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Date
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2019-11-15
34.203.149.158
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2026-02-14
45.60.150.161
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HTTP/1.1 301 Moved PermanentlyServer: CloudFrontDate: Sat, 14 Feb 2026 14:37:32 GMTContent-Type: text/htmlContent-Length: 167Connection: keep-aliveLocation: https://www.inrebicpro.com/X-Cache: Redirect from cloudfrontVia: 1.1 33d72803ad26b392c1b578a2b1276580.cloudfront.net (CloudFront)X-Amz-Cf-Pop: SEA73-P2X-Amz-Cf-Id: vrVq_sGWbM56m8ldCSuAa13zQnGrHqR-vqXtWeSNBgjRy0C63VZPVQSet-Cookie: visid_incap_3231850rKQ3uUx8QaWAmaGhxA4JzqyIkGkAAAAAQUIPAAAAAACtdPkCjwhn+qmD+GLeV9QV; expiresSun, 14 Feb 2027 06:15:07 GMT; HttpOnly; path/; Domain.inrebicpro.comSet-Cookie: nlbi_3231850Ybi9Spd3HGfUw8bFg9l5QgAAAACbtXLDbUskVOC+gA0zcpu+; HttpOnly; path/; Domain.inrebicpro.comSet-Cookie: incap_ses_2105_32318502776JBcOZ1M/NTe9pXY2HayIkGkAAAAAe0YEbOtn+BX3f50+fwh+wQ; path/; Domain.inrebicpro.comX-CDN: ImpervaX-Iinfo: 1011-5562189-5562196 NNNN CT(0 -1 0) RT(1771079852888 0) q(0 1 1 1) r(1 1) U24 html>head>title>301 Moved Permanently/title>/head>body>center>h1>301 Moved Permanently/h1>/center>hr>center>CloudFront/center>/body>/html>
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HTTP/1.1 200 OKContent-Type: text/html;charsetutf-8Transfer-Encoding: chunkedConnection: keep-aliveDate: Sat, 14 Feb 2026 14:37:33 GMTcontent-security-policy: default-src wss: https: blob: unsafe-inline unsafe-eval; media-src https: blob:; font-src https: data:;img-src https: data:;Cache-Control: max-age600,s-maxage600Server: ApacheX-Content-Type-Options: nosniffAccept-Ranges: bytesX-Dispatcher: dispatcher3useast1-28583340X-Dispatcher-Number: 3X-Vhost: publishX-Frame-Options: SAMEORIGINStrict-Transport-Security: max-age63072000; includeSubDomains; preloadVary: Accept-Encoding,User-AgentX-Cache: Miss from cloudfrontVia: 1.1 33d72803ad26b392c1b578a2b1276580.cloudfront.net (CloudFront)X-Amz-Cf-Pop: SEA73-P2X-Amz-Cf-Id: AjVw_v_wYKdrlvmxWaOPSYsZ4A084KQQ4naMCBqm0qG3E8JuPcZ3ZASet-Cookie: visid_incap_3231850xMwms1IbSfSV/+HXeHDDU6yIkGkAAAAAQUIPAAAAAAAeuEiW7IMRi0qXEMKKMILp; expiresSun, 14 Feb 2027 06:15:07 GMT; HttpOnly; path/; Domain.inrebicpro.com; Secure; SameSiteNoneSet-Cookie: nlbi_3231850YLMDAr6T7hAEyGPAg9l5QgAAAADys9LpzXcVOGtymD0Zm7Wl; HttpOnly; path/; Domain.inrebicpro.com; Secure; SameSiteNoneSet-Cookie: incap_ses_2105_3231850dkIGf26M1zCXNTe9pXY2HayIkGkAAAAAIC20b5+PisqUQNejvN8CSA; path/; Domain.inrebicpro.com; Secure; SameSiteNoneX-CDN: ImpervaX-Iinfo: 14-14695757-14695758 NNNN CT(0 3 0) RT(1771079852986 24) q(0 0 0 -1) r(0 1) U24 !DOCTYPE HTML>html langen> head> meta nameviewport contentwidthdevice-width, initial-scale1.0/> meta charsetUTF-8/>!--/ Commercial Code integration starts here/--> link href/content/dam/commercial/us/inrebicpro/en/images/Inrebic-favicon.ico typeimage/x-icon relicon/>link hrefhttps://fonts.googleapis.com/css2?familyRoboto:wght@400;500;700&displayswap relstylesheet>meta propertyog:type contentwebsite> meta propertyog:url contenthttps://www.inrebicpro.com/> meta propertyog:title contentINREBIC® (fedratinib) | For Healthcare Professionals> meta propertyog:description contentINREBIC® (fedratinib) is a treatment for adult patients with INT-2 or high-risk myelofibrosis. See full Prescribing Information, including Boxed Warning on encephalopathy, including Wernickes.> meta nametitle contentINREBIC® (fedratinib) | For Healthcare Professionals/>meta namedescription contentINREBIC® (fedratinib) is a treatment for adult patients with INT-2 or high-risk myelofibrosis. See full Prescribing Information, including Boxed Warning on encephalopathy, including Wernickes./>meta namegoogle-site-verification contentNCMh2AdOIMvcZYMfWxYp2MUh2fO6a2ycPjao5Meq-PY /> meta namekeywords content/> title>INREBIC® (fedratinib) | For Healthcare Professionals/title> link relcanonical hrefhttps://www.inrebicpro.com/> script>var digitalData { friendly_name : Inrebic-hcp-US-EN-branded, // Friendly Site Name (brand + dtc/hcp + country + language + branded/unbranded) brand_name : INREBIC, // Brand of Site (prop7) user_type : HCP, // hcp, dtc (prop10) site_country : US, // Country of Site (prop12) site_language : EN, // Language of Site (prop13) site_type : Branded, // Branded/unbranded franchise_name: Hematology, // What Franchise is this under (prop8) indication : MF(Myelofibrosis), site_abbreviation: inrebicpro-com-hcp-us // prop18 domain of the site + dtc/hcp + country}/script>!-- OneTrust Cookies Consent Notice start for inrebicpro.com -->script typetext/javascript srchttps://cdn.cookielaw.org/consent/15f5565d-ad07-4aac-9be8-99e2f2ed5efa/OtAutoBlock.js>/script>script srchttps://cdn.cookielaw.org/scripttemplates/otSDKStub.js typetext/javascript charsetUTF-8 data-domain-script15f5565d-ad07-4aac-9be8-99e2f2ed5efa>/script>script typetext/javascript>function OptanonWrapper() { }/script>!-- OneTrust Cookies Consent Notice end for inrebicpro.com --> !--/ Commercial Code integration ends here /-->input typehidden value/content/commercial/us/inrebicpro/en/home idcurrentpage/> script typetext/javascript srcfalse>/script> link typetext/css hreffalse/> script typetext/javascript> window.iswcmModeEditMode false;/script>input typehidden namegoogle_mapskey valueAIzaSyAIw2Rd_v0lfgsSjlj-txEBxxtDGxpP-q4/> script srchttps://maps.googleapis.com/maps/api/js?keyAIzaSyAIw2Rd_v0lfgsSjlj-txEBxxtDGxpP-q4&librariesplaces async defer>/script> link relstylesheet href/etc.clientlibs/bms-commercial-shared/clientlibs/base.min.css typetext/css> script src/etc.clientlibs/bms-commercial-shared/clientlibs/dependencies/jquery.min.js>/script> link relstylesheet href/etc.clientlibs/granite/ui/components/coral/foundation/components/clientlibs/components.min.css typetext/css>link relstylesheet href/etc.clientlibs/granite/ui/components/coral/foundation/clientlibs/foundation.min.css typetext/css>link relstylesheet href/etc.clientlibs/bmscorp/clientlibs/clientlibs/shared/clientlib-granite-authoring-overides.min.css typetext/css>link relstylesheet href/etc.clientlibs/bms-commercial/design/themes-clientlbs/commercial-global.min.css typetext/css> link href/content/dam/commercial/us/inrebicpro/en/inrebicpro-us-en_us-publish/css/style.css relstylesheet typetext/css/> link href/content/dam/commercial/us/inrebicpro/en/inrebicpro-us-en_us-publish/css/owl.carousel.css relstylesheet typetext/css/> link href/content/dam/commercial/us/inrebicpro/en/inrebicpro-us-en_us-publish/css/owl.theme.default.min.css relstylesheet typetext/css/> script typetext/javascript srchttps://assets.adobedtm.com/1fd9f4907f6d/9cfabfda1fed/launch-dd068ba0990d.min.js async>/script> /head> body classdisabled > input typehidden nameallRunmodes valueprod, s7connect, crx3, nosamplecontent, publish, crx3tar, publish3/> div classroot responsivegrid>div classaem-Grid aem-Grid--12 aem-Grid--default--12 > div classcolumn-control aem-GridColumn aem-GridColumn--default--12> div classrow idhome-page> div classcol col-12> div classcolumn-control-column> div classexperiencefragment section> div> div classaem-Grid aem-Grid--12 aem-Grid--default--12 > div classopentext aem-GridColumn aem-GridColumn--default--12> header classtop-header> nav classnavbar navbar-expand-lg d-none d-lg-block idtop-additional-links> div classcontainer> ul classnavbar-nav> li classnav-item>a classnav-link generic-modal-button hrefjavascript:void(0); data-togglemodal data-target#indication>Indication/a>/li> li classnav-item>a hrefhttps://packageinserts.bms.com/pi/pi_inrebic.pdf classnav-link target_blank>US full prescribing info including boxed warning/a>/li> li classnav-item>a hrefhttps://packageinserts.bms.com/medguide/medguide_inrebic.pdf classnav-link target_blank>Medication guide/a>/li> !-- li classnav-item>a hrefhttps://www.bmscustomerconnect.com/ data-authorurlhttps://www.bmscustomerconnect.com title aria-label classopen-modal nav-link data-targetexternalLink data-url/content/commercial/us/inrebicpro/en.warning.html data-classnameexternal-link-warning-modal data-aa-popuphttps://www.bmscustomerconnect.com|BMS connect>BMS connect/a>/li> --> li classnav-item>a href# id title classopenResources target aria-label>BMS Connect/a>/li> li classnav-item>a hrefhttps://www.inrebic.com/ data-authorurlhttps://www.inrebic.com title aria-label classopen-modal nav-link data-targetexternalLink data-url/content/commercial/us/inrebicpro/en.warning.html data-classnameexternal-link-warning-modal data-aa-popuphttps://www.inrebic.com|Patient site>Patient site/a>/li> /ul> /div> /nav> nav classnavbar navbar-expand-lg idmainNav> ul classmob-indication d-block d-lg-none> li>a classnav-link generic-modal-button hrefjavascript:void(0); data-togglemodal data-target#indication>Indication/a>/li> li>a hrefhttps://packageinserts.bms.com/medguide/medguide_inrebic.pdf classnav-link target_blank>Medication guide/a>/li> /ul> div classcontainer> div classmobile-top-menu> a href/ classbrand-logo> img classd-page src/assets/commercial/us/inrebicpro/en/images/logo-inrebic-desktop.svg width150 altINREBIC® (fedratinib) logo/> img classm-page src/assets/commercial/us/inrebicpro/en/images/logo-inrebic-mobile.svg width150 altINREBIC® (fedratinib) logo/> /a> button classnavbar-toggler typebutton data-togglecollapse data-target#toggleNav aria-controlstoggleNav aria-expandedfalse aria-labelToggle navigation>span classnavbar-toggler-icon>/span>/button> /div> div classheader-dropdown-content> div classcollapse navbar-collapse idtoggleNav> ul classnavbar-nav> li classnav-item>a href/about-inrebic id title classnav-link target aria-label>About br classd-page/>INREBICsup>®/sup>/a>/li> li classnav-item>a href/efficacy-safety id title classnav-link target aria-label>Efficacy br classd-page/>& Safety/a>/li> li classnav-item>a href/starting-inrebic id title classnav-link target aria-label>Starting br classd-page/>INREBICsup>®/sup>/a>/li> li classnav-item>a href/patient-management id title classnav-link target aria-label>Managing br classd-page/>Risks/a>/li> li classnav-item>a href/resources-access id title classnav-link target aria-label>Resources br classd-page/>& Access/a>/li> /ul> ul classnavbar-nav m-page additional-links> !-- li classnav-item>a hrefhttps://www.bmscustomerconnect.com/ data-authorurlhttps://www.bmscustomerconnect.com title aria-label classopen-modal nav-link data-targetexternalLink data-url/content/commercial/us/inrebicpro/en.warning.html data-classnameexternal-link-warning-modal data-aa-popuphttps://www.bmscustomerconnect.com|BMS connect>BMS Connect/a>/li> --> li classnav-item>a href# id title classopenResources target aria-label>BMS Connect/a>/li> li classnav-item>a target_blank hrefhttps://www.inrebic.com/>Patient Site/a>/li> li classnav-item>a hrefhttps://packageinserts.bms.com/pi/pi_inrebic.pdf classnav-link target_blank>US Full Prescribing Informationbr/>including BOXED WARNING/a>/li> /ul> /div> /div> /div> /nav>/header>div classmodal fade idindication roledialog aria-hiddentrue> div classmodal-dialog lightbox-modal modal-sm data-preventclosetrue> div classmodal-content > div classindication-body> button typebutton classclose data-dismissmodal aria-labelClose>/button> h2 classmodal-title>INDICATION/h2> div classindicationBody> p classindiHead>INREBICsup>®/sup> (fedratinib) is indicated for br classm-page/>the treatment of adult patients with br/>intermediate-2 or high-risk primary or br classm-page/>secondary (post-polycythemia vera br classd-page/>or br classm-page/>post-essential thrombocythemia) br classm-page/>myelofibrosis (MF)./p> /div> div classindication-close> button classlast-button typebutton data-dismissmodal aria-label>Proceed to Site/button> /div> /div> /div> /div>/div>div idresourcesPopup styledisplay: none; position: fixed; height: 100%; top: 0;left: 0;width: 100%;> div idclose_btn_new>X/div> div classresourcesContent> /div> /div> style> #close_btn_new{cursor: pointer; height: 20px; right: 50%; transform: translateX(520px); font-size: 22px; position: absolute; top: 0; width: 20px; z-index: 999999; display: inline-block;} .resourcesContent{width: 1140px; background: #fff; left: 50%; margin-left: -570px; position: absolute; overflow-y: auto; overflow-x: hidden; height: 100%;} #resourcesPopup{background-color: rgba(0,0,0,0.7); background-repeat: no-repeat; background-position: center center; z-index: 9999;} @media (max-width:575px){ #close_btn_new{right: 0;transform: translateX(0);} .cust_conn_rightbox {height:95px} } /style> /div> /div> /div>/div>div classcolumn-control content-testing-body-wrapper section> div classrow idbody-content> div classcol col-12> div classcolumn-control-column> div classexperiencefragment section> div> div classaem-Grid aem-Grid--12 aem-Grid--default--12 > div classcolumn-control aem-GridColumn aem-GridColumn--default--12> div classrow idhome-page-banner> div classcol col-12> div classcolumn-control-column> div classbgimage section>div classcmp-bgimage> div classdesktop-img-container mx-auto stylewidth:100%;height:858px;background-image:url(\2f content\2f dam\2f commercial\2fus\2finrebicpro\2f en\2fimages\2fimg-hero-home-page-desktop.png)> div classoverlay-element> div classhtml section>div> div classhome-banner-content> div classcontainer> div classpage-title> !-- h1 class>span classmainhead>GO ALL span classgradient>IN/span> /span>br> --> !-- span classsubhead>span classgradient>IN/span>REBICsup>®/sup> FROM THE START/span>/h1> --> img classd-page src/assets/commercial/us/inrebicpro/en/images/home-headline-desktop.svg/> img classm-page src/assets/commercial/us/inrebicpro/en/images/home-headline-mobile.svg/> div classarrow-link-section d-lg-block d-none> p>For adult patients with intermediate-2 br classm-page/>or high-riskbr classd-lg-block d-none> myelofibrosis (MF) who have platelet counts ≥50 × 10sup>9/sup>/Lsup>1/sup>/p> a href/about-inrebic title classarrow-link target aria-label lang>DISCOVER MORE ABOUT INREBICsup>®/sup>/a> /div> /div> /div>/div> /div>/div> /div> /div> div classmobile-img-container mx-auto stylewidth:100%;height:232px;background-image:url(\2f content\2f dam\2f commercial\2fus\2finrebicpro\2f en\2fimages\2fimg-hero-home-page-mobile.png)> div classoverlay-element> div classhtml section>div> div classhome-banner-content> div classcontainer> div classpage-title> !-- h1 class>span classmainhead>GO ALL span classgradient>IN/span> /span>br> --> !-- span classsubhead>span classgradient>IN/span>REBICsup>®/sup> FROM THE START/span>/h1> --> img classd-page src/assets/commercial/us/inrebicpro/en/images/home-headline-desktop.svg/> img classm-page src/assets/commercial/us/inrebicpro/en/images/home-headline-mobile.svg/> div classarrow-link-section d-lg-block d-none> p>For adult patients with intermediate-2 br classm-page/>or high-riskbr classd-lg-block d-none> myelofibrosis (MF) who have platelet counts ≥50 × 10sup>9/sup>/Lsup>1/sup>/p> a href/about-inrebic title classarrow-link target aria-label lang>DISCOVER MORE ABOUT INREBICsup>®/sup>/a> /div> /div> /div>/div> /div>/div> /div> /div> /div> /div>div classhtml section>div> div classarrow-link-section d-block d-lg-none> p>For adult patients with intermediate-2 br classm-page/>or high-riskbr classd-lg-block d-none> myelofibrosis who have platelet counts ≥50 × 10sup>9/sup>/Lsup>1/sup>/p> a href/about-inrebic title classarrow-link target aria-label lang>DISCOVER MORE ABOUT INREBICsup>®/sup>/a> /div> /div>/div>div classbgimage section>div classcmp-bgimage idhome-cta> div classdesktop-img-container mx-auto stylewidth:100%;height:209px;background-image:url(\2f content\2f dam\2f commercial\2fus\2finrebicpro\2f en\2fimages\2fhomepage-cta-desktop.png)> div classoverlay-element> div classhtml section>div> div classhomebanner-btmblk>!-- img classd-lg-block d-none img-fluid src/content/dam/commercial/us/inrebicpro/en/images/NCCN-lockup-container-homepage-desktop.svg> -->!-- img classd-block d-lg-none img-fluid src/content/dam/commercial/us/inrebicpro/en/images/NCCN-lockup-container-homepage-mobile.svg> -->div classimage-left>img classd-lg-block d-none img-fluid src/assets/commercial/us/inrebicpro/en/images/NCCN_homepage_desktop.svg stylewidth:604px;>img classd-block d-lg-none img-fluid src/assets/commercial/us/inrebicpro/en/images/NCCN_homepage_mobile.svg>/div>div classcnt-right>p>NCCN Guidelinessup>®/sup> recommend fedratinib (INREBICsup>®/sup>) as an initial treatment option (Category 1) for patients with higher-risk (intermediate-2 or high-risk) MF who have platelet counts ≥50 × 10sup>9/sup>/L.sup>†/sup>/p>p>*NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.br>sup>†/sup>Patients who are not transplant candidates./p>/div>/div> /div>/div> /div> /div> div classmobile-img-container mx-auto stylewidth:100%;height:584px;background-image:url(\2f content\2f dam\2f commercial\2fus\2finrebicpro\2f en\2fimages\2fhomepage-cta-mob.png)> div classoverlay-element> div classhtml section>div> div classhomebanner-btmblk>!-- img classd-lg-block d-none img-fluid src/content/dam/commercial/us/inrebicpro/en/images/NCCN-lockup-container-homepage-desktop.svg> -->!-- img classd-block d-lg-none img-fluid src/content/dam/commercial/us/inrebicpro/en/images/NCCN-lockup-container-homepage-mobile.svg> -->div classimage-left>img classd-lg-block d-none img-fluid src/assets/commercial/us/inrebicpro/en/images/NCCN_homepage_desktop.svg stylewidth:604px;>img classd-block d-lg-none img-fluid src/assets/commercial/us/inrebicpro/en/images/NCCN_homepage_mobile.svg>/div>div classcnt-right>p>NCCN Guidelinessup>®/sup> recommend fedratinib (INREBICsup>®/sup>) as an initial treatment option (Category 1) for patients with higher-risk (intermediate-2 or high-risk) MF who have platelet counts ≥50 × 10sup>9/sup>/L.sup>†/sup>/p>p>*NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.br>sup>†/sup>Patients who are not transplant candidates./p>/div>/div> /div>/div> /div> /div> /div> /div> /div> /div> /div> !--//row --> /div> /div> /div>/div>div classexperiencefragment section> div> div classaem-Grid aem-Grid--12 aem-Grid--default--12 > div classhtml aem-GridColumn aem-GridColumn--default--12>div> div classhome-demo carousel-wrapper> div classowl-carousel home-slider owl-theme> div classcol-md-4 first> a href/efficacy-safety> div classitem> img src/assets/commercial/us/inrebicpro/en/images/ico-Discover.svg width51/> h3 classsection-title>DISCOVER THE DATA/h3> p>See results for INREBICsup>®/sup> as br/>an initial JAK therapy/p> img classico-circle src/assets/commercial/us/inrebicpro/en/images/ico-circled-arrow-mint.svg/> img classico-circle-hover src/assets/commercial/us/inrebicpro/en/images/ico-circled-arrow-white.svg/> /div> /a> /div> div classcol-md-4 second> a href/starting-inrebic> div classitem> img src/assets/commercial/us/inrebicpro/en/images/ico-Dosing.svg width60/> h3 classsection-title>REVIEW DOSING DETAILS/h3> p>Getting your patients started on br/>INREBICsup>®/sup>/p> img classico-circle src/assets/commercial/us/inrebicpro/en/images/ico-circled-arrow-mint.svg/> img classico-circle-hover src/assets/commercial/us/inrebicpro/en/images/ico-circled-arrow-white.svg/> /div> /a> /div> div classcol-md-4 third> a href/resources-access> div classitem> img src/assets/commercial/us/inrebicpro/en/images/ico-Resources.svg width51/> h3 classsection-title>EXPLORE THE RESOURCES/h3> p>Help your patients br/>access INREBICsup>®/sup>/p> img classico-circle src/assets/commercial/us/inrebicpro/en/images/ico-circled-arrow-mint.svg/> img classico-circle-hover src/assets/commercial/us/inrebicpro/en/images/ico-circled-arrow-white.svg/> /div> /a> /div> /div>/div> /div>/div>div classhtml aem-GridColumn aem-GridColumn--default--12>div> !-- div classlink-wrapper green-bg-wrapper> --> !-- div classcontainer> --> !-- h3>INREBICsup>®/sup> was also studied in patients who failed ruxolitinib treatment/h3> --> !-- a href/content/commercial/us/inrebicpro/en/efficacy-safety.html title classdiagnal-btn target aria-label lang>SEE the data/a> --> !-- /div> -->!-- /div> --> /div>/div>div classhtml aem-GridColumn aem-GridColumn--default--12>div> style>@media only screen and (min-width: 1024px){.cmp-isi .hide-text-container { max-width: 25%;}}/style> /div>/div> /div> /div>/div> /div> /div> /div> !--//row --> /div>div classexperiencefragment section> div> div classaem-Grid aem-Grid--12 aem-Grid--default--12 > div classdevice-orientation aem-GridColumn aem-GridColumn--default--12>div classrotation-error iddevice-rotate> div classtab-portrait-error> div classerror-flex-content> img classimg-fluid src/assets/commercial/us/inrebicpro/en/images/tablet-horizontal.svg/> p>p>This website is best viewedbr />using the horizontal display onbr />your tablet device./p>/p> /div> /div> div classmobile-landscape-error> div classerror-flex-content> img classimg-fluid src/assets/commercial/us/inrebicpro/en/images/mobile-vertical.svg/> p>p>This website is best viewedbr />using the vertical display onbr />your mobile device./p>/p> /div> /div>/div> /div>div classcard-container aem-GridColumn aem-GridColumn--default--12>div classcmp-card-container row justify-content-center> div classcol-12> div classcard-color-container d-block mx-auto data-value#EBEDF0 stylebackground-color: #EBEDF0;width:%;height:px> div classoverlay-element> /div> /div> /div> /div> /div> /div> /div>/div>div classfooter section> div> footer classfooter footer-variation-one my-4> !-- /* ISI Rendering component is only rendered when showIsi property is checked as true on the current page */ --> div classcontainer px-lg-0 cmp-footer-isi-content-element> div classisi-content>div classindicationISI>div classcontentISI idisiLeftCol>p classisiHeader>u>INDICATION/u>/p>p classpara>INREBICsup>®/sup> (fedratinib) is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF)./p>p classisiHeader>u>IMPORTANT SAFETY INFORMATION/u>/p>div classitem>p classbold border-box>WARNING: ENCEPHALOPATHY INCLUDING WERNICKE’Sbr />Serious and fatal encephalopathy, including Wernicke’s, has occurred in patients treated with INREBIC. Wernicke’s encephalopathy is a neurologic emergency. Assess thiamine levels in all patients prior to starting INREBIC. Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation. While on treatment all patients should receive prophylaxis with daily oral thiamine and should have thiamine levels assessed as clinically indicated. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize./p>p classsubcaption>WARNINGS AND PRECAUTIONS/p>p classpara>b>Encephalopathy, including Wernicke’s:/b> Serious and fatal encephalopathy, including Wernicke’s encephalopathy, has occurred in INREBIC-treated patients. Serious cases were reported in 1.3% (8/608) of patients treated with INREBIC in clinical trials and 0.16% (1/608) of cases were fatal. span>Wernicke’s encephalopathy is a neurologic emergency resulting from thiamine (Vitamin B1) deficiency. Signs and symptoms of Wernicke’s encephalopathy may include ataxia, mental status changes, and ophthalmoplegia (e.g., nystagmus, diplopia). Any change in mental status, confusion, or memory impairment should raise concern for potential encephalopathy, including Wernicke’s, and prompt a full evaluation including a neurologic examination, assessment of thiamine levels, and imaging. Assess thiamine levels in all patients prior to starting INREBIC. Do not start INREBIC in patients with thiamine deficiency. However, if thiamine levels are low, replete thiamine prior to starting treatment. While on treatment all patients should receive prophylaxis with oral thiamine and should have thiamine levels assessed as clinically indicated. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize./span>/p>p classpara>b>Anemia:/b> New or worsening Grade 3 anemia occurred in 34% of INREBIC-treated patients. The median time to onset of the first Grade 3 anemia was approximately 2 months, with 75% of cases occurring within 3 months. Mean hemoglobin levels reached a nadir after 12 to 16 weeks with partial recovery and stabilization after 16 weeks. Red blood cell transfusions were received by 51% of INREBIC-treated patients and permanent discontinuation of INREBIC due to anemia occurred in 1% of patients. Consider dose reduction for patients who become red blood cell transfusion dependent./p>p classpara>b>Thrombocytopenia:/b> New or worsening Grade 3 or higher thrombocytopenia during the randomized treatment period occurred in 12% of INREBIC-treated patients. The median time to onset of the first Grade 3 thrombocytopenia was approximately 1 month, with 75% of cases occurring within 4 months. Platelet transfusions were received by 3.1% of INREBIC-treated patients. Permanent discontinuation of treatment due to thrombocytopenia and bleeding that required clinical intervention both occurred in 2.1% of INREBIC-treated patients. Obtain a complete blood count (CBC) at baseline, periodically during treatment, and as clinically indicated. For Grade 3 thrombocytopenia with active bleeding or Grade 4 thrombocytopenia, interrupt INREBIC until resolved to Grade 2 or lower or to baseline. Restart dose at 100 mg daily below the last given dose and monitor platelets as clinically indicated./p>p classpara>b>Gastrointestinal Toxicity:/b> Gastrointestinal toxicities are the most frequent adverse reactions in INREBIC-treated patients. During the randomized treatment period, diarrhea occurred in 66% of patients, nausea in 62% of patients, and vomiting in 39% of patients. Grade 3 diarrhea occurred in 5% and Grade 3 vomiting in 3.1%. The median time to onset of any grade nausea, vomiting, and diarrhea was 1 day, with 75% of cases occurring within 2 weeks of treatment. Consider providing appropriate prophylactic antiemetic therapy (e.g., 5-HT3 receptor antagonists) during INREBIC treatment. Treat diarrhea with antidiarrheal medications promptly at the first onset of symptoms. For Grade 3 or higher nausea, vomiting, or diarrhea not responsive to supportive measures within 48 hours, interrupt INREBIC until resolved to Grade 1 or lower or to baseline. Restart dose at 100 mg daily below the last given dose. Monitor thiamine levels and replete as needed./p>p classpara>b>Hepatic Toxicity:/b> Elevations of ALT and AST (all grades) during the randomized treatment period occurred in 43% and 40%, respectively, with Grade 3 or 4 in 1% and 0%, respectively, of INREBIC-treated patients. The median time to onset of any grade transaminase elevation was approximately 1 month, with 75% of cases occurring within 3 months. Monitor hepatic function at baseline, periodically during treatment, and as clinically indicated. For Grade 3 or higher ALT and/or AST elevations (greater than 5 × ULN), interrupt INREBIC dose until resolved to Grade 1 or less or to baseline. Restart dose at 100 mg daily below the last given dose. If reoccurrence of a Grade 3 or higher elevation of ALT/AST, discontinue treatment with INREBIC./p>p classpara>b>Amylase and Lipase Elevation:/b> Grade 3 or higher amylase and/or lipase elevations developed in 2% and 10% of INREBIC-treated patients, respectively. The median time to onset of any grade amylase or lipase elevation was 15 days, with 75% of cases occurring within 1 month of starting treatment. One patient developed pancreatitis in the fedratinib clinical development program (n608) and pancreatitis resolved with treatment discontinuation. Monitor amylase and lipase at baseline, periodically during treatment, and as clinically indicated. For Grade 3 or higher amylase and/or lipase elevations, interrupt INREBIC until resolved to Grade 1 or less or to baseline. Restart dose at 100 mg daily below the last given dose./p>p classpara>b>Uveitis:/b> Uveitis has been observed in post-approval clinical studies with an overall incidence of 4% (11/251). Among patients with INREBIC-associated uveitis, more than half the cases observed were Japanese patients (55%; 6/11). INREBIC-associated uveitis is a late-onset adverse reaction, with the first episode occurring at a median of 14 months after starting treatment, with a range of 8 to 22 months. Recurrent uveitis was reported in some patients who continued INREBIC. The uveitis episodes varied in severity, with grade 1/2 in 60% of episodes, and grade 3/4 in 40% of episodes. Topical steroids were sufficient for treatment in 75% of episodes, and systemic steroids were required in 25% of episodes. Among the patients developing uveitis, INREBIC was discontinued due to uveitis in 27% of patients. span>Advise patients on the risks of developing uveitis before starting INREBIC therapy. Common uveitis symptoms include eye pain, redness, photophobia, floaters, and decreased vision. In case of symptoms, prompt ophthalmologic evaluation is recommended./span>/p>p classpara>b>Major Adverse Cardiac Events (MACE):/b> Another JAK inhibitor has increased the risk of MACE, including cardiovascular death, myocardial infarction, and stroke in patients with rheumatoid arthritis (compared to those treated with TNF blockers), a condition for which INREBIC is not indicated. Consider the benefits and risks of the individual patients prior to initiating or continuing therapy with INREBIC, particularly in patients who are current or past smokers, or have other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and what to do if they occur./p>p classpara>b>Thrombosis:/b> Another JAK inhibitor has increased the risk of thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis in patients with rheumatoid arthritis (compared to those treated with TNF blockers), a condition for which INREBIC is not indicated. In patients with MF treated with INREBIC in clinical trials, the rates of thromboembolic events were similar in INREBIC and placebo treated patients. Promptly evaluate and treat patients with symptoms of thrombosis./p>p classpara>b>Secondary Malignancies:/b> Another JAK inhibitor has increased the risk of lymphoma and other malignancies excluding nonmelanoma skin cancer (NMSC) (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which INREBIC is not indicated. Patients who are current or past smokers are at additional increased risk. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with INREBIC, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers./p>/div>div classitem>p classsubcaption>ADVERSE REACTIONS/p>p classpara>The most common adverse reactions for INREBIC treated vs. placebo were diarrhea (66% vs. 16%), nausea (62% vs. 15%), anemia (40% vs. 14%), and vomiting (39% vs. 5%). Dosage interruptions due to an adverse reaction during the randomized treatment period occurred in 21% of patients who received INREBIC. Adverse reactions requiring dosage interruption in >3% of patients who received INREBIC included diarrhea and nausea. Dosage reductions due to an adverse reaction during the randomized treatment period occurred in 19% of patients who received INREBIC. Adverse reactions requiring dosage reduction in >2% of patients who received INREBIC included anemia (6%), diarrhea (3%), vomiting (3%), and thrombocytopenia (2%)./p>/div>div classitem>p classsubcaption>DRUG INTERACTIONS/p>p classpara>Coadministration of INREBIC with a strong CYP3A4 inhibitor increases fedratinib exposure. Increased exposure may increase the risk of adverse reactions. Consider alternative therapies that do not strongly inhibit CYP3A4 activity. Alternatively, reduce the dose of INREBIC when administering with a strong CYP3A4 inhibitor. Avoid INREBIC with strong and moderate CYP3A4 inducers. Coadministration of INREBIC with a dual CYP3A4 and CYP2C19 inhibitor increases fedratinib exposure. Increased exposure may increase the risk of adverse reactions. Due to potential increase of exposure, patients taking concomitant dual CYP3A4 and CYP2C19 inhibitors require more intensive safety monitoring and, if necessary, dose modifications of INREBIC based on adverse reactions. Coadministration of INREBIC with drugs that are CYP3A4, CYP2C19, or CYP2D6 substrates increases the concentrations of these drugs, which may increase the risk of adverse reactions of these drugs. Monitor for adverse reactions and adjust the dose of drugs that are CYP3A4, CYP2C19, or CYP2D6 substrates as necessary when coadministered with INREBIC. Coadministration of INREBIC with drugs that are renally excreted via organic cation transporter (OCT2) and multidrug and toxin extrusion (MATE)1/2-K can decrease renal clearance of those drugs. Monitor for adverse reactions and consider dose modifications for drugs that are renally excreted via OCT2 or MATE1/2-K (e.g., metformin) as necessary when coadministered with INREBIC./p>/div>div classitem>p classsubcaption>PREGNANCY/LACTATION/p>p classpara>Consider the benefits and risks of INREBIC for the mother and possible risks to the fetus when prescribing INREBIC to a pregnant woman. Due to the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with INREBIC, and for at least 1 month after the last dose./p>/div>div classitem>p classsubcaption>RENAL IMPAIRMENT/p>p classpara>Reduce INREBIC dose when administered to patients with severe renal impairment. No modification of the starting dose is recommended for patients with mild to moderate renal impairment. Due to potential increase of exposure, patients with preexisting moderate renal impairment require more intensive safety monitoring, and if necessary, dose modifications based on adverse reactions./p>/div>div classitem>p classbold link-one>Please see full a hrefhttps://packageinserts.bms.com/pi/pi_inrebic.pdf target_blank>Prescribing Information, including Boxed WARNING/a>./p>/div>div classitem>a hrefhttps://www.celgene.com/about/compliance/vermont-prescriber-information/ classopen-modal bold last-two data-authorurlhttps://www.celgene.com/about/compliance/vermont-prescriber-information/ data-targetexternalLink data-classnameexternal-link-warning-modal data-url/content/commercial/us/inrebicpro/en.warning.html data-aa-popuphttps://www.celgene.com/about/compliance/vermont-prescriber-information/|Information for Vermont prescribers of prescription drugs target_blank>Information for Vermont prescribers of prescription drugs/a>/div>div classisi-reference>h6>References/h6>ol classnumber-list>li classhome about safety starting managing>INREBICsup>®/sup> package insert. Summit, NJ: Celgene Corporation; 2024./li>li classhome starting>Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelinessup>®/sup>) for Myeloproliferative Neoplasms V.2.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed July 29, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org./li>li classsafety>Pardanani A, Harrison C, Cortes JE, et al. Safety and efficacy of fedratinib in patients with primary or secondary myelofibrosis: a randomized clinical trial. i>JAMA Oncol./i> 2015;1:643-651./li>li classsafety>Protocol for: Pardanani A, Harrison C, Cortes JE, et al. Safety and efficacy of fedratinib in patients with primary or secondary myelofibrosis: a randomized clinical trial. i>JAMA Oncol./i> 2015. doi:10.1001/jamaoncol.2015.1590./li>li classsafety>Supplemental content for: Pardanani A, Harrison C, Cortes JE, et al. Safety and efficacy of fedratinib in patients with primary or secondary myelofibrosis: a randomized clinical trial. i>JAMA Oncol./i> 2015. doi:10.1001/jamaoncol.2015.1590./li>li classsafety>Harrison C, Schaap N, Vannucchi AM, et al. Fedratinib induces spleen responses and reduces symptom burden in patients with myeloproliferative neoplasm (MPN)-associated myelofibrosis (MF) and low platelet counts, who were ruxolitinib-naïve or previously treated with ruxolitinib. Poster presented at the 61st Annual Meeting of the American Society of Hematology (ASH); December 7-9, 2019; Orlando, FL./li>li classsafety>Data on file. FED-0005. Princeton, NJ: Bristol-Myers Squibb Company; 2022./li>li classsafety>Data on file. FED-0006. Princeton, NJ: Bristol-Myers Squibb Company; 2022./li>li classsafety>Harrison CN, Schaap N, Vannucchi AM, et al. Fedratinib in patients with myelofibrosis previously treated with ruxolitinib: an updated analysis of the JAKARTA2 study using stringent criteria for ruxolitinib failure. i>Am J Hematol/i>. 2020;95:594-603./li>li classsafety>Data on file. FED-0008. Princeton, NJ: Bristol-Myers Squibb Company; 2022./li>li classsafety>Data on file. FED-0009. Princeton, NJ: Bristol-Myers Squibb Company; 2022./li>li classmanaging>Data on file. FED-0007. Princeton, NJ; Bristol-Myers Squibb Company; 2022./li>li classmanaging>Data on file. FED-0004. Princeton, NJ; Bristol-Myers Squibb Company; 2022./li>/ol>/div>/div>/div>/div> /div> div classisi-master-container> div classisi-rendering-footer isi-rendering> input typehidden namedefaultTrayStatus valuecollapsed/>input typehidden namesuppressRememberStatus valuefalse/>input typehidden nameenableExpandButton valuefalse/>input typehidden nameenableCollapseButton valuefalse/> !-- /* When in Edit mode, showing the help text */--> !-- /* When in Preview/Disabled mode, rendering the component */--> div classcmp-isi hidden sticky-element col-12 is-collapsed> div classisi-container preview-container> div classisi-mobile-view-links d-block> a hrefhttps://packageinserts.bms.com/pi/pi_inrebic.pdf>/>US FULL PRESCRIBING INFO INCLUDING BOXED WARNING /a> a>/a> /div> div classd-flex flex-row isi-header> div classisi-container-title col-9 pl-0>/div> div classmore-text-container text-right px-0 col-3> span classarrow up-arrow>/span> /div> /div> div classisi-content preview-text> div classindicationISI>div classcontentISI idisiLeftCol>p classisiHeader>u>INDICATION/u>/p>p classpara>INREBICsup>®/sup> (fedratinib) is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF)./p>p classisiHeader>u>IMPORTANT SAFETY INFORMATION/u>/p>div classitem>p classbold border-box>WARNING: ENCEPHALOPATHY INCLUDING WERNICKE’Sbr />Serious and fatal encephalopathy, including Wernicke’s, has occurred in patients treated with INREBIC. Wernicke’s encephalopathy is a neurologic emergency. Assess thiamine levels in all patients prior to starting INREBIC. Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation. While on treatment all patients should receive prophylaxis with daily oral thiamine and should have thiamine levels assessed as clinically indicated. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize./p>p classsubcaption>WARNINGS AND PRECAUTIONS/p>p classpara>b>Encephalopathy, including Wernicke’s:/b> Serious and fatal encephalopathy, including Wernicke’s encephalopathy, has occurred in INREBIC-treated patients. Serious cases were reported in 1.3% (8/608) of patients treated with INREBIC in clinical trials and 0.16% (1/608) of cases were fatal. span>Wernicke’s encephalopathy is a neurologic emergency resulting from thiamine (Vitamin B1) deficiency. Signs and symptoms of Wernicke’s encephalopathy may include ataxia, mental status changes, and ophthalmoplegia (e.g., nystagmus, diplopia). Any change in mental status, confusion, or memory impairment should raise concern for potential encephalopathy, including Wernicke’s, and prompt a full evaluation including a neurologic examination, assessment of thiamine levels, and imaging. Assess thiamine levels in all patients prior to starting INREBIC. Do not start INREBIC in patients with thiamine deficiency. However, if thiamine levels are low, replete thiamine prior to starting treatment. While on treatment all patients should receive prophylaxis with oral thiamine and should have thiamine levels assessed as clinically indicated. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize./span>/p>p classpara>b>Anemia:/b> New or worsening Grade 3 anemia occurred in 34% of INREBIC-treated patients. The median time to onset of the first Grade 3 anemia was approximately 2 months, with 75% of cases occurring within 3 months. Mean hemoglobin levels reached a nadir after 12 to 16 weeks with partial recovery and stabilization after 16 weeks. Red blood cell transfusions were received by 51% of INREBIC-treated patients and permanent discontinuation of INREBIC due to anemia occurred in 1% of patients. Consider dose reduction for patients who become red blood cell transfusion dependent./p>p classpara>b>Thrombocytopenia:/b> New or worsening Grade 3 or higher thrombocytopenia during the randomized treatment period occurred in 12% of INREBIC-treated patients. The median time to onset of the first Grade 3 thrombocytopenia was approximately 1 month, with 75% of cases occurring within 4 months. Platelet transfusions were received by 3.1% of INREBIC-treated patients. Permanent discontinuation of treatment due to thrombocytopenia and bleeding that required clinical intervention both occurred in 2.1% of INREBIC-treated patients. Obtain a complete blood count (CBC) at baseline, periodically during treatment, and as clinically indicated. For Grade 3 thrombocytopenia with active bleeding or Grade 4 thrombocytopenia, interrupt INREBIC until resolved to Grade 2 or lower or to baseline. Restart dose at 100 mg daily below the last given dose and monitor platelets as clinically indicated./p>p classpara>b>Gastrointestinal Toxicity:/b> Gastrointestinal toxicities are the most frequent adverse reactions in INREBIC-treated patients. During the randomized treatment period, diarrhea occurred in 66% of patients, nausea in 62% of patients, and vomiting in 39% of patients. Grade 3 diarrhea occurred in 5% and Grade 3 vomiting in 3.1%. The median time to onset of any grade nausea, vomiting, and diarrhea was 1 day, with 75% of cases occurring within 2 weeks of treatment. Consider providing appropriate prophylactic antiemetic therapy (e.g., 5-HT3 receptor antagonists) during INREBIC treatment. Treat diarrhea with antidiarrheal medications promptly at the first onset of symptoms. For Grade 3 or higher nausea, vomiting, or diarrhea not responsive to supportive measures within 48 hours, interrupt INREBIC until resolved to Grade 1 or lower or to baseline. Restart dose at 100 mg daily below the last given dose. Monitor thiamine levels and replete as needed./p>p classpara>b>Hepatic Toxicity:/b> Elevations of ALT and AST (all grades) during the randomized treatment period occurred in 43% and 40%, respectively, with Grade 3 or 4 in 1% and 0%, respectively, of INREBIC-treated patients. The median time to onset of any grade transaminase elevation was approximately 1 month, with 75% of cases occurring within 3 months. Monitor hepatic function at baseline, periodically during treatment, and as clinically indicated. For Grade 3 or higher ALT and/or AST elevations (greater than 5 × ULN), interrupt INREBIC dose until resolved to Grade 1 or less or to baseline. Restart dose at 100 mg daily below the last given dose. If reoccurrence of a Grade 3 or higher elevation of ALT/AST, discontinue treatment with INREBIC./p>p classpara>b>Amylase and Lipase Elevation:/b> Grade 3 or higher amylase and/or lipase elevations developed in 2% and 10% of INREBIC-treated patients, respectively. The median time to onset of any grade amylase or lipase elevation was 15 days, with 75% of cases occurring within 1 month of starting treatment. One patient developed pancreatitis in the fedratinib clinical development program (n608) and pancreatitis resolved with treatment discontinuation. Monitor amylase and lipase at baseline, periodically during treatment, and as clinically indicated. For Grade 3 or higher amylase and/or lipase elevations, interrupt INREBIC until resolved to Grade 1 or less or to baseline. Restart dose at 100 mg daily below the last given dose./p>p classpara>b>Major Adverse Cardiac Events (MACE):/b> Another JAK inhibitor has increased the risk of MACE, including cardiovascular death, myocardial infarction, and stroke in patients with rheumatoid arthritis (compared to those treated with TNF blockers), a condition for which INREBIC is not indicated. Consider the benefits and risks of the individual patients prior to initiating or continuing therapy with INREBIC, particularly in patients who are current or past smokers, or have other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and what to do if they occur./p>p classpara>b>Thrombosis:/b> Another JAK inhibitor has increased the risk of thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis in patients with rheumatoid arthritis (compared to those treated with TNF blockers), a condition for which INREBIC is not indicated. In patients with MF treated with INREBIC in clinical trials, the rates of thromboembolic events were similar in INREBIC and placebo treated patients. Promptly evaluate and treat patients with symptoms of thrombosis./p>p classpara>b>Secondary Malignancies:/b> Another JAK inhibitor has increased the risk of lymphoma and other malignancies excluding nonmelanoma skin cancer (NMSC) (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which INREBIC is not indicated. Patients who are current or past smokers are at additional increased risk. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with INREBIC, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers./p>/div>div classitem>p classsubcaption>ADVERSE REACTIONS/p>p classpara>The most common adverse reactions for INREBIC treated vs. placebo were diarrhea (66% vs. 16%), nausea (62% vs. 15%), anemia (40% vs. 14%), and vomiting (39% vs. 5%). Dosage interruptions due to an adverse reaction during the randomized treatment period occurred in 21% of patients who received INREBIC. Adverse reactions requiring dosage interruption in >3% of patients who received INREBIC included diarrhea and nausea. Dosage reductions due to an adverse reaction during the randomized treatment period occurred in 19% of patients who received INREBIC. Adverse reactions requiring dosage reduction in >2% of patients who received INREBIC included anemia (6%), diarrhea (3%), vomiting (3%), and thrombocytopenia (2%)./p>/div>div classitem>p classsubcaption>DRUG INTERACTIONS/p>p classpara>Coadministration of INREBIC with a strong CYP3A4 inhibitor increases fedratinib exposure. Increased exposure may increase the risk of adverse reactions. Consider alternative therapies that do not strongly inhibit CYP3A4 activity. Alternatively, reduce the dose of INREBIC when administering with a strong CYP3A4 inhibitor. Avoid INREBIC with strong and moderate CYP3A4 inducers. Coadministration of INREBIC with a dual CYP3A4 and CYP2C19 inhibitor increases fedratinib exposure. Increased exposure may increase the risk of adverse reactions. Due to potential increase of exposure, patients taking concomitant dual CYP3A4 and CYP2C19 inhibitors require more intensive safety monitoring and, if necessary, dose modifications of INREBIC based on adverse reactions. Coadministration of INREBIC with drugs that are CYP3A4, CYP2C19, or CYP2D6 substrates increases the concentrations of these drugs, which may increase the risk of adverse reactions of these drugs. Monitor for adverse reactions and adjust the dose of drugs that are CYP3A4, CYP2C19, or CYP2D6 substrates as necessary when coadministered with INREBIC. Coadministration of INREBIC with drugs that are renally excreted via organic cation transporter (OCT2) and multidrug and toxin extrusion (MATE)1/2-K can decrease renal clearance of those drugs. Monitor for adverse reactions and consider dose modifications for drugs that are renally excreted via OCT2 or MATE1/2-K (e.g., metformin) as necessary when coadministered with INREBIC./p>/div>div classitem>p classsubcaption>PREGNANCY/LACTATION/p>p classpara>Consider the benefits and risks of INREBIC for the mother and possible risks to the fetus when prescribing INREBIC to a pregnant woman. Due to the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with INREBIC, and for at least 1 month after the last dose./p>/div>div classitem>p classsubcaption>RENAL IMPAIRMENT/p>p classpara>Reduce INREBIC dose when administered to patients with severe renal impairment. No modification of the starting dose is recommended for patients with mild to moderate renal impairment. Due to potential increase of exposure, patients with preexisting moderate renal impairment require more intensive safety monitoring, and if necessary, dose modifications based on adverse reactions./p>/div>div classitem>p classbold link-one>Please see full a hrefhttps://packageinserts.bms.com/pi/pi_inrebic.pdf title target_blank aria-label>Prescribing Information, including Boxed WARNING/a>./p>/div>div classitem>p classsubcaption>INDICATION/p>p>INREBICsup>®/sup> (fedratinib) is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF)./p>a hrefhttps://www.celgene.com/about/compliance/vermont-prescriber-information data-authorurlhttps://www.celgene.com/about/compliance/vermont-prescriber-information title aria-label classopen-modal open-modal bold last-two data-targetexternalLink data-url/content/commercial/us/inrebicpro/en.warning.html data-aa-launchidRich Text Editor data-aa-launchdataInformation for Vermont prescribers of prescription drugs data-classnameexternal-link-warning-modal data-aa-popuphttps://www.celgene.com/about/compliance/vermont-prescriber-information|Information for Vermont prescribers of prescription drugs>Information for Vermont prescribers of prescription drugs/a>/div>div classisi-reference>h6>References/h6>ol classnumber-list>li classhome about safety starting managing>INREBICsup>®/sup> package insert. Summit, NJ: Celgene Corporation; 2024./li>li classhome starting>Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelinessup>®/sup>) for Myeloproliferative Neoplasms V.2.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed August 9, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org./li>li classsafety>Pardanani A, Harrison C, Cortes JE, et al. Safety and efficacy of fedratinib in patients with primary or secondary myelofibrosis: a randomized clinical trial. i>JAMA Oncol./i> 2015;1:643-651./li>li classsafety>Protocol for: Pardanani A, Harrison C, Cortes JE, et al. Safety and efficacy of fedratinib in patients with primary or secondary myelofibrosis: a randomized clinical trial. i>JAMA Oncol./i> 2015. doi:10.1001/jamaoncol.2015.1590./li>li classsafety>Supplemental content for: Pardanani A, Harrison C, Cortes JE, et al. Safety and efficacy of fedratinib in patients with primary or secondary myelofibrosis: a randomized clinical trial. i>JAMA Oncol./i> 2015. doi:10.1001/jamaoncol.2015.1590./li>li classsafety>Harrison C, Schaap N, Vannucchi AM, et al. Fedratinib induces spleen responses and reduces symptom burden in patients with myeloproliferative neoplasm (MPN)-associated myelofibrosis (MF) and low platelet counts, who were ruxolitinib-naïve or previously treated with ruxolitinib. Poster presented at the 61st Annual Meeting of the American Society of Hematology (ASH); December 7-9, 2019; Orlando, FL./li>li classsafety>Data on file. FED-0005. Princeton, NJ: Bristol-Myers Squibb Company; 2022./li>li classsafety>Data on file. FED-0006. Princeton, NJ: Bristol-Myers Squibb Company; 2022./li>li classsafety>Harrison CN, Schaap N, Vannucchi AM, et al. Fedratinib in patients with myelofibrosis previously treated with ruxolitinib: an updated analysis of the JAKARTA2 study using stringent criteria for ruxolitinib failure. i>Am J Hematol/i>. 2020;95:594-603./li>li classsafety>Data on file. FED-0008. Princeton, NJ: Bristol-Myers Squibb Company; 2022./li>li classsafety>Data on file. FED-0009. Princeton, NJ: Bristol-Myers Squibb Company; 2022./li>li classmanaging>Data on file. FED-0007. Princeton, NJ; Bristol-Myers Squibb Company; 2022./li>li classmanaging>Data on file. FED-0004. Princeton, NJ; Bristol-Myers Squibb Company; 2022./li>/ol>/div>/div>/div> /div> /div> div classisi-container collapse-container> div classd-flex flex-row isi-header> div classisi-container-title col-9 pl-0>/div> div classhide-text-container text-right px-0 col-3> span classarrow down-arrow>/span> /div> /div> div classisi-content collapse-text> /div> /div> div classisi-container expand-container> div classd-flex flex-row isi-header> div classisi-container-title col-9 pl-0>/div> div classhide-text-container text-right px-0 col-3> span classarrow down-arrow>/span> /div> /div> div classisi-content expand-text> div classindicationISI>div classcontentISI idisiLeftCol>p classisiHeader>u>INDICATION/u>/p>p classpara>INREBICsup>®/sup> (fedratinib) is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF)./p>p classisiHeader>u>IMPORTANT SAFETY INFORMATION/u>/p>div classitem>p classbold border-box>WARNING: ENCEPHALOPATHY INCLUDING WERNICKE’Sbr />Serious and fatal encephalopathy, including Wernicke’s, has occurred in patients treated with INREBIC. Wernicke’s encephalopathy is a neurologic emergency. Assess thiamine levels in all patients prior to starting INREBIC. Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation. While on treatment all patients should receive prophylaxis with daily oral thiamine and should have thiamine levels assessed as clinically indicated. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize./p>p classsubcaption>WARNINGS AND PRECAUTIONS/p>p classpara>b>Encephalopathy, including Wernicke’s:/b> Serious and fatal encephalopathy, including Wernicke’s encephalopathy, has occurred in INREBIC-treated patients. Serious cases were reported in 1.3% (8/608) of patients treated with INREBIC in clinical trials and 0.16% (1/608) of cases were fatal. span>Wernicke’s encephalopathy is a neurologic emergency resulting from thiamine (Vitamin B1) deficiency. Signs and symptoms of Wernicke’s encephalopathy may include ataxia, mental status changes, and ophthalmoplegia (e.g., nystagmus, diplopia). Any change in mental status, confusion, or memory impairment should raise concern for potential encephalopathy, including Wernicke’s, and prompt a full evaluation including a neurologic examination, assessment of thiamine levels, and imaging. Assess thiamine levels in all patients prior to starting INREBIC. Do not start INREBIC in patients with thiamine deficiency. However, if thiamine levels are low, replete thiamine prior to starting treatment. While on treatment all patients should receive prophylaxis with oral thiamine and should have thiamine levels assessed as clinically indicated. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize./span>/p>p classpara>b>Anemia:/b> New or worsening Grade 3 anemia occurred in 34% of INREBIC-treated patients. The median time to onset of the first Grade 3 anemia was approximately 2 months, with 75% of cases occurring within 3 months. Mean hemoglobin levels reached a nadir after 12 to 16 weeks with partial recovery and stabilization after 16 weeks. Red blood cell transfusions were received by 51% of INREBIC-treated patients and permanent discontinuation of INREBIC due to anemia occurred in 1% of patients. Consider dose reduction for patients who become red blood cell transfusion dependent./p>p classpara>b>Thrombocytopenia:/b> New or worsening Grade 3 or higher thrombocytopenia during the randomized treatment period occurred in 12% of INREBIC-treated patients. The median time to onset of the first Grade 3 thrombocytopenia was approximately 1 month, with 75% of cases occurring within 4 months. Platelet transfusions were received by 3.1% of INREBIC-treated patients. Permanent discontinuation of treatment due to thrombocytopenia and bleeding that required clinical intervention both occurred in 2.1% of INREBIC-treated patients. Obtain a complete blood count (CBC) at baseline, periodically during treatment, and as clinically indicated. For Grade 3 thrombocytopenia with active bleeding or Grade 4 thrombocytopenia, interrupt INREBIC until resolved to Grade 2 or lower or to baseline. Restart dose at 100 mg daily below the last given dose and monitor platelets as clinically indicated./p>p classpara>b>Gastrointestinal Toxicity:/b> Gastrointestinal toxicities are the most frequent adverse reactions in INREBIC-treated patients. During the randomized treatment period, diarrhea occurred in 66% of patients, nausea in 62% of patients, and vomiting in 39% of patients. Grade 3 diarrhea occurred in 5% and Grade 3 vomiting in 3.1%. The median time to onset of any grade nausea, vomiting, and diarrhea was 1 day, with 75% of cases occurring within 2 weeks of treatment. Consider providing appropriate prophylactic antiemetic therapy (e.g., 5-HT3 receptor antagonists) during INREBIC treatment. Treat diarrhea with antidiarrheal medications promptly at the first onset of symptoms. For Grade 3 or higher nausea, vomiting, or diarrhea not responsive to supportive measures within 48 hours, interrupt INREBIC until resolved to Grade 1 or lower or to baseline. Restart dose at 100 mg daily below the last given dose. Monitor thiamine levels and replete as needed./p>p classpara>b>Hepatic Toxicity:/b> Elevations of ALT and AST (all grades) during the randomized treatment period occurred in 43% and 40%, respectively, with Grade 3 or 4 in 1% and 0%, respectively, of INREBIC-treated patients. The median time to onset of any grade transaminase elevation was approximately 1 month, with 75% of cases occurring within 3 months. Monitor hepatic function at baseline, periodically during treatment, and as clinically indicated. For Grade 3 or higher ALT and/or AST elevations (greater than 5 × ULN), interrupt INREBIC dose until resolved to Grade 1 or less or to baseline. Restart dose at 100 mg daily below the last given dose. If reoccurrence of a Grade 3 or higher elevation of ALT/AST, discontinue treatment with INREBIC./p>p classpara>b>Amylase and Lipase Elevation:/b> Grade 3 or higher amylase and/or lipase elevations developed in 2% and 10% of INREBIC-treated patients, respectively. The median time to onset of any grade amylase or lipase elevation was 15 days, with 75% of cases occurring within 1 month of starting treatment. One patient developed pancreatitis in the fedratinib clinical development program (n608) and pancreatitis resolved with treatment discontinuation. Monitor amylase and lipase at baseline, periodically during treatment, and as clinically indicated. For Grade 3 or higher amylase and/or lipase elevations, interrupt INREBIC until resolved to Grade 1 or less or to baseline. Restart dose at 100 mg daily below the last given dose./p>p classpara>b>Uveitis:/b> Uveitis has been observed in post-approval clinical studies with an overall incidence of 4% (11/251). Among patients with INREBIC-associated uveitis, more than half the cases observed were Japanese patients (55%; 6/11). INREBIC-associated uveitis is a late-onset adverse reaction, with the first episode occurring at a median of 14 months after starting treatment, with a range of 8 to 22 months. Recurrent uveitis was reported in some patients who continued INREBIC. The uveitis episodes varied in severity, with grade 1/2 in 60% of episodes, and grade 3/4 in 40% of episodes. Topical steroids were sufficient for treatment in 75% of episodes, and systemic steroids were required in 25% of episodes. Among the patients developing uveitis, INREBIC was discontinued due to uveitis in 27% of patients. span>Advise patients on the risks of developing uveitis before starting INREBIC therapy. Common uveitis symptoms include eye pain, redness, photophobia, floaters, and decreased vision. In case of symptoms, prompt ophthalmologic evaluation is recommended./span>/p>p classpara>b>Major Adverse Cardiac Events (MACE):/b> Another JAK inhibitor has increased the risk of MACE, including cardiovascular death, myocardial infarction, and stroke in patients with rheumatoid arthritis (compared to those treated with TNF blockers), a condition for which INREBIC is not indicated. Consider the benefits and risks of the individual patients prior to initiating or continuing therapy with INREBIC, particularly in patients who are current or past smokers, or have other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and what to do if they occur./p>p classpara>b>Thrombosis:/b> Another JAK inhibitor has increased the risk of thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis in patients with rheumatoid arthritis (compared to those treated with TNF blockers), a condition for which INREBIC is not indicated. In patients with MF treated with INREBIC in clinical trials, the rates of thromboembolic events were similar in INREBIC and placebo treated patients. Promptly evaluate and treat patients with symptoms of thrombosis./p>p classpara>b>Secondary Malignancies:/b> Another JAK inhibitor has increased the risk of lymphoma and other malignancies excluding nonmelanoma skin cancer (NMSC) (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which INREBIC is not indicated. Patients who are current or past smokers are at additional increased risk. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with INREBIC, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers./p>/div>div classitem>p classsubcaption>ADVERSE REACTIONS/p>p classpara>The most common adverse reactions for INREBIC treated vs. placebo were diarrhea (66% vs. 16%), nausea (62% vs. 15%), anemia (40% vs. 14%), and vomiting (39% vs. 5%). Dosage interruptions due to an adverse reaction during the randomized treatment period occurred in 21% of patients who received INREBIC. Adverse reactions requiring dosage interruption in >3% of patients who received INREBIC included diarrhea and nausea. Dosage reductions due to an adverse reaction during the randomized treatment period occurred in 19% of patients who received INREBIC. Adverse reactions requiring dosage reduction in >2% of patients who received INREBIC included anemia (6%), diarrhea (3%), vomiting (3%), and thrombocytopenia (2%)./p>/div>div classitem>p classsubcaption>DRUG INTERACTIONS/p>p classpara>Coadministration of INREBIC with a strong CYP3A4 inhibitor increases fedratinib exposure. Increased exposure may increase the risk of adverse reactions. Consider alternative therapies that do not strongly inhibit CYP3A4 activity. Alternatively, reduce the dose of INREBIC when administering with a strong CYP3A4 inhibitor. Avoid INREBIC with strong and moderate CYP3A4 inducers. Coadministration of INREBIC with a dual CYP3A4 and CYP2C19 inhibitor increases fedratinib exposure. Increased exposure may increase the risk of adverse reactions. Due to potential increase of exposure, patients taking concomitant dual CYP3A4 and CYP2C19 inhibitors require more intensive safety monitoring and, if necessary, dose modifications of INREBIC based on adverse reactions. Coadministration of INREBIC with drugs that are CYP3A4, CYP2C19, or CYP2D6 substrates increases the concentrations of these drugs, which may increase the risk of adverse reactions of these drugs. Monitor for adverse reactions and adjust the dose of drugs that are CYP3A4, CYP2C19, or CYP2D6 substrates as necessary when coadministered with INREBIC. Coadministration of INREBIC with drugs that are renally excreted via organic cation transporter (OCT2) and multidrug and toxin extrusion (MATE)1/2-K can decrease renal clearance of those drugs. Monitor for adverse reactions and consider dose modifications for drugs that are renally excreted via OCT2 or MATE1/2-K (e.g., metformin) as necessary when coadministered with INREBIC./p>/div>div classitem>p classsubcaption>PREGNANCY/LACTATION/p>p classpara>Consider the benefits and risks of INREBIC for the mother and possible risks to the fetus when prescribing INREBIC to a pregnant woman. Due to the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with INREBIC, and for at least 1 month after the last dose./p>/div>div classitem>p classsubcaption>RENAL IMPAIRMENT/p>p classpara>Reduce INREBIC dose when administered to patients with severe renal impairment. No modification of the starting dose is recommended for patients with mild to moderate renal impairment. Due to potential increase of exposure, patients with preexisting moderate renal impairment require more intensive safety monitoring, and if necessary, dose modifications based on adverse reactions./p>/div>div classitem>p classbold link-one>Please see full a hrefhttps://packageinserts.bms.com/pi/pi_inrebic.pdf title target_blank aria-label>Prescribing Information, including Boxed WARNING/a>./p>/div>div classitem>a hrefhttps://www.celgene.com/about/compliance/vermont-prescriber-information data-authorurlhttps://www.celgene.com/about/compliance/vermont-prescriber-information title aria-label classopen-modal open-modal bold last-two data-targetexternalLink data-url/content/commercial/us/inrebicpro/en.warning.html data-aa-launchidRich Text Editor data-aa-launchdataInformation for Vermont prescribers of prescription drugs data-classnameexternal-link-warning-modal data-aa-popuphttps://www.celgene.com/about/compliance/vermont-prescriber-information|Information for Vermont prescribers of prescription drugs>Information for Vermont prescribers of prescription drugs/a>/div>div classisi-reference>h6>References/h6>ol classnumber-list>li classhome about safety starting managing>INREBICsup>®/sup> package insert. Summit, NJ: Celgene Corporation; 2024./li>li classhome starting>Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelinessup>®/sup>) for Myeloproliferative Neoplasms V.2.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed July 29, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org./li>li classsafety>Pardanani A, Harrison C, Cortes JE, et al. Safety and efficacy of fedratinib in patients with primary or secondary myelofibrosis: a randomized clinical trial. i>JAMA Oncol./i> 2015;1:643-651./li>li classsafety>Protocol for: Pardanani A, Harrison C, Cortes JE, et al. Safety and efficacy of fedratinib in patients with primary or secondary myelofibrosis: a randomized clinical trial. i>JAMA Oncol./i> 2015. doi:10.1001/jamaoncol.2015.1590./li>li classsafety>Supplemental content for: Pardanani A, Harrison C, Cortes JE, et al. Safety and efficacy of fedratinib in patients with primary or secondary myelofibrosis: a randomized clinical trial. i>JAMA Oncol./i> 2015. doi:10.1001/jamaoncol.2015.1590./li>li classsafety>Harrison C, Schaap N, Vannucchi AM, et al. Fedratinib induces spleen responses and reduces symptom burden in patients with myeloproliferative neoplasm (MPN)-associated myelofibrosis (MF) and low platelet counts, who were ruxolitinib-naïve or previously treated with ruxolitinib. Poster presented at the 61st Annual Meeting of the American Society of Hematology (ASH); December 7-9, 2019; Orlando, FL./li>li classsafety>Data on file. FED-0005. Princeton, NJ: Bristol-Myers Squibb Company; 2022./li>li classsafety>Data on file. FED-0006. Princeton, NJ: Bristol-Myers Squibb Company; 2022./li>li classsafety>Harrison CN, Schaap N, Vannucchi AM, et al. Fedratinib in patients with myelofibrosis previously treated with ruxolitinib: an updated analysis of the JAKARTA2 study using stringent criteria for ruxolitinib failure. i>Am J Hematol/i>. 2020;95:594-603./li>li classsafety>Data on file. FED-0008. Princeton, NJ: Bristol-Myers Squibb Company; 2022./li>li classsafety>Data on file. FED-0009. Princeton, NJ: Bristol-Myers Squibb Company; 2022./li>li classmanaging>Data on file. FED-0007. Princeton, NJ; Bristol-Myers Squibb Company; 2022./li>li classmanaging>Data on file. FED-0004. Princeton, NJ; Bristol-Myers Squibb Company; 2022./li>/ol>/div>/div>/div> /div> /div> /div> div classisi-overlay>/div> /div> /div> div classisi-footer-wrapper> div classcomp-footer-references> div classfoot-notes-rte rich-text text> /div> /div> div classbg-lighter-blue py-5 footer-links-section> div classcontainer px-lg-0> div classcolumn-control-list column-control> div classrow idfooter-content> div classcol col-12> div classcolumn-control-column> div classhtml section>div> div classfooter-logo>span>img classd-lg-inline-block d-none src/assets/commercial/us/inrebicpro/en/images/logo-inrebic.svg altINREBIC® (fedratinib) logo>img classd-block d-lg-none src/assets/commercial/us/inrebicpro/en/images/logo-inrebic-mob.svg altINREBIC® (fedratinib) logo>/span>span>img classd-lg-inline-block d-none src/assets/commercial/us/inrebicpro/en/images/bms-logo.svg altBristol Myers SquibbTM Logo>img classd-block d-lg-none src/assets/commercial/us/inrebicpro/en/images/bms-logo-mob.svg altBristol Myers SquibbTM Logo>/span>/div> /div>/div>div classutilitynav section> div classcontainer px-0 cmp-utilitynav-wrapper> nav classcmp-utility-nav d-none d-lg-block rolenavigation> div classd-flex flex-row leftnav-utility-nosocial> ul classnav cmp-utility-nav-list justify-content-around justify-content-lg-start col-md-12 data-listsize4> li classnav-item cmp-utility-nav-list-item> a classopen-modal nav-link hrefhttps://www.bms.com/about-us/contact-us.html data-authorurlhttps://www.bms.com/about-us/contact-us.html data-targetexternalLink data-classnameexternal-link-warning-modal data-url/content/commercial/us/inrebicpro/en.warning.html data-aa-popuphttps://www.bms.com/about-us/contact-us.html|Contact Us relnoopener noreferrer target_blank> !-- a classnav-link hrefhttps://www.bms.com/about-us/contact-us.html data-sly-attribute{relnoopener noreferrer, target_blank}>--> Contact Us/a> /li> li classnav-item cmp-utility-nav-list-item> a classopen-modal nav-link hrefhttps://www.bms.com/privacy-policy.html data-authorurlhttps://www.bms.com/privacy-policy.html data-targetexternalLink data-classnameexternal-link-warning-modal data-url/content/commercial/us/inrebicpro/en.warning.html data-aa-popuphttps://www.bms.com/privacy-policy.html|Privacy Policy relnoopener noreferrer target_blank> !-- a classnav-link hrefhttps://www.bms.com/privacy-policy.html data-sly-attribute{relnoopener noreferrer, target_blank}>--> Privacy Policy/a> /li> li classnav-item cmp-utility-nav-list-item> a classopen-modal nav-link hrefhttps://www.bms.com/legal-notice.html data-authorurlhttps://www.bms.com/legal-notice.html data-targetexternalLink data-classnameexternal-link-warning-modal data-url/content/commercial/us/inrebicpro/en.warning.html data-aa-popuphttps://www.bms.com/legal-notice.html|Terms of Use relnoopener noreferrer target_blank> !-- a classnav-link hrefhttps://www.bms.com/legal-notice.html data-sly-attribute{relnoopener noreferrer, target_blank}>--> Terms of Use/a> /li> li classnav-item cmp-utility-nav-list-item> a classnav-link href/site-map target_self> !-- a classnav-link href/content/commercial/us/inrebicpro/en//site-map.html data-sly-attribute{target_self}>--> Site Map/a> /li> /ul> /div> /nav> nav classcmp-utility-nav-mbl d-block d-lg-none rolenavigation> /nav> /div> /div>div classhtml section>div> !--script>$(document).ready(function(){$(.cmp-utility-nav ul.nav>li.cmp-utility-nav-list-item:nth-child(2)).after(`li classnav-item onetrust cmp-utility-nav-list-item privacy_choice>a hrefjavascript:void(0) onclickOneTrust.ToggleInfoDisplay() classnav-link>Your Privacy Choices img stylewidth:25px !important src/content/dam/commercial/global/privacyoptions.svg altPrivacy Link/>/a>/li>`);$(window).resize(function(){ if(window.matchMedia((max-width: 768px)).matches){ $(.onetrust).removeClass(cmp-utility-nav-list-item).addClass(cmp-utility-nav-mbl-list-item);}});});/script>-->p classfirst>This website is intended for US Healthcare br classm-page/>Professionals./p>p classsecond>INREBICsup>®/sup> is a registered trademark of Impact Biomedicines, Inc. 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Wernicke’s encephalopathy is a neurologic emergency. Assess thiamine levels in all patients prior to starting INREBIC. Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation. While on treatment all patients should receive prophylaxis with daily oral thiamine and should have thiamine levels assessed as clinically indicated. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize./p>p classsubcaption>WARNINGS AND PRECAUTIONS/p>p classpara>b>Encephalopathy, including Wernicke’s:/b> Serious and fatal encephalopathy, including Wernicke’s encephalopathy, has occurred in INREBIC-treated patients. Serious cases were reported in 1.3% (8/608) of patients treated with INREBIC in clinical trials and 0.16% (1/608) of cases were fatal. span>Wernicke’s encephalopathy is a neurologic emergency resulting from thiamine (Vitamin B1) deficiency. Signs and symptoms of Wernicke’s encephalopathy may include ataxia, mental status changes, and ophthalmoplegia (e.g., nystagmus, diplopia). Any change in mental status, confusion, or memory impairment should raise concern for potential encephalopathy, including Wernicke’s, and prompt a full evaluation including a neurologic examination, assessment of thiamine levels, and imaging. Assess thiamine levels in all patients prior to starting INREBIC. Do not start INREBIC in patients with thiamine deficiency. However, if thiamine levels are low, replete thiamine prior to starting treatment. While on treatment all patients should receive prophylaxis with oral thiamine and should have thiamine levels assessed as clinically indicated. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize./span>/p>p classpara>b>Anemia:/b> New or worsening Grade 3 anemia occurred in 34% of INREBIC-treated patients. The median time to onset of the first Grade 3 anemia was approximately 2 months, with 75% of cases occurring within 3 months. Mean hemoglobin levels reached a nadir after 12 to 16 weeks with partial recovery and stabilization after 16 weeks. Red blood cell transfusions were received by 51% of INREBIC-treated patients and permanent discontinuation of INREBIC due to anemia occurred in 1% of patients. Consider dose reduction for patients who become red blood cell transfusion dependent./p>p classpara>b>Thrombocytopenia:/b> New or worsening Grade 3 or higher thrombocytopenia during the randomized treatment period occurred in 12% of INREBIC-treated patients. The median time to onset of the first Grade 3 thrombocytopenia was approximately 1 month, with 75% of cases occurring within 4 months. Platelet transfusions were received by 3.1% of INREBIC-treated patients. Permanent discontinuation of treatment due to thrombocytopenia and bleeding that required clinical intervention both occurred in 2.1% of INREBIC-treated patients. Obtain a complete blood count (CBC) at baseline, periodically during treatment, and as clinically indicated. For Grade 3 thrombocytopenia with active bleeding or Grade 4 thrombocytopenia, interrupt INREBIC until resolved to Grade 2 or lower or to baseline. Restart dose at 100 mg daily below the last given dose and monitor platelets as clinically indicated./p>p classpara>b>Gastrointestinal Toxicity:/b> Gastrointestinal toxicities are the most frequent adverse reactions in INREBIC-treated patients. During the randomized treatment period, diarrhea occurred in 66% of patients, nausea in 62% of patients, and vomiting in 39% of patients. Grade 3 diarrhea occurred in 5% and Grade 3 vomiting in 3.1%. The median time to onset of any grade nausea, vomiting, and diarrhea was 1 day, with 75% of cases occurring within 2 weeks of treatment. Consider providing appropriate prophylactic antiemetic therapy (e.g., 5-HT3 receptor antagonists) during INREBIC treatment. Treat diarrhea with antidiarrheal medications promptly at the first onset of symptoms. For Grade 3 or higher nausea, vomiting, or diarrhea not responsive to supportive measures within 48 hours, interrupt INREBIC until resolved to Grade 1 or lower or to baseline. Restart dose at 100 mg daily below the last given dose. Monitor thiamine levels and replete as needed./p>p classpara>b>Hepatic Toxicity:/b> Elevations of ALT and AST (all grades) during the randomized treatment period occurred in 43% and 40%, respectively, with Grade 3 or 4 in 1% and 0%, respectively, of INREBIC-treated patients. The median time to onset of any grade transaminase elevation was approximately 1 month, with 75% of cases occurring within 3 months. Monitor hepatic function at baseline, periodically during treatment, and as clinically indicated. For Grade 3 or higher ALT and/or AST elevations (greater than 5 × ULN), interrupt INREBIC dose until resolved to Grade 1 or less or to baseline. Restart dose at 100 mg daily below the last given dose. If reoccurrence of a Grade 3 or higher elevation of ALT/AST, discontinue treatment with INREBIC./p>p classpara>b>Amylase and Lipase Elevation:/b> Grade 3 or higher amylase and/or lipase elevations developed in 2% and 10% of INREBIC-treated patients, respectively. The median time to onset of any grade amylase or lipase elevation was 15 days, with 75% of cases occurring within 1 month of starting treatment. One patient developed pancreatitis in the fedratinib clinical development program (n608) and pancreatitis resolved with treatment discontinuation. Monitor amylase and lipase at baseline, periodically during treatment, and as clinically indicated. For Grade 3 or higher amylase and/or lipase elevations, interrupt INREBIC until resolved to Grade 1 or less or to baseline. Restart dose at 100 mg daily below the last given dose./p>p classpara>b>Major Adverse Cardiac Events (MACE):/b> Another JAK inhibitor has increased the risk of MACE, including cardiovascular death, myocardial infarction, and stroke in patients with rheumatoid arthritis (compared to those treated with TNF blockers), a condition for which INREBIC is not indicated. Consider the benefits and risks of the individual patients prior to initiating or continuing therapy with INREBIC, particularly in patients who are current or past smokers, or have other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and what to do if they occur./p>p classpara>b>Thrombosis:/b> Another JAK inhibitor has increased the risk of thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis in patients with rheumatoid arthritis (compared to those treated with TNF blockers), a condition for which INREBIC is not indicated. In patients with MF treated with INREBIC in clinical trials, the rates of thromboembolic events were similar in INREBIC and placebo treated patients. Promptly evaluate and treat patients with symptoms of thrombosis./p>p classpara>b>Secondary Malignancies:/b> Another JAK inhibitor has increased the risk of lymphoma and other malignancies excluding nonmelanoma skin cancer (NMSC) (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which INREBIC is not indicated. Patients who are current or past smokers are at additional increased risk. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with INREBIC, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers./p>/div>div classitem>p classsubcaption>ADVERSE REACTIONS/p>p classpara>The most common adverse reactions for INREBIC treated vs. placebo were diarrhea (66% vs. 16%), nausea (62% vs. 15%), anemia (40% vs. 14%), and vomiting (39% vs. 5%). Dosage interruptions due to an adverse reaction during the randomized treatment period occurred in 21% of patients who received INREBIC. Adverse reactions requiring dosage interruption in >3% of patients who received INREBIC included diarrhea and nausea. Dosage reductions due to an adverse reaction during the randomized treatment period occurred in 19% of patients who received INREBIC. Adverse reactions requiring dosage reduction in >2% of patients who received INREBIC included anemia (6%), diarrhea (3%), vomiting (3%), and thrombocytopenia (2%)./p>/div>div classitem>p classsubcaption>DRUG INTERACTIONS/p>p classpara>Coadministration of INREBIC with a strong CYP3A4 inhibitor increases fedratinib exposure. Increased exposure may increase the risk of adverse reactions. Consider alternative therapies that do not strongly inhibit CYP3A4 activity. Alternatively, reduce the dose of INREBIC when administering with a strong CYP3A4 inhibitor. Avoid INREBIC with strong and moderate CYP3A4 inducers. Coadministration of INREBIC with a dual CYP3A4 and CYP2C19 inhibitor increases fedratinib exposure. Increased exposure may increase the risk of adverse reactions. Due to potential increase of exposure, patients taking concomitant dual CYP3A4 and CYP2C19 inhibitors require more intensive safety monitoring and, if necessary, dose modifications of INREBIC based on adverse reactions. Coadministration of INREBIC with drugs that are CYP3A4, CYP2C19, or CYP2D6 substrates increases the concentrations of these drugs, which may increase the risk of adverse reactions of these drugs. Monitor for adverse reactions and adjust the dose of drugs that are CYP3A4, CYP2C19, or CYP2D6 substrates as necessary when coadministered with INREBIC. Coadministration of INREBIC with drugs that are renally excreted via organic cation transporter (OCT2) and multidrug and toxin extrusion (MATE)1/2-K can decrease renal clearance of those drugs. Monitor for adverse reactions and consider dose modifications for drugs that are renally excreted via OCT2 or MATE1/2-K (e.g., metformin) as necessary when coadministered with INREBIC./p>/div>div classitem>p classsubcaption>PREGNANCY/LACTATION/p>p classpara>Consider the benefits and risks of INREBIC for the mother and possible risks to the fetus when prescribing INREBIC to a pregnant woman. Due to the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with INREBIC, and for at least 1 month after the last dose./p>/div>div classitem>p classsubcaption>RENAL IMPAIRMENT/p>p classpara>Reduce INREBIC dose when administered to patients with severe renal impairment. No modification of the starting dose is recommended for patients with mild to moderate renal impairment. Due to potential increase of exposure, patients with preexisting moderate renal impairment require more intensive safety monitoring, and if necessary, dose modifications based on adverse reactions./p>/div>div classitem>p classbold link-one>Please see full a hrefhttps://packageinserts.bms.com/pi/pi_inrebic.pdf title target_blank aria-label>Prescribing Information, including Boxed WARNING/a>./p>/div>div classitem>p classsubcaption>INDICATION/p>p>INREBICsup>®/sup> (fedratinib) is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF)./p>a hrefhttps://www.celgene.com/about/compliance/vermont-prescriber-information data-authorurlhttps://www.celgene.com/about/compliance/vermont-prescriber-information title aria-label classopen-modal open-modal bold last-two data-targetexternalLink data-url/content/commercial/us/inrebicpro/en.warning.html data-aa-launchidRich Text Editor data-aa-launchdataInformation for Vermont prescribers of prescription drugs data-classnameexternal-link-warning-modal data-aa-popuphttps://www.celgene.com/about/compliance/vermont-prescriber-information|Information for Vermont prescribers of prescription drugs>Information for Vermont prescribers of prescription drugs/a>/div>div classisi-reference>h6>References/h6>ol classnumber-list>li classhome about safety starting managing>INREBICsup>®/sup> package insert. Summit, NJ: Celgene Corporation; 2024./li>li classhome starting>Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelinessup>®/sup>) for Myeloproliferative Neoplasms V.2.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed August 9, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org./li>li classsafety>Pardanani A, Harrison C, Cortes JE, et al. Safety and efficacy of fedratinib in patients with primary or secondary myelofibrosis: a randomized clinical trial. i>JAMA Oncol./i> 2015;1:643-651./li>li classsafety>Protocol for: Pardanani A, Harrison C, Cortes JE, et al. Safety and efficacy of fedratinib in patients with primary or secondary myelofibrosis: a randomized clinical trial. i>JAMA Oncol./i> 2015. doi:10.1001/jamaoncol.2015.1590./li>li classsafety>Supplemental content for: Pardanani A, Harrison C, Cortes JE, et al. Safety and efficacy of fedratinib in patients with primary or secondary myelofibrosis: a randomized clinical trial. i>JAMA Oncol./i> 2015. doi:10.1001/jamaoncol.2015.1590./li>li classsafety>Harrison C, Schaap N, Vannucchi AM, et al. Fedratinib induces spleen responses and reduces symptom burden in patients with myeloproliferative neoplasm (MPN)-associated myelofibrosis (MF) and low platelet counts, who were ruxolitinib-naïve or previously treated with ruxolitinib. Poster presented at the 61st Annual Meeting of the American Society of Hematology (ASH); December 7-9, 2019; Orlando, FL./li>li classsafety>Data on file. FED-0005. Princeton, NJ: Bristol-Myers Squibb Company; 2022./li>li classsafety>Data on file. FED-0006. Princeton, NJ: Bristol-Myers Squibb Company; 2022./li>li classsafety>Harrison CN, Schaap N, Vannucchi AM, et al. Fedratinib in patients with myelofibrosis previously treated with ruxolitinib: an updated analysis of the JAKARTA2 study using stringent criteria for ruxolitinib failure. i>Am J Hematol/i>. 2020;95:594-603./li>li classsafety>Data on file. FED-0008. Princeton, NJ: Bristol-Myers Squibb Company; 2022./li>li classsafety>Data on file. FED-0009. Princeton, NJ: Bristol-Myers Squibb Company; 2022./li>li classmanaging>Data on file. FED-0007. Princeton, NJ; Bristol-Myers Squibb Company; 2022./li>li classmanaging>Data on file. FED-0004. Princeton, NJ; Bristol-Myers Squibb Company; 2022./li>/ol>/div>/div>/div> /div> /div> div classisi-container collapse-container> div classd-flex flex-row isi-header> div classisi-container-title col-9 pl-0>/div> div classhide-text-container text-right px-0 col-3> span classarrow down-arrow>/span> /div> /div> div classisi-content collapse-text> /div> /div> div classisi-container expand-container> div classd-flex flex-row isi-header> div classisi-container-title col-9 pl-0>/div> div classhide-text-container text-right px-0 col-3> span classarrow down-arrow>/span> /div> /div> div classisi-content expand-text> div classindicationISI>div classcontentISI idisiLeftCol>p classisiHeader>u>INDICATION/u>/p>p classpara>INREBICsup>®/sup> (fedratinib) is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF)./p>p classisiHeader>u>IMPORTANT SAFETY INFORMATION/u>/p>div classitem>p classbold border-box>WARNING: ENCEPHALOPATHY INCLUDING WERNICKE’Sbr />Serious and fatal encephalopathy, including Wernicke’s, has occurred in patients treated with INREBIC. Wernicke’s encephalopathy is a neurologic emergency. Assess thiamine levels in all patients prior to starting INREBIC. Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation. While on treatment all patients should receive prophylaxis with daily oral thiamine and should have thiamine levels assessed as clinically indicated. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize./p>p classsubcaption>WARNINGS AND PRECAUTIONS/p>p classpara>b>Encephalopathy, including Wernicke’s:/b> Serious and fatal encephalopathy, including Wernicke’s encephalopathy, has occurred in INREBIC-treated patients. Serious cases were reported in 1.3% (8/608) of patients treated with INREBIC in clinical trials and 0.16% (1/608) of cases were fatal. span>Wernicke’s encephalopathy is a neurologic emergency resulting from thiamine (Vitamin B1) deficiency. Signs and symptoms of Wernicke’s encephalopathy may include ataxia, mental status changes, and ophthalmoplegia (e.g., nystagmus, diplopia). Any change in mental status, confusion, or memory impairment should raise concern for potential encephalopathy, including Wernicke’s, and prompt a full evaluation including a neurologic examination, assessment of thiamine levels, and imaging. Assess thiamine levels in all patients prior to starting INREBIC. Do not start INREBIC in patients with thiamine deficiency. However, if thiamine levels are low, replete thiamine prior to starting treatment. While on treatment all patients should receive prophylaxis with oral thiamine and should have thiamine levels assessed as clinically indicated. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize./span>/p>p classpara>b>Anemia:/b> New or worsening Grade 3 anemia occurred in 34% of INREBIC-treated patients. The median time to onset of the first Grade 3 anemia was approximately 2 months, with 75% of cases occurring within 3 months. Mean hemoglobin levels reached a nadir after 12 to 16 weeks with partial recovery and stabilization after 16 weeks. Red blood cell transfusions were received by 51% of INREBIC-treated patients and permanent discontinuation of INREBIC due to anemia occurred in 1% of patients. Consider dose reduction for patients who become red blood cell transfusion dependent./p>p classpara>b>Thrombocytopenia:/b> New or worsening Grade 3 or higher thrombocytopenia during the randomized treatment period occurred in 12% of INREBIC-treated patients. The median time to onset of the first Grade 3 thrombocytopenia was approximately 1 month, with 75% of cases occurring within 4 months. Platelet transfusions were received by 3.1% of INREBIC-treated patients. Permanent discontinuation of treatment due to thrombocytopenia and bleeding that required clinical intervention both occurred in 2.1% of INREBIC-treated patients. Obtain a complete blood count (CBC) at baseline, periodically during treatment, and as clinically indicated. For Grade 3 thrombocytopenia with active bleeding or Grade 4 thrombocytopenia, interrupt INREBIC until resolved to Grade 2 or lower or to baseline. Restart dose at 100 mg daily below the last given dose and monitor platelets as clinically indicated./p>p classpara>b>Gastrointestinal Toxicity:/b> Gastrointestinal toxicities are the most frequent adverse reactions in INREBIC-treated patients. During the randomized treatment period, diarrhea occurred in 66% of patients, nausea in 62% of patients, and vomiting in 39% of patients. Grade 3 diarrhea occurred in 5% and Grade 3 vomiting in 3.1%. The median time to onset of any grade nausea, vomiting, and diarrhea was 1 day, with 75% of cases occurring within 2 weeks of treatment. Consider providing appropriate prophylactic antiemetic therapy (e.g., 5-HT3 receptor antagonists) during INREBIC treatment. Treat diarrhea with antidiarrheal medications promptly at the first onset of symptoms. For Grade 3 or higher nausea, vomiting, or diarrhea not responsive to supportive measures within 48 hours, interrupt INREBIC until resolved to Grade 1 or lower or to baseline. Restart dose at 100 mg daily below the last given dose. Monitor thiamine levels and replete as needed./p>p classpara>b>Hepatic Toxicity:/b> Elevations of ALT and AST (all grades) during the randomized treatment period occurred in 43% and 40%, respectively, with Grade 3 or 4 in 1% and 0%, respectively, of INREBIC-treated patients. The median time to onset of any grade transaminase elevation was approximately 1 month, with 75% of cases occurring within 3 months. Monitor hepatic function at baseline, periodically during treatment, and as clinically indicated. For Grade 3 or higher ALT and/or AST elevations (greater than 5 × ULN), interrupt INREBIC dose until resolved to Grade 1 or less or to baseline. Restart dose at 100 mg daily below the last given dose. If reoccurrence of a Grade 3 or higher elevation of ALT/AST, discontinue treatment with INREBIC./p>p classpara>b>Amylase and Lipase Elevation:/b> Grade 3 or higher amylase and/or lipase elevations developed in 2% and 10% of INREBIC-treated patients, respectively. The median time to onset of any grade amylase or lipase elevation was 15 days, with 75% of cases occurring within 1 month of starting treatment. One patient developed pancreatitis in the fedratinib clinical development program (n608) and pancreatitis resolved with treatment discontinuation. Monitor amylase and lipase at baseline, periodically during treatment, and as clinically indicated. For Grade 3 or higher amylase and/or lipase elevations, interrupt INREBIC until resolved to Grade 1 or less or to baseline. Restart dose at 100 mg daily below the last given dose./p>p classpara>b>Uveitis:/b> Uveitis has been observed in post-approval clinical studies with an overall incidence of 4% (11/251). Among patients with INREBIC-associated uveitis, more than half the cases observed were Japanese patients (55%; 6/11). INREBIC-associated uveitis is a late-onset adverse reaction, with the first episode occurring at a median of 14 months after starting treatment, with a range of 8 to 22 months. Recurrent uveitis was reported in some patients who continued INREBIC. The uveitis episodes varied in severity, with grade 1/2 in 60% of episodes, and grade 3/4 in 40% of episodes. Topical steroids were sufficient for treatment in 75% of episodes, and systemic steroids were required in 25% of episodes. Among the patients developing uveitis, INREBIC was discontinued due to uveitis in 27% of patients. span>Advise patients on the risks of developing uveitis before starting INREBIC therapy. Common uveitis symptoms include eye pain, redness, photophobia, floaters, and decreased vision. In case of symptoms, prompt ophthalmologic evaluation is recommended./span>/p>p classpara>b>Major Adverse Cardiac Events (MACE):/b> Another JAK inhibitor has increased the risk of MACE, including cardiovascular death, myocardial infarction, and stroke in patients with rheumatoid arthritis (compared to those treated with TNF blockers), a condition for which INREBIC is not indicated. Consider the benefits and risks of the individual patients prior to initiating or continuing therapy with INREBIC, particularly in patients who are current or past smokers, or have other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and what to do if they occur./p>p classpara>b>Thrombosis:/b> Another JAK inhibitor has increased the risk of thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis in patients with rheumatoid arthritis (compared to those treated with TNF blockers), a condition for which INREBIC is not indicated. In patients with MF treated with INREBIC in clinical trials, the rates of thromboembolic events were similar in INREBIC and placebo treated patients. Promptly evaluate and treat patients with symptoms of thrombosis./p>p classpara>b>Secondary Malignancies:/b> Another JAK inhibitor has increased the risk of lymphoma and other malignancies excluding nonmelanoma skin cancer (NMSC) (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which INREBIC is not indicated. Patients who are current or past smokers are at additional increased risk. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with INREBIC, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers./p>/div>div classitem>p classsubcaption>ADVERSE REACTIONS/p>p classpara>The most common adverse reactions for INREBIC treated vs. placebo were diarrhea (66% vs. 16%), nausea (62% vs. 15%), anemia (40% vs. 14%), and vomiting (39% vs. 5%). Dosage interruptions due to an adverse reaction during the randomized treatment period occurred in 21% of patients who received INREBIC. Adverse reactions requiring dosage interruption in >3% of patients who received INREBIC included diarrhea and nausea. Dosage reductions due to an adverse reaction during the randomized treatment period occurred in 19% of patients who received INREBIC. Adverse reactions requiring dosage reduction in >2% of patients who received INREBIC included anemia (6%), diarrhea (3%), vomiting (3%), and thrombocytopenia (2%)./p>/div>div classitem>p classsubcaption>DRUG INTERACTIONS/p>p classpara>Coadministration of INREBIC with a strong CYP3A4 inhibitor increases fedratinib exposure. Increased exposure may increase the risk of adverse reactions. Consider alternative therapies that do not strongly inhibit CYP3A4 activity. Alternatively, reduce the dose of INREBIC when administering with a strong CYP3A4 inhibitor. Avoid INREBIC with strong and moderate CYP3A4 inducers. Coadministration of INREBIC with a dual CYP3A4 and CYP2C19 inhibitor increases fedratinib exposure. Increased exposure may increase the risk of adverse reactions. Due to potential increase of exposure, patients taking concomitant dual CYP3A4 and CYP2C19 inhibitors require more intensive safety monitoring and, if necessary, dose modifications of INREBIC based on adverse reactions. Coadministration of INREBIC with drugs that are CYP3A4, CYP2C19, or CYP2D6 substrates increases the concentrations of these drugs, which may increase the risk of adverse reactions of these drugs. Monitor for adverse reactions and adjust the dose of drugs that are CYP3A4, CYP2C19, or CYP2D6 substrates as necessary when coadministered with INREBIC. Coadministration of INREBIC with drugs that are renally excreted via organic cation transporter (OCT2) and multidrug and toxin extrusion (MATE)1/2-K can decrease renal clearance of those drugs. Monitor for adverse reactions and consider dose modifications for drugs that are renally excreted via OCT2 or MATE1/2-K (e.g., metformin) as necessary when coadministered with INREBIC./p>/div>div classitem>p classsubcaption>PREGNANCY/LACTATION/p>p classpara>Consider the benefits and risks of INREBIC for the mother and possible risks to the fetus when prescribing INREBIC to a pregnant woman. Due to the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with INREBIC, and for at least 1 month after the last dose./p>/div>div classitem>p classsubcaption>RENAL IMPAIRMENT/p>p classpara>Reduce INREBIC dose when administered to patients with severe renal impairment. No modification of the starting dose is recommended for patients with mild to moderate renal impairment. Due to potential increase of exposure, patients with preexisting moderate renal impairment require more intensive safety monitoring, and if necessary, dose modifications based on adverse reactions./p>/div>div classitem>p classbold link-one>Please see full a hrefhttps://packageinserts.bms.com/pi/pi_inrebic.pdf title target_blank aria-label>Prescribing Information, including Boxed WARNING/a>./p>/div>div classitem>a hrefhttps://www.celgene.com/about/compliance/vermont-prescriber-information data-authorurlhttps://www.celgene.com/about/compliance/vermont-prescriber-information title aria-label classopen-modal open-modal bold last-two data-targetexternalLink data-url/content/commercial/us/inrebicpro/en.warning.html data-aa-launchidRich Text Editor data-aa-launchdataInformation for Vermont prescribers of prescription drugs data-classnameexternal-link-warning-modal data-aa-popuphttps://www.celgene.com/about/compliance/vermont-prescriber-information|Information for Vermont prescribers of prescription drugs>Information for Vermont prescribers of prescription drugs/a>/div>div classisi-reference>h6>References/h6>ol classnumber-list>li classhome about safety starting managing>INREBICsup>®/sup> package insert. Summit, NJ: Celgene Corporation; 2024./li>li classhome starting>Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelinessup>®/sup>) for Myeloproliferative Neoplasms V.2.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed July 29, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org./li>li classsafety>Pardanani A, Harrison C, Cortes JE, et al. Safety and efficacy of fedratinib in patients with primary or secondary myelofibrosis: a randomized clinical trial. i>JAMA Oncol./i> 2015;1:643-651./li>li classsafety>Protocol for: Pardanani A, Harrison C, Cortes JE, et al. Safety and efficacy of fedratinib in patients with primary or secondary myelofibrosis: a randomized clinical trial. i>JAMA Oncol./i> 2015. doi:10.1001/jamaoncol.2015.1590./li>li classsafety>Supplemental content for: Pardanani A, Harrison C, Cortes JE, et al. Safety and efficacy of fedratinib in patients with primary or secondary myelofibrosis: a randomized clinical trial. i>JAMA Oncol./i> 2015. doi:10.1001/jamaoncol.2015.1590./li>li classsafety>Harrison C, Schaap N, Vannucchi AM, et al. Fedratinib induces spleen responses and reduces symptom burden in patients with myeloproliferative neoplasm (MPN)-associated myelofibrosis (MF) and low platelet counts, who were ruxolitinib-naïve or previously treated with ruxolitinib. Poster presented at the 61st Annual Meeting of the American Society of Hematology (ASH); December 7-9, 2019; Orlando, FL./li>li classsafety>Data on file. FED-0005. Princeton, NJ: Bristol-Myers Squibb Company; 2022./li>li classsafety>Data on file. FED-0006. Princeton, NJ: Bristol-Myers Squibb Company; 2022./li>li classsafety>Harrison CN, Schaap N, Vannucchi AM, et al. Fedratinib in patients with myelofibrosis previously treated with ruxolitinib: an updated analysis of the JAKARTA2 study using stringent criteria for ruxolitinib failure. i>Am J Hematol/i>. 2020;95:594-603./li>li classsafety>Data on file. FED-0008. Princeton, NJ: Bristol-Myers Squibb Company; 2022./li>li classsafety>Data on file. FED-0009. Princeton, NJ: Bristol-Myers Squibb Company; 2022./li>li classmanaging>Data on file. FED-0007. Princeton, NJ; Bristol-Myers Squibb Company; 2022./li>li classmanaging>Data on file. FED-0004. Princeton, NJ; Bristol-Myers Squibb Company; 2022./li>/ol>/div>/div>/div> /div> /div> /div> div classisi-overlay>/div> /div> /div>/div> !-- This code is a markup for modal which will be loaded in the end before close of body tag -->div classmodal fade idgenericLightbox roledialog aria-labelledbymodal-headingID> div classlightbox-modal modal-dialog> /div>/div> script src/etc.clientlibs/clientlibs/granite/jquery/granite/csrf.min.js>/script>script src/etc/clientlibs/granite/jquery/granite/csrf.min.js>/script>script src/etc.clientlibs/clientlibs/granite/jquery.min.js>/script>script src/etc.clientlibs/bms-commercial-shared/clientlibs/base.min.js>/script> script src/etc.clientlibs/core/wcm/components/commons/site/clientlibs/container.min.js>/script>script src/etc.clientlibs/clientlibs/granite/moment.min.js>/script>script src/etc.clientlibs/clientlibs/granite/uritemplate.min.js>/script>script src/etc.clientlibs/clientlibs/granite/utils.min.js>/script>script src/etc.clientlibs/granite/ui/components/coral/foundation/components/clientlibs/components.min.js>/script>script src/etc.clientlibs/clientlibs/granite/jquery/granite.min.js>/script>script src/etc.clientlibs/clientlibs/granite/history.min.js>/script>script src/etc.clientlibs/clientlibs/granite/dompurify.min.js>/script>script src/etc.clientlibs/granite/ui/components/coral/foundation/clientlibs/foundation.min.js>/script>script src/etc.clientlibs/bmscorp/components/content/general/stakeholderinfo/clientlib-multifield.min.js>/script>script src/etc.clientlibs/bmscorp/clientlibs/clientlibs/shared/clientlib-granite-authoring-overides.min.js>/script>script src/etc.clientlibs/bms-commercial/design/themes-clientlbs/commercial-global.min.js>/script> script src/content/dam/commercial/us/inrebicpro/en/inrebicpro-us-en_us-publish/js/script.js typetext/javascript>/script> script src/content/dam/commercial/us/inrebicpro/en/inrebicpro-us-en_us-publish/js/owl.carousel.js typetext/javascript>/script> script typeapplication/ld+json>{ @context: http://schema.org, @type: Drug, proprietaryName: INREBIC, activeIngredient: (fedratinib), mechanismOfAction: INREBIC® is an oral once-daily kinase inhibitor with activity against both wild type and mutated JAK2, as well as FLT3, dosageForm: capsule, doseSchedule: 400mg orally once daily with or without food for patients with a baseline platelet count of greater than or equal to 50 x 109/L, drugUnit: 100mg capsule, administrationRoute: oral, interactingDrug: Strong CYP3A4 Inhibitors: Reduce INREBIC dose as recommended, Strong and Moderate CYP3A4 Inducers: Avoid use of INREBIC, Dual CYP3A4 and CYP2C19 Inhibitor: Avoid use of INREBIC, manufacturer: Bristol Myers Squibb, url: https://www.inrebicpro.com/, prescribingInfo: https://packageinserts.bms.com/pi/pi_inrebic.pdf, warning: Serious and fatal encephalopathy, including Wernicke’s, has occurred in patients treated with INREBIC. Wernicke’s encephalopathy is a neurologic emergency. Assess thiamine levels in all patients prior to starting INREBIC, periodically during treatment, and as clinically indicated. Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize. (2.6, 5.1, 6.1).},{ @context: http://schema.org, @type: MedicalIndication, name: Indication, description: INREBIC is a kinase inhibitor indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemiavera or post-essential thrombocythemia) myelofibrosis},{ @context: http://schema.org, @type: MedicalTherapy, name: INREBIC®, description: INREBIC® is started at the full dose (400 mg) in patients with platelets ≥50 x 109/L and is given once daily, adverseOutcome: Anemia, Thrombocytopenia, Neutropenia, Diarrhea, Nausea, Vomiting, Constipation, Fatigue, Headache, Urinary Tract Infection, Asthenia, Dizziness, Creatinine Increased, AST Increaed, ALT Increased, Lipase Increased, Amylase Increased, seriousAdverseOutcome: Cardiac Failure, Anemia, Cardiogenic Shock},{ @context: http://schema.org, @type: Organization, name: Bristol Myers Squibb Access Support, url: www.bmsaccesssupport.com, telephone: 1-800-861-0048}/script> /body>/html>
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