{"id":19431,"date":"2022-03-09T15:48:30","date_gmt":"2022-03-09T15:48:30","guid":{"rendered":"https:\/\/zeepedia.com\/?p=19431"},"modified":"2022-03-11T12:40:13","modified_gmt":"2022-03-11T12:40:13","slug":"ocaliva","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/ocaliva\/","title":{"rendered":"Ocaliva &#8211; Obeticholic acid uses, dose and side effects"},"content":{"rendered":"\n<p>5 mg and 10 mg&nbsp;film-coated tablets<br>obeticholic acid<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Ocaliva is and what it is used for<\/h2>\n\n\n\n<p>Ocaliva contains the active substance obeticholic acid (farnesoid X\u00a0receptor agonist\u00a0) which helps to improve the function of your liver by reducing the formation and accumulation of bile in the liver and also by reducing\u00a0inflammation.<\/p>\n\n\n\n<p>This medicine is used to treat adult patients with a type of liver disease called primary biliary cholangitis (also known as primary&nbsp;biliary cirrhosis&nbsp;), either alone or in combination with another medicine, ursodeoxycholic acid.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before you take Ocaliva<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not take Ocaliva:<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to obeticholic acid or any of the other ingredients of this medicine (listed in section 6).<\/li><li>if you have a complete blockage of the bile ducts (liver, gallbladder and bile ducts).<\/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 Ocaliva.<\/p>\n\n\n\n<p>Your doctor may need to adjust your&nbsp;dose&nbsp;of Ocaliva if your liver function deteriorates.&nbsp;Your doctor will take blood samples to check your liver function when you start treatment and regularly thereafter.<\/p>\n\n\n\n<p>Itching&nbsp;can occur during treatment with Ocaliva and it can sometimes be severe (intense&nbsp;itching&nbsp;or&nbsp;itching&nbsp;over large parts of the body).&nbsp;Your doctor may prescribe other medicines to treat&nbsp;itching&nbsp;or adjust your&nbsp;dose&nbsp;of Ocaliva.&nbsp;Talk to your doctor if you experience&nbsp;itching&nbsp;that is difficult to tolerate.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>This medicine is not intended for use in children or adolescents.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Ocaliva<\/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>In particular, you should tell your doctor if you are taking so-called bile acid sequestrants (cholestyramine, colestipol, colesevelam) which are used to lower blood cholesterol levels as they may reduce the effect of Ocaliva.\u00a0If you are taking any of these medicines, you should take Ocaliva at least 4 to 6 hours before or<\/p>\n\n\n\n<p>4 to 6 hours after taking a bile acid-binding resin, so that it lasts as long as possible in between.<\/p>\n\n\n\n<p>The doses&nbsp;for certain drugs such as&nbsp;Theophylline (a medicine that facilitates breathing) or tizanidine (a medicine that relieves muscle stiffness and inhibition) may need to be raised and must be checked by your doctor while you are taking Ocaliva.&nbsp;Your doctor may need to check how well your blood is coagulating (clotting) when you are taking medicines such as&nbsp;warfarin&nbsp;(a medicine that facilitates blood flow) together with Ocaliva.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy<\/h2>\n\n\n\n<p>There is no experience with the use of Ocaliva during pregnancy.&nbsp;As a precautionary measure, do not take Ocaliva if you are pregnant.<\/p>\n\n\n\n<p><strong>Breast-feeding<\/strong><\/p>\n\n\n\n<p>It is not known if this medicine is excreted in human milk.\u00a0Your doctor will decide if you should stop breastfeeding or stop\/discontinue treatment with Ocaliva after taking into account the benefit of breastfeeding to your baby and the benefit of treatment to the woman.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>This medicine has no or negligible effect on the ability to drive and use machines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Ocaliva contains sodium<\/h2>\n\n\n\n<p>This medicine contains less than 1 mmol (23 mg)&nbsp;sodium&nbsp;per film-coated tablet, ie essentially &#8216;sodium-free&#8217;.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to take Ocaliva<\/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>The recommended starting dose is one 5 mg tablet once a day or once a week, depending on your liver function.&nbsp;Swallowed.<\/p>\n\n\n\n<p>Your doctor may adjust the&nbsp;dose&nbsp;based on your liver function or if you experience&nbsp;itching&nbsp;that is difficult to tolerate.<\/p>\n\n\n\n<p>Depending on your body&#8217;s response after 3 or 6 months, your doctor may increase your&nbsp;dose&nbsp;to 10 mg once a day or twice a week, depending on your liver function.&nbsp;Your doctor will discuss any&nbsp;dose&nbsp;change with you.<\/p>\n\n\n\n<p>You can take Ocliva with or without food.&nbsp;If you are taking bile acid-binding resins, you should take this medicine at least 4 to 6 hours before or 4 to 6 hours after the bile acid-binding resin (see section \u201cOther medicines and Ocaliva\u201d).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you take more Ocaliva than you should<\/h2>\n\n\n\n<p>If you accidentally take too many tablets, you may experience&nbsp;itching&nbsp;or liver side effects, such as&nbsp;yellowing of the skin.&nbsp;Contact a doctor immediately or go to a hospital for advice.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to take Ocaliva<\/h2>\n\n\n\n<p>Skip the missed&nbsp;dose&nbsp;one and take your next&nbsp;dose&nbsp;when you would normally take it.&nbsp;Do not take a double&nbsp;dose&nbsp;to make up for a forgotten tablet.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you stop taking Ocaliva<\/h2>\n\n\n\n<p>You should continue to take Ocaliva for as long as your doctor tells you to.&nbsp;Do not stop taking the medicine without talking to your doctor first.<\/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>Tell your doctor or pharmacist if you experience itchy skin or that the itching worsens while you are taking this medicine.&nbsp;Skin itching is a very common&nbsp;side effect&nbsp;(may affect more than 1 in 10 people) that usually occurs within the first month after starting treatment with Ocaliva and usually becomes less severe over time.<\/p>\n\n\n\n<p>Other possible&nbsp;side effects&nbsp;can be:<\/p>\n\n\n\n<p><strong>Very common&nbsp;side effects&nbsp;are<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>magont<\/li><li>feeling tired<\/li><\/ul>\n\n\n\n<p><strong>Common&nbsp;side effects&nbsp;(<\/strong>&nbsp;may affect up to 1 in 10 people)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>thyroid hormone disorders<\/li><li>dizziness<\/li><li>fast or irregular heartbeat (palpitations)<\/li><li>pain in the mouth and throat<\/li><li>constipation<\/li><li>itchy, dry and \/ or red skin (&nbsp;eczema&nbsp;)<\/li><li>rash<\/li><li>joint pain<\/li><li>swelling of hands and feet<\/li><li>fever<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Ocaliva<\/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 bottle 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 obeticholic acid.- Ocaliva 5 mg film-coated tablets: Each film-coated tablet contains 5 mg obeticholic acid.- Ocaliva 10 mg film-coated tablets: Each film-coated tablet contains 10 mg obeticholic acid.<\/li><li>Other ingredients are:- Tablet core: Microcrystalline cellulose (E 460), sodium starch glycolate (type A) (see section 2, &#8216;Ocaliva contains sodium&#8217;), magnesium stearate.- Film coating: Partially hydrolysed polyvinyl alcohol, (E 1203), titanium dioxide (E 171), macrogol 3350 (E1521), talc (E 553b), yellow iron oxide (E 172).<\/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<ul class=\"wp-block-list\"><li>Ocaliva 5 mg is a yellow, 8 mm round film-coated tablet marked with \u201cINT\u201d on one side and \u201c5\u201d on the other side of the film-coated tablet.<\/li><li>Ocaliva 10 mg is a yellow, 8 mm x 7 mm triangular film-coated tablet marked with \u201cINT\u201d on one side and \u201c10\u201d on the other side of the film-coated tablet.<\/li><\/ul>\n\n\n\n<p><strong>Pack sizes<\/strong><\/p>\n\n\n\n<p>1 jar of 30 or 100 film-coated tablets<\/p>\n\n\n\n<p>Not all pack sizes may be marketed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorisation Holder<\/h2>\n\n\n\n<p>Intercept Pharma International Ltd.<\/p>\n\n\n\n<p>Ormond Building<\/p>\n\n\n\n<p>31 &#8211; 36 Ormond Quay Upper<\/p>\n\n\n\n<p>Dublin 7<\/p>\n\n\n\n<p>Ireland<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Almac Pharma Services (Ireland) Limited<\/p>\n\n\n\n<p>Finnabair Industrial Estate<\/p>\n\n\n\n<p>Dundalk<\/p>\n\n\n\n<p>Co.Louth<\/p>\n\n\n\n<p>A91 P9KD<\/p>\n\n\n\n<p>Ireland<\/p>\n\n\n\n<p>Almac Pharma Services<\/p>\n\n\n\n<p>Seagoe Industrial Estate<\/p>\n\n\n\n<p>Portadown<\/p>\n\n\n\n<p>Craigavon<\/p>\n\n\n\n<p>BT63 5UA<\/p>\n\n\n\n<p>UK<\/p>\n\n\n\n<p>Millmount Healthcare Limited<\/p>\n\n\n\n<p>Block-7, City North Business Campus<\/p>\n\n\n\n<p>Stamullen<\/p>\n\n\n\n<p>Co.&nbsp;Meath<\/p>\n\n\n\n<p>K32 YD60<\/p>\n\n\n\n<p>Ireland<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>Belgium \/ Belgique \/ Belgien<\/strong>AOP Orphan Pharmaceuticals AG Netherlands \/ Pays \u2011 Bas \/ NetherlandsTel: +43 1 5037244<\/td><td><strong>Lithuania<\/strong>AOP Orphan Pharmaceuticals AG Tel .: +370 672 12222<\/td><\/tr><tr><td><strong>Bulgaria<\/strong>AOP Orphan Pharmaceuticals AGTel: +359 88 6666096<\/td><td><strong>Luxembourg \/ Luxemburg<\/strong>Intercept Pharma Nederland BV, Netherlands \u2011 Bas \/ Netherlands&nbsp;Tel: +352 27861461<\/td><\/tr><tr><td><strong>Czech Republic<\/strong>AOP Orphan Pharmaceuticals AG Tel .: +420 251 512 947<\/td><td><strong>Hungary<\/strong>AOP Orphan Pharmaceuticals AG Tel .: +36 1 3192633<\/td><\/tr><tr><td><strong>Denmark<\/strong>AOP Orphan Pharmaceuticals AGAustriaTel: +46 70578 61 00<\/td><td><strong>Malta<\/strong>Intercept Pharma International Ltd.&nbsp;IrelandTel: +353 144 75 196<\/td><\/tr><tr><td><strong>Germany<\/strong>Intercept Pharma Deutschland GmbHTel: + 49 30 30 80 767 5<\/td><td><strong>The Netherlands<\/strong>AOP Orphan Pharmaceuticals AGThe NetherlandsTel: +43 1 5037244<\/td><\/tr><tr><td><strong>Eesti<\/strong>AOP Orphan Pharmaceuticals AGLeeduTel: +370 672 12222<\/td><td><strong>Norway<\/strong>AOP Orphan Pharmaceuticals AG AustriaTel: +46 70578 61 00<\/td><\/tr><tr><td><strong>Greece<\/strong>Intercept Pharma International Ltd.Ireland:\u0397\u03bb: +353 144 75 196<\/td><td><strong>Austria<\/strong>Intercept Pharma Austria GmbHTel: + 43 1928 4012<\/td><\/tr><tr><td><strong>Spain<\/strong>Intercept Pharma Spain SLUTel: + 34 914 194 970<\/td><td><strong>Poland<\/strong>AOP Orphan Pharmaceuticals AG Tel: +48 22 542 81 80<\/td><\/tr><tr><td><strong>France<\/strong>Intercept Pharma France SASTel: + 33 176 701 049<\/td><td><strong>Portugal<\/strong>Intercept Pharma Portugal, Unipessoal LdaTel: + 351 308 805 674<\/td><\/tr><tr><td><strong>Croatia<\/strong>AOP Orphan Pharmaceuticals AG AustriaTel: +43 1 5037244<\/td><td><strong>Romania<\/strong>AOP Orphan Pharmaceuticals AG Tel: +407 303 522 42<\/td><\/tr><tr><td><strong>Ireland<\/strong>Intercept Pharma International Ltd.&nbsp;IrelandTel: +353 144 75 196<\/td><td><strong>Slovenia<\/strong>AOP Orphan Pharmaceuticals AG AustriaTel: +43 1 5037244<\/td><\/tr><tr><td><strong>Iceland<\/strong>AOP Orphan Pharmaceuticals AG AustriaTel: +46 70578 61 00<\/td><td><strong>Slovak Republic<\/strong>AOP Orphan Pharmaceuticals AG Tel: +421 902 566 333<\/td><\/tr><tr><td><strong>Italy<\/strong>Intercept Italia SrlTel: +39 0236026571<\/td><td><strong>Finland \/ Finland<\/strong>AOP Orphan Pharmaceuticals AG It\u00e4valtaTel: +46 70578 61 00<\/td><\/tr><tr><td><strong>.\u03a0\u03c1\u03bf\u03c2<\/strong>Intercept Pharma International Ltd.Ireland:\u0397\u03bb: +353 144 75 196<\/td><td><strong>Sweden<\/strong>AOP Orphan Pharmaceuticals AG AustriaTel: +46 70578 61 00<\/td><\/tr><tr><td><strong>Latvia<\/strong>AOP Orphan Pharmaceuticals AG LithuaniaTel: +370 672 12222<\/td><td><strong>United Kingdom<\/strong>Intercept Pharma UK &amp; Ireland Ltd.Tel: + 44 330 100 3694<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>Ocaliva contains the active substance obeticholic acid (farnesoid X receptor agonist ) which helps to improve the function of your liver by reducing the formation and accumulation of bile in the liver and also by reducing inflammation .<\/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":[19488,19493,19483,19487,19486,19489,19492,19494,19484,19490,19485,19491],"class_list":["post-19431","post","type-post","status-publish","format-standard","hentry","category-medicines","category-o","tag-benefits-of-obeticholic-acid","tag-benefits-of-ocaliva","tag-obeticholic-acid","tag-obeticholic-acid-side-effects","tag-obeticholic-acid-tablet","tag-ocaliva","tag-ocaliva-side-effects","tag-ocaliva-tablet","tag-what-is-obeticholic-acid","tag-what-is-ocaliva","tag-what-obeticholic-acid-is-used-for","tag-what-ocaliva-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19431","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=19431"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19431\/revisions"}],"predecessor-version":[{"id":19458,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19431\/revisions\/19458"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=19431"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=19431"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=19431"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}