{"id":26043,"date":"2022-10-10T14:21:10","date_gmt":"2022-10-10T14:21:10","guid":{"rendered":"https:\/\/zeepedia.com\/?p=26043"},"modified":"2022-10-11T08:15:40","modified_gmt":"2022-10-11T08:15:40","slug":"vabysmo","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/vabysmo\/","title":{"rendered":"Vabysmo &#8211; Faricimab uses, dose and side effects"},"content":{"rendered":"\n<p>120 mg\/ml&nbsp;solution&nbsp;<\/p>\n\n\n\n<p>for injection<br>faricimab<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Vabysmo is and what it is used for<\/h2>\n\n\n\n<p><strong>What Vabysmo is and what it is used for<\/strong><\/p>\n\n\n\n<p>Vabysmo contains the active substance faricimab, which belongs to a group of medicines called antineovascular agents.<\/p>\n\n\n\n<p>Vabysmo is injected into the eye by a doctor to treat adults with eye diseases:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>neovascular (wet) age-related\u00a0macular degeneration\u00a0(AMD),<\/li><li>visual impairment caused by diabetic macular edema (DME).<\/li><\/ul>\n\n\n\n<p>These conditions affect the\u00a0macula\u00a0(\u00a0yellow spot\u00a0), which sits in the center of the retina (the light-sensitive area at the back of the eye) and is responsible for central visual acuity.\u00a0AMD is caused by the growth of abnormal blood vessels that leak blood and fluid into the\u00a0macula, and DME is caused by leaky blood vessels that cause the\u00a0macula\u00a0to swell.<\/p>\n\n\n\n<p><strong>How does Vabysmo work<\/strong><\/p>\n\n\n\n<p>Vabysmo specifically recognizes the\u00a0proteins\u00a0angiopoietin-2 and\u00a0vascular\u00a0endothelial growth factor A and blocks their activity.\u00a0When these\u00a0proteins\u00a0are present at higher than normal levels, they can cause the growth of abnormal blood vessels and\/or damage to normal blood vessels.\u00a0This leads to leakage into the\u00a0macula\u00a0causing swelling or damage, which can negatively affect vision.\u00a0By binding to these\u00a0proteins, Vabysmo can block their activity and prevent abnormal growth of blood vessels as well as leakage and swelling.\u00a0Vabysmo can improve the disease and\/or slow down the deterioration of the disease and thereby preserve or even improve vision.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before you are given Vabysmo<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">You should not be given Vabysmo:<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to faricimab or any of the other ingredients of this medicine (listed in section 6).<\/li><li>if you have an active or suspected&nbsp;infection&nbsp;in or around the eye.<\/li><li>if you have eye pain or if the eye is red (ophthalmitis).<\/li><\/ul>\n\n\n\n<p>If any of these apply to you, tell your doctor.&nbsp;You should then not be treated with Vabysmo.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and precautions<\/h2>\n\n\n\n<p>Talk to your doctor before receiving Vabysmo:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you have\u00a0glaucoma\u00a0(\u00a0glaucoma, a condition usually caused by high pressure in the eye).<\/li><li>if you have previously seen flashes of light or dark dots floating in\u00a0your field\u00a0of vision or if the number and size of such dots have suddenly increased.<\/li><li>if you have had eye surgery in the last four weeks or if eye surgery is planned within the next four weeks.<\/li><li>if you have or have ever had any eye disease or received eye treatments.<\/li><\/ul>\n\n\n\n<p>Talk to your doctor immediately:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if vision suddenly deteriorates.<\/li><li>if you notice signs of a possible\u00a0infection\u00a0or\u00a0inflammation\u00a0in the eye such as increased\u00a0redness\u00a0in the eye, eye pain, increased discomfort in the eye, blurred or impaired vision, increased number of small dots in the\u00a0field\u00a0of vision, and increased sensitivity to light.<\/li><\/ul>\n\n\n\n<p>It is also important for you to know that:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>safety and efficacy of Vabysmo given simultaneously in both eyes have not been studied and if it is used in this way, it may be associated with an increased risk of suffering\u00a0side effects.<\/li><li>injection\u00a0of Vabysmo may temporarily increase the pressure in the eye (\u00a0intraocular pressure\u00a0) in some patients within 60 minutes of\u00a0injection.\u00a0Your doctor will check this after each\u00a0injection.<\/li><li>the doctor will examine whether you have other risk factors that may increase the risk of a hole in or detachment of one of the layers in the back of the eye (retinal detachment or\u00a0rupture, pigment epithelium detachment or\u00a0rupture\u00a0).\u00a0In such a case, Vabysmo should be given with caution.<\/li><\/ul>\n\n\n\n<p>When certain medicines that work in a similar way to Vabysmo are given, there is a known risk of blood clots blocking blood vessels (arterial thromboembolic events), which can lead to heart attack or\u00a0stroke.\u00a0Because small amounts of the drug are absorbed into the blood, there is a theoretical risk of such events following\u00a0the injection\u00a0of Vabysmo into the eye.<\/p>\n\n\n\n<p>There is only limited experience in the treatment of:<\/p>\n\n\n\n<p>patients&nbsp;with active&nbsp;infection<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>patients with neovascular (wet) age-related\u00a0macular degeneration\u00a0(AMD) who are 85 years or older<\/li><li>patients with diabetic macular edema (DME) caused by type I\u00a0diabetes<\/li><li>diabetics with high average blood sugar (Hb1c above 10%)<\/li><li>diabetics with eye disease caused by so-called\u00a0diabetic\u00a0proliferative\u00a0diabetic\u00a0retinopathy<\/li><li>diabetics with high\u00a0blood pressure, higher than 140\/90 mmHg, and blood vessel disease<\/li><li>patients with DME who receive\u00a0injections\u00a0less often than every 8 weeks for a longer period<\/li><\/ul>\n\n\n\n<p>There is only limited experience in the treatment of patients who receive\u00a0injections\u00a0less than every 8 weeks for a longer period and these patients may be at a greater risk of\u00a0side effects.<\/p>\n\n\n\n<p>There is no experience in the treatment of:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>diabetics with uncontrolled high\u00a0blood pressure.<\/li><\/ul>\n\n\n\n<p>If any of the above applies to you, your doctor will consider this lack of information when treating you with Vabysmo.&nbsp;<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>The use of Vabysmo in children and adolescents has not been studied because AMD and DME mainly occur in adults.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Vabysmo<\/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 and breastfeeding<\/h2>\n\n\n\n<p>Vabysmo has not been studied in pregnant women.&nbsp;Vabysmo should not be used during pregnancy unless the expected benefit to the patient outweighs the potential risk to the fetus.<\/p>\n\n\n\n<p>If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before being treated with this medicine.<\/p>\n\n\n\n<p>Breastfeeding is not recommended during treatment with Vabysmo as it is unknown whether Vabysmo passes into breast milk.<\/p>\n\n\n\n<p>Women of childbearing potential must use an effective method of contraception during treatment and for at least three months after treatment with Vabysmo has stopped.&nbsp;If you become pregnant or think you are pregnant during treatment, tell your doctor immediately.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving ability and use of machinery<\/h2>\n\n\n\n<p>After an&nbsp;injection&nbsp;of Vabysmo, temporary vision problems may occur (eg, blurred vision).&nbsp;Do not drive vehicles or use machinery while these last.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Vabysmo contains sodium<\/h2>\n\n\n\n<p>This medicine contains less than 1 mmol (23 mg) of\u00a0sodium\u00a0per\u00a0dose, i.e. it is almost &#8220;sodium-free&#8221;.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to use Vabysmo<\/h2>\n\n\n\n<p><strong>How Vabysmo is given<\/strong><\/p>\n\n\n\n<p>The recommended&nbsp;dose&nbsp;is 6 mg faricimab.<\/p>\n\n\n\n<p>Wet neovascular age-related\u00a0macular degeneration\u00a0(wet AMD,\u00a0AMD\u00a0)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>During the first 4 months, you will receive one&nbsp;injection per&nbsp;month.<\/li><li>After that, you can receive&nbsp;injections&nbsp;at intervals of no more than 4 months.&nbsp;Your doctor will decide how often the&nbsp;injections&nbsp;should be given depending on the condition of the eye.<\/li><\/ul>\n\n\n\n<p>Visual impairment caused by diabetic macular edema (&nbsp;DME&nbsp;)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>During the first 4 months, you will receive one&nbsp;injection per&nbsp;month.<\/li><li>After that, you can receive&nbsp;injections&nbsp;at intervals of no more than 4 months.&nbsp;Your doctor will decide how often the&nbsp;injections&nbsp;should be given depending on the condition of the eye.<\/li><\/ul>\n\n\n\n<p><strong>Mode of administration<\/strong><\/p>\n\n\n\n<p>Vabysmo is injected into the eye (intravitreal&nbsp;injection&nbsp;) by a doctor who is experienced in giving&nbsp;injections&nbsp;into the eye.<\/p>\n\n\n\n<p>Before the\u00a0injection, the doctor will carefully clean your eye with disinfectant eye wash to prevent\u00a0infection.\u00a0The doctor will give you\u00a0eye drops\u00a0(\u00a0local anesthetic\u00a0) to numb the eye and reduce or prevent pain during the\u00a0injection.<\/p>\n\n\n\n<p><strong>How long does treatment with Vabysmo last?<\/strong><\/p>\n\n\n\n<p>This is a long-term treatment that can last for months or years.&nbsp;Your doctor will regularly check your condition to make sure the treatment is working.&nbsp;Depending on how you respond to treatment with Vabysmo, your doctor may ask you to come for treatment at shorter or longer intervals.<br><a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you have missed a dose of Vabysmo<\/h2>\n\n\n\n<p>If you have missed a\u00a0dose, make a new appointment with your doctor as soon as possible.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you stop using Vabysmo<\/h2>\n\n\n\n<p>Talk to your doctor before stopping treatment.&nbsp;The risk of vision loss may increase and vision may deteriorate if you stop treatment.<\/p>\n\n\n\n<p>If you have any further questions about this medicine, ask your doctor.<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, but not everyone who is treated will get them.<\/p>\n\n\n\n<p>The side effects\u00a0of\u00a0injection\u00a0with Vabysmo depend either on the drug itself or on the\u00a0injection, and the\u00a0side effects\u00a0mainly affect the eye.<\/p>\n\n\n\n<p><strong>Some&nbsp;side effects&nbsp;can be serious<\/strong><\/p>\n\n\n\n<p>Contact the doctor\u00a0<strong>immediately<\/strong>\u00a0if you notice any of the following, which are signs of allergic reactions,\u00a0inflammation,\u00a0or infection:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>eye pain, increased discomfort, increased eye redness, blurred or impaired vision, increased number of small spots in the\u00a0field\u00a0of vision, or increased sensitivity to light \u2013 these are signs of a possible\u00a0infection,\u00a0inflammation\u00a0of the eye, or an\u00a0allergic reaction.<\/li><li>sudden deterioration or change in vision.<\/li><\/ul>\n\n\n\n<p><strong>Other possible\u00a0side effects\u00a0are<\/strong><\/p>\n\n\n\n<p>Other&nbsp;side effects&nbsp;that may occur after treatment with Vabysmo are listed below.<\/p>\n\n\n\n<p>Most\u00a0side effects\u00a0are mild to moderate and generally disappear within a week after each\u00a0injection.<\/p>\n\n\n\n<p>Contact a doctor if any of the following&nbsp;side effects&nbsp;become severe.<\/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>The cloudy lens in the eye (\u00a0cataract\u00a0).<\/li><\/ul>\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>Hole or tear in the retina (the layer at the back of the eye that perceives light) or in one of its layers<\/li><li>Increased pressure inside the eye (increased&nbsp;intraocular pressure&nbsp;)<\/li><li>Bleeding from small blood vessels in the outer layer of the eye (conjunctival hemorrhage)<\/li><li>Moving dots or dark shadows in the field of&nbsp;vision&nbsp;(vitreous opacities)<\/li><li>Eye pain<\/li><li>Increased tear production<\/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>Severe\u00a0inflammation\u00a0or\u00a0infection\u00a0inside the eye (\u00a0endophthalmitis\u00a0)<\/li><li>Inflammation\u00a0of the gel-like substance inside the eye\/red eye (vitreous)<\/li><li>Inflammation\u00a0of the iris and surrounding\u00a0tissue\u00a0of the eye (\u00a0iritis,\u00a0iridocyclitis,\u00a0uveitis\u00a0)<\/li><li>Bleeding in the eye (vitreous hemorrhage)<\/li><li>Scratched\u00a0cornea, damage to the cornea (the clear layer of the eye that covers the iris [cornealabrasion])<\/li><li>Eye irritation<\/li><li>Eye discomfort<\/li><li>Itchy eyes<\/li><li>Red-eye (ocular\/conjunctival\u00a0hyperemia\u00a0)<\/li><li>A feeling of having caught something in the eye<\/li><li>Blurred vision<\/li><li>Decreased\u00a0visual acuity\u00a0(impaired vision)<\/li><\/ul>\n\n\n\n<p><strong>Rare<\/strong>&nbsp;(may affect up to 1 in 1,000 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Retinal detachment<\/li><li>Temporarily impaired&nbsp;visual acuity&nbsp;(transient reduced&nbsp;visual acuity&nbsp;)<\/li><\/ul>\n\n\n\n<p>When certain medicines that work in a similar way to Vabysmo are given, there is a known risk of blood clots blocking blood vessels (arterial thromboembolic events), which can lead to heart attack or\u00a0stroke.\u00a0Because small amounts of the drug are absorbed into the blood, there is a theoretical risk of such events following\u00a0the injection\u00a0of Vabysmo into the eye.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How Vabysmo should be stored<\/h2>\n\n\n\n<p>Doctors, pharmacists, or nurses are responsible for storing this medicine and disposing of unused medicine properly.\u00a0The following information is intended for healthcare professionals.<\/p>\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 carton and label after EXP.&nbsp;The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>Store in a refrigerator at 2 \u00b0C-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>Before use, the unopened vial can be stored at room temperature, 20\u00b0C to 25\u00b0C for up to 24 hours.<a><\/a><\/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 faricimab.\u00a0One ml of solution contains 120 mg of faricimab.\u00a0Each\u00a0vial\u00a0contains 28.8 mg faricimab in 0.24 ml solution.\u00a0This provides a sufficient amount to deliver a single dose of 0.05 ml solution containing 6 mg faricimab.<\/li><li>Other ingredients are L-histidine, acetic acid 30%, L-methionine, sodium chloride, sucrose, 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>Vabysmo is clear to opalescent, colorless to the brownish-yellow solution.<\/p>\n\n\n\n<p>Package size with a glass&nbsp;vial&nbsp;and a 5 \u00b5m blunt filter transfer cannula (18 G x 1\u00bd in., 1.2 mm x 40 mm), for single use only.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorisation Holder<\/h2>\n\n\n\n<p>Roche Registration GmbH<\/p>\n\n\n\n<p>Emil-Barell-Strasse 1<\/p>\n\n\n\n<p>Grenzach-Wyhlen<\/p>\n\n\n\n<p>79639<\/p>\n\n\n\n<p>Germany<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Roche Pharma AG<\/p>\n\n\n\n<p>Emil-Barell-Str 1<\/p>\n\n\n\n<p>Grenzach-Whylen<\/p>\n\n\n\n<p>79639<\/p>\n\n\n\n<p>Germany<\/p>\n\n\n\n<p>Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>Finland\/Finland<\/strong>Roche OyTel: +358 (0) 10 554 500<\/td><\/tr><tr><td><strong>Sweden<\/strong>Roche ABPhone: +46 (0) 8 726 1200<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>Vabysmo contains the active substance faricimab, which belongs to a group of medicines called antineovascular agents.<\/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":[26783,26787,26779,26780,26782,26786,26781,26788,26784,26785],"class_list":["post-26043","post","type-post","status-publish","format-standard","hentry","category-medicines","category-v","tag-benefits-of-faricimab","tag-benefits-of-vabysmo","tag-faricimab","tag-faricimab-side-effects","tag-vabysmo","tag-vabysmo-side-effects","tag-what-faricimab-is-used-for","tag-what-is-faricimab","tag-what-is-vabysmo","tag-what-vabysmo-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/26043","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=26043"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/26043\/revisions"}],"predecessor-version":[{"id":26069,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/26043\/revisions\/26069"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=26043"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=26043"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=26043"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}