{"id":8215,"date":"2021-03-08T06:43:13","date_gmt":"2021-03-08T06:43:13","guid":{"rendered":"https:\/\/zeepedia.com\/?p=8215"},"modified":"2021-04-28T13:27:58","modified_gmt":"2021-04-28T13:27:58","slug":"epclusa","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/epclusa\/","title":{"rendered":"Epclusa \/ Sofosbuvir \/ Velpatasvir uses, dose and side effects"},"content":{"rendered":"\n<p> 400 mg \/ 100 mg\u00a0film-coated tablets, 200 mg \/ 50 mg film-coated tablets\u00a0<br>sofosbuvir \/ velpatasvir<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1. What Epclusa is and what it is used for<\/h2>\n\n\n\n<p>Epclusa is a medicine that contains the active substances sofosbuvir and velpatasvir in a single tablet.&nbsp;It is given to treat a&nbsp;chronic&nbsp;(long-term) viral infection in the liver called&nbsp;hepatitis&nbsp;C, in patients aged 6 years and older, and weighing at least 17 kg.<br><\/p>\n\n\n\n<p>The active substances in the medicine work together by blocking two different&nbsp;proteins&nbsp;that the&nbsp;virus&nbsp;needs to grow and reproduce, which makes it possible to permanently remove&nbsp;an infection&nbsp;from the body.<br><\/p>\n\n\n\n<p>Epclusa is sometimes taken with another medicine, ribavirin.<br><\/p>\n\n\n\n<p>It is very important that you also read the package leaflets for the other medicines that you are taking with Epclusa.&nbsp;If you have any further questions on the use of this product, ask your doctor or pharmacist.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2. What you need to know before taking Epclusa<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not take Epclusa<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>If you are allergic<\/strong>&nbsp;to sofosbuvir, velpatasvir, or any of the other ingredients of this medicine (listed in section 6 of this leaflet).<\/li><\/ul>\n\n\n\n<p><strong>\u2192<\/strong>&nbsp;If this applies to you,&nbsp;<strong>do not take Epclusa but tell your doctor immediately.<\/strong><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><strong>If you are currently taking any of the following medicines:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>rifampicin<\/strong>&nbsp;and&nbsp;<strong>rifabutin<\/strong>&nbsp;(&nbsp;antibiotics&nbsp;used to treat&nbsp;infections, including&nbsp;tuberculosis&nbsp;)<\/li><li><strong>St. John&#8217;s wort<\/strong>&nbsp;(herbal medicine used to treat mild depression)<\/li><li><strong>carbamazepine, phenobarbital, and&nbsp;phenytoin<\/strong>&nbsp;(medicines used to treat&nbsp;epilepsy&nbsp;and prevent epileptic seizures).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Talk to a doctor if you:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>have other liver problems<\/strong>&nbsp;in addition to&nbsp;hepatitis&nbsp;C, for example<ul><li><strong>have<\/strong>&nbsp;or have had an&nbsp;infection&nbsp;with&nbsp;<strong>hepatitis&nbsp;B<\/strong>&nbsp;&#8211;&nbsp;the virus,&nbsp;because the doctor wants to monitor you more closely<\/li><li>has undergone a liver transplant.<\/li><\/ul><\/li><li>have kidney problems or if you receive kidney dialysis,&nbsp;as Epclusa has not been fully tested in patients with certain severe kidney problems<\/li><li>undergoing treatment for&nbsp;HIV&nbsp;&#8211;&nbsp;infection&nbsp;(human immunodeficiency virus), as your doctor may need to monitor you more closely.<\/li><\/ul>\n\n\n\n<p>Talk to your doctor or pharmacist before taking Epclusa if:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>you are currently taking, or in recent months, have been taking the drug&nbsp;amiodarone&nbsp;to treat irregular heartbeats, as it can cause your heart rate to drop to a life-threatening level.&nbsp;Your doctor may consider alternative treatments if you have taken this medicine.&nbsp;If you need treatment with Epclusa, extracardiac monitoring may be necessary.<\/li><li>have&nbsp;diabetes.&nbsp;Your blood sugar levels may need to be monitored more closely and\/or adjustment of your diabetes medicines may be needed after you start taking Epclusa.&nbsp;In some diabetic patients, blood sugar levels have dropped (hypoglycemia) after starting treatment with medicines such as Epclusa.<\/li><\/ul>\n\n\n\n<p><strong>Tell<\/strong>&nbsp;your&nbsp;<strong>doctor immediately if<\/strong>&nbsp;you are currently taking, or have taken any medicines for heart problems in the last few months, and your experience during treatment:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>slow or irregular heartbeat, or problems with heart rhythm<\/li><li>shortness of breath or worsening of pre-existing shortness of breath<\/li><li>chest pain<\/li><li>dizziness<\/li><li>palpitation<\/li><li>that you almost faint or faint<\/li><\/ul>\n\n\n\n<p><strong>Blood tests<\/strong><\/p>\n\n\n\n<p>Your doctor will examine your blood before, during, and after treatment with Epclusa.&nbsp;This is to:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Your doctor should be able to decide if you should take Epclusa and for how long.<\/li><li>Your doctor should be able to confirm that the treatment has worked and that you no longer carry the&nbsp;hepatitis&nbsp;C&nbsp;virus.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>Do not give this medicine to children under 6 years of age or weighing less than 17 kg.&nbsp;The use of Epclusa in patients under 6 years of age has not yet been studied.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Epclusa<\/h2>\n\n\n\n<p><strong>Tell<\/strong>&nbsp;your&nbsp;<strong>doctor or pharmacist<\/strong>&nbsp;if you are taking, have recently taken, or might take any other medicines.<br><\/p>\n\n\n\n<p>Warfarin&nbsp;and other similar medicines called&nbsp;vitamin&nbsp;K&nbsp;antagonists&nbsp;are used to thin the blood.&nbsp;Your doctor may need to test your blood more often to check your blood&#8217;s coagulation ability.<br><\/p>\n\n\n\n<p>The function of your liver may change with the treatment of&nbsp;hepatitis&nbsp;C and may therefore affect other medicines (eg medicines used to&nbsp;suppress&nbsp;your immune system, etc.).&nbsp;Your doctor may need to monitor these other medicines you are taking care and adjustments may need to be made after starting treatment with Epiclusa.<br><\/p>\n\n\n\n<p>If you are not sure, talk to your doctor or pharmacist.<br><\/p>\n\n\n\n<p><strong>Some medicines should not be taken with Epclusa.<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Do not take any other medicine that contains sofosbuvir, one of the active substances in Epclusa.<\/strong><\/li><\/ul>\n\n\n\n<p><strong>Tell<\/strong>&nbsp;your&nbsp;<strong>doctor or pharmacist<\/strong>&nbsp;if you are taking any of the following medicines:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>amiodarone&nbsp;<\/strong>is used to treat irregular heartbeats<\/li><li>rifapentine&nbsp;(an&nbsp;antibiotic&nbsp;used to treat&nbsp;infections, including&nbsp;tuberculosis&nbsp;)<\/li><li>oxcarbazepine&nbsp;(a medicine used to treat&nbsp;epilepsy&nbsp;and prevent epileptic seizures)<\/li><li>tenofovir disoproxil fumarate, or any medicine containing tenofovir, which is used to treat&nbsp;HIV&nbsp;&#8211;&nbsp;infection<\/li><li>efavirenz is&nbsp;used to treat&nbsp;HIV&nbsp;&#8211;&nbsp;infection<\/li><li>digoxin&nbsp;used to treat heart disease<\/li><li>dabigatran&nbsp;used to thin the blood<\/li><li>modafinil&nbsp;used to treat sleep disorders<\/li><li>rosuvastatin&nbsp;or&nbsp;other statins&nbsp;used to treat high&nbsp;cholesterol.<\/li><\/ul>\n\n\n\n<p>If you take Epclusa with any of these medicines, the medicines may not work properly or any&nbsp;side effects&nbsp;may get&nbsp;worse.&nbsp;Your doctor may need to give you another medicine or change the dose of medicine you are taking.&nbsp;This change may apply to Epclusa or any other medicine you are taking.<br><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Ask your doctor or pharmacist<\/strong>&nbsp;for&nbsp;<strong>advice<\/strong>&nbsp;if you are taking medicines used to treat&nbsp;<strong>stomach ulcers<\/strong>, heartburn, or acid reflux&nbsp;as they may reduce the amount of velpatasvir in your blood.&nbsp;These are:<ul><li>antacids (eg aluminum\/magnesium hydroxide or&nbsp;calcium carbonate&nbsp;).&nbsp;These should be taken at least 4 hours before or 4 hours after Epclusa.<\/li><li>proton pump inhibitors&nbsp;(eg omeprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole).&nbsp;Epclusa should be taken with food 4 hours before taking a&nbsp;proton pump inhibitor.<\/li><li>H&nbsp;2&nbsp;-receptor antagonists (eg famotidine, cimetidine, nizatidine, or ranitidine).&nbsp;If you need high&nbsp;doses&nbsp;of these medicines, your doctor may give you another medicine or change the dose of medicine you are taking.<\/li><\/ul><\/li><\/ul>\n\n\n\n<p>These medicines can reduce the amount of velpatasvir in your blood.&nbsp;If you are taking any of these medicines, your doctor will either give you another medicine for&nbsp;stomach ulcers, heartburn, or acid reflux or recommend how and when to take it.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and contraception<\/h2>\n\n\n\n<p>The effect of Epclusa during pregnancy is unknown.&nbsp;If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.<\/p>\n\n\n\n<p>Epclusa is sometimes used with ribavirin.&nbsp;Ribavirin may cause birth defects.&nbsp;It is therefore very important that you (or your partner) do not become pregnant during this treatment or for a period of time after the treatment.&nbsp;You must read the &#8220;Pregnancy&#8221; section of the ribavirin package leaflet very carefully.&nbsp;Ask your doctor about an effective method of contraception that is suitable for you and your partner.<br><\/p>\n\n\n\n<p><strong>Breast-feeding<\/strong><\/p>\n\n\n\n<p><strong>Do not breast-feed during treatment with Epclusa.&nbsp;<\/strong>It is not known whether sofosbuvir or velpatasvir, the two active substances in Epclusa, pass into breast milk.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Epclusa should not affect your ability to drive or use any tools or machines.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. How to take Epclusa<\/h2>\n\n\n\n<p>Always take this medicine exactly as your doctor has told you.&nbsp;Ask your doctor or pharmacist if you are unsure.<br><\/p>\n\n\n\n<p><strong>Recommended&nbsp;dose<\/strong><\/p>\n\n\n\n<p>The recommended&nbsp;dose&nbsp;of Epclusa&nbsp;<strong>in adults <\/strong>is&nbsp;one&nbsp;400 mg \/ 100 mg tablet once daily for 12 weeks.<br><\/p>\n\n\n\n<p>The recommended&nbsp;dose&nbsp;of Epclusa&nbsp;<strong>in <\/strong>patients aged 6 years to less than 18 years, weighing at least 17 kg, is by weight.&nbsp;<strong>Take Epclusa exactly as your doctor has told you.<\/strong><br><\/p>\n\n\n\n<p>Swallow the tablet (s) whole\/whole with or without food.&nbsp;Do not chew, crush or split the tablet as it has a very bitter taste.<br><\/p>\n\n\n\n<p><strong>If you are taking an antacid,<\/strong>&nbsp;take it at least 4 hours before or at least 4 hours after Epclusa.<br><\/p>\n\n\n\n<p><strong>If you take a&nbsp;proton pump inhibitor,<\/strong>&nbsp;take Epclusa with food 4 hours before&nbsp;proton pump inhibitors&nbsp;are taken.<br><\/p>\n\n\n\n<p><strong>If you vomit after taking Epclusa<\/strong>, it may affect the amount of Epclusa in your blood.&nbsp;This may mean that Epclusa does not work as well.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>If you vomit&nbsp;<strong>less than 3 hours after<\/strong>&nbsp;taking Epclusa, take a new tablet.<\/li><li>If you vomit&nbsp;<strong>more than 3 hours after<\/strong>&nbsp;taking Epclusa, you do not need to take any more tablets until you take the next tablet according to the treatment schedule.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">If you take more Epclusa then you should<\/h2>\n\n\n\n<p>If you accidentally take more than the recommended&nbsp;dose, contact your doctor, hospital, or Poison Information Center immediately for advice.&nbsp;Bring the jar of tablets with you so that you can easily describe what you have taken.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to take Epclusa<\/h2>\n\n\n\n<p>You mustn&#8217;t miss a&nbsp;dose&nbsp;of this medicine.<\/p>\n\n\n\n<p>If you miss a&nbsp;dose, calculate how long it has been since you last took Epclusa:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>If you notice it less than 18 hours<\/strong>&nbsp;after the time you usually take Epclusa, you must take the tablet as soon as possible.&nbsp;Then take the next&nbsp;dose&nbsp;at the usual time.<\/li><li><strong>If it has been 18 hours or more<\/strong>&nbsp;after the time you usually take Epclusa, wait and take the next&nbsp;dose&nbsp;at the usual time.&nbsp;Do not take a double&nbsp;dose&nbsp;(two&nbsp;doses&nbsp;close together).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Do not stop taking Epclusa<\/h2>\n\n\n\n<p>Do not stop taking this medicine unless your doctor tells you to.&nbsp;You must complete the entire course of treatment to give the medicine the best conditions to treat an&nbsp;infection&nbsp;with the&nbsp;hepatitis&nbsp;C&nbsp;virus.<br><\/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\">4. Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause&nbsp;side effects, although not everybody gets them.<br><\/p>\n\n\n\n<p><strong>Common&nbsp;side effects&nbsp;are<\/strong><\/p>\n\n\n\n<p><em>(may affect up to 1 in 10 users)<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>rash<\/li><\/ul>\n\n\n\n<p><strong>Uncommon&nbsp;side effects&nbsp;are<\/strong><\/p>\n\n\n\n<p><em>(may affect up to 1 in 100 people)<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>swelling of the face, lips, tongue, or throat (&nbsp;angioedema&nbsp;).<\/li><\/ul>\n\n\n\n<p><strong>Other effects that can be seen with sofosbuvir treatment:<\/strong><\/p>\n\n\n\n<p>The frequency of the following&nbsp;side effects&nbsp;is unknown (frequency cannot be estimated from the available data).<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>widespread, severe rash with scaly skin that may be accompanied by fever,&nbsp;flu-like symptoms, blisters in the mouth, eyes, and\/or genitals (Steven-Johnson syndrome).<\/li><\/ul>\n\n\n\n<p><strong>\u2192&nbsp;If you get&nbsp;any side effects, talk to your doctor.<\/strong><br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">5. How to store Epclusa<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<br><\/p>\n\n\n\n<p>Do not use this medicine after the expiry date which is stated on the can and carton after \u201cEXP\u201d.&nbsp;The expiration date is the last day of the specified month.<br><\/p>\n\n\n\n<p>No special storage instructions.<br><\/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\">6. Contents of the packaging 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><strong>The active substances <\/strong>are&nbsp;sofosbuvir and velpatasvir.&nbsp;Each film-coated tablet contains either 400 mg sofosbuvir and 100 mg velpatasvir or 200 mg sofosbuvir and 50 mg velpatasvir.<\/li><li>Other ingredients are tablet core: Copovidone, microcrystalline cellulose, croscarmellose sodium, magnesium stearate.<br>Film coating: Polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, red iron oxide.<br><\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n<p>Epclusa 400 mg \/ 100 mg film-coated tablets are pink, diamond-shaped tablets, debossed with \u201cGSI\u201d on one side and \u201c7916\u201d on the other side.&nbsp;The tablet is 20 mm long and 10 mm wide.<br><\/p>\n\n\n\n<p>Epclusa 200 mg \/ 50 mg film-coated&nbsp;tablets are pink, oval tablets, debossed with \u201cGSI\u201d on one side and \u201cS \/ V\u201d on the other side.&nbsp;The tablet is 14 mm long and 7 mm wide.<br><\/p>\n\n\n\n<p>The following pack sizes are available for both 400 mg \/ 100 mg and 200 mg \/ 50 mg film-coated tablets:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>outer cartons containing 1 jar of 28 film-coated tablets.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorisation Holder<\/h2>\n\n\n\n<p>Gilead Sciences Ireland UC<\/p>\n\n\n\n<p>Carrigtohill<\/p>\n\n\n\n<p>County Cork, T45 DP77<\/p>\n\n\n\n<p>Ireland<br><\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Gilead Sciences Ireland UC<\/p>\n\n\n\n<p>IDA Business &amp; Technology Park<\/p>\n\n\n\n<p>Carrigtohill<\/p>\n\n\n\n<p>County Cork<\/p>\n\n\n\n<p>Ireland<br><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Epclusa is a medicine that contains the active substances sofosbuvir and velpatasvir in a single tablet. It is given to treat a chronic (long-term) viral infection in the liver called hepatitis C, in patients aged 6 years and older, and weighing at least 17 kg.<\/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":[2205,2200],"tags":[4080,4082,2213,4083,4085,2211,4086,4088,4081,4084,4087],"class_list":["post-8215","post","type-post","status-publish","format-standard","hentry","category-e","category-medicines","tag-epclusa","tag-epclusa-side-effects","tag-medicines","tag-sofosbuvir","tag-sofosbuvir-side-effects","tag-tablets","tag-velpatasvir","tag-velpatasvir-side-effects","tag-what-is-epclusa","tag-what-is-sofosbuvir","tag-what-is-velpatasvir"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/8215","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=8215"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/8215\/revisions"}],"predecessor-version":[{"id":10486,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/8215\/revisions\/10486"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=8215"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=8215"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=8215"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}