{"id":6649,"date":"2021-01-11T13:27:19","date_gmt":"2021-01-11T13:27:19","guid":{"rendered":"https:\/\/zeepedia.com\/?p=6649"},"modified":"2021-06-14T07:38:52","modified_gmt":"2021-06-14T07:38:52","slug":"cerdelga","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/cerdelga\/","title":{"rendered":"Cerdelga &#8211; Eliglustat uses, dose and side effects"},"content":{"rendered":"\n<p>\n\n84 mg&nbsp;hard capsules&nbsp;<br>eliglustat<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1. What Cerdelga is and what it is used for<\/h2>\n\n\n\n<p>Cerdelga contains the active substance eliglustat and is used for long-term treatment of adult patients with&nbsp;Gaucher&nbsp;type 1&nbsp;disease&nbsp;.<br><\/p>\n\n\n\n<p>Gaucher&#8217;s&nbsp;type 1&nbsp;disease&nbsp;is a rare, inherited disease in which a substance called glucosylceramide cannot be completely broken down by the body.&nbsp;Therefore, glucosylceramide is stored in the spleen, liver and skeleton.&nbsp;The storage prevents these organs from functioning normally.&nbsp;Cerdelga contains the active substance eliglustat, which reduces the formation of glucosylceramide and thereby prevents its storage.&nbsp;This in turn helps your organs to function better.<br><\/p>\n\n\n\n<p>Different people break down this drug at different speeds in the body.&nbsp;The amount of drug in the blood can therefore vary between patients and affect how patients respond to treatment.&nbsp;Cerdelga is for use in patients who break down this medicine at a normal rate (also known as intermediate or fast metabolizers) or slow speed (slow metabolizers).&nbsp;Your doctor will determine if Cerdelga is suitable for you before you start treatment, through a simple laboratory test.<br><\/p>\n\n\n\n<p>Gaucher&nbsp;type 1&nbsp;disease&nbsp;is a lifelong condition and you must continue to take this medicine as your doctor prescribes to get the maximum benefit from your medicine.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before you take Cerdelga<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not take Cerdelga<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to eliglustat or any of the other ingredients of this medicine (listed in section 6).<\/li><li>if you are an&nbsp;intermediate&nbsp;or fast metaboliser and are using medicines known to be strong or moderate CYP2D6 inhibitors (such as&nbsp;quinidine&nbsp;and terbinafine) in combination with strong or moderate CYP3A inhibitors (such as erythromycin and itraconazole) .&nbsp;The combination of these drugs affects your body&#8217;s ability to break down Cerdelga and it can lead to higher levels of the active substance in your blood (see section \u201cOther drugs and Cerdelga\u201d for a more comprehensive list of these drugs).<\/li><li>if you are a slow metaboliser and are taking medicines called strong CYP3A inhibitors (eg itraconazole).&nbsp;Drugs of this type will interfere with the body&#8217;s ability to break down Cerdelga and may lead to higher levels of the active substance in the blood (see section &#8220;Other medicines and Cerdelga&#8221; for an extended list of these medicines).<\/li><li>if you are a fast metabolizer and have severe hepatic impairment.<\/li><li>if you are a fast metaboliser and have mild or moderate hepatic impairment while taking a strong or moderate CYP2D6 inhibitor.<\/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 Cerdelga if you:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>receive treatment, or should start treatment, with any of the medicines listed in the section&nbsp;<em>\u201cOther medicines and Cerdelga\u201d<\/em>&nbsp;.<\/li><li>have had a heart attack or&nbsp;heart failure&nbsp;.<\/li><li>has a low&nbsp;heart rate&nbsp;.<\/li><li>have irregular or abnormal heartbeats, including a condition called long&nbsp;QTsyndrome.<\/li><li>have some other heart problems<\/li><li>taking any antiarrhythmic medicine (used to treat)irregular heartbeats) such as&nbsp;quinidine&nbsp;,&nbsp;amiodarone&nbsp;or sotalol.<\/li><li>if you are a fast metabolizer and have moderate hepatic impairment.<\/li><li>if you are an&nbsp;intermediate&nbsp;or slow metabolizer and have any degree of hepatic impairment.<\/li><li>is an&nbsp;intermediate&nbsp;or slow metabolizer and has impaired renal function.<\/li><li>is a patient with end-stage renal disease (ESRD).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>Cerdelga has not been tested in children and adolescents under 18 years of age.&nbsp;Do not give this medicine to children or adolescents.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Cerdelga<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.<br><\/p>\n\n\n\n<p><strong>Medicines that must not be taken in combination with each other and Cerdelga<\/strong><\/p>\n\n\n\n<p>Cerdelga must not be taken in combination with certain types of medicines.&nbsp;These medicines can affect your body&#8217;s ability to break down Cerdelga and this can lead to higher levels of Cerdelga in the blood.&nbsp;These drugs are known as strong or moderate CYP2D6 inhibitors and strong or moderate CYP3A inhibitors.&nbsp;There are many drugs like these and depending on how your body breaks down Cerdelga, the effects can differ from person to person.&nbsp;Talk to your doctor about these medicines before you start taking Cerdelga.&nbsp;Your doctor will decide which medicines you can use depending on how fast your body breaks down eliglustat.<br><\/p>\n\n\n\n<p><strong>Drugs that may increase the level of Cerdelga in the blood:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>paroxetine&nbsp;,&nbsp;fluoxetine&nbsp;, fluvoxamine, duloxetine, bupropion, moclobemide &#8211;&nbsp;<strong>antidepressants<\/strong>&nbsp;(used to treat depression)<\/li><li>dronedarone,&nbsp;quinidine&nbsp;, verapamil &#8211;&nbsp;<strong>antiarrhythmics<\/strong>&nbsp;(used to treat irregular heartbeat)<\/li><li>ciprofloxacin&nbsp;, clarithromycin, erythromycin, telithromycin &#8211;&nbsp;<strong>antibiotics<\/strong>&nbsp;(used to treat&nbsp;infections&nbsp;)<\/li><li>terbinafine, itraconazole,&nbsp;fluconazole&nbsp;, posaconazole, voriconazole &#8211;&nbsp;<strong>antifungals<\/strong>(used to treat fungal infections)<\/li><li>mirabegron &#8211; (used to treat overactive&nbsp;bladder&nbsp;)<\/li><li>cinacalcet &#8211;&nbsp;<strong>calcimimetic<\/strong>&nbsp;(used by some dialysis patients and in certain cancers)<\/li><li>atazanavir, darunavir, fosamprevir, indinavir, lopinavir, ritonavir, saquinavir, tipranavir &#8211;&nbsp;<strong>antiretroviral agents<\/strong>&nbsp;(used to treat&nbsp;HIV&nbsp;)<\/li><li>kobicitat &#8211; used to improve the effect of certain&nbsp;HIV&nbsp;medicines<\/li><li>aprepitant &#8211;&nbsp;<strong>antiemetic<\/strong>&nbsp;(against vomiting)<\/li><li>diltiazem&nbsp;&#8211;&nbsp;<strong>antihypertensive agent<\/strong>&nbsp;(used to increase blood flow and lower heart rate)<\/li><li>konivaptan &#8211;&nbsp;<strong>diuretic<\/strong>&nbsp;(used to raise low levels of sodium in the blood)<\/li><li>boceprevir, telaprevir &#8211; antiviral medicine (used to treat hepatitis C)<\/li><li>imatinib &#8211; cancer medicine<\/li><li>amlodipine, ranolazine &#8211; used to treat angina<\/li><li>cilostazol &#8211; used to treat a cramp-like pain in the legs when walking due to insufficient blood flow in the legs<\/li><li>isoniazid&nbsp;&#8211; used to treat&nbsp;tuberculosis<\/li><li>cimetidine, ranitidine &#8211;&nbsp;<strong>antacid<\/strong>&nbsp;(used to treat indigestion)<\/li><li>Canadian Carrot (goldenseal) &#8211; (also known as&nbsp;<em>Hydrastis canadensis<\/em>&nbsp;) an over-the-counter herbal preparation used to facilitate digestion.<\/li><\/ul>\n\n\n\n<p><strong>Medicines that can reduce the level of Cerdelga in the blood:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>rifampicin, rifabutin &#8211;&nbsp;<strong>antibiotics<\/strong>&nbsp;(used to treat&nbsp;infections&nbsp;)<\/li><li>carbamazepine, phenobarbital,&nbsp;phenytoin&nbsp;&#8211;&nbsp;<strong>antiepileptics<\/strong>&nbsp;(used to treat&nbsp;epilepsyand seizures)<\/li><li>St. John&#8217;s wort&nbsp;&#8211; (also known as&nbsp;<em>Hypericum perforatum<\/em>&nbsp;) an over-the-counter herbal preparation used to treat depression and other conditions<\/li><\/ul>\n\n\n\n<p><strong>Cerdelga may increase the levels of the following types of medicines in the blood:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>dabigatran &#8211;&nbsp;<strong>anticoagulant<\/strong>&nbsp;(used to thin the blood)<\/li><li>phenytoin&nbsp;&#8211;&nbsp;<strong>antiepileptic drug<\/strong>&nbsp;(used to treat&nbsp;epilepsy&nbsp;and seizures)<\/li><li>nortriptyline, amitriptyline, imipramine, desipramine &#8211;&nbsp;<strong>antidepressants<\/strong>&nbsp;(used to treat depression)<\/li><li>phenothiazines &#8211;&nbsp;<strong>antipsychotics<\/strong>&nbsp;(used to treat schizophrenia and&nbsp;psychosis&nbsp;)<\/li><li>digoxin&nbsp;&#8211; used to treat&nbsp;<strong>heart failure&nbsp;and&nbsp;atrial fibrillation<\/strong><\/li><li>colchicine &#8211; used to treat&nbsp;<strong>gout<\/strong><\/li><li>metoprolol&nbsp;&#8211; used to&nbsp;<strong>lower&nbsp;blood pressure&nbsp;and \/ or heart rate<\/strong><\/li><li>dextromethorphan &#8211;&nbsp;<strong>cough medicine<\/strong><\/li><li>atomoxetine &#8211; used to treat&nbsp;<strong>ADHD<\/strong><\/li><li>pravastatin &#8211; used to&nbsp;<strong>lower&nbsp;cholesterol&nbsp;and prevent heart disease<\/strong><\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Cerdelga with food and drink<\/h2>\n\n\n\n<p>Avoid consuming grapefruit or grapefruit juice as it may increase the level of Cerdelga in the blood.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy, breastfeeding and fertility<\/h2>\n\n\n\n<p>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.<br><\/p>\n\n\n\n<p>Trace amounts of the active substance in this medicine have been shown to be transferred to breast milk in animals.&nbsp;Breast-feeding is not recommended during treatment with this medicine.&nbsp;Tell your doctor if you are breast-feeding.<br><\/p>\n\n\n\n<p>There is no known effect on&nbsp;fertility&nbsp;at normal&nbsp;doses&nbsp;.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Cerdelga has no or negligible effect on the ability to drive and use machines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Cerdelga contains excipients<\/h2>\n\n\n\n<p>If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to take Cerdelga&nbsp;<\/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.<br><\/p>\n\n\n\n<p><strong>If you are an&nbsp;intermediate&nbsp;or fast metabolizer:<\/strong><\/p>\n\n\n\n<p>Swallow one 84 mg capsule whole, twice daily with water.&nbsp;It can be taken with or without food.&nbsp;Take one capsule in the morning and one capsule in the evening.<br><\/p>\n\n\n\n<p><strong>If you are a slow metabolizer:<\/strong><\/p>\n\n\n\n<p>Swallow one 84 mg capsule whole, once a day with water.&nbsp;It can be taken with or without food.&nbsp;Take the capsule at the same time each day.<br><\/p>\n\n\n\n<p>Do not open, crush, dissolve or chew on the capsule before swallowing.&nbsp;Talk to your doctor if you can not swallow the capsule whole.<br><\/p>\n\n\n\n<p>Continue to take Cerdelga every day for as long as your doctor prescribes it.<br><\/p>\n\n\n\n<p><strong>How to remove the blister \/ map from the case<\/strong><\/p>\n\n\n\n<p>Gently press with your thumb and a finger on one end of the case (1), gently pull out the blister \/ card to open the case (2).<\/p>\n\n\n\n<figure class=\"wp-block-image\"><a href=\"https:\/\/www.fass.se\/LIF\/product?userType=2&amp;nplId=20131009000082#\" rel=\"noopener\"><img decoding=\"async\" src=\"https:\/\/www.fass.se\/res\/RootMedia\/sanofi\/Media\/Cerdelga\/Cerdelga20Opening.jpg\" alt=\"blister \"\/><\/a><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">If you take more Cerdelga than you should&nbsp;<\/h2>\n\n\n\n<p>If you take more capsules than you were instructed to do, contact your doctor immediately.&nbsp;You may have dizziness characterized by poor balance, slow heartbeat, nausea, vomiting and fainting.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to take Cerdelga<\/h2>\n\n\n\n<p>Take the next capsule at your usual time.&nbsp;Do not take a double&nbsp;dose&nbsp;to make up for a forgotten&nbsp;dose&nbsp;.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you stop taking Cerdelga<\/h2>\n\n\n\n<p>Do not stop taking Cerdelga without talking to your doctor.<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&nbsp;, although not everybody gets them.<br><\/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>Headache<\/li><li>Dizziness<\/li><li>Taste change (&nbsp;dysgeusia&nbsp;)<\/li><li>Palpitation<\/li><li>Throat irritation<\/li><li>Heartburn (&nbsp;dyspepsia&nbsp;)<\/li><li>Nausea<\/li><li>Diarrhea<\/li><li>Constipation<\/li><li>Abdominal pain<\/li><li>Stomach pain (pain in the upper abdomen)<\/li><li>Acid reflux (&nbsp;gastroesophageal reflux disease&nbsp;)<\/li><li>Swollen stomach<\/li><li>Inflammation&nbsp;of the stomach (&nbsp;gastritis&nbsp;)<\/li><li>Difficulty swallowing (&nbsp;dysphagia&nbsp;)<\/li><li>Vomiting<\/li><li>Dry mouth<\/li><li>Flatulence (&nbsp;flatulence&nbsp;)<\/li><li>Dry skin<\/li><li>Hives&nbsp;(&nbsp;urticaria&nbsp;)<\/li><li>Joint pain (&nbsp;arthralgia&nbsp;)<\/li><li>Pain in arms, legs or back<\/li><li>Fatigue (exhaustion)<\/li><\/ul>\n\n\n\n<p><em>Reporting of side effects<\/em><\/p>\n\n\n\n<p>If you get any side effects, talk to your doctor, pharmacist, or nurse.&nbsp;This includes any possible side effects not listed in this leaflet.&nbsp;You can also report side effects directly to the Medical Products Agency,&nbsp;www.lakemedelsverket.se.&nbsp;By reporting side effects, you can help increase drug safety information.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">5. How to store Cerdelga<\/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 carton, case and blister 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>The active substance is eliglustat (as tartrate).&nbsp;Each capsule contains 84 mg of eliglustat.<\/li><li>Other ingredients are:<ul><li>In the capsule: microcrystalline cellulose,&nbsp;lactose monohydrate&nbsp;(see section 2 under \u201cCerdelga contains lactose\u201d), hypromellose and glycerol dibehenate.<\/li><li>In the capsule casing: gelatin, potassium aluminum silicate (E555), titanium dioxide (E171), yellow iron oxide (E172) and indigotine (E132).<\/li><li>In the ink: shellac, black iron oxide (E172), propylene glycol and ammonia, concentrated.<\/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>Cerdelga capsules have a pearlescent blue-green, opaque top and pearlescent white, opaque base with \u201cGZ02\u201d printed in black on the capsule.<br><\/p>\n\n\n\n<p>Pack sizes of 14 hard capsules in 1 blister card with 56 hard capsules in 4 blister cards with 14 capsules each or 196 hard capsules in 14 blister cards with 14 capsules each.<br><\/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>Genzyme Europe BV<\/p>\n\n\n\n<p>Paasheuvelweg 25&nbsp;<br>1105 BP Amsterdam<\/p>\n\n\n\n<p>Netherlands<br><\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Genzyme Ireland Ltd<\/p>\n\n\n\n<p>IDA Industrial Park<\/p>\n\n\n\n<p>Old Kilmeaden Road<\/p>\n\n\n\n<p>Waterford<\/p>\n\n\n\n<p>Ireland<br><\/p>\n\n\n\n<p>Contact the representative of the marketing authorization holder to find out more about this medicine:<br><\/p>\n\n\n\n<p>Sanofi AB<\/p>\n\n\n\n<p>Tel: +46 (0) 8 634 50 00<br><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Cerdelga contains the active substance eliglustat and is used for long-term treatment of adult patients with Gaucher type 1 disease <\/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":[2203,2200],"tags":[7474,7477,7476,2212,7475],"class_list":["post-6649","post","type-post","status-publish","format-standard","hentry","category-c","category-medicines","tag-eliglustat","tag-eliglustat-capsule","tag-eliglustat-side-effects","tag-medicine","tag-what-is-eliglustat"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/6649","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=6649"}],"version-history":[{"count":3,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/6649\/revisions"}],"predecessor-version":[{"id":11525,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/6649\/revisions\/11525"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=6649"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=6649"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=6649"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}