low levels of the male sex hormone\u00a0testosterone<\/a>.\u00a0Patients treated with\u00a0glucocorticoids\u00a0(eg\u00a0cortisone,\u00a0prednisolone,\u00a0or dexamethasone<\/a>) may also be affected.\u00a0Many patients with\u00a0osteoporosis have no symptoms but still risk breaking bones, especially in the back, hips, and wrists.<\/p>\n\n\n\n Surgeries or medications used to stop the production of estrogen or testosterone in patients with breast or prostate cancer can also cause loss of bone mass. This leads to the legs becoming weaker and breaking more easily.<\/p>\n\n\n\n What Prolia is used for<\/strong><\/p>\n\n\n\n Prolia is used to treat:<\/p>\n\n\n\n Talk to your doctor or pharmacist before using Prolia.<\/p>\n\n\n\n During treatment with Prolia, you may develop a skin infection with symptoms such as a swollen, red area of \u200b\u200bskin, usually on the lower leg, which feels hot or tender ( cellulite ), and possibly with fever symptoms. Tell your doctor immediately if you experience any of these symptoms.<\/p>\n\n\n\n You should also take calcium and vitamin D supplements during treatment with Prolia. Your doctor will talk to you about this.<\/p>\n\n\n\n You may have low blood calcium levels during treatment with Prolia.\u00a0Tell your doctor immediately if you experience any of the following symptoms: muscle spasms, twitching or cramping and\/or numbness or tingling in the fingers, toes, or around the mouth and\/or seizures, confusion, or loss of consciousness.<\/p>\n\n\n\n Tell your doctor if you have or have had severe kidney problems,\u00a0kidney failure,\u00a0or need dialysis treatment, or if you are taking medicines called\u00a0glucocorticoids\u00a0(eg\u00a0cortisone,\u00a0prednisolone,\u00a0or dexamethasone), which may increase your risk of low calcium levels. in the blood, if you do not take calcium supplements.<\/p>\n\n\n\n Problems with the mouth, teeth, or jaw<\/strong><\/p>\n\n\n\n A\u00a0side effect\u00a0called\u00a0osteonecrosis\u00a0of the jaw (ONJ) \u200b\u200b(skeletal injuries of the jaw) has been reported in rare cases (may affect up to 1 in 1,000 users) in patients receiving Prolia for\u00a0osteoporosis.\u00a0The risk of ONJ increases in patients treated for a long time (may affect up to 1 in 200 patients if they have been treated for 10 years).\u00a0ONJ can also occur when treatment is completed.\u00a0It is important to try to prevent ONJ from developing, as it can be a painful condition that is difficult to treat.\u00a0To reduce the risk of developing ONJ, observe the following precautions:<\/p>\n\n\n\n Before treatment, tell your doctor or nurse (healthcare professional) if you:<\/p>\n\n\n\n Your doctor may ask you to undergo a dental examination before starting treatment with Prolia.<\/p>\n\n\n\n During the treatment, you should maintain good oral hygiene and go to regular dental visits. If you use a denture, make sure it fits snugly. If you are undergoing dental treatment or are about to undergo dental surgery (eg tooth extractions), tell your doctor about dental treatment and tell your dentist that you are being treated with Prolia.<\/p>\n\n\n\n Contact a doctor and dentist immediately if you have problems with your mouth or teeth, e.g.\u00a0loose teeth, pain or swelling, or wounds that do not heal or secrete fluid, as this may be a sign of ONJ.<\/p>\n\n\n\n Unusual femoral fractures<\/strong><\/p>\n\n\n\n Some patients have suffered unusual femoral fractures during treatment with Prolia.\u00a0Contact a doctor if you experience new or unusual pain in the hip, groin, or thigh.<\/p>\n\n\n\n Prolia is not recommended for children and adolescents under 18 years of age. The use of Prolia in children and adolescents has not been studied.<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.\u00a0You must tell your doctor if you are being treated with any other medicine that contains denosumab.<\/p>\n\n\n\n You should not take Prolia with other medicines that contain denosumab.<\/p>\n\n\n\n Prolia has not been tested in pregnant women.\u00a0It is important that you tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.\u00a0It is not recommended that you use Prolia if you are pregnant.\u00a0Women of\u00a0childbearing potential\u00a0should use an effective method of contraception when treated with Prolia and for at least 5 months after stopping treatment with Prolia.<\/p>\n\n\n\n If you become pregnant during treatment with Prolia or within 5 months after stopping treatment with Prolia, tell your doctor.<\/p>\n\n\n\n It is not known whether Prolia is excreted in human milk.\u00a0You must tell your doctor if you are breastfeeding or planning to do so.\u00a0Your doctor will help you decide whether to stop breastfeeding or stop taking Prolia, taking into account your baby’s benefit from breastfeeding and your benefit from Prolia.<\/p>\n\n\n\n If you are breastfeeding during treatment with Prolia, tell your doctor.<\/p>\n\n\n\n Ask your doctor or pharmacist for advice before taking any medicine.<\/p>\n\n\n\n Prolia has no or negligible effect on the ability to drive and use machines.<\/p>\n\n\n\n This medicine contains 47 mg sorbitol per ml solution.<\/p>\n\n\n\n This medicine contains less than 1 mmol sodium (23 mg) per 60 mg, ie essentially ‘sodium-free’.<\/p>\n\n\n\n The recommended\u00a0dose\u00a0is a pre-filled\u00a0syringe\u00a0of 60 mg given once every 6 months, as a single injection under the skin (\u00a0subcutaneously\u00a0).\u00a0The best injection sites are high up on the thighs and the abdomen.\u00a0Your healthcare provider may also use the outside of your upper arms.\u00a0Talk to your doctor about the date you should get a possible next\u00a0injection.\u00a0Each pack of Prolia contains a reminder card that can be removed from the carton and used to keep track of the next injection date.<\/p>\n\n\n\n You should also take calcium and vitamin D supplements during treatment with Prolia. Your doctor will talk to you about this.<\/p>\n\n\n\n Your doctor may decide that it is best for you or a healthcare provider to inject Prolia. Your doctor or healthcare professional will show you or your healthcare provider how to use Prolia. For instructions on how to inject Prolia, read the section at the end of this leaflet.<\/p>\n\n\n\n Do not shake.<\/p>\n\n\n\n If you forget to take a\u00a0dose\u00a0of Prolia, inject\u00a0one\u00a0as soon as possible.\u00a0Thereafter, your\u00a0injection\u00a0should be taken every 6 months from the date of the last\u00a0injection.<\/p>\n\n\n\n To get the most out of your treatment for the reduced risk of\u00a0fractures, you must use Prolia for as long as your doctor prescribes it.\u00a0Do not stop treatment without consulting your doctor.<\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n In less common cases, patients receiving Prolia may develop skin infections (mainly cellulite ). Tell your doctor immediately if<\/strong> you develop any of the following symptoms while you are being treated with Prolia: swollen, red areas of skin, usually on the lower legs, which feel warm and sore, possibly with symptoms of fever.<\/p>\n\n\n\n In rare cases, patients receiving Prolia may experience pain in the mouth and\/or jaw, swelling or sores that do not heal in the mouth or jaw, sores that secrete fluid, numbness, or heaviness in the jaw, or\u00a0tooth loss.\u00a0This may be a sign of skeletal damage in the jaw (\u00a0osteonecrosis\u00a0).\u00a0Tell your doctor and dentist immediately<\/strong>\u00a0if you experience such symptoms while you are being treated with Prolia or when treatment is over.<\/p>\n\n\n\n In rare cases, patients receiving Prolia may have low blood calcium levels (hypocalcemia).\u00a0Symptoms include\u00a0spasms, twitching or cramps in the muscles, and\/or numbness or tingling in the fingers, toes, or around the mouth, and\/or seizures, confusion, or loss of consciousness.\u00a0If you get any of these\u00a0symptoms, contact your doctor immediately.\u00a0Low calcium levels in the blood can also lead to a change in heart rate called prolonged\u00a0QT interval, which is observed using electrocardiography (\u00a0ECG\u00a0).<\/p>\n\n\n\n In rare cases, unusual femoral fractures may occur in patients taking Prolia.\u00a0Contact a doctor<\/strong>\u00a0if you experience new or unusual pain in the hip, groin, or thigh, as this may be an early sign of a possible femoral fracture.<\/p>\n\n\n\n In rare cases, patients taking Prolia may experience allergic reactions.\u00a0Symptoms include swelling of the face, lips, tongue, throat, or other parts of the body;\u00a0skin rash,\u00a0itching\u00a0or\u00a0hives, wheezing, or difficulty breathing.\u00a0Tell your doctor<\/strong>\u00a0if you develop any of these symptoms while you are being treated with Prolia.<\/p>\n\n\n\n Very common side effects (<\/strong> may affect more than 1 user in 10):<\/p>\n\n\n\n Common side effects (<\/strong> may affect up to 1 in 10 people):<\/p>\n\n\n\n Uncommon side effects (<\/strong> may affect up to 1 in 100 people):<\/p>\n\n\n\n Very rare side effects (<\/strong> may affect up to 1 in 10,000 people):<\/p>\n\n\n\n Has been reported<\/strong> (occurs in an unknown number of users):<\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.<\/p>\n\n\n\n Store in a refrigerator (2 \u00b0 C – 8 \u00b0 C).<\/p>\n\n\n\n Do not freeze.<\/p>\n\n\n\n Store the syringe in the outer carton. Sensitive to light.<\/p>\n\n\n\n You can leave the pre-filled syringe outside the refrigerator to reach room temperature (up to 25 \u00b0 C) before\u00a0injecting it.\u00a0This makes\u00a0injection\u00a0more comfortable.\u00a0Once the syringe has been removed from the refrigerator and allowed to reach room temperature (up to 25 \u00b0 C), it must be used within 30 days.<\/p>\n\n\n\n Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.<\/p>\n\n\n\n Prolia is a clear, colorless to pale yellow solution for injection that is delivered in ready-to-use, pre-filled syringes.<\/p>\n\n\n\n Each pack contains a pre-filled syringe with a needle guard.<\/p>\n\n\n\n Not all pack sizes may be marketed.<\/p>\n\n\n\n Amgen Europe BV<\/p>\n\n\n\n Minervum 7061<\/p>\n\n\n\n 4817 ZK Breda<\/p>\n\n\n\n Netherlands<\/p>\n","protected":false},"excerpt":{"rendered":" Prolia contains denosumab, a protein (a monoclonal antibody ) that inhibits the function of another protein in order to counteract the loss of bone mass and treat osteoporosis (osteoporosis). Treatment with Prolia strengthens the bone tissue and reduces the risk of bone fractures.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2200,18527],"tags":[21985,21990,21981,21984,21986,21989,21983,21982,21987,21988],"class_list":["post-21315","post","type-post","status-publish","format-standard","hentry","category-medicines","category-p","tag-benefits-of-denosumab","tag-benefits-of-prolia","tag-denosumab","tag-denosumab-side-effects","tag-prolia","tag-prolia-side-effects","tag-what-denosumab-is-used-for","tag-what-is-denosumab","tag-what-is-prolia","tag-what-prolia-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/21315","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=21315"}],"version-history":[{"count":3,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/21315\/revisions"}],"predecessor-version":[{"id":21363,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/21315\/revisions\/21363"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=21315"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=21315"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=21315"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}What you need to know before using Prolia<\/h2>\n\n\n\n
Do not use Prolia<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Children and young people<\/h2>\n\n\n\n
Other medicines and Prolia<\/h2>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Prolia contains sorbitol<\/h2>\n\n\n\n
Prolia contains sodium<\/strong><\/p>\n\n\n\nHow to use Prolia<\/h2>\n\n\n\n
If you forget to use Prolia<\/h2>\n\n\n\n
If you stop using Prolia<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store Prolia<\/h2>\n\n\n\n
Contents of the packaging and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n