{"id":7137,"date":"2021-02-18T09:02:01","date_gmt":"2021-02-18T09:02:01","guid":{"rendered":"https:\/\/zeepedia.com\/?p=7137"},"modified":"2021-05-29T09:32:30","modified_gmt":"2021-05-29T09:32:30","slug":"crysvita","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/crysvita\/","title":{"rendered":"Crysvita &#8211; Burosumab uses, dose and side effects"},"content":{"rendered":"\n<p> 10 mg, 20 mg, and 30 mg,&nbsp;injection, solution&nbsp;<br>burosumab<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1. What CRYSVITA is and what it is used for<\/h2>\n\n\n\n<p><strong>What CRYSVITA is<\/strong><\/p>\n\n\n\n<p>CRYSVITA contains the active substance burosumab.&nbsp;This is a type of drug called a&nbsp;human&nbsp;monoclonal&nbsp;antibody.<br><\/p>\n\n\n\n<p><strong>What CRYSVITA is used for<\/strong><\/p>\n\n\n\n<p>CRYSVITA is used to treat x-chromosome-&nbsp;bound hypophosphatemia&nbsp;(XLH).&nbsp;It is used for children and adolescents aged 1 to 17 years, and adults.<br><\/p>\n\n\n\n<p><strong>What is x-chromosome-&nbsp;bound hypophosphatemia&nbsp;(XLH)<\/strong><\/p>\n\n\n\n<p>X-chromosome-&nbsp;bound hypophosphatemia&nbsp;(XLH) is an inherited disease.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>People with XLH have higher levels of a&nbsp;hormone&nbsp;called fibroblast growth factor 23 (FGF23).<\/li><li>FGF23 lowers the phosphate level in the blood.<\/li><li>The low phosphate level can lead to<ul><li>that the skeleton cannot harden properly and the skeleton in children and adolescents cannot grow properly<\/li><li>that pain and stiffness occur in the skeleton and joints.<\/li><\/ul><\/li><\/ul>\n\n\n\n<p><strong>How CRYSVITA works<\/strong><\/p>\n\n\n\n<p>CRYSVITA attaches to FGF23 in the blood, which prevents FGF23 from working.&nbsp;This increases the phosphate levels in the blood and normal phosphate levels can be achieved.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2. What you need to know before using CRYSVITA<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use CRYSVITA<\/h2>\n\n\n\n<p><strong>Do not use CRYSVITA if:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>you are allergic to burosumab or any of the other ingredients of this medicine (listed in section 6)<\/li><li>you are taking a phosphate supplement or certain vitamin D supplements (which contain so-called active&nbsp;vitamin D, eg calcitriol)<\/li><li>you already have high levels of phosphate in your blood (&nbsp;hyperphosphatemia&nbsp;)<\/li><li>you have severe kidney disease or kidney failure.<\/li><\/ul>\n\n\n\n<p><strong>Allergic reactions<\/strong><\/p>\n\n\n\n<p>Stop taking CRYSVITA and talk to your doctor immediately if you get any of the following&nbsp;side effects, as it may be a sign of an allergic reaction:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>skin rash and&nbsp;itching&nbsp;all over the body<\/li><li>severe swelling of the eyelids, mouth, and lips (&nbsp;angioedema&nbsp;)<\/li><li>respiratory distress<\/li><li>palpitation<\/li><li>sweating.<\/li><\/ul>\n\n\n\n<p>Do not take CRYSVITA if any of the above apply to you.&nbsp;If you are not sure, talk to your doctor before using CRYSVITA.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p><strong>Skin reactions<\/strong><\/p>\n\n\n\n<p>You may get skin reactions at the injection site.&nbsp;See section 4 for more information.&nbsp;Tell your doctor if these reactions become severe.<br><\/p>\n\n\n\n<p><strong>Sampling and inspections<\/strong><\/p>\n\n\n\n<p>Your doctor will check the&nbsp;phosphate&nbsp;and calcium levels in your blood and urine and may also perform an ultrasound of your kidneys during treatment to reduce the risk of&nbsp;hyperphosphatemia&nbsp;(too much&nbsp;phosphate&nbsp;in your blood) and ectopic mineralization (an accumulation of&nbsp;calcium&nbsp;in&nbsp;tissues&nbsp;such as your kidneys).&nbsp;Your&nbsp;serum&nbsp;thyroid hormone&nbsp;levels&nbsp;will also be checked occasionally.<br><\/p>\n\n\n\n<p><strong>Children under 1 year<\/strong><\/p>\n\n\n\n<p>Crysvita should not be given to children under 1 year of age as the safety and efficacy of the drug have not been studied in this age group.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and CRYSVITA<\/h2>\n\n\n\n<p>Tell your doctor if you are taking, have recently taken, or might take any other medicines.<br><\/p>\n\n\n\n<p>Do not take CRYSVITA and tell your doctor if you are taking:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>phosphate supplements<\/li><li>certain vitamin D supplements (which contain so-called active&nbsp;vitamin D, eg calcitriol).&nbsp;There are some vitamin D supplements that you can start with or continue to use.&nbsp;The doctor will inform you about who they are.<\/li><\/ul>\n\n\n\n<p>Talk to your doctor before taking CRYSVITA if you are taking:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>drugs that act in the same way as&nbsp;calcium&nbsp;in the body (calcimimetic).&nbsp;They can lower the level of calcium in the blood is used at the same time.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n<p>If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.&nbsp;This is because it is not known if CRYSVITA affects the baby.<br><\/p>\n\n\n\n<p>CRYSVITA is not recommended during pregnancy.<br><\/p>\n\n\n\n<p>Women of childbearing potential should use effective contraception during treatment with CRYSVITA.&nbsp;You should discuss this with your doctor.<br><\/p>\n\n\n\n<p>It is not known if CRYSVITA passes into breast milk and the risk to newborns or infants cannot be ruled out.&nbsp;You should discuss this with your doctor.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>CRYSVITA may cause dizziness and prevent you from cycling, using tools or machines, or driving vehicles.&nbsp;If you think you are affected, tell your doctor and do not cycle, use tools or machines, or drive vehicles<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">CRYSVITA contains excipients<\/h2>\n\n\n\n<p>This medicine contains 45.91 mg sorbitol in each&nbsp;vial, which is equivalent to 45.91 mg\/ml.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. How to use CRYSVITA<\/h2>\n\n\n\n<p>CRYSVITA should be given by&nbsp;injection&nbsp;under the skin of the abdomen, an arm, buttock, or thigh by a healthcare professional.<br><\/p>\n\n\n\n<p><strong>How much CRYSVITA you get<\/strong><\/p>\n\n\n\n<p>Dose&nbsp;one is based on your body weight.&nbsp;Your doctor will calculate the correct&nbsp;dose for you.<\/p>\n\n\n\n<p>CRYSVITA is injected<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>every two weeks in children and adolescents aged 1\u201317 years<\/li><li>every four weeks in adults.<\/li><\/ul>\n\n\n\n<p>Your doctor will perform checks to make sure you are getting the right&nbsp;dose&nbsp;and can change your&nbsp;dose&nbsp;as needed.<br><\/p>\n\n\n\n<p>The maximum&nbsp;dose&nbsp;is 90 mg.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you use more CRYSVITA then you should&nbsp;<\/h2>\n\n\n\n<p>Talk to your doctor immediately if you think you have received too much CRYSVITA.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to use CRYSVITA<\/h2>\n\n\n\n<p>Talk to your doctor immediately if a&nbsp;dose is&nbsp;missed.&nbsp;The missed&nbsp;dose&nbsp;should be given as soon as possible and the doctor will also decide how the next&nbsp;doses&nbsp;should be given.<br><\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">4. Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause&nbsp;side effects, although not everybody gets them.<br><\/p>\n\n\n\n<p><strong>Side&nbsp;<\/strong><strong>effects in children and adolescents<\/strong><\/p>\n\n\n\n<p><strong>Very common (may affect more than 1 in 10 children&nbsp;<\/strong><strong>and adolescents&nbsp;<\/strong><strong>)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Dental abscess&nbsp;(&nbsp;infection&nbsp;)<\/li><li>Cough<\/li><li>Headache<\/li><li>Vomiting<\/li><li>Nausea<\/li><li>Diarrhea<\/li><li>Constipation<\/li><li>Caries&nbsp;(holes in the teeth)<\/li><li>Rash<\/li><li>Pain in muscles (&nbsp;myalgia&nbsp;) and hands and feet<\/li><li>Injection site reactions, which may include:<ul><li>redness&nbsp;or rash<\/li><li>pain or&nbsp;itching<\/li><li>swelling<\/li><li>bleeding or bruisingThese injection site reactions are usually mild and occur within one day after&nbsp;injection&nbsp;and usually resolve within about 1 to 3 days.<\/li><\/ul><\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>Fever<\/li><li>Low vitamin D in the blood<\/li><\/ul>\n\n\n\n<p><strong>Common (may affect up to 1 in 10&nbsp;<\/strong><strong>children and adolescents&nbsp;<\/strong><strong>)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Dizziness<\/li><\/ul>\n\n\n\n<p><strong>Has been reported (occurs in an unknown number of users)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Increased phosphate content in the blood<br><\/li><\/ul>\n\n\n\n<p><strong>Side effects&nbsp;are in adults<\/strong><\/p>\n\n\n\n<p><strong><em>Very common (may affect more than 1 in 10 adults)<\/em><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Dental abscess&nbsp;(&nbsp;infection&nbsp;)<\/li><li>Headache<\/li><li>Dizziness<\/li><li>Restless legs syndrome (very strong drive to move the legs to get rid of discomfort, pain, or strange feelings in the legs, especially before falling asleep and at night)<\/li><li>Back pain<\/li><li>Muscle spasms<\/li><li>Low vitamin D in the blood<\/li><\/ul>\n\n\n\n<p><strong><em>Common (may affect more than 1 in 10 adults)<\/em><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Constipation<\/li><li>Increased phosphate content in the blood<br><\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">5. How to store CRYSVITA<\/h2>\n\n\n\n<p>Keep out of sight and reach of children.<\/p>\n\n\n\n<p>Do not use this medicine after the expiry date which is stated on the carton and label.<\/p>\n\n\n\n<p>Store in a refrigerator (2 \u00b0 C &#8211; 8 \u00b0 C).&nbsp;Do not freeze.<\/p>\n\n\n\n<p>Keep the vial in the outer carton.&nbsp;Sensitive to light.&nbsp;Do not use CRYSVITA if it contains visible particles.<\/p>\n\n\n\n<p>Any unused product or waste material should be disposed of by local requirements.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">6. Contents of the packaging and other information<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Content declaration<\/h2>\n\n\n\n<p>The active substance is burosumab.&nbsp;Each&nbsp;vial&nbsp;contains 10, 20, or 30 mg of burosumab.&nbsp;The other ingredients are L-histidine, D-sorbitol E420, polysorbate 80, L-methionine, 10%&nbsp;hydrochloric acid,&nbsp;and water for injections.&nbsp;(See \u201cCRYSVITA contains sorbitol\u201d in section 2 for more information).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n<p>CRYSVITA is a clear to slightly opalescent, colorless to slightly brownish\/yellowish&nbsp;solution for injection&nbsp;in a small&nbsp;glass&nbsp;vial.&nbsp;Each pack contains 1&nbsp;vial.<\/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>Kyowa Kirin Holdings BV<\/p>\n\n\n\n<p>Bloemlaan 2<\/p>\n\n\n\n<p>2132NP Hoofddorp<\/p>\n\n\n\n<p>Netherlands<\/p>\n\n\n\n<p>medinfo@kyowakirin.com<br><\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Piramal Healthcare UK Limited Whalton Road<\/p>\n\n\n\n<p>Morpeth NE61 3YA<\/p>\n\n\n\n<p>UK<br><\/p>\n\n\n\n<p>allphamed PHARBIL Arzneimittel GmbH<\/p>\n\n\n\n<p>Hildebrandstr.&nbsp;10-12<\/p>\n\n\n\n<p>37081 G\u00f6ttingen<\/p>\n\n\n\n<p>Germany<\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>CRYSVITA contains the active substance burosumab. This is a type of drug called a human monoclonal antibody.<\/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":[2203,2200],"tags":[6434,6436,6437,6439,6442,6441,2212,6438,6443,6435,6440],"class_list":["post-7137","post","type-post","status-publish","format-standard","hentry","category-c","category-medicines","tag-burosumab","tag-burosumab-injection","tag-burosumab-side-effects","tag-crysvita","tag-crysvita-injection","tag-crysvita-side-effects","tag-medicine","tag-side-effects-of-burosumab","tag-side-effects-of-crysvita","tag-what-is-burosumab","tag-what-is-crysvita"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/7137","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=7137"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/7137\/revisions"}],"predecessor-version":[{"id":11230,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/7137\/revisions\/11230"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=7137"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=7137"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=7137"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}