{"id":19990,"date":"2022-03-22T11:38:21","date_gmt":"2022-03-22T11:38:21","guid":{"rendered":"https:\/\/zeepedia.com\/?p=19990"},"modified":"2022-03-24T11:07:01","modified_gmt":"2022-03-24T11:07:01","slug":"orladeyo","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/orladeyo\/","title":{"rendered":"Orladeyo &#8211; Berotralstat uses, dose and side effects"},"content":{"rendered":"\n<p>150 mg&nbsp;hard capsules<br>berotralstat<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Orladeyo is and what it is used for<\/h2>\n\n\n\n<p>Orladeyo is a medicine that contains the active substance berotralstat.\u00a0It is used to\u00a0<strong>prevent angioedema<\/strong>\u00a0in adults and adolescents from the age of 12 with hereditary (hereditary)\u00a0angioedema.<\/p>\n\n\n\n<p><strong>What&nbsp;is hereditary&nbsp;angioedema?<\/strong><\/p>\n\n\n\n<p>Hereditary&nbsp;angioedema&nbsp;is a disease that can affect several people in the same family.&nbsp;The disease can complicate your daily activities by causing sudden swelling and pain in various parts of the body such as<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>hands and feet<\/li><li>face, eyelids, lips or tongue<\/li><li>larynx, which can make it difficult to breathe<\/li><li>genitals<\/li><li>stomach and intestines.<\/li><\/ul>\n\n\n\n<p><strong>How Orladeyo works<\/strong><\/p>\n\n\n\n<p>In hereditary\u00a0angioedema, the blood contains too little of a\u00a0protein\u00a0called a C1 inhibitor, or the\u00a0protein\u00a0does not work properly.\u00a0The result is an excessive amount of\u00a0enzyme\u00a0plasma kallikrein, which in turn increases the amount of bradykinin in the blood.\u00a0Too much bradykinin leads to symptoms of hereditary\u00a0angioedema.\u00a0Berotralstat, the active substance in Orladeyo, inhibits the activity of plasma calligraphy and thus reduces the amount of bradykinin.\u00a0This prevents the swelling and pain that hereditary\u00a0angioedema\u00a0can cause.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before using Orladeyo<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not take Orladeyo<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to berotralstat 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 cautions<\/h2>\n\n\n\n<p>Talk to your doctor or pharmacist before taking Orladeyo<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>have moderate or severe hepatic impairment as it may increase the amount of berotralstat in the blood<\/li><li>has severe renal impairment<\/li><li>is at risk for a certain heart problem, so-called&nbsp;QT&nbsp;prolongation.<\/li><\/ul>\n\n\n\n<p>If you get about of hereditary\u00a0angioedema, you should take your usual emergency medicine without any extra\u00a0dose\u00a0of Orladeyo.\u00a0It is not known whether Orladeyo works as an emergency treatment for hereditary\u00a0angioedema\u00a0attacks.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>Orladeyo is not recommended for children under 12 years of age as Orladeyo has not been studied in this age group.<\/p>\n\n\n\n<p>Orladeyo has not been studied in adolescents weighing less than 40 kg.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other drugs and Orladeyo<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n<p>You must tell your doctor before using Orladeyo if you are taking<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>thioridazine or pimozide, medicines for mental disorders<\/li><li>amlodipine, a medicine for high&nbsp;blood pressure&nbsp;or a type of chest pain called angina (angina)<\/li><li>ciclosporin, a drug for suppressing the immune system, treating serious skin diseases and serious eye or joint inflammation<\/li><li>dabigatran, a medicine that prevents blood clots<\/li><li>rifampicin, a medicine for&nbsp;tuberculosis&nbsp;and some&nbsp;other&nbsp;infection<\/li><li>desipramine, St. John&#8217;s&nbsp;wort&nbsp;and other antidepressants, so-called&nbsp;tricyclic antidepressants<\/li><li>dextromethorphan, a cough suppressant<\/li><li>digoxin&nbsp;, a drug for heart problems and irregular heartbeats<\/li><li>fentanyl&nbsp;, a powerful painkiller<\/li><li>midazolam, a medicine for sleep disorders and for&nbsp;anesthesia<\/li><li>tolbutamide, a drug to reduce blood sugar<\/li><li>birth control pills&nbsp;.<br>Orladeyo may impair the effect of&nbsp;birth control pills&nbsp;, e.g.&nbsp;desogestrel.&nbsp;Women who use only desogestrel as a contraceptive should therefore switch to another effective method of contraception, e.g.&nbsp;barrier method&nbsp;, contraceptive syringes with&nbsp;progesterone&nbsp;or combined&nbsp;oral contraceptives<\/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 taking this medicine.<\/p>\n\n\n\n<p>Information on the use of Orladeyo during pregnancy and lactation is limited.\u00a0As a precautionary measure, the use of Orladeyo during pregnancy and lactation should be avoided.\u00a0Your doctor will talk to you about the benefits and risks of taking this medicine.<\/p>\n\n\n\n<p>Women of childbearing potential must use effective contraception during treatment and for at least 1 month after the last\u00a0dose.\u00a0Orladeyo is not recommended for women of childbearing potential not using contraception.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Orladeyo has no or negligible effect on the ability to drive and use machines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to take Orladeyo<\/h2>\n\n\n\n<p>Always take this medicine exactly as your doctor or pharmacist has told you.&nbsp;Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n<p><strong>The recommended&nbsp;dose&nbsp;is<\/strong><\/p>\n\n\n\n<p>The recommended&nbsp;dose&nbsp;for adults and adolescents from 12 years of age weighing 40 kg or more is one capsule once daily.<\/p>\n\n\n\n<p>Orladeyo is not recommended for patients with moderate or severe hepatic impairment.\u00a0As a precautionary measure, this also applies to patients receiving\u00a0dialysis.<\/p>\n\n\n\n<p><strong>Method of administration<\/strong><\/p>\n\n\n\n<p>Take the capsule with food and a glass of water, at the same time each day.&nbsp;The time of day does not matter.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you take more Orladeyo than you should<\/h2>\n\n\n\n<p>Contact your doctor immediately if this happens.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to take Orladeyo<\/h2>\n\n\n\n<p>Do not take a double&nbsp;dose&nbsp;to make up for a forgotten capsule.&nbsp;Take the&nbsp;dose&nbsp;you missed as soon as you remember, but never take more than one&nbsp;dose&nbsp;per day.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you stop taking Orladeyo<\/h2>\n\n\n\n<p>It is important to\u00a0<strong>take<\/strong>\u00a0this medicine regularly and\u00a0<strong>for as long as your doctor prescribes it<\/strong>.\u00a0Do not stop taking it without your doctor&#8217;s approval.<\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/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>Side effects&nbsp;can occur with the following frequencies:<\/p>\n\n\n\n<p><strong>Very common<\/strong>, may affect more than 1 user in 10:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>headache<\/li><li>abdominal pain, which includes abdominal discomfort, abdominal pain<\/li><li>diarrhea and frequent bowel movements.<\/li><\/ul>\n\n\n\n<p><strong>Common<\/strong>, may affect up to 1 in 10 users:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>vomiting<\/li><li>heartburn<\/li><li>intestinal gases<\/li><li>increased amount of the liver enzymes&nbsp;ALT&nbsp;and&nbsp;AST&nbsp;detected in blood samples<\/li><li>rash.&nbsp;\u00b7 \u00b7 \u00b7 \u00b7&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Orladeyo<\/h2>\n\n\n\n<p>Keep this medicine out of the 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 blister after \u201cEXP\u201d.&nbsp;The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>No special storage instructions.<\/p>\n\n\n\n<p>Medicines should not be disposed of via wastewater or household waste.&nbsp;Ask your pharmacist how to dispose of medicines no longer required.&nbsp;These measures will help to protect the environment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Contents of the pack and other information<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Content declaration<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>The active substance is berotral state.&nbsp;Each capsule contains 150 mg of berotralstat (as dihydrochloride).<\/li><li>The other ingredients are<ul><li>pregelatinized&nbsp;starch&nbsp;, crospovidone (type A),&nbsp;colloidal&nbsp;anhydrous silica gel, magnesium stearate, gelatin, titanium dioxide (E 171)<\/li><li>dyes: indigo carmine (E 132), black iron oxide (E 172), red iron oxide (E 172)<\/li><li>Inks for labeling: black iron oxide (E 172), potassium hydroxide, shellac, propylene glycol (E 1520).<\/li><\/ul><\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and contents of the pack<\/h2>\n\n\n\n<p>Orladeyo capsules have a white opaque body labeled \u201c150\u201d and a light blue opaque body labeled \u201cBCX\u201d (19.4 mm \u00d7 6.9 mm).\u00a0They are packed in plastic\/aluminum blister cards, in a box with 7 capsules per blister.<\/p>\n\n\n\n<p>Pack size: 28 or 98 hard capsules.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Marketing Authorization Holder BioCryst<\/strong><br>Ireland Limited<br>Block 4, Harcourt Center, Harcourt Road, DUBLIN 2, D02HW77<br>Ireland<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Manufacturer<\/strong><br>Millmount Healthcare Limited<br>Block-7, City North Business Campus,<br>Stamullen,<br>Co.&nbsp;Meath, K32 YD60<br>Ireland<\/li><\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Orladeyo is a medicine that contains the active substance berotralstat. It is used to prevent angioedema in adults and adolescents from the age of 12 with hereditary (hereditary) angioedema .<\/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":[2200,18526],"tags":[20373,20378,20369,20372,20374,20377,20371,20370,20375,20376],"class_list":["post-19990","post","type-post","status-publish","format-standard","hentry","category-medicines","category-o","tag-benefits-of-berotralstat","tag-benefits-of-orladeyo","tag-berotralstat","tag-berotralstat-side-effects","tag-orladeyo","tag-orladeyo-side-effects","tag-what-berotralstat-is-used-for","tag-what-is-fberotralstat","tag-what-is-orladeyo","tag-what-orladeyo-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19990","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=19990"}],"version-history":[{"count":3,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19990\/revisions"}],"predecessor-version":[{"id":20053,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19990\/revisions\/20053"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=19990"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=19990"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=19990"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}