{"id":31403,"date":"2022-11-09T07:23:57","date_gmt":"2022-11-09T07:23:57","guid":{"rendered":"https:\/\/zeepedia.com\/?p=31403"},"modified":"2022-11-10T07:43:41","modified_gmt":"2022-11-10T07:43:41","slug":"vpriv","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/vpriv\/","title":{"rendered":"VPRIV &#8211; Velaglucerase alfa uses, dose and side effects"},"content":{"rendered":"\n<p>400 units&nbsp;of powder for&nbsp;infusion&nbsp;solution,<br>velaglucerase alfa<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What VPRIV is and what it is used for<\/h2>\n\n\n\n<p>VPRIV is a long-term enzyme replacement therapy (ERT) for patients with\u00a0type 1\u00a0Gaucher disease.<\/p>\n\n\n\n<p>Gaucher disease\u00a0is a genetic disorder caused by the absence or\u00a0defect of an\u00a0enzyme\u00a0called glucocerebrosidase.\u00a0When this\u00a0enzyme\u00a0is missing or not working properly, a substance called glucocerebroside accumulates inside the body&#8217;s cells.\u00a0The accumulation of this substance causes the signs and symptoms that occur in\u00a0Gaucher disease.<\/p>\n\n\n\n<p>VPRIV contains a substance called velaglucerase alfa that is designed to replace the missing or defective\u00a0enzyme, glucocerebrosidase, in patients with\u00a0Gaucher disease.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before using VPRIV<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use VPRIV<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are severely allergic to velaglucerase alfa or any of the other ingredients of this medicine (listed in section 6).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and precautions<\/h2>\n\n\n\n<p>Talk to your doctor before using VPRIV.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>If you are treated with VPRIV, you may experience\u00a0side effects\u00a0during or after the\u00a0infusion\u00a0(see section 4, Possible\u00a0side effects\u00a0).\u00a0These are called infusion-related reactions and can manifest as a\u00a0hypersensitivity reaction\u00a0with symptoms such as nausea, rash, difficulty breathing, back pain, chest discomfort (chest pressure), hives, joint pain, or headache.<\/li><li>In addition to symptoms of\u00a0hypersensitivity reaction, infusion-related reactions can manifest as dizziness, high\u00a0blood pressure, fatigue, fever,\u00a0itching, blurred vision, or vomiting.<\/li><li>If you experience any of these symptoms, you must tell your doctor immediately.<\/li><li>You may be given additional medicines for treatment or to prevent future reactions.\u00a0These drugs may include\u00a0antihistamines, antipyretics, and\u00a0corticosteroids.<\/li><li>If the reaction is severe, your doctor will immediately stop the intravenous\u00a0infusion\u00a0and start giving you appropriate medical treatment.<\/li><li>If the reactions are severe and\/or the medicine loses its effect, your doctor will take a blood sample to check if there are\u00a0antibodies\u00a0that could affect the results of your treatment.<\/li><li>The doctor or nurse may decide to continue\u00a0administering\u00a0VPRIV even if you experience infusion-related reactions.\u00a0Your condition will be closely monitored.<\/li><\/ul>\n\n\n\n<p><br>Tell your doctor if you have previously had any infusion-related reaction with other ERT for\u00a0Gaucher disease.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children<\/h2>\n\n\n\n<p>Do not use in children younger than 4 years as there is no experience of using the medicine in this age group.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and VPRIV<\/h2>\n\n\n\n<p>Tell your doctor if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy<\/h2>\n\n\n\n<p>Gaucher disease&nbsp;can become more active in a woman during pregnancy and a few weeks after giving birth.&nbsp;Women with&nbsp;Gaucher disease&nbsp;who are pregnant or planning to become pregnant should talk to their doctor before using this medicine.<\/p>\n\n\n\n<p><strong>Breast-feeding<\/strong><\/p>\n\n\n\n<p>It is not known whether VPRIV passes into breast milk.\u00a0If you are breastfeeding or plan to breastfeed, talk to your doctor before using this medicine.\u00a0The doctor will then help you decide whether to stop breastfeeding or whether to stop using VPRIV, taking into account the benefit of breastfeeding for the baby and the benefit of VPRIV for the mother.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving ability and use of machinery<\/h2>\n\n\n\n<p>VPRIV has no or negligible effect on the ability to drive or use machines.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">VPRIV contains sodium<\/h2>\n\n\n\n<p>This medicine contains 12.15 mg of\u00a0sodium\u00a0(the main ingredient in common\/table salt) per\u00a0vial.\u00a0This corresponds to 0.6% of the maximum recommended daily intake of\u00a0sodium\u00a0for adults.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to use VPRIV<\/h2>\n\n\n\n<p>This medicine should only be used under appropriate medical supervision by a physician experienced in the treatment of\u00a0Gaucher&#8217;s disease.\u00a0It is given by a doctor or nurse by\u00a0intravenous\u00a0infusion.<\/p>\n\n\n\n<p><strong>Dose<\/strong><\/p>\n\n\n\n<p>The recommended&nbsp;dose&nbsp;is 60 units\/kg given every two weeks.<\/p>\n\n\n\n<p>If you are currently being treated for Gaucher disease with another ERT and your doctor wants you to switch to VPRIV, you can&nbsp;initially&nbsp;receive VPRIV at the same&nbsp;dose&nbsp;and frequency as you have received the other ERT.<\/p>\n\n\n\n<p><strong>Use for children and adolescents<\/strong><\/p>\n\n\n\n<p>VPRIV can be given to children and adolescents (aged 4 to 17 years) at the same&nbsp;dose&nbsp;and frequency as in adults.<\/p>\n\n\n\n<p><strong>Older<\/strong><\/p>\n\n\n\n<p>VPRIV can be given to the elderly (over 65 years of age) at the same&nbsp;dose&nbsp;and frequency as in other adults.<\/p>\n\n\n\n<p><strong>Treatment response<\/strong><\/p>\n\n\n\n<p>Your doctor will monitor your response to treatment and may change your&nbsp;dose&nbsp;(up or down) over time.<\/p>\n\n\n\n<p>If you tolerate your&nbsp;infusions&nbsp;well at the clinic, your doctor or nurse can give you your&nbsp;infusions&nbsp;at home.<\/p>\n\n\n\n<p><strong>Administration<\/strong><\/p>\n\n\n\n<p>VPRIV is supplied in a\u00a0vial\u00a0as a packed powder that is mixed with sterile water and then further diluted in sodium chloride 9 mg\/ml (0.9%) solution for\u00a0infusion\u00a0before\u00a0intravenous\u00a0infusion.<\/p>\n\n\n\n<p>After\u00a0preparation, your doctor or nurse gives you the medicine as a drip into a vein (by\u00a0intravenous\u00a0infusion\u00a0) over 60 minutes.<\/p>\n\n\n\n<p>If you have any further questions about this medicine, ask your doctor or pharmacist.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n<p>Commonly (may affect up to 1 in 10 people) patients experienced a serious\u00a0allergic reaction\u00a0with difficulty breathing, chest discomfort (chest pressure), nausea, swelling of the face, lips, tongue, or throat (anaphylactic\/anaphylactoid reactions), commonly also an allergic skin reaction such as hives, severe rash or\u00a0itching.\u00a0If any of these occur, tell your doctor immediately.<\/p>\n\n\n\n<p>Most\u00a0side effects, including allergic reactions, occurred during\u00a0or shortly after the\u00a0infusion.\u00a0These are called infusion-related reactions.\u00a0Other infusion-related reactions that occurred very commonly (may affect more than 1 in 10 people) include headache, dizziness, fever\/increased body temperature, back pain, joint pain and tiredness, as well as high\u00a0blood pressure\u00a0(commonly reported), blurred vision and vomiting (less commonly reported). .\u00a0If any of these occur, tell your doctor immediately.<\/p>\n\n\n\n<p>Other&nbsp;side effects&nbsp;include:<\/p>\n\n\n\n<p><strong>Very&nbsp;<\/strong><strong>common&nbsp;side effects&nbsp;(may affect more than 1 in 10 people):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>bone pain<\/li><li>weakness\/powerlessness<\/li><li>stomach pain<\/li><\/ul>\n\n\n\n<p><strong>Common&nbsp;side effects&nbsp;(may affect up to 1 in 10 people):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>prolongation of the time it takes for a cut to stop bleeding which may lead to easy\/spontaneous bleeding\/easy bruising<\/li><li>redness<\/li><li>rapid heartbeat<\/li><li>development of&nbsp;antibodies&nbsp;against VPRIV (see section 2)<\/li><li>lowered&nbsp;blood pressure<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">How to store VPRIV<\/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 stated on the carton and label after &#8220;EXP&#8221;.&nbsp;The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>Store in a refrigerator (2 \u00baC\u20138 \u00baC).<\/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><em>Prepared and diluted solution for infusion:<\/em><\/p>\n\n\n\n<p>Use immediately.&nbsp;Do not leave for longer than 24 hours at 2\u20138 \u00b0C.<\/p>\n\n\n\n<p>Do not use VPRIV if the solution is discolored or foreign particles are present.<\/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 velaglucase alfa. Each\u00a0vial\u00a0contains 400 units of velaglucase alfa.<br>After\u00a0preparation, one ml of solution contains 100 units of velaglucase alfa.<\/li><li>The other ingredients are sucrose, sodium citrate dihydrate, citric acid monohydrate, and polysorbate 20 (see section 2, &#8220;VPRIV contains sodium&#8221;).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Appearance and package sizes of the medicine<\/h2>\n\n\n\n<p>20 ml glass\u00a0vial\u00a0containing a white to off-white powder for\u00a0infusion solution, solution.<\/p>\n\n\n\n<p>Packs of 1, 5, or 25 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 authorization holder and manufacturer<\/strong><\/p>\n\n\n\n<p><strong>Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n<p>Takeda Pharmaceuticals International AG Ireland Branch<\/p>\n\n\n\n<p>Block 2Miesian Plaza<\/p>\n\n\n\n<p>50-58 Baggot Street Lower<\/p>\n\n\n\n<p>Dublin 2<\/p>\n\n\n\n<p>Ireland<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Takeda Pharmaceuticals International AG Ireland Branch<br>Block 2 Miesian Plaza<br>50-58 Baggot Street Lower<br>Dublin 2<br>D02 HW68 Ireland<\/p>\n\n\n\n<p>Shire Pharmaceuticals Ireland Limited<\/p>\n\n\n\n<p>Block 2 &amp; 3 Miesian Plaza<\/p>\n\n\n\n<p>50 \u2013 58 Baggot Street Lower<\/p>\n\n\n\n<p>Dublin 2<\/p>\n\n\n\n<p>Ireland<\/p>\n","protected":false},"excerpt":{"rendered":"<p>VPRIV is a long-term enzyme replacement therapy (ERT) for patients with\u00a0type 1\u00a0Gaucher disease .<\/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":[2200,22502],"tags":[27770,27774,27765,27768,27771,27773,27766,27772,27767,27769],"class_list":["post-31403","post","type-post","status-publish","format-standard","hentry","category-medicines","category-v","tag-benefits-of-velaglucerase-alfa","tag-benefits-of-vpriv","tag-velaglucerase-alfa","tag-velaglucerase-alfa-side-effects","tag-vpriv","tag-vpriv-side-effects","tag-what-is-velaglucerase-alfa","tag-what-is-vpriv","tag-what-velaglucerase-alfa-is-used-for","tag-what-vpriv-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/31403","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=31403"}],"version-history":[{"count":3,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/31403\/revisions"}],"predecessor-version":[{"id":31509,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/31403\/revisions\/31509"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=31403"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=31403"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=31403"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}