How Was AMVUTTRA Studied? | AMVUTTRA® (vutrisiran)

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data-history-node-id="9" role="article" about="/about-amvuttra/how-amvuttra-was-studied" class="node node--basic-page-with-sections --view-mode--full"> <div class="node__content"> <div class="sections basic_page_with_sections__item"> <div class="sections__item --large_text"> <h1 class="page__title">How was AMVUTTRA® studied?</h1> <h3>The safety and efficacy of AMVUTTRA were evaluated in an 18-month study of 164 adult patients with polyneuropathy caused by hATTR amyloidosis.</h3> <p>The clinical study of AMVUTTRA focused on changes in <strong>nerve function</strong> and <strong>quality of life</strong>.</p> <p>The effects of AMVUTTRA on other aspects of the disease, including <strong>walking speed, nutritional health,</strong> and <strong>ability to perform activities of daily living,</strong> were also evaluated.</p> </div> <div class="sections__item --title"> <div class="title"> <div class="title__item">In the Study:</div> </div> </div> <div class="sections__item 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</div> </div> </div> </div> </div> </div> <div class="blocks__item --large_text"> <p><strong>The efficacy of AMVUTTRA was evaluated using multiple assessments.</strong></p> </div> </div> </div> <div class="blocks__item --container_block"> <div class="blocks"> <div class="blocks__item --image"> <div class="image-default"> <div class="image-default__item"> <div class="media media--svg --view-mode--full"> <div class="media-svg-1"> <div class="media-svg-1__item"> <svg xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" width="55.259" height="76.769" viewBox="0 0 55.259 76.769"> <defs> <clipPath id="clip-path"> <rect id="Rectangle_235" data-name="Rectangle 235" width="55.259" height="76.769" transform="translate(14.855)" fill="none"/> </clipPath> </defs> <g id="Group_1241" data-name="Group 1241" transform="translate(-14.855)" clip-path="url(#clip-path)"> <path id="Path_5474" data-name="Path 5474" 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</a></div> </div> </div> </article> </div> <div id="isi" id="block-isi" class="isi-inline"> <div class="container"> <div class="body"> <div class="body__item"><h2>Important Safety Information and Indication</h2> <h3>Important Safety Information</h3> <h4>What are the most important things I should know about AMVUTTRA<sup>®</sup> (vutrisiran)?</h4> <p>AMVUTTRA can cause:</p> <ul><li> <h4>Low Vitamin A Levels</h4> <p>Treatment with AMVUTTRA lowers the amount of vitamin A in your blood. Your doctor will tell you to take a vitamin A supplement every day. You should not take more than the amount of vitamin A recommended by your doctor.</p> <p>Low vitamin A levels can affect vision. If you have problems with your vision (e.g., night blindness) while taking AMVUTTRA, talk to your doctor. Your doctor may refer you to an eye specialist.</p> </li> </ul><h4>What are the common side effects of AMVUTTRA?</h4> <p>The most common side effects of AMVUTTRA are pain in the arms or legs, pain in the joints (arthralgia), shortness of breath (dyspnea), and low vitamin A levels.</p> <p>These are not all the possible side effects of AMVUTTRA. Talk to your doctor about side effects that you experience. You are encouraged to report negative side effects of prescription drugs to the U.S. Food and Drug Administration (FDA). Visit <a href="https://www.fda.gov/medwatch">www.fda.gov/medwatch</a>, or call 1-800-FDA-1088.</p> <h3>Indication</h3> <h4>What is AMVUTTRA?</h4> <p>AMVUTTRA is a prescription medicine that treats the polyneuropathy caused by an illness called hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis). AMVUTTRA is used in adults only.</p> <h4>For additional information about AMVUTTRA, please see the full <a href="https://www.alnylam.com/sites/default/files/pdfs/amvuttra-us-prescribing-information.pdf" target="_blank">Prescribing Information</a>.</h4> <div class="w-full text-center"><a class="for-hcp" href="https://www.amvuttrahcp.com">For healthcare providers</a></div></div> </div> </div> </div><div class="isi-tray collapsed"> <div class="container relative"> <button class="toggle-isi"> <img class="open" src="/themes/amvuttra/assets/images/0.0-icn-plus.svg" alt="Open ISI" /> <img class="close" src="/themes/amvuttra/assets/images/0.0-icn-x-lg.svg" alt="Close ISI" /> </button> <div class="paragraphs"> <div class="paragraphs__item --embed_block"> <div class="block"> <div class="block__item"><div id="block-isicontent" class="block-block-content:0a26fb4c-c9db-4f7e-9c83-83eee0fd1104"> <div class="body"> <div class="body__item"><div class="h1">Important Safety Information and Indication</div> <div class="h2">Important Safety Information</div> <div class="h3">What are the most important things I should know about AMVUTTRA® (vutrisiran)?</div> <div class="p">AMVUTTRA can cause:</div> <div class="ul"> <div class="li"> <div class="h3">Low Vitamin A Levels</div> <div class="p">Treatment with AMVUTTRA lowers the amount of vitamin A in your blood. Your doctor will tell you to take a vitamin A supplement every day. You should not take more than the amount of vitamin A recommended by your doctor.</div> <div class="p">Low vitamin A levels can affect vision. If you have problems with your vision (e.g., night blindness) while taking AMVUTTRA, talk to your doctor. Your doctor may refer you to an eye specialist.</div> </div> </div> <div class="h3">What are the common side effects of AMVUTTRA?</div> <div class="p">The most common side effects of AMVUTTRA are pain in the arms or legs, pain in the joints (arthralgia), shortness of breath (dyspnea), and low vitamin A levels.</div> <div class="p">These are not all the possible side effects of AMVUTTRA. Talk to your doctor about side effects that you experience. You are encouraged to report negative side effects of prescription drugs to the U.S. Food and Drug Administration (FDA). Visit <a href="https://www.fda.gov/medwatch">www.fda.gov/medwatch</a>, or call 1-800-FDA-1088.</div> <div class="h2">Indication</div> <div class="h3">What is AMVUTTRA?</div> <div class="p">AMVUTTRA is a prescription medicine that treats the polyneuropathy caused by an illness called hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis). AMVUTTRA is used in adults only.</div> <div class="h3">For additional information about AMVUTTRA, please see the full <a href="https://www.alnylam.com/sites/default/files/pdfs/amvuttra-us-prescribing-information.pdf">Prescribing Information</a>.</div> <div class="p"><a href="https://www.amvuttrahcp.com">For healthcare providers</a></div> </div> </div> </div> </div> </div> </div> <div class="paragraphs__item --container_block"> <div class="blocks"> <div class="blocks__item --link"> <div class="link"> <div class="link__item"><a href="/stay-informed">Stay Informed</a></div> </div> </div> <div class="blocks__item --link_icon"><a class="link" href="https://www.amvuttrahcp.com" title="For healthcare providers" > For healthcare providers <div class="image-default"> <div class="image-default__item"> <div class="media media--svg --view-mode--default"> <div class="media-svg-1"> <div class="media-svg-1__item"> <span class="svg-title" aria-hidden="true">Go to page icon</span> <svg xmlns="http://www.w3.org/2000/svg" width="15.811" height="15.811" viewBox="0 0 15.811 15.811"><g transform="translate(0.75 1.061)"><path d="M6.125,0H1.75A1.75,1.75,0,0,0,0,1.75V9.625a1.75,1.75,0,0,0,1.75,1.75H9.625a1.75,1.75,0,0,0,1.75-1.75V5.25" transform="translate(0 2.625)" fill="none" stroke="#e7004c" stroke-linecap="round" stroke-linejoin="round" stroke-miterlimit="10" stroke-width="1.5"/><path d="M0,8.75,8.75,0" transform="translate(5.25 0)" fill="none" stroke="#e7004c" stroke-linecap="round" stroke-linejoin="round" stroke-miterlimit="10" stroke-width="1.5"/><path d="M0,0H4.375V4.375" transform="translate(9.625)" fill="none" stroke="#e7004c" stroke-linecap="round" stroke-linejoin="round" stroke-miterlimit="10" stroke-width="1.5"/></g></svg> </div> </div> </div> </div> </div> </a> </div> </div> </div> </div> </div> </div> </div> </div>  <div class="fixed hidden inset-0 overflow-y-auto h-full w-full items-start md:items-center" id="modals-overflow">  <div class="modal" id="welcome-popup"> <div class="modal-body px-4"> <div class="logo"> <img src="/themes/amvuttra/logo.svg" alt="AMVUTTRA™ (vutrisiran) logo"> </div> <div class="content"> <h2 class="title">The site you are about to enter is intended for US healthcare professionals.</h2> <p class="description">Are you a US healthcare professional?</p> <a href="#" tabindex="1" class="confirm-btn" data-modal-target="1"> Confirm and enter <svg class="inline" version="1.1" id="Layer_1" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" x="0px" y="0px" width="18px" height="18px" viewBox="0 0 20 20" style="enable-background:new 0 0 20 20;" xml:space="preserve"> <path class="st0" d="M18.995,10c0-0.282-0.118-0.534-0.306-0.716l-7.019-7.018c-0.391-0.391-1.023-0.391-1.414,0 s-0.391,1.023,0,1.414L15.577,9H1.595c-0.552,0-1,0.448-1,1s0.448,1,1,1h13.982l-5.32,5.319c-0.391,0.391-0.391,1.023,0,1.414 c0.195,0.195,0.451,0.293,0.707,0.293s0.512-0.098,0.707-0.293l7.019-7.018C18.878,10.534,18.995,10.281,18.995,10z" /> </svg> </a> <a tabindex="2" class="close-btn icon-link-external-right" href="#" data-modal-target="1">Visit patient site</a> </div> </div> </div> <div class="modal" id="corporative-popup"> <div class="modal-body px-4"> <div class="logo"> <img src="/themes/amvuttra/logo.svg" alt="AMVUTTRA™ (vutrisiran) logo"> </div> <div class="content"> <h2 class="title">You are now leaving amvuttra.com.</h2> <p class="description">You are now being directed to another Alnylam website.</p> <a class="confirm-btn" href="#" target="_blank" data-modal-target="2"> Proceed <svg class="inline" version="1.1" id="Layer_1" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" x="0px" y="0px" width="18px" height="18px" viewBox="0 0 20 20" style="enable-background:new 0 0 20 20;" xml:space="preserve"> <path class="st0" d="M18.995,10c0-0.282-0.118-0.534-0.306-0.716l-7.019-7.018c-0.391-0.391-1.023-0.391-1.414,0 s-0.391,1.023,0,1.414L15.577,9H1.595c-0.552,0-1,0.448-1,1s0.448,1,1,1h13.982l-5.32,5.319c-0.391,0.391-0.391,1.023,0,1.414 c0.195,0.195,0.451,0.293,0.707,0.293s0.512-0.098,0.707-0.293l7.019-7.018C18.878,10.534,18.995,10.281,18.995,10z" /> </svg> </a> <a tabindex="2" class="close-btn" href="#" data-modal-target="2">Cancel</a> </div> </div> </div> <div class="modal" id="thirdparty-popup"> <div class="modal-body px-4"> <div class="logo"> <img src="/themes/amvuttra/logo.svg" alt="AMVUTTRA™ (vutrisiran) logo"> </div> <div class="content"> <h2 class="title">You are now leaving amvuttra.com.</h2> <p class="description"> Links to all outside sites are provided as a reference for our visitors. 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