{"id":32421,"date":"2022-11-14T07:29:22","date_gmt":"2022-11-14T07:29:22","guid":{"rendered":"https:\/\/zeepedia.com\/?p=32421"},"modified":"2022-11-15T09:16:16","modified_gmt":"2022-11-15T09:16:16","slug":"%ef%bf%bc","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/%ef%bf%bc\/","title":{"rendered":"XGEVA &#8211; Denosumab uses, dose and side effects"},"content":{"rendered":"\n<p>120 mg&nbsp;solution for injection&nbsp;(&nbsp;solution for injection&nbsp;)<br>denosumab<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What XGEVA is and what it is used for<\/h2>\n\n\n\n<p>XGEVA contains denosumab, a\u00a0protein\u00a0(monoclonal\u00a0antibody\u00a0) that works by slowing the breakdown of bone caused by cancer spreading to the bone (skeletal metastases) or giant cell tumors of the bone.<\/p>\n\n\n\n<p>XGEVA is used in adult patients with advanced cancer to prevent the serious complications that bone metastases can cause (for example,\u00a0fractures, pressure on the spinal cord, or the need for radiation therapy or\u00a0surgery\u00a0).<\/p>\n\n\n\n<p>XGEVA is also used to treat giant cell tumors of the bone that cannot be operated on or when surgery is not the best treatment option in adults and adolescents whose bones have stopped growing.<br><a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before using XGEVA<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use XGEVA<\/h2>\n\n\n\n<p>&#8211; if you are allergic to denosumab or any other ingredient in this medicine (listed in section 6).<\/p>\n\n\n\n<p>Your healthcare professional will not give you XGEVA if you have very low levels of calcium in your blood that have not been treated.<\/p>\n\n\n\n<p>Healthcare professionals will not give you XGEVA if you have unhealed wounds after dental or oral surgery.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and precautions<\/h2>\n\n\n\n<p><strong>Talk to your doctor before using XGEVA.<\/strong><\/p>\n\n\n\n<p>Supplementation of&nbsp;calcium&nbsp;and&nbsp;vitamin&nbsp;D<\/p>\n\n\n\n<p>When you are treated with XGEVA, you must take&nbsp;calcium&nbsp;and&nbsp;vitamin&nbsp;D supplements if you do not have high levels of&nbsp;calcium&nbsp;in your blood.&nbsp;Your doctor will discuss this with you.&nbsp;If the level of&nbsp;calcium&nbsp;in your blood is low, your doctor may give you calcium supplements before you start treatment with XGEVA.<\/p>\n\n\n\n<p>Low levels of&nbsp;calcium&nbsp;in the blood<\/p>\n\n\n\n<p>Tell your doctor immediately if you experience\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 while being treated with XGEVA.\u00a0It is then possible that you have low calcium levels in your blood.<\/p>\n\n\n\n<p>Impaired kidney function<\/p>\n\n\n\n<p>Tell your doctor if you have or have had severe kidney problems,\u00a0kidney failure\u00a0or need to be treated with\u00a0dialysis.\u00a0This can increase the risk of you suffering from low calcium levels in the blood, especially if you do not take calcium supplements.<\/p>\n\n\n\n<p>Problems with the mouth, teeth, or jaw<\/p>\n\n\n\n<p>A\u00a0side effect\u00a0called\u00a0osteonecrosis\u00a0of the jaw (bone damage to the jaw) has been reported commonly (may affect up to 1 in 10 people) in patients receiving XGEVA\u00a0injections\u00a0for cancer-related conditions.\u00a0Osteonecrosis\u00a0of the jaw may also occur when treatment is completed.<\/p>\n\n\n\n<p>It is important to try to prevent&nbsp;osteonecrosis&nbsp;of the jaw from developing, as it can be a painful condition that is difficult to treat.&nbsp;To reduce the risk of&nbsp;osteonecrosis&nbsp;of the jaw, you should take the following precautions:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Before the treatment, you must tell the doctor or nurse (medical staff) if you have any oral or dental problems.\u00a0The doctor should postpone the start of treatment if you have unhealed wounds in the mouth due to dental or oral surgery.\u00a0Your doctor may recommend a dental examination before you can start treatment with XGEVA.<\/li><li>During treatment, you should maintain good oral hygiene and go for regular dental check-ups.\u00a0If you use a denture, you should make sure it fits well.<\/li><li>If you are receiving any type of dental care or are going to undergo dental surgery (eg, tooth extraction), inform the doctor and tell the dentist that you are being treated with XGEVA.<\/li><li>Contact your doctor or dentist immediately if you experience any problems with your mouth or teeth, such as loose teeth, pain or swelling, and non-healing or oozing sores, as these may be signs of\u00a0osteonecrosis\u00a0of the jaw.<\/li><\/ul>\n\n\n\n<p>Patients who receive\u00a0chemotherapy\u00a0and radiation therapy, use\u00a0steroids\u00a0or angiogenesis inhibitors (used to treat cancer), undergo dental surgery, do not have regular dental checkups, have gum disease, or are smokers may have a higher risk of developing\u00a0osteonecrosis\u00a0in the jaw.<\/p>\n\n\n\n<p>Unusual femur fractures<\/p>\n\n\n\n<p>Some people have suffered unusual femur fractures when treated with XGEVA.\u00a0Contact a doctor if you experience new or unusual pain in the hip, groin, or thigh.<\/p>\n\n\n\n<p>High levels of&nbsp;calcium&nbsp;in the blood after stopping treatment with XGEVA<\/p>\n\n\n\n<p>Some patients with giant cell tumors of the skeleton have had high levels of\u00a0calcium\u00a0in their blood for weeks to months after treatment has ended.\u00a0Your doctor will monitor you for signs and symptoms of high\u00a0calcium\u00a0levels after you stop taking XGEVA.<\/p>\n\n\n\n<p><strong>Children and young people<\/strong><\/p>\n\n\n\n<p>XGEVA is not recommended for children and adolescents under 18 years of age, except for adolescents with giant cell tumors of the skeleton and whose bones have stopped growing.\u00a0The use of XGEVA has not been studied in children and adolescents with other cancers that have spread to the bone.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and XGEVA<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.\u00a0This also applies to over-the-counter medicines.\u00a0You must tell the doctor if you are being treated with<\/p>\n\n\n\n<p>\u2022 another medicine containing denosumab<\/p>\n\n\n\n<p>\u2022 a bisphosphonate<\/p>\n\n\n\n<p>You should not use XGEVA together with other medicines containing denosumab or bisphosphonates.<a><\/a><br><a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p>XGEVA has not been tested in pregnant women.\u00a0You must tell the doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.\u00a0It is not recommended that you use XGEVA if you are pregnant.\u00a0Women of\u00a0childbearing potential\u00a0should use an effective method of contraception while being treated with XGEVA and for at least 5 months after treatment with XGEVA has ended.<\/p>\n\n\n\n<p>If you become pregnant during treatment with XGEVA or within 5 months of stopping treatment with XGEVA, tell your doctor.<\/p>\n\n\n\n<p>It is not known whether XGEVA is excreted in human milk.\u00a0You must tell the doctor if you are breastfeeding or plan to breastfeed.\u00a0The doctor will help you decide whether to stop breastfeeding or to stop taking XGEVA, taking into account the benefit of breastfeeding to the baby and your benefit from XGEVA.<\/p>\n\n\n\n<p>If you are breastfeeding during treatment with XGEVA, tell your doctor.<\/p>\n\n\n\n<p>Ask your doctor or pharmacist for advice before taking any medicine.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving ability and use of machinery<\/h2>\n\n\n\n<p>XGEVA has no or negligible effect on the ability to drive and use machines.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Important information about any ingredient(s) in XGEVA<\/h2>\n\n\n\n<p><strong>XGEVA contains sorbitol<\/strong><\/p>\n\n\n\n<p>This medicine contains 78 mg of sorbitol per\u00a0vial.<\/p>\n\n\n\n<p><strong>XGEVA contains&nbsp;sodium<\/strong><\/p>\n\n\n\n<p>This medicine contains less than 1 mmol (23 mg)\u00a0of sodium\u00a0per 120 mg\u00a0dose, i.e. it is almost &#8220;sodium-free&#8221;.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to use XGEVA<\/h2>\n\n\n\n<p>XGEVA should be administered under the responsibility of the physician.<\/p>\n\n\n\n<p>The recommended\u00a0dose\u00a0of XGEVA is 120 mg every 4 weeks as a single\u00a0injection\u00a0under the skin (\u00a0subcutaneously\u00a0).\u00a0XGEVA can be injected into the thigh, abdomen, or upper arm.\u00a0If you are being treated for a giant cell tumor of the skeleton, you will receive another\u00a0dose\u00a01 week and 2 weeks after the first\u00a0dose.<\/p>\n\n\n\n<p>Must not be shaken.<\/p>\n\n\n\n<p>You should also take\u00a0calcium\u00a0and\u00a0vitamin\u00a0D supplements during treatment with XGEVA unless you have an excess of\u00a0calcium\u00a0in your blood.\u00a0Your doctor will discuss this with you.<\/p>\n\n\n\n<p>If you have further questions about the use of this medicine, contact your doctor, pharmacist, or nurse.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Possible side effects<\/h2>\n\n\n\n<p>This medicine can cause\u00a0side effects\u00a0like all medicines, although not everybody gets them.<\/p>\n\n\n\n<p><strong>Tell your doctor immediately if<\/strong>\u00a0you develop any of the following symptoms while being treated with XGEVA (it may affect more than 1 in 10 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>spasms, twitching, muscle cramps, numbness or tingling in the fingers, toes, or around the mouth and\/or seizures, confusion, or loss of consciousness.\u00a0Such symptoms may be signs that you have low calcium levels in your blood.\u00a0Low blood calcium levels can also lead to an altered heart rhythm known as a prolonged\u00a0QT interval, which is observed using electrocardiography (\u00a0ECG\u00a0).<\/li><\/ul>\n\n\n\n<p><strong>Tell your doctor and dentist immediately<\/strong>&nbsp;if you experience any of the following symptoms while being treated with XGEVA or after stopping treatment (may affect up to 1 in 10 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>persistent pain in the mouth and\/or jaw, and\/or swelling or unhealed sores in the mouth or jaw, blistering, numbness, or a heavy feeling in the jaw or loose teeth may be signs of bone damage in the jaw (\u00a0osteonecrosis\u00a0).<\/li><\/ul>\n\n\n\n<p><strong>Very common&nbsp;side effects&nbsp;(<\/strong>&nbsp;may affect more than 1 in 10 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>pain in the bones, joints, or muscles which can sometimes be severe<\/li><li>respiratory distress<\/li><li>diarrhea<\/li><\/ul>\n\n\n\n<p><strong>Common&nbsp;side effects&nbsp;(<\/strong>&nbsp;may affect up to 1 in 10 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>low levels of&nbsp;phosphate&nbsp;in the blood (&nbsp;hypophosphatemia&nbsp;)<\/li><li>tooth extraction<\/li><li>profuse sweating<\/li><li>for patients with advanced cancer: development of another type of cancer.<\/li><\/ul>\n\n\n\n<p><strong>Uncommon&nbsp;side effects&nbsp;(<\/strong>&nbsp;may affect up to 1 in 100 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>high levels of\u00a0calcium\u00a0in the blood (\u00a0hypercalcemia\u00a0) after completion of treatment in patients with giant cell tumors of the skeleton,<\/li><li>new or unusual pain in the hip, groin, or thigh (these may be early signs of a possible femur fracture),<\/li><li>rash that may appear on the skin or sores in the mouth (a lichenoid rash caused by medicines).<\/li><\/ul>\n\n\n\n<p><strong>Rare&nbsp;side effects&nbsp;(<\/strong>&nbsp;may affect up to 1 in 1,000 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>allergic reactions (including wheezing or difficulty breathing; swelling of the face, lips, tongue, throat, or other parts of the body; rash,\u00a0itching,\u00a0or\u00a0hives\u00a0on the skin).\u00a0In rare cases, allergic reactions can be serious<\/li><\/ul>\n\n\n\n<p><strong>Has been reported<\/strong>&nbsp;(occurring in an unknown number of users):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Contact a doctor if you experience pain in the ears if fluid flows from the ear, and\/or if you suffer from an ear infection.\u00a0This may be a sign of bone damage in the ear.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">How to store XGEVA<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n<p>Use before the expiry date which is stated on the label and carton after EXP.&nbsp;The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>Store in a refrigerator (2\u00b0C\u2013 8\u00b0C).<\/p>\n\n\n\n<p>Do not freeze.<\/p>\n\n\n\n<p>Store the vial in the outer carton.&nbsp;Light sensitive.<\/p>\n\n\n\n<p>You can leave the vial outside the refrigerator to reach room temperature (up to 25 \u00b0C) before\u00a0injection.\u00a0This makes the\u00a0injection\u00a0more comfortable.\u00a0Once the vial has been removed from the refrigerator and has reached room temperature (up to 25\u00b0C), it must be used within 30 days.<\/p>\n\n\n\n<p>Medicines must not be thrown into the drain or among the household waste.\u00a0Ask the pharmacist how to dispose of medicines that are no longer used.\u00a0These measures will help to protect the environment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Contents of the packaging and other information<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Contents declaration<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>The active substance is denosumab.\u00a0Each\u00a0vial\u00a0contains 120 mg of denosumab in 1.7 ml of solution (corresponding to 70 mg\/ml).<\/li><li>Other ingredients are glacial acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 20, and water for injections.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Appearance and package sizes of the medicine<\/h2>\n\n\n\n<p>XGEVA is a&nbsp;solution for injection&nbsp;(&nbsp;injection&nbsp;).<\/p>\n\n\n\n<p>XGEVA is a clear, colorless slightly yellow solution.\u00a0It may contain trace amounts of transparent to white particles.<\/p>\n\n\n\n<p>Each pack contains one, three, or four single-use vials.<\/p>\n\n\n\n<p>Not all pack sizes may be marketed.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing authorization holder and manufacturer<\/h2>\n\n\n\n<p><strong>Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n<p>Amgen Europe BV<\/p>\n\n\n\n<p>Minervum 7061,<\/p>\n\n\n\n<p>4817 ZK Breda,<\/p>\n\n\n\n<p>Netherlands<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Amgen Technology (Ireland) Unlimited Company<\/p>\n\n\n\n<p>Pottery Road<\/p>\n\n\n\n<p>Dun Laoghaire<\/p>\n\n\n\n<p>Co Dublin<\/p>\n\n\n\n<p>Ireland<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Amgen NV<\/p>\n\n\n\n<p>Telecom claim 5-7<\/p>\n\n\n\n<p>1831 Diegem<\/p>\n\n\n\n<p>Belgium<\/p>\n","protected":false},"excerpt":{"rendered":"<p>XGEVA contains denosumab, a\u00a0protein\u00a0(monoclonal\u00a0antibody\u00a0) that works by slowing the breakdown of bone caused by cancer spreading to the bone (skeletal metastases) or giant cell tumor of the bone.<\/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":[2200,22504],"tags":[21981,21984,28009,21983,21982,28011,28012,28010,28013],"class_list":["post-32421","post","type-post","status-publish","format-standard","hentry","category-medicines","category-x","tag-denosumab","tag-denosumab-side-effects","tag-denosumabinjection","tag-what-denosumab-is-used-for","tag-what-is-denosumab","tag-what-is-xgeva","tag-what-xgeva-os-ised-fpr-xgeva-injection","tag-xgeva","tag-xgeva-side-effects"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/32421","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=32421"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/32421\/revisions"}],"predecessor-version":[{"id":32925,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/32421\/revisions\/32925"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=32421"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=32421"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=32421"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}