{"id":31405,"date":"2022-11-09T07:25:06","date_gmt":"2022-11-09T07:25:06","guid":{"rendered":"https:\/\/zeepedia.com\/?p=31405"},"modified":"2022-11-10T07:43:30","modified_gmt":"2022-11-10T07:43:30","slug":"vumerity","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/vumerity\/","title":{"rendered":"Vumerity &#8211; Fumarate uses, dose and side effects"},"content":{"rendered":"\n<p>231 mg&nbsp;hard enteric capsules diroximel<br>fumarate (diroximel fumarate)<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Vumerity is and what it is used for<\/h2>\n\n\n\n<p><strong>What Vumerity is<\/strong><\/p>\n\n\n\n<p>Vumerity contains the active substance diroximel fumarate.<\/p>\n\n\n\n<p><strong>What Vumerity is used for<\/strong><\/p>\n\n\n\n<p>Vumerity is used to treat relapsing-remitting&nbsp;multiple sclerosis&nbsp;(MS) in adults.<\/p>\n\n\n\n<p>MS is a long-term disease in which the immune system, the body&#8217;s natural defense, malfunctions and attacks parts of the\u00a0central nervous system\u00a0(the brain, spinal cord, and\u00a0optic nerve\u00a0one to the eye) and causes\u00a0inflammation\u00a0that damages the nerves and the insulation around them.\u00a0Relapsing-remitting MS is characterized by repeated attacks (attacks\u00a0)\u00a0on the nervous system.\u00a0Symptoms vary between patients but usually include walking problems, a feeling of poor balance, and vision problems (eg, blurred vision or double vision).\u00a0These symptoms may disappear completely when the\u00a0relapse\u00a0is over, but some problems may remain.<\/p>\n\n\n\n<p><strong>How Vumerity works<\/strong><\/p>\n\n\n\n<p>The drug is believed to work by increasing the effect that a&nbsp;protein&nbsp;called &#8220;Nrf2&#8221; exerts, i.e. it controls certain genes that form antioxidants that help protect cells from damage.&nbsp;This helps control immune system activity and reduce damage to the brain and spinal cord.<br><a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before taking Vumerity<\/h2>\n\n\n\n<p><strong>Do not take Vumerity<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>if you are allergic to proximal<\/strong> fumarate, related substances (so-called fumarates or fumaric acid esters),\u00a0or any other ingredient in this medicine (listed in section 6).<\/li><li><strong>if you are suspected of suffering from a rare brain infection called\u00a0progressive\u00a0multifocal\u00a0leukoencephalopathy (PML) or if you have confirmed PML.<\/strong><\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and precautions<\/h2>\n\n\n\n<p>Vumerity can affect your\u00a0<strong>white blood cells<\/strong>,\u00a0kidneys,\u00a0and\u00a0liver.\u00a0Before you start taking Vumerity, your doctor will test your blood to count the number of\u00a0white blood cells\u00a0and check that your kidneys and liver are working properly.\u00a0The doctor tests this regularly during the treatment.\u00a0If your\u00a0white blood cell count\u00a0drops during treatment, your doctor may consider taking additional tests or stopping your treatment.<\/p>\n\n\n\n<p>Talk to your doctor straight away if you think your MS is getting worse (eg weakness or vision changes) or if you notice new symptoms.&nbsp;These may be symptoms of a rare brain infection called&nbsp;progressive&nbsp;multifocal&nbsp;leukoencephalopathy (PML).&nbsp;PML is a serious condition that can lead to severe disability or be life-threatening.&nbsp;Read the information about PML and low&nbsp;lymphocyte&nbsp;counts in section 4 of this leaflet.<\/p>\n\n\n\n<p><strong>Talk to your doctor<\/strong>&nbsp;before taking Vumerity if you have:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>a serious&nbsp;<strong>infection<\/strong>&nbsp;(eg&nbsp;pneumonia&nbsp;)<\/li><li>severe&nbsp;<strong>kidney disease<\/strong><\/li><li>severe&nbsp;<strong>liver disease<\/strong><\/li><li>a disease of the&nbsp;<strong>stomach<\/strong>&nbsp;or&nbsp;<strong>intestine<\/strong><\/li><\/ul>\n\n\n\n<p>Skin flushing (\u00a0redness\u00a0on the face and body) is a common\u00a0side effect.\u00a0Severe reddening of the skin with additional symptoms may be a sign of a severe\u00a0allergic reaction\u00a0and has been seen in a small number of patients &#8211; see &#8216;Severe allergic reactions&#8217; in section 4 of this leaflet.\u00a0Talk to your doctor if you experience skin redness that bothers you.\u00a0Your doctor may be able to give you medication to treat the redness.<\/p>\n\n\n\n<p>Vumerity can cause a serious\u00a0allergic reaction\u00a0called a\u00a0hypersensitivity reaction.\u00a0You need to know all the important signs and symptoms to watch out for when taking Vumerity.\u00a0Read the information about serious allergic reactions in section 4 of this leaflet.<\/p>\n\n\n\n<p>Shingles\u00a0(\u00a0<em>herpes\u00a0zoster<\/em>\u00a0) may occur during treatment with Vumerity.\u00a0In some cases, serious complications have occurred.\u00a0<strong>You should inform your doctor immediately<\/strong>\u00a0if you suspect that you have any symptoms of\u00a0shingles.\u00a0The symptoms are described in section 4 of this leaflet.<\/p>\n\n\n\n<p>A rare but serious kidney disease (Fanconi syndrome) has been reported for a drug containing active substances related to Vumerity (dimethyl fumarate, in combination with other fumaric acid esters).\u00a0If you notice that you urinate more, are thirstier, and drink more than usual, or if your muscles seem weak, if you break a bone or just have aches and pains, talk to your doctor as soon as possible so that this can be investigated further.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>Vumerity should not be given to children and adolescents as the experience of the safety and efficacy of this medicine in this patient group is limited.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Vumerity<\/h2>\n\n\n\n<p><strong>Tell your doctor or pharmacist<\/strong>\u00a0if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n<p>Especially:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>medicines containing\u00a0<strong>fumaric acid<\/strong>\u00a0esters (fumarates)<\/li><li><strong>medicines that affect the body&#8217;s immune system<\/strong>\u00a0including\u00a0<strong>chemotherapy<\/strong>,\u00a0immunosuppressants,\u00a0or\u00a0other medicines used to treat MS<\/li><li>medicines that affect the kidneys including\u00a0some\u00a0antibiotics\u00a0(such as\u00a0aminoglycosides\u00a0used to treat\u00a0infections\u00a0), &#8221;\u00a0<strong>water tablets<\/strong>\u00a0&#8221; (\u00a0<em>diuretics<\/em>\u00a0),\u00a0<strong>certain types of painkillers<\/strong>\u00a0(such as\u00a0ibuprofen\u00a0and other similar anti-inflammatory medicines and over-the-counter medicines) and medicines containing\u00a0<strong>lithium<\/strong><\/li><li>If you take Vumerity with certain types of vaccines (\u00a0<em>live vaccines<\/em>\u00a0), you may get an\u00a0infection\u00a0and you should therefore avoid such vaccines.\u00a0The doctor will decide whether other types of vaccines (\u00a0<em>non-live vaccines<\/em>\u00a0) should be given.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p>If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.<\/p>\n\n\n\n<p>Pregnancy<\/p>\n\n\n\n<p>Do not use Vumerity if you are pregnant unless you have first discussed it with your doctor.&nbsp;This is because Vumerity could harm your unborn baby.&nbsp;If you can get pregnant, use reliable contraception.<\/p>\n\n\n\n<p>Breast-feeding<\/p>\n\n\n\n<p>It is unknown whether proximal fumarate or its\u00a0metabolite\u00a0is passed into breast milk.\u00a0Your doctor will help you decide whether to stop breastfeeding or stop using Vumerity.\u00a0This means that the benefit of breastfeeding for the baby is compared to the benefit of the treatment for you.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving ability and use of machinery<\/h2>\n\n\n\n<p>Vumerity is not expected to affect the ability to drive or use machines.<a><\/a><br><a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to take Vumerity<\/h2>\n\n\n\n<p>Always take this medicine as directed by your doctor.&nbsp;Consult a doctor if you are unsure.<\/p>\n\n\n\n<p><strong>Starting dose<\/strong><\/p>\n\n\n\n<p>The recommended starting dose is 231 mg (one capsule) twice daily.<\/p>\n\n\n\n<p>Take the starting dose for the first 7 days and then take the maintenance dose.<\/p>\n\n\n\n<p><strong>Maintenance dose<\/strong><\/p>\n\n\n\n<p>The recommended maintenance dose is 462 mg (two capsules) twice daily.<\/p>\n\n\n\n<p>Vumerity should be swallowed.<\/p>\n\n\n\n<p>Swallow the capsules whole with water.\u00a0Do not crush or chew the capsule and do not sprinkle the contents of the capsule over food as this may increase some\u00a0side effects.<\/p>\n\n\n\n<p>You can take Vumerity with food or on an empty stomach.&nbsp;If you have&nbsp;side effects&nbsp;such as skin redness or stomach upset, taking them with food can reduce these symptoms.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you have taken too much Vumerity<\/h2>\n\n\n\n<p>If you have taken too many capsules, talk to your doctor immediately.\u00a0You may experience\u00a0side effects\u00a0similar to those described below in section 4.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to take Vumerity<\/h2>\n\n\n\n<p><strong>Do not take a double\u00a0dose<\/strong>\u00a0to make up for a missed\u00a0dose.<\/p>\n\n\n\n<p>If it is still at least 4 hours until your next scheduled\u00a0dose, you can take the missed\u00a0dose.\u00a0Otherwise, skip the missed\u00a0dose\u00a0and take the next scheduled\u00a0dose\u00a0at the usual time.<\/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><strong>Serious&nbsp;side effects&nbsp;are<\/strong><\/p>\n\n\n\n<p><strong>PML and decreased lymphocyte counts<\/strong><\/p>\n\n\n\n<p>The frequency of PML cannot be estimated from the available data (no known frequency).<\/p>\n\n\n\n<p>Vumerity can lower the number of\u00a0lymphocytes\u00a0(a type of\u00a0white blood cell\u00a0).\u00a0Having a low\u00a0white blood cell count\u00a0can increase your risk of\u00a0infection, including the risk of getting an unusual brain infection called\u00a0progressive\u00a0multifocal\u00a0leukoencephalopathy (PML).\u00a0PML can lead to severe disability or be life-threatening.\u00a0PML has occurred after 1 to 5 years of treatment with the related drug dimethyl fumarate and the doctor should therefore continue to check the\u00a0white blood cell count throughout treatment you should be alert for any symptoms of PML described below.\u00a0The risk of PML may be higher if you have previously taken medication that weakens the body&#8217;s immune system.<\/p>\n\n\n\n<p>The symptoms of PML can be similar to an MS\u00a0relapse.\u00a0Symptoms may include new or worsening weakness on one side of the body, clumsiness, vision changes, thinking, or memory, confusion or personality changes, or speech and communication difficulties that last longer than a few days.<\/p>\n\n\n\n<p>It is therefore very important that you talk to your doctor as soon as possible if you think your MS is getting worse or if you notice any new symptoms while you are being treated with Vumerity.\u00a0Also, talk to your partner or carer and tell them about your treatment.\u00a0Symptoms may occur that you do not notice yourself.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Contact a doctor immediately if you experience any of these symptoms<\/strong><\/li><\/ul>\n\n\n\n<p><strong>Severe allergic reactions<\/strong><\/p>\n\n\n\n<p>The frequency of severe allergic reactions cannot be estimated from the available data (no frequency is known).<\/p>\n\n\n\n<p>Skin redness is a very common\u00a0side effect.\u00a0If, however, you\u00a0develop redness\u00a0on your face or body along with a red rash or hives\u00a0<strong>and<\/strong>\u00a0experience any of these symptoms:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>swelling of the face, lips, mouth, or tongue\u00a0(\u00a0angioedema\u00a0)<\/li><li>wheezing, difficulty breathing, or shortness of breath\u00a0(\u00a0dyspnea<em>,\u00a0hypoxia\u00a0)<\/em><\/li><li>dizziness or fainting\u00a0<em>(\u00a0hypotension\u00a0)<\/em><\/li><\/ul>\n\n\n\n<p>it could be a severe&nbsp;allergic reaction&nbsp;<em>(&nbsp;anaphylactic reaction&nbsp;).<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Stop taking Vumerity and see a doctor immediately<\/strong><\/li><\/ul>\n\n\n\n<p><strong>Other\u00a0side effects\u00a0ar<\/strong><\/p>\n\n\n\n<p><strong>Very common<\/strong>&nbsp;(may affect more than 1 in 10 people)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>redness\u00a0of the face or body, feeling of heat, hotness, burning, or\u00a0itching\u00a0<em>(\u00a0flush<\/em>\u00a0)<\/li><li>loose stools\u00a0<em>(diarrhea)<\/em><\/li><li>nausea<\/li><li>stomach pain or stomach cramps<\/li><\/ul>\n\n\n\n<p>Side effects&nbsp;that can show up in blood or urine tests<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>substances called ketones, which are produced naturally in the body, are very common in urine tests while taking Vumerity.<\/li><li>a low number of\u00a0white blood cells\u00a0(\u00a0lymphopenia,\u00a0leukopenia\u00a0) in the blood.\u00a0A reduced number of\u00a0white blood cells\u00a0can mean that the body has less ability to fight infection.\u00a0If you get a serious\u00a0infection\u00a0(e.g.\u00a0pneumonia\u00a0), you must talk to your doctor straight away<\/li><\/ul>\n\n\n\n<p><strong>Talk to your doctor<\/strong>\u00a0about how to manage these\u00a0side effects.\u00a0The doctor may lower the\u00a0dose.\u00a0Do not lower the\u00a0dose\u00a0unless your doctor tells you to.<\/p>\n\n\n\n<p><strong>Common<\/strong>&nbsp;(may affect up to 1 in 10 people)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>inflammation&nbsp;of the intestines (&nbsp;<em>gastroenteritis<\/em>&nbsp;)<\/li><li>vomiting<\/li><li>indigestion (&nbsp;<em>dyspepsia<\/em>&nbsp;)<\/li><li>inflammation&nbsp;of the stomach (&nbsp;<em>gastritis<\/em>&nbsp;)<\/li><li>indigestion (&nbsp;<em>disorder in the gastrointestinal tract<\/em>&nbsp;)<\/li><li>burning sensation<\/li><li>hot flush, feeling of warmth<\/li><li>itching&nbsp;of the skin&nbsp;<em>(&nbsp;pruritus&nbsp;)<\/em><\/li><li>rash<\/li><li>pink or red spots on the skin (&nbsp;<em>erythema<\/em>&nbsp;)<\/li><li>hair loss (&nbsp;<em>alopecia<\/em>&nbsp;)<\/li><\/ul>\n\n\n\n<p>Side effects&nbsp;that can show up in blood or urine tests<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>protein\u00a0(\u00a0<em>albumin<\/em>\u00a0) in the urine (\u00a0<em>proteinuria<\/em>\u00a0)<\/li><li>elevation of liver enzymes (\u00a0<em>ALT,\u00a0AST<\/em>\u00a0) in the blood<\/li><\/ul>\n\n\n\n<p><strong>Uncommon<\/strong>&nbsp;(may affect up to 1 in 100 people)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>allergic reactions (&nbsp;<em>hypersensitivity<\/em>&nbsp;)<\/li><li>decreased number of&nbsp;platelets<\/li><\/ul>\n\n\n\n<p><strong>Frequency not known<\/strong>&nbsp;(cannot be estimated from available data)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>liver damage due to drugs and elevated levels of liver enzymes checked with blood tests (\u00a0<em>ALT\u00a0or\u00a0AST\u00a0in combination with\u00a0bilirubin<\/em>\u00a0)<\/li><li>&#8211;\u00a0shingles\u00a0(\u00a0herpes\u00a0zoster) with symptoms such as blisters, burning sensation,\u00a0itching,\u00a0or pain in the skin, typically on one side of the upper body or face, and other symptoms such as fever and weakness during the early stages of\u00a0infection\u00a0followed by numbness,\u00a0itching\u00a0or red spots with severe pain.<\/li><li>runny nose (\u00a0<em>rhinorrhea<\/em>\u00a0)<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">How Vumerity should be stored<\/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 can and carton after EXP.<\/p>\n\n\n\n<p>The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>Store at a maximum of 25 \u00b0C.<\/p>\n\n\n\n<p>Store in the original jar.&nbsp;Moisture sensitive.<\/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<p><strong>The active substance<\/strong>\u00a0is proximal fumarate.<\/p>\n\n\n\n<p>Each capsule contains 231 mg of proximal fumarate.<\/p>\n\n\n\n<p><strong>Other ingredients<\/strong>\u00a0are Capsule content: methacrylic acid-ethyl acrylate copolymer (1:1) of type A;\u00a0crospovidone type A;\u00a0microcrystalline cellulose;\u00a0colloidal\u00a0anhydrous silica;\u00a0triethyl citrate;\u00a0talc;\u00a0magnesium stearate.\u00a0Capsule shell: hypromellose;\u00a0titanium dioxide (E171);\u00a0potassium chloride;\u00a0carrageenan.\u00a0Capsule print: black iron oxide (E172), shellac, potassium hydroxide.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Appearance and package sizes of the medicine<\/h2>\n\n\n\n<p>Vumerity 231 mg hard enteric capsules are white and marked with &#8220;DRF 231 mg&#8221; in black ink.<\/p>\n\n\n\n<p>Vumerity is available in packs containing 120 or 360 (3 x 120) capsules.<\/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 Authorisation Holder<\/h2>\n\n\n\n<p>Biogen Netherlands BV<\/p>\n\n\n\n<p>Prins Mauritslaan 13<\/p>\n\n\n\n<p>1171 LP Badhoevedorp<\/p>\n\n\n\n<p>Netherlands<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Alkermes Pharma Ireland Limited<\/p>\n\n\n\n<p>Monksland<\/p>\n\n\n\n<p>Athlone<\/p>\n\n\n\n<p>Co.&nbsp;Westmeath<\/p>\n\n\n\n<p>Ireland<\/p>\n\n\n\n<p>N37 EA09<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Vumerity contains the active substance diroximel fumarate.<\/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":[27764,27754,27757,27758,27760,27762,27763,27756,27755,27761,27759],"class_list":["post-31405","post","type-post","status-publish","format-standard","hentry","category-medicines","category-v","tag-diroximel-fumarate","tag-fumarate","tag-fumarate-capsule","tag-fumarate-side-effects","tag-vumerity","tag-vumerity-capsule","tag-vumerity-side-effects","tag-what-fumarate-is-used-for","tag-what-is-fumarate","tag-what-is-vumerity","tag-what-vumerity-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/31405","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=31405"}],"version-history":[{"count":3,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/31405\/revisions"}],"predecessor-version":[{"id":31508,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/31405\/revisions\/31508"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=31405"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=31405"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=31405"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}