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data-title="Preparation & administration" data-drupal-link-system-path="node/246">Preparation & administration</a> </li> <li class="last"> <a href="/starting-on-epidiolex#nurse-navigator" class="ajax-link" rel="#ajax-container" data-title="Nurse Navigator program" data-drupal-link-system-path="node/246">Nurse Navigator program</a> </li> </ul> </li> <li class="expanded dropdown"> <a href="/patient-stories" class="ajax-link dropdown-toggle" rel="#ajax-container" data-toggle="dropdown" data-drupal-link-system-path="node/256"><span class="title">Patient Stories</span> <span class="caret"></span></a> <ul class="dropdown-menu"> <li class="first"> <a href="/patient-stories#caregiver-series" class="ajax-link" rel="#ajax-container" data-title="The Care Giver series" data-drupal-link-system-path="node/256">The Care Giver series</a> </li> <li> <a href="/patient-stories#lgs" class="ajax-link" rel="#ajax-container" data-title="LGS" data-drupal-link-system-path="node/256">LGS</a> </li> <li> <a href="/patient-stories#dravet-syndrome" class="ajax-link" rel="#ajax-container" data-title="Dravet syndrome" data-drupal-link-system-path="node/256">Dravet syndrome</a> </li> <li class="last"> <a href="/patient-stories#tsc" class="ajax-link" rel="#ajax-container" data-title="TSC" data-drupal-link-system-path="node/256">TSC</a> </li> </ul> </li> <li> <a href="/savings" class="ajax-link" rel="#ajax-container" data-drupal-link-system-path="node/346">Savings</a> </li> <li class="expanded dropdown"> <a href="/resources" class="ajax-link dropdown-toggle" rel="#ajax-container" data-toggle="dropdown" data-drupal-link-system-path="node/251"><span class="title">Resources</span> <span class="caret"></span></a> <ul class="dropdown-menu"> <li class="first"> <a href="/resources#starting-and-taking-epidiolex" class="ajax-link" rel="#ajax-container" data-title="Starting & taking EPIDIOLEX" data-drupal-link-system-path="node/251">Starting & taking EPIDIOLEX</a> </li> <li> <a href="/resources#considering-epidiolex" class="ajax-link" rel="#ajax-container" data-title="Considering EPIDIOLEX" data-drupal-link-system-path="node/251">Considering EPIDIOLEX</a> </li> <li> <a href="/resources#faqs" class="ajax-link" rel="#ajax-container" data-title="FAQs" data-drupal-link-system-path="node/251">FAQs</a> </li> <li class="last"> <a href="/resources#advocacy-groups" class="ajax-link" rel="#ajax-container" data-title="Advocacy groups" data-drupal-link-system-path="node/251">Advocacy groups</a> </li> </ul> </li> <li class="last"> <a href="" class="cta-link green">STAY INFORMED</a> </li> </ul> </nav> </div> </div> </div> </header> <div id="ajax-container" role="main" class="main-container js-quickedit-main-content"> <div class="row"> <section class="col-sm-12"> <noscript> <style type="text/css"> .path-frontpage .noscript-warning { margin-top: 22px; } body:not(.path-frontpage) .noscript-warning { margin-top: 80px; } .page-node-type-template-driven-page[data-node-id] .region-content { opacity: 1 !important; transition: none; } </style> <div class="alert alert-warning noscript-warning">Please enable javascript as some features and content will be inaccessible.</div> </noscript> <div class="region region-content"> <div data-drupal-messages-fallback class="hidden"></div> <article class="template-driven-page full clearfix"> <div class="content"> <div class="image-banner"> <div class="flex-h"> <div class="text-content"> <h1 class="blue"><span class="green">EPIDIOLEX:</span><br>A treatment innovation</h1> <p>EPIDIOLEX is the first and only FDA-approved prescription CBD used to treat seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC) in patients 1 year of age and older.</p> </div> <div class="image-content"> <img src="/themes/custom/epidiolex/images/epidiolex-product.png" alt="EPIDIOLEX cannabidiol the first FDA approved CBD drug" title="EPIDIOLEX® (cannabidiol) Bottle and Packaging"> </div> </div> </div> <div id="study-results"> <div class="text-container indications-title"> <div class="text-content pb-zero"> <h2 class="blue">Seizure reduction in these hard-to-treat epilepsies</h2> <h3>See clinical study results</h3> </div> </div> <div class="content-tabs indications"> <div class="tabs-container"><ul class="nav nav-tabs" role="tablist"><li role="presentation" class="active"><a href="#lgs-tab" aria-controls="lgs-tab" role="tab" data-toggle="tab">LGS</a></li><li role="presentation"><a href="#dravet-tab" aria-controls="dravet-tab" role="tab" data-toggle="tab">DRAVET SYNDROME</a></li><li role="presentation"><a href="#tsc-tab" aria-controls="tsc-tab" role="tab" data-toggle="tab">TSC</a></li></ul><div class="tab-content"><div role="tabpanel" class="tab-pane active" id="lgs-tab"><h2 class="blue">Fewer seizures in people living with LGS</h2><p>EPIDIOLEX significantly reduced drop seizures in people living with LGS</p><p>Monthly drop-seizure* reduction over the 14-week treatment period.</p><div class="percents-container lgs"><div class="flex-h percents"><div><div class="box green"><svg xmlns="http://www.w3.org/2000/svg" width="40.871" height="54.362" viewBox="0 0 40.871 54.362"><path id="Path_625" data-name="Path 625" d="M30.169,1.662V32.283H39.21a1.662,1.662,0,0,1,1.175,2.837L21.611,53.895a1.711,1.711,0,0,1-2.35,0L.487,35.12a1.662,1.662,0,0,1,1.175-2.837H10.7V1.662A1.662,1.662,0,0,1,12.365,0H28.507A1.662,1.662,0,0,1,30.169,1.662ZM14.027,33.945a1.662,1.662,0,0,1-1.662,1.662H5.674L20.436,50.369,35.2,35.607H28.507a1.662,1.662,0,0,1-1.662-1.662V3.324H14.027Z" transform="translate(0)" fill="#97c93c"/></svg><div class="text"><span>37<span class="percent-char">%</span></span><p class="reduction">REDUCTION</p><p class="blue">EPIDIOLEX</p><p class="small">10 mg/kg/day dose</p></div></div></div><div><div class="box green"><svg xmlns="http://www.w3.org/2000/svg" width="40.871" height="54.362" viewBox="0 0 40.871 54.362"><path id="Path_625" data-name="Path 625" d="M30.169,1.662V32.283H39.21a1.662,1.662,0,0,1,1.175,2.837L21.611,53.895a1.711,1.711,0,0,1-2.35,0L.487,35.12a1.662,1.662,0,0,1,1.175-2.837H10.7V1.662A1.662,1.662,0,0,1,12.365,0H28.507A1.662,1.662,0,0,1,30.169,1.662ZM14.027,33.945a1.662,1.662,0,0,1-1.662,1.662H5.674L20.436,50.369,35.2,35.607H28.507a1.662,1.662,0,0,1-1.662-1.662V3.324H14.027Z" transform="translate(0)" fill="#97c93c"/></svg><div class="text"><span>42<span class="percent-char">%</span></span><p class="reduction">REDUCTION</p><p class="blue">EPIDIOLEX</p><p class="small">20 mg/kg/day dose</p></div></div></div><div class="vs"><h4 class="blue">VS</h4></div><div><div class="box"><svg xmlns="http://www.w3.org/2000/svg" width="40.871" height="54.362" viewBox="0 0 40.871 54.362"><path id="Path_626" data-name="Path 626" d="M30.169,1.662V32.283H39.21a1.662,1.662,0,0,1,1.175,2.837L21.611,53.895a1.711,1.711,0,0,1-2.35,0L.487,35.12a1.662,1.662,0,0,1,1.175-2.837H10.7V1.662A1.662,1.662,0,0,1,12.365,0H28.507A1.662,1.662,0,0,1,30.169,1.662ZM14.027,33.945a1.662,1.662,0,0,1-1.662,1.662H5.674L20.436,50.369,35.2,35.607H28.507a1.662,1.662,0,0,1-1.662-1.662V3.324H14.027Z" transform="translate(0)" fill="#666"/></svg><div class="text"><span>17<span class="percent-char">%</span></span><p class="reduction">REDUCTION</p><p class="blue">In the placebo group</p><p class="small hidden-xs"> </p></div></div></div></div><hr><p>In another study, there was a <strong>44% monthly reduction</strong> in drop seizures among patients taking EPIDIOLEX in the 20 mg/kg/day group, compared with a 22% reduction taking placebo.</p></div><div class="cols col-3"><div class="flex-h no-padding"><div class="col"><div><svg width="102px" height="80px" viewBox="0 0 70 55" version="1.1" xmlns="http://www.w3.org/2000/svg" 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Even after these trials were completed, the majority of people continued taking EPIDIOLEX for more than a year.</p></div></div></div><div class="cols col-3"><div class="flex-h no-padding"><div class="col"><div><svg xmlns="http://www.w3.org/2000/svg" width="78.143" height="62.701" viewBox="0 0 78.143 62.701"><title>Two pills stacked on top of each other</title><g id="Group_15380" data-name="Group 15380" transform="translate(-2111.521 -171.631)"><g id="Group_15378" data-name="Group 15378" transform="translate(2130.165 172.883)"><path id="Path_695" data-name="Path 695" d="M2175.855,198.814l-16.571,17.453-.2.2,8.162,7.86a12.221,12.221,0,0,0,17.274-.556l.041-.042a12.223,12.223,0,0,0-.558-17.276Z" transform="translate(-2135.507 -175.873)" fill="#97c940"/><path id="Path_696" data-name="Path 696" d="M2132.646,193.027a17.335,17.335,0,0,1,4.484-14.594l.057-.061a17.368,17.368,0,0,1,24.549-.791l23.455,21.99a17.368,17.368,0,0,1,.792,24.549l-.057.06a17.369,17.369,0,0,1-24.549.792l-6.848-6.42" transform="translate(-2132.433 -172.883)" fill="none" stroke="#036" stroke-miterlimit="10" stroke-width="2.5"/><path id="Path_697" data-name="Path 697" d="M2165.028,189.218l-4.6-4.911a10.429,10.429,0,0,0-11.035-2.718" transform="translate(-2134.389 -173.82)" fill="none" stroke="#036" stroke-miterlimit="10" stroke-width="2.5"/></g><line id="Line_205" data-name="Line 205" x1="18.804" y2="20.057" transform="translate(2152.542 188.716)" fill="none" stroke="#036" stroke-miterlimit="10" stroke-width="2.5"/><g id="Group_15379" data-name="Group 15379" transform="translate(2112.771 192.869)"><line id="Line_206" data-name="Line 206" x1="39.912" y1="2.574" transform="translate(0.041 18.819)" fill="none" stroke="#036" stroke-miterlimit="10" stroke-width="2.5"/><circle id="Ellipse_51" data-name="Ellipse 51" cx="20.106" cy="20.106" r="20.106" transform="translate(0)" fill="none" stroke="#036" stroke-miterlimit="10" stroke-width="2.5"/></g></g></svg></div><h3 class="blue">Included patients<br class="wide"/> who failed on several medicines</h3><p>EPIDIOLEX clinical trials included people who had typically failed on 4-6 prior antiseizure medicines. These people were typically also taking 3 antiseizure medicines at the time, but their seizures were still uncontrolled.</p></div><div class="col"><div><svg id="ICON_Document" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" width="66.498" height="70" viewBox="0 0 66.498 70"><title>Notepaper and pencil</title><image id="Rectangle_774" data-name="Rectangle 774" width="58" height="70" 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data-name="Path 643" d="M138.5,84.743l-4.2-4.187-32.2,32.1-4.2,8.375,8.4-4.187Z" fill="none" stroke="#97c93c" stroke-linecap="round" stroke-linejoin="round" stroke-width="2"/><line id="Line_201" data-name="Line 201" x2="4.2" y2="4.188" transform="translate(130.098 84.743)" fill="none" stroke="#97c93c" stroke-linejoin="round" stroke-width="2"/></g></svg></div><h3 class="blue">Most common side effects</h3><p>The most common side effects of EPIDIOLEX include increase in liver enzymes, sleepiness, decreased appetite, diarrhea, fever, vomiting, feeling very tired and weak, rash, sleep problems, and infections.</p></div><div class="col"></div></div></div><div class="panel-group" id="lgs-accordion" role="tablist" aria-multiselectable="true"><h3 class="blue">Common questions</h3><div class="panel panel-default"><div class="panel-heading" role="tab" id="lgsHeadingOne"><h4 class="panel-title"><a class="collapsed" role="button" data-toggle="collapse" href="#common-seizure-medications" aria-expanded="false" aria-controls="common-seizure-medications"> What were the most common antiseizure medications patients were taking during the trial? </a></h4></div><div id="common-seizure-medications" class="panel-collapse collapse" role="tabpanel" aria-labelledby="lgsHeadingOne"><div class="panel-body"><p>Clobazam, valproate, lamotrigine, and levetiracetam.</p></div></div></div><div class="panel panel-default"><div class="panel-heading" role="tab" id="lgsHeadingTwo"><h4 class="panel-title"><a class="collapsed" role="button" data-toggle="collapse" href="#increased-dosage" aria-expanded="false" aria-controls="increased-dosage"> What happened when the EPIDIOLEX dose was increased? </a></h4></div><div id="increased-dosage" class="panel-collapse collapse" role="tabpanel" aria-labelledby="lgsHeadingTwo"><div class="panel-body"><p>At 20 mg/kg/day doses, there was a somewhat greater reduction in seizure rates than with 10 mg/kg/day doses; however, there was also an increase in EPIDIOLEX side effects.</p></div></div></div><div class="panel panel-default"><div class="panel-heading" role="tab" id="lgsHeadingThree"><h4 class="panel-title"><a class="collapsed" role="button" data-toggle="collapse" href="#response-to-epidiolex" aria-expanded="false" aria-controls="response-to-epidiolex"> What did caregivers report about their loved one’s response to EPIDIOLEX? </a></h4></div><div id="response-to-epidiolex" class="panel-collapse collapse" role="tabpanel" aria-labelledby="lgsHeadingThree"><div class="panel-body"><div class="flex-h aic"><div><strong>With<br> EPIDIOLEX,</strong><span class="percent">59<span class="symbol">%</span></span><p>of caregivers reported an improvement in their loved one’s overall condition on the Subject/Caregiver Impression of change (S/CGIC) scale.*</p></div><div> VS </div><div><strong>With<br> placebo,</strong><span class="percent">35<span class="symbol">%</span></span><p>of caregivers reported an improvement in their loved one’s overall condition on the scale.*</p></div></div><p class="small"><span>*</span>The S/CGIC is a 7-point scale that ranges from “Very Much Improved” to “Very Much Worse,” evaluating patient or caregiver assessment of the patient’s overall condition from the beginning of the study to the end of the study.</p></div></div></div><div class="panel panel-default"><div class="panel-heading" role="tab" id="lgsHeadingFour"><h4 class="panel-title"><a class="collapsed" role="button" data-toggle="collapse" href="#use-over-time" aria-expanded="false" aria-controls="use-over-time"> Is there any data on patients using EPIDIOLEX over time? </a></h4></div><div id="use-over-time" class="panel-collapse collapse" role="tabpanel" aria-labelledby="lgsHeadingFour"><div class="panel-body"><div class="flex-h"><p>Patients who stayed on EPIDIOLEX after the initial trial maintained seizure reduction in a 3-year open-label phase.</p><svg xmlns="http://www.w3.org/2000/svg" width="166.872" height="49.5" viewBox="0 0 166.872 49.5"><g 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indent-for-sup"><sup>*</sup>Drop seizures included tonic, atonic, and tonic-clonic that led, or could have led, to a fall or injury.</p><p class="small indent-for-sup"><sup>&dagger;</sup>During the 12-week maintenance period.</p></div><div role="tabpanel" class="tab-pane" id="dravet-tab"><h2 class="blue">Fewer seizures in people living with Dravet syndrome</h2><p>EPIDIOLEX reduced convulsive seizures in people living with Dravet syndrome</p><p>Monthly convulsive-seizure* reduction over the 14-week treatment period.</p><div class="percents-container dravet"><div class="flex-h percents"><div><div class="box pink"><svg xmlns="http://www.w3.org/2000/svg" width="40.871" height="54.362" viewBox="0 0 40.871 54.362"><path id="Path_625" data-name="Path 625" 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150.3253479003906 103.5540390014648 L 150.3253479003906 114.1770629882812 L 107.3609924316406 114.1770629882812 L 107.3609924316406 103.5540390014648 C 107.3609924316406 91.6737060546875 114.9209594726562 87.61680603027344 124.1612243652344 87.61680603027344 Z" stroke="none" fill="#036"/></g><path id="Path_642" data-name="Path 642" d="M98.637,69.913a11.016,11.016,0,1,0,11.016,11.016A11.017,11.017,0,0,0,98.637,69.913Zm-4.682,25.08c-9.24,0-16.8,4.057-16.8,15.937v10.623h42.964V110.93c0-11.88-7.56-15.937-16.8-15.937Z" transform="translate(-3.137 -0.766)" fill="#97c940" fill-rule="evenodd"/></g></svg></div><h3 class="blue">More than 500 participants</h3><p>More than 500 people with LGS and Dravet syndrome took part in 3 clinical studies—the largest placebo-controlled, clinical study program of these conditions to date. Even after these trials were completed, the majority of people continued taking EPIDIOLEX for more than a year.</p></div></div></div><div class="cols col-3"><div class="flex-h no-padding"><div class="col"><div><svg xmlns="http://www.w3.org/2000/svg" width="78.143" height="62.701" viewBox="0 0 78.143 62.701"><title>Two pills stacked on top of each other</title><g id="Group_15380" data-name="Group 15380" transform="translate(-2111.521 -171.631)"><g id="Group_15378" data-name="Group 15378" transform="translate(2130.165 172.883)"><path id="Path_695" data-name="Path 695" d="M2175.855,198.814l-16.571,17.453-.2.2,8.162,7.86a12.221,12.221,0,0,0,17.274-.556l.041-.042a12.223,12.223,0,0,0-.558-17.276Z" transform="translate(-2135.507 -175.873)" fill="#97c940"/><path id="Path_696" data-name="Path 696" d="M2132.646,193.027a17.335,17.335,0,0,1,4.484-14.594l.057-.061a17.368,17.368,0,0,1,24.549-.791l23.455,21.99a17.368,17.368,0,0,1,.792,24.549l-.057.06a17.369,17.369,0,0,1-24.549.792l-6.848-6.42" transform="translate(-2132.433 -172.883)" fill="none" stroke="#036" stroke-miterlimit="10" stroke-width="2.5"/><path id="Path_697" data-name="Path 697" d="M2165.028,189.218l-4.6-4.911a10.429,10.429,0,0,0-11.035-2.718" transform="translate(-2134.389 -173.82)" fill="none" stroke="#036" stroke-miterlimit="10" stroke-width="2.5"/></g><line id="Line_205" data-name="Line 205" x1="18.804" y2="20.057" transform="translate(2152.542 188.716)" fill="none" stroke="#036" stroke-miterlimit="10" stroke-width="2.5"/><g id="Group_15379" data-name="Group 15379" transform="translate(2112.771 192.869)"><line id="Line_206" data-name="Line 206" x1="39.912" y1="2.574" transform="translate(0.041 18.819)" fill="none" stroke="#036" stroke-miterlimit="10" stroke-width="2.5"/><circle id="Ellipse_51" data-name="Ellipse 51" cx="20.106" cy="20.106" r="20.106" transform="translate(0)" fill="none" stroke="#036" stroke-miterlimit="10" stroke-width="2.5"/></g></g></svg></div><h3 class="blue">Included patients who failed on several medicines</h3><p>EPIDIOLEX clinical trials included people who had typically failed on 4-6 prior antiseizure medicines. These people were typically also taking 3 antiseizure medicines at the time, but their seizures were still uncontrolled.</p></div><div class="col"><div><svg id="ICON_Document" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" width="66.498" height="70" viewBox="0 0 66.498 70"><title>Notepaper and pencil</title><image id="Rectangle_774" data-name="Rectangle 774" width="58" height="70" 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data-name="Path 643" d="M138.5,84.743l-4.2-4.187-32.2,32.1-4.2,8.375,8.4-4.187Z" fill="none" stroke="#97c93c" stroke-linecap="round" stroke-linejoin="round" stroke-width="2"/><line id="Line_201" data-name="Line 201" x2="4.2" y2="4.188" transform="translate(130.098 84.743)" fill="none" stroke="#97c93c" stroke-linejoin="round" stroke-width="2"/></g></svg></div><h3 class="blue">Most common side effects</h3><p>The most common side effects of EPIDIOLEX include increase in liver enzymes, sleepiness, decreased appetite, diarrhea, fever, vomiting, feeling very tired and weak, rash, sleep problems, and infections.</p></div><div class="col"></div></div></div><div class="panel-group" id="dravet-accordion" role="tablist" aria-multiselectable="true"><h3 class="blue">Common questions</h3><div class="panel panel-default"><div class="panel-heading" role="tab" id="dravetHeadingOne"><h4 class="panel-title"><a class="collapsed" role="button" data-toggle="collapse" href="#dravet-common-seizure-medications" aria-expanded="false" aria-controls="dravet-common-seizure-medications"> What were the most common antiseizure medications patients were taking during the trial? </a></h4></div><div id="dravet-common-seizure-medications" class="panel-collapse collapse" role="tabpanel" aria-labelledby="dravetHeadingOne"><div class="panel-body"><p>Clobazam, valproate, and stiripentol.</p></div></div></div><div class="panel panel-default"><div class="panel-heading" role="tab" id="dravetHeadingTwo"><h4 class="panel-title"><a class="collapsed" role="button" data-toggle="collapse" href="#dravet-recommended-epidiolex-dosage" aria-expanded="false" aria-controls="dravet-recommended-epidiolex-dosage"> What is the recommended EPIDIOLEX dose? </a></h4></div><div id="dravet-recommended-epidiolex-dosage" class="panel-collapse collapse" role="tabpanel" aria-labelledby="dravetHeadingTwo"><div class="panel-body"><p><span class="green"><strong>10 mg/kg/day</strong></span> as a maintenance dose.</p><p><span class="blue"><strong>20 mg/kg/day</strong></span> as a maximum dose.</p></div></div></div><div class="panel panel-default"><div class="panel-heading" role="tab" id="dravetHeadingThree"><h4 class="panel-title"><a class="collapsed" role="button" data-toggle="collapse" href="#dravet-epidiolex-usage-over-time" aria-expanded="false" aria-controls="dravet-epidiolex-usage-over-time"> Is there any data on patients using EPIDIOLEX over time? </a></h4></div><div id="dravet-epidiolex-usage-over-time" class="panel-collapse collapse" role="tabpanel" aria-labelledby="dravetHeadingThree"><div class="panel-body"><div class="flex-h"><p>Patients who stayed on EPIDIOLEX after the initial trial maintained seizure reduction in a 3-year open-label phase.</p><svg xmlns="http://www.w3.org/2000/svg" width="166.872" height="49.5" viewBox="0 0 166.872 49.5"><g id="seizure_reduction" data-name="seizure reduction" transform="translate(-600.128 -2784.59)"><text id="Reduction" transform="translate(647 2829.09)" fill="#b41782" font-size="20" font-family="WorkSans-ExtraBold, Work Sans" font-weight="800" letter-spacing="0.01em"><tspan x="0" y="0">REDUCTION</tspan></text><text id="SEIZURE" transform="translate(647 2803.59)" fill="#b41782" font-size="20" font-family="WorkSans-ExtraBold, Work Sans" font-weight="800" letter-spacing="0.01em"><tspan x="0" y="0">SEIZURE</tspan></text><path id="Path_808" data-name="Path 808" d="M24.141,1.33v24.5h7.235a1.33,1.33,0,0,1,.94,2.27L17.293,43.126a1.369,1.369,0,0,1-1.88,0L.39,28.1a1.33,1.33,0,0,1,.94-2.27H8.565V1.33A1.33,1.33,0,0,1,9.894,0H22.811A1.33,1.33,0,0,1,24.141,1.33ZM11.224,27.163a1.33,1.33,0,0,1-1.33,1.33H4.54L16.353,40.3,28.165,28.492H22.811a1.33,1.33,0,0,1-1.33-1.33V2.66H11.224Z" transform="translate(600.128 2787.59)" fill="#97c93c"/></g></svg></div></div></div></div></div><p class="small indent-for-sup"><sup>*</sup>Convulsive seizures include several seizure types: tonic, tonic-clonic, atonic, and clonic.</p><p class="small indent-for-sup"><sup>†</sup>During the 12-week maintenance period.</p></div><div role="tabpanel" class="tab-pane" id="tsc-tab"><h2 class="blue">EPIDIOLEX reduced the frequency of seizures in TSC by half</h2><p>Reduction in TSC-associated seizures* over the 16-week treatment period.</p><div class="percents-container tsc"><div class="flex-h percents"><div><div class="box tsc-blue"><svg xmlns="http://www.w3.org/2000/svg" width="40.871" height="54.362" viewBox="0 0 40.871 54.362"><path id="Path_625" data-name="Path 625" d="M30.169,1.662V32.283H39.21a1.662,1.662,0,0,1,1.175,2.837L21.611,53.895a1.711,1.711,0,0,1-2.35,0L.487,35.12a1.662,1.662,0,0,1,1.175-2.837H10.7V1.662A1.662,1.662,0,0,1,12.365,0H28.507A1.662,1.662,0,0,1,30.169,1.662ZM14.027,33.945a1.662,1.662,0,0,1-1.662,1.662H5.674L20.436,50.369,35.2,35.607H28.507a1.662,1.662,0,0,1-1.662-1.662V3.324H14.027Z" transform="translate(0)" fill="#50bbc7"/></svg><div class="text"><span>48<span class="percent-char">%</span></span><p class="reduction">REDUCTION</p><p class="blue">EPIDIOLEX</p><p class="small">25 mg/kg/day dose</p></div></div></div><div class="vs"><h4 class="blue">VS</h4></div><div><div class="box"><svg xmlns="http://www.w3.org/2000/svg" width="40.871" height="54.362" viewBox="0 0 40.871 54.362"><path id="Path_626" data-name="Path 626" d="M30.169,1.662V32.283H39.21a1.662,1.662,0,0,1,1.175,2.837L21.611,53.895a1.711,1.711,0,0,1-2.35,0L.487,35.12a1.662,1.662,0,0,1,1.175-2.837H10.7V1.662A1.662,1.662,0,0,1,12.365,0H28.507A1.662,1.662,0,0,1,30.169,1.662ZM14.027,33.945a1.662,1.662,0,0,1-1.662,1.662H5.674L20.436,50.369,35.2,35.607H28.507a1.662,1.662,0,0,1-1.662-1.662V3.324H14.027Z" transform="translate(0)" fill="#666"/></svg><div class="text"><span>24<span class="percent-char">%</span></span><p class="reduction">REDUCTION</p><p class="blue">In the placebo group</p><p class="small hidden-xs"> </p></div></div></div></div></div><div class="cols col-3"><div class="flex-h no-padding"><div class="col"><div><svg 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79.63744354248047 117.8263092041016 73.55344390869141 C 117.8263092041016 67.46943664550781 122.7587585449219 62.53700256347656 128.8427276611328 62.53700256347656 Z M 124.1612243652344 87.61680603027344 L 133.5242462158203 87.61680603027344 C 142.7653961181641 87.61680603027344 150.3253479003906 91.6737060546875 150.3253479003906 103.5540390014648 L 150.3253479003906 114.1770629882812 L 107.3609924316406 114.1770629882812 L 107.3609924316406 103.5540390014648 C 107.3609924316406 91.6737060546875 114.9209594726562 87.61680603027344 124.1612243652344 87.61680603027344 Z" stroke="none" fill="#036"/></g><path id="Path_642" data-name="Path 642" d="M98.637,69.913a11.016,11.016,0,1,0,11.016,11.016A11.017,11.017,0,0,0,98.637,69.913Zm-4.682,25.08c-9.24,0-16.8,4.057-16.8,15.937v10.623h42.964V110.93c0-11.88-7.56-15.937-16.8-15.937Z" transform="translate(-3.137 -0.766)" fill="#97c940" fill-rule="evenodd"/></g></svg></div><h3 class="blue">More than 200 participants</h3><p>More than 200 people with TSC took part in a clinical trial to determine if EPIDIOLEX reduced the rate of seizures associated with TSC. After this trial was completed, almost all patients continued taking EPIDIOLEX as part of an extension of the study.</p></div></div></div><div class="cols col-3"><div class="flex-h no-padding"><div class="col"><div><svg xmlns="http://www.w3.org/2000/svg" width="78.143" height="62.701" viewBox="0 0 78.143 62.701"><title>Two pills stacked on top of each other</title><g id="Group_15380" data-name="Group 15380" transform="translate(-2111.521 -171.631)"><g id="Group_15378" data-name="Group 15378" transform="translate(2130.165 172.883)"><path id="Path_695" data-name="Path 695" d="M2175.855,198.814l-16.571,17.453-.2.2,8.162,7.86a12.221,12.221,0,0,0,17.274-.556l.041-.042a12.223,12.223,0,0,0-.558-17.276Z" transform="translate(-2135.507 -175.873)" fill="#97c940"/><path id="Path_696" data-name="Path 696" d="M2132.646,193.027a17.335,17.335,0,0,1,4.484-14.594l.057-.061a17.368,17.368,0,0,1,24.549-.791l23.455,21.99a17.368,17.368,0,0,1,.792,24.549l-.057.06a17.369,17.369,0,0,1-24.549.792l-6.848-6.42" transform="translate(-2132.433 -172.883)" fill="none" stroke="#036" stroke-miterlimit="10" stroke-width="2.5"/><path id="Path_697" data-name="Path 697" d="M2165.028,189.218l-4.6-4.911a10.429,10.429,0,0,0-11.035-2.718" transform="translate(-2134.389 -173.82)" fill="none" stroke="#036" stroke-miterlimit="10" stroke-width="2.5"/></g><line id="Line_205" data-name="Line 205" x1="18.804" y2="20.057" transform="translate(2152.542 188.716)" fill="none" stroke="#036" stroke-miterlimit="10" stroke-width="2.5"/><g id="Group_15379" data-name="Group 15379" transform="translate(2112.771 192.869)"><line id="Line_206" data-name="Line 206" x1="39.912" y1="2.574" transform="translate(0.041 18.819)" fill="none" stroke="#036" stroke-miterlimit="10" stroke-width="2.5"/><circle id="Ellipse_51" data-name="Ellipse 51" cx="20.106" cy="20.106" r="20.106" transform="translate(0)" fill="none" stroke="#036" stroke-miterlimit="10" stroke-width="2.5"/></g></g></svg></div><h3 class="blue">Included patients who failed on several medicines</h3><p>People with TSC in the EPIDIOLEX clinical trial had typically failed on 4 prior antiseizure medicines. They were also taking an average of 3 antiseizure medicines at the time of the study, but their seizures were still uncontrolled.</p></div><div class="col"><div><svg id="ICON_Document" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" width="66.498" height="70" viewBox="0 0 66.498 70"><title>Notepaper and pencil</title><image id="Rectangle_774" data-name="Rectangle 774" width="58" height="70" xlink:href="data:image/png;base64,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"/><g id="Group_15306" data-name="Group 15306" transform="translate(-73 -68.108)"><path id="Path_643" data-name="Path 643" d="M138.5,84.743l-4.2-4.187-32.2,32.1-4.2,8.375,8.4-4.187Z" fill="none" stroke="#97c93c" stroke-linecap="round" stroke-linejoin="round" stroke-width="2"/><line id="Line_201" data-name="Line 201" x2="4.2" y2="4.188" transform="translate(130.098 84.743)" fill="none" stroke="#97c93c" stroke-linejoin="round" stroke-width="2"/></g></svg></div><h3 class="blue">Most common side effects</h3><p>The most common side effects of EPIDIOLEX include increase in liver enzymes, sleepiness, decreased appetite, diarrhea, fever, vomiting, feeling very tired and weak, rash, sleep problems, and infections.</p></div><div class="col"></div></div></div><div class="panel-group" id="tsc-accordion" role="tablist" aria-multiselectable="true"><h3 class="blue">Common questions</h3><div class="panel panel-default"><div class="panel-heading" role="tab" id="tscHeadingOne"><h4 class="panel-title"><a class="collapsed" role="button" data-toggle="collapse" href="#tsc-common-seizure-medications" aria-expanded="false" aria-controls="tsc-common-seizure-medications"> What were the most common antiseizure medications patients were taking during the trial? </a></h4></div><div id="tsc-common-seizure-medications" class="panel-collapse collapse" role="tabpanel" aria-labelledby="tscHeadingOne"><div class="panel-body"><div class="flex-h"><p>EPIDIOLEX can be used in combination with many commonly prescribed antiseizure medicines. In this study, the most common antiseizure medicines patients had taken, while also taking EPIDIOLEX, were valproate, vigabatrin, levetiracetam, and clobazam.</p><svg xmlns="http://www.w3.org/2000/svg" width="78.143" height="62.701" viewBox="0 0 78.143 62.701"><g id="Group_15380" data-name="Group 15380" transform="translate(-2111.521 -171.631)"><g id="Group_15378" data-name="Group 15378" transform="translate(2130.165 172.883)"><path id="Path_695" data-name="Path 695" d="M2175.855,198.814l-16.571,17.453-.2.2,8.162,7.86a12.221,12.221,0,0,0,17.274-.556l.041-.042a12.223,12.223,0,0,0-.558-17.276Z" transform="translate(-2135.507 -175.873)" fill="#97c940"></path><path id="Path_696" data-name="Path 696" d="M2132.646,193.027a17.335,17.335,0,0,1,4.484-14.594l.057-.061a17.368,17.368,0,0,1,24.549-.791l23.455,21.99a17.368,17.368,0,0,1,.792,24.549l-.057.06a17.369,17.369,0,0,1-24.549.792l-6.848-6.42" transform="translate(-2132.433 -172.883)" fill="none" stroke="#036" stroke-miterlimit="10" stroke-width="2.5"></path><path id="Path_697" data-name="Path 697" d="M2165.028,189.218l-4.6-4.911a10.429,10.429,0,0,0-11.035-2.718" transform="translate(-2134.389 -173.82)" fill="none" stroke="#036" stroke-miterlimit="10" stroke-width="2.5"></path></g><line id="Line_205" data-name="Line 205" x1="18.804" y2="20.057" transform="translate(2152.542 188.716)" fill="none" stroke="#036" stroke-miterlimit="10" stroke-width="2.5"></line><g id="Group_15379" data-name="Group 15379" transform="translate(2112.771 192.869)"><line id="Line_206" data-name="Line 206" x1="39.912" y1="2.574" transform="translate(0.041 18.819)" fill="none" stroke="#036" stroke-miterlimit="10" stroke-width="2.5"></line><circle id="Ellipse_51" data-name="Ellipse 51" cx="20.106" cy="20.106" r="20.106" transform="translate(0)" fill="none" stroke="#036" stroke-miterlimit="10" stroke-width="2.5"></circle></g></g></svg></div></div></div></div><div class="panel panel-default"><div class="panel-heading" role="tab" id="tscHeadingTwo"><h4 class="panel-title"><a class="collapsed" role="button" data-toggle="collapse" href="#tsc-use-over-time" aria-expanded="false" aria-controls="tsc-use-over-time"> Is there any data on patients using EPIDIOLEX over time? </a></h4></div><div id="tsc-use-over-time" class="panel-collapse collapse" role="tabpanel" aria-labelledby="tscHeadingTwo"><div class="panel-body"><div class="flex-h"><p>Patients who stayed on EPIDIOLEX after the initial trial maintained seizure reduction in a 3-year open-label phase.</p><svg xmlns="http://www.w3.org/2000/svg" width="166.872" height="49.5" viewBox="0 0 166.872 49.5"><g id="seizure_reduction" data-name="seizure reduction" transform="translate(-600.128 -2784.59)"><text id="Reduction" transform="translate(647 2829.09)" fill="#b41782" font-size="20" font-family="WorkSans-ExtraBold, Work Sans" font-weight="800" letter-spacing="0.01em"><tspan x="0" y="0">REDUCTION</tspan></text><text id="SEIZURE" transform="translate(647 2803.59)" fill="#b41782" font-size="20" font-family="WorkSans-ExtraBold, Work Sans" font-weight="800" letter-spacing="0.01em"><tspan x="0" y="0">SEIZURE</tspan></text><path id="Path_808" data-name="Path 808" d="M24.141,1.33v24.5h7.235a1.33,1.33,0,0,1,.94,2.27L17.293,43.126a1.369,1.369,0,0,1-1.88,0L.39,28.1a1.33,1.33,0,0,1,.94-2.27H8.565V1.33A1.33,1.33,0,0,1,9.894,0H22.811A1.33,1.33,0,0,1,24.141,1.33ZM11.224,27.163a1.33,1.33,0,0,1-1.33,1.33H4.54L16.353,40.3,28.165,28.492H22.811a1.33,1.33,0,0,1-1.33-1.33V2.66H11.224Z" transform="translate(600.128 2787.59)" fill="#97c93c"/></g></svg></div></div></div></div></div><p class="small indent-for-sup"><sup>*</sup>TSC-associated seizures included different types of partial onset (focal) seizures and generalized seizures.</p></div></div></div> </div> </div> <div id="key-things-to-know" class="pane things-to-know grey-blue"> <div class="pane-content grey-blue"> <div class="flex-h"> <div> <img src="/themes/custom/epidiolex/images/icons/things-to-know.svg" alt="Common EPIDIOLEX cannabidiol side effects and interactions"> </div> <div> <h3 class="blue">Common EPIDIOLEX side effects and interactions</h3> </div> </div> <div class="panel-group" id="things-to-know-accordion" role="tablist" aria-multiselectable="true"> <div class="panel panel-default"> <div class="panel-heading" role="tab" id="ttkHeadingOne"> <h4 class="panel-title"> <a class="collapsed" role="button" data-toggle="collapse" href="#important-information" aria-expanded="false" aria-controls="important-information"> What is the most important information I should know about EPIDIOLEX? </a> </h4> </div> <div id="important-information" class="panel-collapse collapse" role="tabpanel" aria-labelledby="ttkHeadingOne"> <div class="panel-body"> <p>EPIDIOLEX may cause liver problems. Your doctor may order blood tests to check your liver before you start taking EPIDIOLEX and during treatment. In some cases, EPIDIOLEX treatment may need to be stopped. Call your doctor right away if you start to have any of these signs and symptoms of liver problems during treatment with EPIDIOLEX:</p> <ul> <li>loss of appetite, nausea, vomiting</li> <li>fever, feeling unwell, unusual tiredness</li> <li>yellowing of the skin or the whites of the eyes (jaundice)</li> <li>itching</li> <li>unusual darkening of the urine</li> <li>right upper stomach area pain or discomfort</li> </ul> <p>Your doctor may order blood tests to monitor for other EPIDIOLEX side effects.</p> <p>EPIDIOLEX may cause you to feel sleepy, which may get better over time. Other medicines (e.g., clobazam) or alcohol may increase sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how EPIDIOLEX affects you.</p> <p>Like other antiepileptic drugs, EPIDIOLEX may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:</p> <ul> <li>thoughts about suicide or dying</li> <li>attempt to commit suicide</li> <li>new or worse depression</li> <li>new or worse anxiety</li> <li>feeling agitated or restless</li> <li>panic attacks</li> <li>trouble sleeping (insomnia)</li> <li>new or worse irritability</li> <li>acting aggressive, being angry, or violent</li> <li>acting on dangerous impulses</li> <li>an extreme increase in activity and talking (mania)</li> <li>other unusual changes in behavior or mood</li> </ul> <p>How can I watch for early symptoms of suicidal thoughts and actions?</p> <ul> <li>Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings</li> <li>Keep all follow-up visits with your healthcare provider as scheduled</li> </ul> <p>Do not stop taking EPIDIOLEX without first talking to your healthcare provider. Stopping a seizure medicine such as EPIDIOLEX suddenly can cause you to have seizures more often or seizures that do not stop (status epilepticus).</p> <p>Call your healthcare provider between visits as needed, especially if you are worried about symptoms.</p> </div> </div> </div> <div class="panel panel-default"> <div class="panel-heading" role="tab" id="ttkHeadingTwo"> <h4 class="panel-title"> <a class="collapsed" role="button" data-toggle="collapse" href="#who-should-not-take-epidiolex" aria-expanded="false" aria-controls="who-should-not-take-epidiolex"> Who should not take EPIDIOLEX? </a> </h4> </div> <div id="who-should-not-take-epidiolex" class="panel-collapse collapse" role="tabpanel" aria-labelledby="ttkHeadingTwo"> <div class="panel-body"> <p>Do not take EPIDIOLEX if you are allergic to cannabidiol or any other ingredients in EPIDIOLEX.</p> </div> </div> </div> <div class="panel panel-default"> <div class="panel-heading" role="tab" id="ttkHeadingThree"> <h4 class="panel-title"> <a class="collapsed" role="button" data-toggle="collapse" href="#side-effects" aria-expanded="false" aria-controls="side-effects"> What are other possible EPIDIOLEX side effects? </a> </h4> </div> <div id="side-effects" class="panel-collapse collapse" role="tabpanel" aria-labelledby="ttkHeadingThree"> <div class="panel-body"> <ul> <li>The most common side effects include increase in liver enzymes, sleepiness, decreased appetite, diarrhea, fever, vomiting, feeling very tired and weak, rash, sleep problems, and infections</li> <li>Across studies in LGS, Dravet syndrome, and TSC, EPIDIOLEX was found to have a consistent safety profile in both children and adults</li> <li>In the LGS and Dravet syndrome studies, the rate of discontinuation (patients who stopped taking the medicine) for any side effect was 1% for patients taking placebo and 3% for patients taking EPIDIOLEX 10 mg/kg/day. For patients taking EPIDIOLEX 20 mg/kg/day, the rate of discontinuation for any side effect was 12%</li> <li>In the TSC study, the rate of discontinuation for any side effect was 3% for patients taking placebo and 11% for patients taking EPIDIOLEX 25 mg/kg/day</li> <li>The most frequent causes of discontinuation were increase in liver enzymes and sleepiness in the LGS and Dravet syndrome studies, and rash in the TSC study</li> <li>EPIDIOLEX can cause weight loss</li> <li>Your doctor may also order blood tests to look out for other side effects</li> <li>These are not all of the possible EPIDIOLEX side effects. For more information, ask your healthcare provider or pharmacist</li> </ul> </div> </div> </div> <div class="panel panel-default"> <div class="panel-heading" role="tab" id="ttkHeadingFour"> <h4 class="panel-title"> <a class="collapsed" role="button" data-toggle="collapse" href="#medication-interaction" aria-expanded="false" aria-controls="medication-interaction"> Does EPIDIOLEX interact with my other medicines? </a> </h4> </div> <div id="medication-interaction" class="panel-collapse collapse" role="tabpanel" aria-labelledby="ttkHeadingFour"> <div class="panel-body"> <div class="flex-h"> <p>EPIDIOLEX may interact with some antiseizure medicines or other medicines you are taking. Do not start or stop other medicines without talking to your doctor. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and cannabis-based products.</p> <?xml version="1.0" encoding="UTF-8"?> <svg width="67px" height="52px" viewBox="0 0 67 52" version="1.1" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink"> <title>* / ICON / ART / Spacer</title> <g id="Website-Pages-[Day-X]" stroke="none" stroke-width="1" fill="none" fill-rule="evenodd"> <g id="D-03---About-LGS" transform="translate(-617.000000, -3728.000000)"> <g id="D-/-Module-/-Banner-/5" transform="translate(0.000000, 2275.000000)"> <g id="M-/-Module-/-Content-/-3-Column-/-Teaser,-Icon-Copy-6" transform="translate(548.000000, 1411.000000)"> <g id="*-/-ICON-/-ART-/-Spacer" transform="translate(70.900875, 44.000000)"> <path d="M46.9184752,18.7074665 L33.6558232,32.6750201 L33.4959076,32.8357313 L40.026988,39.1257449 C43.9683904,42.8213069 50.1581584,42.6216113 53.8529248,38.6802089 L53.8847488,38.6467937 C57.5795152,34.7053913 57.3798196,28.5156233 53.4392128,24.8208569 L46.9184752,18.7074665 Z" id="Fill-5" fill="#97C940"></path> <path d="M14.7977164,16.4690459 C14.1524848,12.3780707 15.3347464,8.04364187 18.386668,4.78804667 L18.4320172,4.74031067 C23.6821816,-0.859917726 32.4791308,-1.14394693 38.0793592,4.10701307 L56.84995,21.7064807 C62.450974,26.9566451 62.7342076,35.7527987 57.4832476,41.3530271 L57.438694,41.4015587 C52.187734,47.0017871 43.3915804,47.2850207 37.791352,42.0348563 L32.3120548,36.8976671" id="Stroke-7" stroke="#003366" stroke-width="2.8252"></path> <path d="M39.9919816,11.8267199 C38.7810784,10.5346655 37.5749488,9.23783747 36.3584764,7.95135227 C33.79744,5.24233427 29.8584244,4.22635307 26.314822,5.41418387 C24.8652388,5.90029547 25.487398,8.20594427 26.9489152,7.71585467 C29.823418,6.75238307 32.7377008,7.57662467 34.7927356,9.76850267 C35.9630632,11.0167991 37.1333908,12.2658911 38.3037184,13.5141875 C39.3562972,14.6367791 41.0421736,12.9469247 39.9919816,11.8267199" id="Fill-9" fill="#003366"></path> <line x1="47.5843129" y1="13.0194038" x2="32.5355389" y2="29.0706338" id="Stroke-11" stroke="#003366" stroke-width="2.8252"></line> <line x1="32.681611" y1="33.4640962" x2="0.739066628" y2="31.4042878" id="Stroke-13" stroke="#003366" stroke-width="2.8252"></line> <path d="M0.739464428,31.3989572 C0.167428028,40.2675104 6.89343043,47.9211824 15.7619836,48.4924232 C24.6305368,49.0644596 32.2834132,42.3384572 32.8554496,33.4706996 C33.427486,24.6013508 26.7022792,16.9484744 17.8329304,16.376438 C8.96437723,15.8044016 1.31150083,22.530404 0.739464428,31.3989572 Z" id="Stroke-15" stroke="#003366" stroke-width="2.8252"></path> </g> </g> </g> </g> </g> </svg> </div> </div> </div> </div> </div> </div> </div> <div class="cols col-2 blue footer-banner"> <div class="flex-h"> <div class="col"> <h3>Considering EPIDIOLEX?</h3> <p>This brochure is all about the first and only FDA-approved prescription CBD to treat seizures associated with LGS, Dravet syndrome, and TSC.</p> <p><a href="/themes/custom/epidiolex/pdfs/US-EPX-2200175-Rev0424-EPIDIOLEX-Caregiver-Brochure-(PDF)-(3).pdf" class="cta-link download">DOWNLOAD</a></p> </div> <div class="col"> <img src="/themes/custom/epidiolex/images/doc-previews/consider-epidiolex-footer.png" alt="Brochure about the first and only FDA-approved prescription CBD to treat seizures associated with LGS, Dravet syndrome, and TSC" title="Image of the EPIDIOLEX® (cannabidiol) Caregiver Brochure for Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex"> </div> </div> </div> </div> </article> </div> </section> </div> </div> <div id="webforms"> webform <em>was</em> here. Moved into #stay-informed-modal. </div> <div class="region region-isi"> <section id="block-sticky-isi" class="settings-tray-editable block block-block-content block-block-content1a21e897-d75e-4a3d-80ff-8e489832dc8d clearfix" data-drupal-settingstray="editable"> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><div class="sticky"><div class="flex-h"><div><p><strong>Important Safety Information</strong></p><p><strong class="more-margin">What is the Most Important Information I Should Know About EPIDIOLEX (cannabidiol)?</strong><br>Do not take if you are allergic to cannabidiol or any of the ingredients in EPIDIOLEX. EPIDIOLEX may cause liver problems. Your doctor may order blood tests to check your liver before and during EPIDIOLEX treatment. <span>In some cases, EPIDIOLEX treatment may need to be stopped. Call your doctor right away if…</span></p></div><div><p><strong>Indications</strong></p><p><strong class="more-margin">What is EPIDIOLEX (cannabidiol)?</strong><br>EPIDIOLEX is a prescription medicine that is used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex<span class="dot-dot-dot">…</span><span> in patients 1 year of age and older. It is not known if EPIDIOLEX is safe and effective in children under 1 year of age.</span></p></div></div></div><div class="full"><p><strong class="mobile-only">Important Safety Information & Indications</strong> <strong class="desktop-only">Important Safety Information & Indications</strong></p><p><strong>What is the Most Important Information I Should Know About EPIDIOLEX (cannabidiol)?</strong></p><p>Do not take if you are allergic to cannabidiol or any of the ingredients in EPIDIOLEX.</p><p class="gotta-make-this-a-perfect-27px">EPIDIOLEX may cause liver problems. Your doctor may order blood tests to check your liver before and during EPIDIOLEX treatment. In some cases, EPIDIOLEX treatment may need to be stopped. Call your doctor right away if you start to have any of these signs and symptoms of liver problems during treatment with EPIDIOLEX<span>:</span></p><ul class="flex-list"><li>loss of appetite, nausea, vomiting</li><li>itching</li><li>fever, feeling unwell, unusual tiredness</li><li>unusual darkening of the urine</li><li>yellowing of the skin or the whites of the eyes (jaundice)</li><li>right upper stomach area pain or discomfort</li></ul><p>EPIDIOLEX may cause you to feel sleepy, which may get better over time. Other medicines (e.g., clobazam) or alcohol may increase sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how EPIDIOLEX affects you.</p><p>Like other antiseizure medicines, EPIDIOLEX may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your doctor right away if you have any signs of depression or anxiety, thoughts about suicide or self-harm, feelings of agitation or restlessness, aggression, irritability, or other unusual changes in behavior or mood, especially if they are new, worse, or worry you.</p><p>Take EPIDIOLEX exactly as your doctor tells you. Do not stop taking EPIDIOLEX without first talking to your doctor. Stopping an antiseizure medicine suddenly can cause serious problems.</p><p><strong>What Else Should I Know When Taking EPIDIOLEX?</strong></p><p>The most common side effects of EPIDIOLEX include increase in liver enzymes, sleepiness, decreased appetite, diarrhea, fever, vomiting, feeling very tired and weak, rash, sleep problems, and infections.</p><p>EPIDIOLEX may affect the way other medicines work, and other medicines may affect how EPIDIOLEX works. Do not start or stop other medicines without talking to your doctor. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and cannabis-based products.</p><p><strong>What Additional Information Applies to Women?</strong></p><p>If you are pregnant or plan to become pregnant, EPIDIOLEX may harm your unborn baby, and medicines like EPIDIOLEX may be passed into breast milk. You and your doctor will decide if you should take EPIDIOLEX and about the best way to feed your baby while taking EPIDIOLEX. If you become pregnant while taking EPIDIOLEX, discuss registering with the EPIDIOLEX Pregnancy Surveillance Program (<a href="tel:+18552727158">855-272-7158</a> or <a href="https://epidiolexpregnancystudy.com" target="_blank">epidiolexpregnancystudy.com</a>) and the North American Antiepileptic Drug Pregnancy Registry (<a href="tel:+18882332334">888-233-2334</a> or <a href="https://aedpregnancyregistry.org" target="_blank">aedpregnancyregistry.org</a>). The purpose of these registries is to collect information about the safety of antiseizure medicines during pregnancy.</p><p><strong>What is EPIDIOLEX (cannabidiol)?</strong></p><p>EPIDIOLEX is a prescription medicine that is used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients 1 year of age and older. It is not known if EPIDIOLEX is safe and effective in children under 1 year of age.</p><p>Please read the EPIDIOLEX <a href="/MedGuide" target="_blank">Medication Guide</a> and <a href="/IFU" target="_blank">Instructions for Use</a> for additional important information.</p><p>You are encouraged to report side effects of prescription drugs to the FDA. Visit <a href="https://www.fda.gov/medwatch">www.fda.gov/medwatch</a> or call 1-800-FDA-1088. You may also contact Jazz Pharmaceuticals at <a href="tel:+18005205568">1-800-520-5568</a>.</p></div></div> </section> <section id="block-importantsafetyinformation" class="settings-tray-editable block block-block-content block-block-content1a21e897-d75e-4a3d-80ff-8e489832dc8d clearfix" data-drupal-settingstray="editable"> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><div class="sticky"><div class="flex-h"><div><p><strong>Important Safety Information</strong></p><p><strong class="more-margin">What is the Most Important Information I Should Know About EPIDIOLEX (cannabidiol)?</strong><br>Do not take if you are allergic to cannabidiol or any of the ingredients in EPIDIOLEX. EPIDIOLEX may cause liver problems. Your doctor may order blood tests to check your liver before and during EPIDIOLEX treatment. <span>In some cases, EPIDIOLEX treatment may need to be stopped. Call your doctor right away if…</span></p></div><div><p><strong>Indications</strong></p><p><strong class="more-margin">What is EPIDIOLEX (cannabidiol)?</strong><br>EPIDIOLEX is a prescription medicine that is used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex<span class="dot-dot-dot">…</span><span> in patients 1 year of age and older. It is not known if EPIDIOLEX is safe and effective in children under 1 year of age.</span></p></div></div></div><div class="full"><p><strong class="mobile-only">Important Safety Information & Indications</strong> <strong class="desktop-only">Important Safety Information & Indications</strong></p><p><strong>What is the Most Important Information I Should Know About EPIDIOLEX (cannabidiol)?</strong></p><p>Do not take if you are allergic to cannabidiol or any of the ingredients in EPIDIOLEX.</p><p class="gotta-make-this-a-perfect-27px">EPIDIOLEX may cause liver problems. Your doctor may order blood tests to check your liver before and during EPIDIOLEX treatment. In some cases, EPIDIOLEX treatment may need to be stopped. Call your doctor right away if you start to have any of these signs and symptoms of liver problems during treatment with EPIDIOLEX<span>:</span></p><ul class="flex-list"><li>loss of appetite, nausea, vomiting</li><li>itching</li><li>fever, feeling unwell, unusual tiredness</li><li>unusual darkening of the urine</li><li>yellowing of the skin or the whites of the eyes (jaundice)</li><li>right upper stomach area pain or discomfort</li></ul><p>EPIDIOLEX may cause you to feel sleepy, which may get better over time. Other medicines (e.g., clobazam) or alcohol may increase sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how EPIDIOLEX affects you.</p><p>Like other antiseizure medicines, EPIDIOLEX may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your doctor right away if you have any signs of depression or anxiety, thoughts about suicide or self-harm, feelings of agitation or restlessness, aggression, irritability, or other unusual changes in behavior or mood, especially if they are new, worse, or worry you.</p><p>Take EPIDIOLEX exactly as your doctor tells you. Do not stop taking EPIDIOLEX without first talking to your doctor. Stopping an antiseizure medicine suddenly can cause serious problems.</p><p><strong>What Else Should I Know When Taking EPIDIOLEX?</strong></p><p>The most common side effects of EPIDIOLEX include increase in liver enzymes, sleepiness, decreased appetite, diarrhea, fever, vomiting, feeling very tired and weak, rash, sleep problems, and infections.</p><p>EPIDIOLEX may affect the way other medicines work, and other medicines may affect how EPIDIOLEX works. Do not start or stop other medicines without talking to your doctor. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and cannabis-based products.</p><p><strong>What Additional Information Applies to Women?</strong></p><p>If you are pregnant or plan to become pregnant, EPIDIOLEX may harm your unborn baby, and medicines like EPIDIOLEX may be passed into breast milk. You and your doctor will decide if you should take EPIDIOLEX and about the best way to feed your baby while taking EPIDIOLEX. If you become pregnant while taking EPIDIOLEX, discuss registering with the EPIDIOLEX Pregnancy Surveillance Program (<a href="tel:+18552727158">855-272-7158</a> or <a href="https://epidiolexpregnancystudy.com" target="_blank">epidiolexpregnancystudy.com</a>) and the North American Antiepileptic Drug Pregnancy Registry (<a href="tel:+18882332334">888-233-2334</a> or <a href="https://aedpregnancyregistry.org" target="_blank">aedpregnancyregistry.org</a>). The purpose of these registries is to collect information about the safety of antiseizure medicines during pregnancy.</p><p><strong>What is EPIDIOLEX (cannabidiol)?</strong></p><p>EPIDIOLEX is a prescription medicine that is used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients 1 year of age and older. It is not known if EPIDIOLEX is safe and effective in children under 1 year of age.</p><p>Please read the EPIDIOLEX <a href="/MedGuide" target="_blank">Medication Guide</a> and <a href="/IFU" target="_blank">Instructions for Use</a> for additional important information.</p><p>You are encouraged to report side effects of prescription drugs to the FDA. Visit <a href="https://www.fda.gov/medwatch">www.fda.gov/medwatch</a> or call 1-800-FDA-1088. You may also contact Jazz Pharmaceuticals at <a href="tel:+18005205568">1-800-520-5568</a>.</p></div></div> </section> </div> <footer class="footer container-fluid" role="contentinfo"> <div class="region region-footer"> <section id="block-socialicons" class="settings-tray-editable block block-block-content block-block-content1b47d59b-d87e-45fe-b064-20ad6ce55833 clearfix" data-drupal-settingstray="editable"> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><div class="flex-h"><a href="https://www.facebook.com/EPIDIOLEX/"> <svg height="30px" version="1.1" viewbox="0 0 30 30" width="30px" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink">  <title>Facebook Icon</title> <desc>Created with Sketch.</desc> <g fill="none" fill-rule="evenodd" id="Symbols" stroke="none" stroke-width="1"> <g fill="#FFFFFF" id="D-/-Component-/-Footer" transform="translate(-35.000000, -28.000000)"> <g id="Group" 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All rights reserved.</p><p>US-EPX-2200401 Rev0924</p></div> </section> <section id="block-scrolltotop" class="settings-tray-editable block block-block-content block-block-content28d937f2-4e99-4ee2-8b4c-efc948ff5b20 clearfix" data-drupal-settingstray="editable"> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p><img src="/themes/custom/epidiolex/images/icons/scroll-to-top.svg" alt="top scroll icon"></p> </div> </section> </div> </footer> <div class="region region-modals"> <section id="block-tscannouncementmodal" class="settings-tray-editable block block-block-content block-block-contentaef183e3-c00b-4bc5-b557-5747575e9350 clearfix" data-drupal-settingstray="editable"> <div class="modal" tabindex="-1" role="dialog"> <div class="modal-dialog" role="document"> <div class="modal-content"> <div class="modal-body"> <button type="button" class="close" data-dismiss="modal" aria-label="Close"> <span aria-hidden="true">×</span> </button> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><h3>EPIDIOLEX<sup>®</sup> (cannabidiol) is now approved for the treatment of seizures associated with TSC!</h3> <p>EPIDIOLEX was recently approved by the FDA to treat seizures associated with tuberous sclerosis complex (TSC) in people 1 year of age and older. You can find results of the EPIDIOLEX TSC study <a href="/about-epidiolex">here</a> and see the stories on people living with TSC who take EPIDIOLEX <a href="/patient-stories">here</a>.</p> <p><strong>See our updated Prescribing Info, featuring TSC information, <a href="/sites/default/files/pdfs/0820/EPX-03645-0820_EPIDIOLEX_(cannabidiol)_USPI.pdf" target="_blank">here</a>.<img alt data-entity-type data-entity-uuid src="/themes/custom/epidiolex/images/icons/chevron-right.svg"></strong></p></div> </div> </div> </div> </div> </section> </div>  <div id="stay-informed-modal" class="modal" tabindex="-1" role="dialog"> <div class="modal-dialog" role="document"> <div class="modal-content"> <div class="modal-header"> <button type="button" class="close" data-dismiss="modal" aria-label="Close"><span aria-hidden="true"><img src="/themes/custom/epidiolex/images/icons/close-pink.svg" alt="close icon"></span></button> </div> <div class="modal-body"> <div class="image-banner sign-up"> <div 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