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OXLUMO® (lumasiran) | Healthcare Professional Website

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Call 1&#8209;833&#8209;256&#8209;2748</a> </li> <li> <a href="#ISI" class="js-open-isi">Important Safety Information </a> </li> <li> <a href="https://www.alnylam.com/oxlumo-us-prescribing-information" target="_blank" class="fpi">Full Prescribing Information</a> </li> <li class="last"> <a href="https://www.oxlumo.com" class="patient-link show-hcp">Patient Site</a> </li> </ul> </nav> <nav role="navigation" aria-labelledby="block-mainnavigation-menu" id="block-mainnavigation" class="block block-menu navigation menu--main"> <p class="visually-hidden" id="block-mainnavigation-menu">Main navigation</p> <input type="checkbox" name="mobile_btn" class="mobile_btn_ckbox"> <div class="mobile_btn"> <label for="mobile_btn"> <span></span> <span></span> <span></span> </label> </div> <ul class="menu menu--main"> <li class="first"> <a href="/primary-hyperoxaluria-type-1-background" class="hide-day1 show-hcp" data-drupal-link-system-path="node/16">About PH1</a> </li> <li> <a href="/how-oxlumo-works" class="hide-day1 show-hcp" data-drupal-link-system-path="node/17">About OXLUMO<span class="hide_desktop">®</span></a> </li> <li> <a href="/efficacy-and-safety" data-drupal-link-system-path="node/18">Efficacy & Safety</a> </li> <li> <a href="/dosing-and-administration" data-drupal-link-system-path="node/19">Dosing & Administration</a> </li> <li> <a href="/patient-support" data-drupal-link-system-path="node/20">Patient Support Services</a> </li> <li> <a href="/sign-up-for-updates" class="hide-day1" data-drupal-link-system-path="node/4">Get Updates</a> </li> <li> <a href="" class="show-hcp-only hide-day14">Connect With a Representative</a> </li> <li> <a href="tel:1-833-256-2748" class="mobile_call"><span class="title">For Alnylam Assist™</span> <span class="call_box"> <strong>Call <span class="number">1-833-256-2748</span></strong><br> <span class="hours">Monday-Friday, 8<sub>&nbsp;AM</sub>-6<sub>&nbsp;PM</sub></span></a> </li> <li class="last"> <a href="https://www.oxlumo.com" class="patient_site">PATIENT SITE</a> </li> </ul> </nav> </div> <div class="region region-header-third"> <div id="block-connectbutton" class="block block-block-content block-block-contentac762462-41f1-4379-a040-8cb090514b2c"> <div class="field--item"><p><a class="btn js-close-isi js-close-mobile js-open-corp-inter" href="https://alnylamconnect.com/oxlumo">CONNECT&nbsp;WITH A&nbsp;REPRESENTATIVE</a></p> </div> </div> </div> </div> </div> <div class="header_bottom"> <div class="wrapper"> </div> </div> </header> <main role="main" class="main-container js-quickedit-main-content"> <div class="region region-content-top"> <div data-drupal-messages-fallback class="hidden"></div> </div> <section> <a id="main-content"></a> <div class="region region-content"> <div id="block-oxlumo-content" class="block block-system block-system-main-block"> <article data-history-node-id="15" role="article" about="/home" typeof="schema:WebPage" class="node node--type-page node--view-mode-full"> <span property="schema:name" content="Homepage" class="rdf-meta hidden"></span> <div class="node__content"> <div class="field field--name-field-section field--type-entity-reference-revisions field--label-hidden field--items"> <div class="field--item"> <section class="home-hero" > <div class="wrapper"> <div class="field field--name-field-sub-section field--type-entity-reference-revisions field--label-hidden field--items"> <div class="field--item"> <div class="paragraph paragraph--type--full-html-content paragraph--view-mode--default"> <div class="clearfix text-formatted field field--name-field-content field--type-text-long field--label-hidden field--items"> <div class="field--item"><h1>THE FIRST APPROVED PH1 TREATMENT <span style="color:white">FOR PATIENTS OF ALL AGES AND STAGES OF KIDNEY FUNCTION<sup class="hide_desktop">†</sup><span class="hide_mobile">*</span><sup>1-4</sup></span></h1> <p>OXLUMO® (lumasiran) is indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate (UOx) and plasma oxalate (POx) levels in children and adults. OXLUMO acts at the liver, the site of oxalate production. Overproduction of oxalate is the primary cause of disease manifestation in PH1.<sup>1-4</sup></p> <p class="note dagger hide_desktop">In clinical trials, OXLUMO was evaluated in both pediatric and adult patients, including those with an estimated glomerular filtration rate (eGFR) ranging from 8.6 mL/min/1.73 m<sup>2</sup> to ≥90 mL/min/1.73 m<sup>2</sup> and patients on hemodialysis.<sup>1,5</sup></p> <p class="note asterisk hide_mobile">In clinical trials, OXLUMO was evaluated in both pediatric and adult patients, including those with an estimated glomerular filtration rate (eGFR) ranging from 8.6 mL/min/1.73 m<sup>2</sup> to ≥90 mL/min/1.73 m<sup>2</sup> and patients on hemodialysis.<sup>1,5</sup></p> <p><a class="btn arrow" href="/how-oxlumo-works">Tell Me About OXLUMO</a> <a class="btn btn-secondary arrow" href="/primary-hyperoxaluria-type-1-background">Tell Me About PH1</a></p> <div class="caption"> <div class="name"><strong>Grace<br /> <em>Person with PH1<sup class="hide_mobile">†</sup><span class="hide_desktop">*</span></em></strong></div> <strong><sup class="hide_mobile">†</sup><span class="hide_desktop">*</span>Alnylam is proud to feature real patients in our advertising. Patients may or may not be on an Alnylam therapy.</strong></div> </div> </div> </div> </div> </div> </div> </section> </div> <div class="field--item"> <section class="columns image-text" > <div class="wrapper"> <div class="field field--name-field-sub-section field--type-entity-reference-revisions field--label-hidden field--items"> <div class="field--item"> <div class="paragraph paragraph--type--full-html-content paragraph--view-mode--default"> <div class="clearfix text-formatted field field--name-field-content field--type-text-long field--label-hidden field--items"> <div class="field--item"><article class="align-center media media--type-image media--view-mode-default"><div class="field--label sr-only">Image</div> <div class="field--item"> <img src="/sites/default/files/2023-02/patient-with-ph1-1.jpg" width="623" height="530" alt="" loading="lazy" typeof="foaf:Image" /></div> </article><div class="caption white"><strong>Natalie<br /> Person with PH1*</strong></div> <p class="note asterisk mt-16">Alnylam is proud to feature real patients in our advertising. Patients may or may not be on an Alnylam therapy.</p> </div> <div class="field--item"><h2>Treatment with OXLUMO led to powerful reduction in 24-hour urinary oxalate in patients with PH1<sup>1</sup></h2> <p>Treatment with OXLUMO resulted in a 53% reduction in 24-hour UOx excretion from baseline to month 6 (primary endpoint for ILLUMINATE-A) for OXLUMO compared to placebo in a double-blind clinical trial of 39 patients ≥6 years with eGFR ≥30&nbsp;mL/min/1.73&nbsp;m<sup>2</sup>.<sup>†1,3</sup></p> <p class="note dagger">Least squares mean reduction averaged over months 3 through 6, corrected for BSA (OXLUMO, 65%; placebo, 12%); 95% CI: 45, 62; P&lt;0.0001 vs placebo.</p> <p><a class="btn arrow" href="/efficacy-and-safety">Show Me the Data</a></p> </div> </div> </div> </div> </div> </div> </section> </div> <div class="field--item"> <section class="columns text-image" > <div class="wrapper"> <div class="field field--name-field-sub-section field--type-entity-reference-revisions field--label-hidden field--items"> <div class="field--item"> <div class="paragraph paragraph--type--full-html-content paragraph--view-mode--default"> <div class="clearfix text-formatted field field--name-field-content field--type-text-long field--label-hidden field--items"> <div class="field--item"><h2>The dosing regimen for OXLUMO led to a rapid reduction in 24-hr UOx within 2 weeks, which was sustained through 24 months*<sup>1,3,6</sup></h2> <p>OXLUMO is a subcutaneous injection dosed by weight.</p> <p><a class="btn arrow" href="/dosing-and-administration">Show Me the Dosing Regimens</a></p> <p class="note asterisk">In ILLUMINATE-A: OXLUMO demonstrated reduction in 24-hr UOx excretion from baseline to month 6 compared to placebo.</p> </div> <div class="field--item"><article class="align-center media media--type-image media--view-mode-default"><div class="field--label sr-only">Image</div> <div class="field--item"> <img src="/sites/default/files/2021-12/family-boating.jpg" width="623" height="530" alt="Person With PH1 Disease" loading="lazy" typeof="foaf:Image" /></div> </article></div> </div> </div> </div> </div> </div> </section> </div> <div class="field--item"> <section class="callout educator" > <div class="wrapper"> <div class="field field--name-field-sub-section field--type-entity-reference-revisions field--label-hidden field--items"> <div class="field--item"> <div class="paragraph paragraph--type--full-html-content paragraph--view-mode--default"> <div class="clearfix text-formatted field field--name-field-content field--type-text-long field--label-hidden field--items"> <div class="field--item"><article class="align-center media media--type-image media--view-mode-default"><div class="field--label sr-only">Image</div> <div class="field--item"> <img src="/sites/default/files/2021-12/dialog-icon-white.png" width="65" height="62" alt="" loading="lazy" typeof="foaf:Image" /></div> </article><h2 class="text-align-center">WANT TO SPEAK WITH AN OXLUMO REPRESENTATIVE?</h2> <p class="text-align-center">Our representatives are available to provide detailed information about OXLUMO and how it may help your patients with PH1.</p> <p class="text-align-center"><a class="btn js-open-corp-inter" href="https://alnylamconnect.com/oxlumo">Let's Connect</a></p> </div> </div> </div> </div> </div> </div> </section> </div> <div class="field--item"> <section class ="columns support" > <div class="wrapper"> <div class="field field--name-field-sub-section field--type-entity-reference-revisions field--label-hidden field--items"> <div class="field--item"> <div class="paragraph paragraph--type--full-html-content paragraph--view-mode--default"> <div class="clearfix text-formatted field field--name-field-content field--type-text-long field--label-hidden field--items"> <div class="field--item"><article class="align-center media media--type-image media--view-mode-default"><div class="field--label sr-only">Image</div> <div class="field--item"> <img src="/sites/default/files/2020-10/signup-icon.svg" alt="'" loading="lazy" typeof="foaf:Image" /></div> </article><h2>There’s more to learn about OXLUMO</h2> <p>When you sign up, we will keep you informed with updates and resources.</p> <p><a class="btn btn-secondary" href="/sign-up-for-updates">Sign Me Up</a></p> </div> <div class="field--item"><article class="align-center media media--type-image media--view-mode-default"><div class="field--label sr-only">Image</div> <div class="field--item"> <img src="/sites/default/files/2020-09/alnylam-assist-logo-green-bg.svg" alt="Alnylam Assist™ Logo" loading="lazy" typeof="foaf:Image" /></div> </article><h2>Alnylam Assist® provides support services for patients throughout their treatment with OXLUMO.</h2> <p>Alnylam Assist® includes patient services in 4 key areas, including understanding insurance benefits and financial assistance options for eligible patients,* helping ensure access to therapy, and providing PH1 disease education.</p> <p><a class="btn btn-secondary" href="/patient-support">Let's Get Started</a></p> </div> </div> </div> </div> </div> </div> </section> </div> <div class="field--item"> <section class="pt-0 pb-0" > <div class="wrapper"> <div class="field field--name-field-sub-section field--type-entity-reference-revisions field--label-hidden field--items"> <div class="field--item"> <div class="paragraph paragraph--type--full-html-content paragraph--view-mode--default"> <div class="clearfix text-formatted field field--name-field-content field--type-text-long field--label-hidden field--items"> <div class="field--item"><p class="note asterisk">Patients must meet specified eligibility criteria to qualify for assistance. Alnylam reserves the right to make eligibility determinations and to modify or discontinue the program at any time.</p> </div> </div> </div> </div> </div> </div> </section> </div> <div class="field--item"> <section class="callout green" > <div class="wrapper"> <div class="field field--name-field-sub-section field--type-entity-reference-revisions field--label-hidden field--items"> <div class="field--item"> <div class="paragraph paragraph--type--full-html-content paragraph--view-mode--default"> <div class="clearfix text-formatted field field--name-field-content field--type-text-long field--label-hidden field--items"> <div class="field--item"><a href="/primary-hyperoxaluria-type-1-background"> <span class="inner"> <span class="left_text"> <p><em>NEXT:</em></p> <p class="hide_mobile">LEARN MORE ABOUT PH1: A DISEASE OF OXALATE OVERPRODUCTION<sup>3</sup></p> </span> <span class="hide_mobile align-center media"> <img src="/sites/default/files/2020-07/slash.svg" alt="" typeof="foaf:Image"> </span> <span class="right_text">ABOUT<br> <span class="arrow">PH1</span> </span> </span> </a></div> </div> </div> </div> </div> </div> </section> </div> <div class="field--item"> <section class="references" > <div class="wrapper"> <div class="field field--name-field-sub-section field--type-entity-reference-revisions field--label-hidden field--items"> <div class="field--item"> <div class="paragraph paragraph--type--full-html-content paragraph--view-mode--default"> <div class="clearfix text-formatted field field--name-field-content field--type-text-long field--label-hidden field--items"> <div class="field--item"><p><strong>1. </strong>OXLUMO Prescribing Information. Cambridge, MA: Alnylam Pharmaceuticals, Inc. <strong>2.</strong> Lieske J, Sellier-Leclerc A-L, Shasha-Lavsky H, et al. Poster presented at ASN Kidney Week; November 2-5, 2023; Philadelphia, PA. <strong>3.</strong> Garrelfs SF, Frishberg Y, Hulton SA, et al. <em>N Engl J Med</em>. 2021;384(13):1216-1226. <strong>4.&nbsp;</strong>Sas DJ, Magen D, Hayes W, et al. <em>Genet Med</em>. 2022;24(3):654-662. <strong>5.</strong> Michael M, Groothoff JW, Shasha-Lavsky H, et al. <em>Am J Kidney Dis</em>. 2023;81(2):145-155.e1. <strong>6.&nbsp;</strong>Lieske J, Groothoff JW, Frishberg Y, et al. Presented at: National Kidney Foundation Spring Clinical Meetings; April 6-10, 2022; Boston, MA.</p> </div> </div> </div> </div> </div> </div> </section> </div> </div> <div property="schema:text" class="field--item"></div> </div> </article> </div> </div> </section> <div class="region region-content-bottom"> <div id="block-importantsafetyinformation" class="isi block block-block-content block-block-content63d76fc1-b7f0-475f-917b-98825b6fba84"> <span class="close-isi"></span> <span class="open-isi"></span> <div class="field--item"><p class="h3">IMPORTANT SAFETY INFORMATION</p> <p><strong>Adverse Reactions</strong><br /> The most common (≥20%) adverse reaction reported in patients treated with OXLUMO was injection site reaction. Injection site reactions included erythema, swelling, pain, hematoma, pruritus, and discoloration.</p> <p><strong>Pregnancy and Lactation</strong><br /> No data are available on the use of OXLUMO in pregnant women. No data are available on the presence of OXLUMO in human milk or its effects on breastfed infants or milk production. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for OXLUMO and any potential adverse effects on the breastfed child from OXLUMO or the underlying maternal condition.</p> <p class="h3">INDICATION</p> <p>OXLUMO is indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in children and adults.</p> <p><strong style="color: inherit;">For additional information about OXLUMO, please see the full <a href="https://www.alnylam.com/oxlumo-us-prescribing-information" target="_blank">Prescribing Information</a>.</strong></p> </div> </div><div id="block-corporateinterstitial" class="block block-block-content block-block-content6e2edfba-b157-4b45-b715-dc959aab885e"> <div class="field--item"><div class="popup" id="corp_inter"> <div class="wrapper"><a class="close js-close-popup" href="#">×</a> <p class="h3">You are now leaving OXLUMOHCP.com</p> <p>You are now being directed to another Alnylam website.</p> <p><a class="btn link js-close-popup" href="#">Visit Site</a> <a class="btn btn-secondary js-close-popup" href="#">Cancel</a></p> </div> </div> <div class="popup" id="inter"> <div class="wrapper"><a class="close js-close-popup" href="#">×</a> <p class="h3">You are now leaving OXLUMOHCP.com</p> <p>Links to all outside sites are provided as a reference for our visitors. 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