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148 grid-template-columns:repeat(1,minmax(0,1fr)); 149 gap:0px; 150 justify-items:stretch; 151 margin-left:auto; 152 margin-right:auto; 153 width:auto; 154 } 155 156 #hs_cos_wrapper_widget_1781762256264 .cards__card-link { width:100%; } 157 158 #hs_cos_wrapper_widget_1781762256264 .cards__icon:not(.icon-shadow-border) img { 159 width:auto; 160 height:auto; 161 } 162 163 #hs_cos_wrapper_widget_1781762256264 .cards__icon.icon-shadow-border img { 164 width:100%; 165 height:auto; 166 } 167 168 #hs_cos_wrapper_widget_1781762256264 .cards__card.purple-divider-side { 169 flex-direction:row; 170 align-items:flex-start; 171 } 172 173 #hs_cos_wrapper_widget_1781762256264 .card-1 { flex-direction:column; } 174 175 #hs_cos_wrapper_widget_1781762256264 .card-1 {} 176 177 #hs_cos_wrapper_widget_1781762256264 .card-1 .cards__icon {} 178 179 #hs_cos_wrapper_widget_1781762256264 .card-1 .cards__title {} 180 181 #hs_cos_wrapper_widget_1781762256264 .card-1 .cards__copy {} 182 183 #hs_cos_wrapper_widget_1781762256264 .card-1 .cards__btn {} 184} 185 186</style> 187 188<link rel="stylesheet" href="https://www.lyfgeniahcp.com/hubfs/hub_generated/module_assets/1/213192069936/1790953900218/module_footer-global-module.min.css"> 189<link rel="stylesheet" href="https://www.lyfgeniahcp.com/hubfs/hub_generated/module_assets/1/214208692642/1787670526983/module_modal-module.min.css"> 190<link rel="stylesheet" href="https://www.lyfgeniahcp.com/hubfs/hub_generated/module_assets/1/214210175022/1788968077674/module_hero-module.min.css"> 191 192<style>#hs_cos_wrapper_widget_1780477538954 .hero-fullwidth { 193 position:relative; 194 width:100vw; 195 max-width:none; 196 left:50%; 197 right:50%; 198 margin-left:-50vw; 199 margin-right:-50vw; 200} 201 202@media (max-width:767px) { 203 #hs_cos_wrapper_widget_1780477538954 .lyf-homepage-hero { background-image:url(https://www.lyfgeniahcp.com/hubfs/lyfgeniahcp/images/lyf_hcp_image_Hero-M-2x.jpg) !important; } 204} 205</style> 206 207 208<style> 209 #hs_cos_wrapper_widget_1780482725784 .cards { 210 display:flex; 211 flex-direction:row; 212 flex-wrap:wrap; 213 gap:0px; 214 justify-content:flex-start; 215 align-items:stretch; 216 max-width:100%; 217 margin-left:auto; 218 margin-right:auto; 219} 220 221#hs_cos_wrapper_widget_1780482725784 .card-1 { 222 border:none; 223 border-radius:0; 224 flex-direction:column; 225 justify-content:flex-start; 226 align-items:flex-start; 227} 228 229#hs_cos_wrapper_widget_1780482725784 .card-1 .cards__icon {} 230 231#hs_cos_wrapper_widget_1780482725784 .card-1 .cards__title {} 232 233#hs_cos_wrapper_widget_1780482725784 .card-1 .cards__copy {} 234 235#hs_cos_wrapper_widget_1780482725784 .card-1 .cards__btn {} 236 237@media (max-width:767px) { 238 #hs_cos_wrapper_widget_1780482725784 .cards { 239 display:grid !important; 240 grid-template-columns:repeat(1,minmax(0,1fr)); 241 gap:0px; 242 justify-items:stretch; 243 margin-left:auto; 244 margin-right:auto; 245 width:auto; 246 } 247 248 #hs_cos_wrapper_widget_1780482725784 .cards__card-link { width:100%; } 249 250 #hs_cos_wrapper_widget_1780482725784 .cards__icon:not(.icon-shadow-border) img { 251 width:auto; 252 height:auto; 253 } 254 255 #hs_cos_wrapper_widget_1780482725784 .cards__icon.icon-shadow-border img { 256 width:100%; 257 height:auto; 258 } 259 260 #hs_cos_wrapper_widget_1780482725784 .cards__card.purple-divider-side { 261 flex-direction:row; 262 align-items:flex-start; 263 } 264 265 #hs_cos_wrapper_widget_1780482725784 .card-1 { flex-direction:column; } 266 267 #hs_cos_wrapper_widget_1780482725784 .card-1 {} 268 269 #hs_cos_wrapper_widget_1780482725784 .card-1 .cards__icon {} 270 271 #hs_cos_wrapper_widget_1780482725784 .card-1 .cards__title {} 272 273 #hs_cos_wrapper_widget_1780482725784 .card-1 .cards__copy {} 274 275 #hs_cos_wrapper_widget_1780482725784 .card-1 .cards__btn {} 276} 277 278</style> 279 280 281<style> 282 #hs_cos_wrapper_widget_1781779179924 .cards { 283 display:flex; 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424 grid-template-columns:repeat(1,minmax(0,1fr)); 425 gap:0px; 426 justify-items:stretch; 427 margin-left:auto; 428 margin-right:auto; 429 width:auto; 430 } 431 432 #hs_cos_wrapper_widget_1782413235774 .cards__card-link { width:100%; } 433 434 #hs_cos_wrapper_widget_1782413235774 .cards__icon:not(.icon-shadow-border) img { 435 width:auto; 436 height:auto; 437 } 438 439 #hs_cos_wrapper_widget_1782413235774 .cards__icon.icon-shadow-border img { 440 width:100%; 441 height:auto; 442 } 443 444 #hs_cos_wrapper_widget_1782413235774 .cards__card.purple-divider-side { 445 flex-direction:row; 446 align-items:flex-start; 447 } 448 449 #hs_cos_wrapper_widget_1782413235774 .card-1 { flex-direction:column; } 450 451 #hs_cos_wrapper_widget_1782413235774 .card-1 {} 452 453 #hs_cos_wrapper_widget_1782413235774 .card-1 .cards__icon {} 454 455 #hs_cos_wrapper_widget_1782413235774 .card-1 .cards__title {} 456 457 #hs_cos_wrapper_widget_1782413235774 .card-1 .cards__copy {} 458 459 #hs_cos_wrapper_widget_1782413235774 .card-1 .cards__btn {} 460} 461 462</style> 463 464<link rel="stylesheet" href="https://www.lyfgeniahcp.com/hubfs/hub_generated/module_assets/1/214210175037/1784190121954/module_more-topics-module.min.css"> 465 466<style> 467 #hs_cos_wrapper_module_17824135797225 .more-topics-container { 468 position:relative; 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479 color:rgba(255,255,255,1.0); 480} 481 482#hs_cos_wrapper_module_17824135797225 .more-topics .more-topics-heading, 483#hs_cos_wrapper_module_17824135797225 .more-topics .more-topics-heading * { color:rgba(255,255,255,1.0); } 484 485#hs_cos_wrapper_module_17824135797225 .more-topics .more-topics-links { background:rgba(240,244,252,1.0); } 486 487</style> 488 489<!-- Editor Styles --> 490<style id="hs_editor_style" type="text/css"> 491.references-row-0-max-width-section-centering > .row-fluid { 492 max-width: 1140px !important; 493 margin-left: auto !important; 494 margin-right: auto !important; 495} 496.main_content-row-1-max-width-section-centering > .row-fluid { 497 max-width: 1170px !important; 498 margin-left: auto !important; 499 margin-right: auto !important; 500} 501.main_content-row-2-max-width-section-centering > .row-fluid { 502 max-width: 1170px !important; 503 margin-left: auto !important; 504 margin-right: auto !important; 505} 506.main_content-row-3-max-width-section-centering > .row-fluid { 507 max-width: 1140px !important; 508 margin-left: auto !important; 509 margin-right: auto !important; 510} 511.main_content-row-4-max-width-section-centering > .row-fluid { 512 max-width: 1140px !important; 513 margin-left: auto !important; 514 margin-right: auto !important; 515} 516/* HubSpot Styles (default) */ 517.cell_17817626007183-padding { 518 padding-left: 15px !important; 519 padding-right: 15px !important; 520} 521.main_content-row-1-background-layers { 522 background-image: linear-gradient(rgba(0, 39, 143, 1), rgba(0, 39, 143, 1)) !important; 523 background-position: left top !important; 524 background-size: auto !important; 525 background-repeat: no-repeat !important; 526} 527.main_content-row-2-padding { 528 padding-top: 7px !important; 529 padding-bottom: 7px !important; 530} 531.main_content-row-2-background-layers { 532 background-image: linear-gradient(rgba(240, 244, 252, 1), rgba(240, 244, 252, 1)) !important; 533 background-position: left top !important; 534 background-size: auto !important; 535 background-repeat: no-repeat !important; 536} 537.cell_17804827121603-padding { 538 padding-left: 15px !important; 539 padding-right: 15px !important; 540} 541.cell_17804857681092-padding { 542 padding-left: 15px !important; 543 padding-right: 15px !important; 544} 545.cell_1781779099680-padding { 546 padding-left: 15px !important; 547 padding-right: 15px !important; 548} 549.cell_17824135797223-padding { 550 padding-left: 15px !important; 551 padding-right: 15px !important; 552} 553/* HubSpot Styles (mobile) */ 554@media (max-width: 767px) { 555 .main_content-row-4-padding { 556 padding-bottom: 0px !important; 557 } 558} 559</style> 560 561 562 563 <link rel="canonical" href="https://www.lyfgeniahcp.com"> 564 565 566<meta property="og:url" content="https://www.lyfgeniahcp.com"> 567<meta name="twitter:card" content="summary"> 568<meta http-equiv="content-language" content="en"> 569 570 571 572 573 574 575 576<!-- hcp-home-hero-mobile-center --> 577<style> 578/* Mobile: the hero text column carries a desktop `pl-0` (flush-left in the split 579 layout) and renders ~30px narrow, so the centered heading landed off-center to the 580 left. 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734</div> 735 736 737 <header id="site-header"> 738 <div id="hs_cos_wrapper_disclaimer_bar" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"><div class="strip-component sticky-header p-0"> 739 <div class="strip-component bg-tertiary py-0 site-disclaimer"> 740 <div class="grid-component container"> 741 <div class="row"> 742 <div class="col-12 py-2 py-md-1 px-1"> 743 This website is developed by Genetix Biotherapeutics Inc. and is intended for US healthcare professionals only. <a class="text-primary" href="https://www.lyfgenia.com?hsLang=en">Visit Patient Site</a> 744 </div> 745 </div> 746 </div> 747 </div> 748</div></div> 749 <nav class="navbar" id="navbar"> 750 <div id="hs_cos_wrapper_header_branding" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"> 751 752 753 754 755 756 757 758 759 760 761 762 763<div class="container secondary-menu-wrapper"> 764 <div class="row"> 765 <div class="col-12 no-top-padding"> 766 <a class="text-primary" href="https://www.bluebirdbio.com/-/media/bluebirdbio/Corporate%20COM/Files/Lyfgenia/LYFGENIA_Prescribing_Information.pdf" rel="noopener noreferrer" target="_blank">Prescribing Information</a><span class="d-none d-md-inline"> </span><a class="text-primary d-none d-md-inline" href="/important-safety-information?hsLang=en">Important Safety Information</a><span class="d-none d-md-inline"> </span><a class="text-primary" href="/find-a-qualified-treatment-center?hsLang=en">Qualified Treatment Centers</a> 767 </div> 768 </div> 769</div> 770 771 772<div class="container branding-wrapper"> 773 <div class="branding"> 774 <a href="/?hsLang=en"> 775 <img alt="LYFGENIA (lovotibeglogene autotemcel) logo" src="https://www.lyfgeniahcp.com/hubfs/raw_assets/public/themes/lyfgeniahcp-theme/images/logos/lyfgenia-logo.svg"> 776 </a> 777 </div> 778 <div 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id="navbarSupportedContent"> 805 <a href="/?hsLang=en"><img class="mobile-menu-logo" alt="Lyfgenia" src="https://www.lyfgeniahcp.com/hubfs/raw_assets/public/themes/lyfgeniahcp-theme/images/logos/lyfgenia-logo.svg" width="150" height="62"></a> 806 807 <div class="primary-menu-left"></div> 808 <div class="primary-menu-right"></div> 809 <div class="primary-menu"> 810 <div class="container"> 811 <ul class="navbar-nav"> 812 813 814 <li class="nav-item level-1"> 815 <a class="level-1-link navbar-menu-button" href="/mechanism-of-action?hsLang=en" target=""> 816 <i class=""></i> 817 MOA 818 </a> 819 820 </li> 821 822 823 <li class="nav-item level-1"> 824 <a class="level-1-link" href="/clinical-trials?hsLang=en" target=""> 825 <i class=""></i> 826 Studies + Results 827 </a> 828 829 <div class="sub-menu" id="submenu-2"> 830 <div class="sub-menu-column"> 831 <ul class=""> 832 833 <li> 834 <a class="level-2-link" href="/clinical-trials?hsLang=en" target=""> 835 <i class=""></i> 836 Clinical Results 837 </a> 838 <ul></ul> 839 </li> 840 841 <li> 842 <a class="level-2-link" href="/clinical-trials/safety?hsLang=en" target=""> 843 <i class=""></i> 844 Safety 845 </a> 846 <ul></ul> 847 </li> 848 849 </ul> 850 </div> 851 </div> 852 853 </li> 854 855 856 <li class="nav-item level-1"> 857 <a class="level-1-link" href="/treatment-pathway?hsLang=en" target=""> 858 <i class=""></i> 859 Treatment Pathway 860 </a> 861 862 </li> 863 864 865 <li class="nav-item level-1"> 866 <a class="level-1-link" href="/support?hsLang=en" target=""> 867 <i class=""></i> 868 Support + Resources 869 </a> 870 871 </li> 872 873 874 <li class="nav-item level-1"> 875 <a class="level-1-link" href="/faqs?hsLang=en" target=""> 876 <i class=""></i> 877 FAQs 878 </a> 879 880 </li> 881 882 </ul> 883 </div> 884 </div> 885</div></div> 886 </nav> 887 </header> 888 889 890 <main id="content" tabindex="-1"> 891 892 <div class="container-fluid"> 893<div class="row-fluid-wrapper"> 894<div class="row-fluid"> 895<div class="span12 widget-span widget-type-cell " style="" data-widget-type="cell" data-x="0" data-w="12"> 896 897<div class="row-fluid-wrapper row-depth-1 row-number-1 dnd-section"> 898<div class="row-fluid "> 899<div class="span12 widget-span widget-type-cell dnd-column" style="" data-widget-type="cell" data-x="0" data-w="12"> 900 901<div class="row-fluid-wrapper row-depth-1 row-number-2 dnd-row"> 902<div class="row-fluid "> 903<div class="span12 widget-span widget-type-custom_widget dnd-module" style="" data-widget-type="custom_widget" data-x="0" data-w="12"> 904<div id="hs_cos_wrapper_widget_1780477538954" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"> 905 906 907 908 909 910 911 912 913 914 915 916 917 918 919 920 921 922 923 924 925 926 927 928 929 930 931 932 933 934 <div class="strip-component py-0 lyf-custom-banner d-none d-md-block hero-fullwidth" style="background-image: url(https://www.lyfgeniahcp.com/hubfs/lyfgeniahcp/images/lyf_hcp_image_Hero-D-2x.jpg)" role="img" aria-label="lyf_hcp_image_Hero-D-2x"> 935 <div class="grid-component container container-wide"> 936 <div class="row"> 937 <div class="col-md-6 pl-0"> 938 <div class="text-center"> 939 <div class="banner-text-holder"> 940<div class="banner-text-top text-white"> 941<p class="intro-text">Someday, life with sickle cell disease could be different.</p> 942<p class="intro-text">Someday you could help make gene therapy a reality for your patients.</p> 943<p class="intro-headline"><span class="banner-text-large">Someday</span><br>is <span class="banner-text-large">Today</span></p> 944<p><img src="https://www.lyfgeniahcp.com/hubfs/lyfgeniahcp/images/lyf_hcp_icon_wave-large.svg" width="168" height="10" loading="lazy" alt="lyf_hcp_icon_wave-large" style="height: auto; max-width: 100%; width: 168px;"></p> 945</div> 946<div class="banner-text-bottom"> 947<p class="intro-subheadline mb-3 text-white">LYFGENIA⢠is the longest-studied* approved <br class="d-none d-lg-block">gene therapy for sickle cell disease<sup>1,2</sup></p> 948<p class="font-small text-white" style="margin-bottom: 50px;">*The key registrational clinical trial that <br class="d-none d-md-block">evaluated LYFGENIA started in February 2015.<sup>1</sup></p> 949</div> 950</div> 951 952 953 954 955 956 957 958 959 960 961 962 963 964 965 966 967 968 969 970 971 972 973 974 <a class="btn btn-secondary arrow" href="/clinical-trials?hsLang=en">See results from clinical trials</a> 975 976 977 </div> 978 </div> 979 <div class="col-md-6"></div> 980 </div> 981 </div> 982 983 <div class="banner-caption"> 984 <div class="actor-portrayal"><span class="text-white">Actor Portrayals</span></div> 985 </div> 986 987 </div> 988 989 990 991 992 993 <div class="strip-component py-0 lyf-custom-banner d-block d-md-none hero-fullwidth" style="background-image: url(https://www.lyfgeniahcp.com/hubfs/lyfgeniahcp/images/lyf_hcp_image_Hero-M-2x.jpg)" role="img" aria-label="lyf_hcp_image_Hero-D-2x"> 994 <div class="grid-component container container-wide"> 995 <div class="row"> 996 <div class="col-md-6 pl-0"> 997 <div class="text-center"> 998 <div class="banner-text-holder"> 999<div class="banner-text-top text-white"> 1000<p class="intro-text">Someday, life with sickle cell disease could be different.</p> 1001<p class="intro-text">Someday you could help make gene therapy a reality for your patients.</p> 1002<p class="intro-headline"><span class="banner-text-large">Someday</span><br>is <span class="banner-text-large">Today</span></p> 1003<p><img src="https://www.lyfgeniahcp.com/hubfs/lyfgeniahcp/images/lyf_hcp_icon_wave-large.svg" width="168" height="10" loading="lazy" alt="lyf_hcp_icon_wave-large" style="height: auto; max-width: 100%; width: 168px;"></p> 1004</div> 1005<div class="banner-text-bottom"> 1006<p class="intro-subheadline mb-3 text-white">LYFGENIA⢠is the longest-studied* approved <br class="d-none d-lg-block">gene therapy for sickle cell disease<sup>1,2</sup></p> 1007<p class="font-small text-white" style="margin-bottom: 50px;">*The key registrational clinical trial that <br class="d-none d-md-block">evaluated LYFGENIA started in February 2015.<sup>1</sup></p> 1008</div> 1009</div> 1010 1011 1012 1013 1014 1015 1016 1017 1018 1019 1020 1021 1022 1023 1024 1025 1026 1027 1028 1029 1030 1031 1032 1033 <a class="btn btn-secondary arrow" href="/clinical-trials?hsLang=en">See results from clinical trials</a> 1034 1035 1036 </div> 1037 </div> 1038 <div class="col-md-6"></div> 1039 </div> 1040 </div> 1041 1042 <div class="banner-caption"> 1043 <div class="actor-portrayal"><span class="text-white">Actor Portrayals</span></div> 1044 </div> 1045 1046 </div> 1047 1048 1049 1050</div> 1051 1052</div><!--end widget-span --> 1053</div><!--end row--> 1054</div><!--end row-wrapper --> 1055 1056</div><!--end widget-span --> 1057</div><!--end row--> 1058</div><!--end row-wrapper --> 1059 1060<div class="row-fluid-wrapper row-depth-1 row-number-3 main_content-row-1-background-layers main_content-row-1-background-color dnd-section main_content-row-1-max-width-section-centering"> 1061<div class="row-fluid "> 1062<div class="span12 widget-span widget-type-cell cell_17804827121603-padding dnd-column" style="" data-widget-type="cell" data-x="0" data-w="12"> 1063 1064<div class="row-fluid-wrapper row-depth-1 row-number-4 dnd-row"> 1065<div class="row-fluid "> 1066<div class="span12 widget-span widget-type-custom_widget dnd-module" style="" data-widget-type="custom_widget" data-x="0" data-w="12"> 1067<div id="hs_cos_wrapper_widget_1780482725784" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"> 1068 1069 1070 1071 1072 1073 1074 1075 1076 1077 1078 1079 1080 1081 1082 1083 1084 1085 1086 1087 1088 1089 1090 1091 1092 1093 1094<div id="widget_1780482725784" class="cards"> 1095 1096
1097 1098 1099 1100 1101 <div class="cards__card card-1"> 1102 1103 1104 1105 1106 1107 <div class="cards__content"> 1108 1109 1110 1111 1112 <div class="cards__copy"><div class="strip-component bg-primary"> 1113<div class="grid-component container"> 1114<div class="row"> 1115<div class="col-md-12 py-2"> 1116<div class="text-white"> 1117<p class="mb-0 pt-4 pt-lg-0">LYFGENIA is an autologous hematopoietic stem cell-based gene therapy <span class="IBMPlexSans-Bold">indicated for the treatment of patients 12 years of age or older with sickle cell disease</span> and a history of vaso-occlusive events.<sup>2</sup></p> 1118</div> 1119</div> 1120</div> 1121</div> 1122</div></div> 1123 1124 1125 1126 </div> 1127 1128 1129 1130 1131 1132 </div> 1133 1134 1135</div> 1136</div> 1137 1138</div><!--end widget-span --> 1139</div><!--end row--> 1140</div><!--end row-wrapper --> 1141 1142</div><!--end widget-span --> 1143</div><!--end row--> 1144</div><!--end row-wrapper --> 1145 1146<div class="row-fluid-wrapper row-depth-1 row-number-5 dnd-section main_content-row-2-background-color main_content-row-2-padding main_content-row-2-max-width-section-centering main_content-row-2-background-layers"> 1147<div class="row-fluid "> 1148<div class="span12 widget-span widget-type-cell cell_17804857681092-padding dnd-column" style="" data-widget-type="cell" data-x="0" data-w="12"> 1149 1150<div class="row-fluid-wrapper row-depth-1 row-number-6 dnd-row"> 1151<div class="row-fluid "> 1152<div class="span12 widget-span widget-type-custom_widget dnd-module" style="" data-widget-type="custom_widget" data-x="0" data-w="12"> 1153<div id="hs_cos_wrapper_widget_1780485981048" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module widget-type-rich_text" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"><span id="hs_cos_wrapper_widget_1780485981048_" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_rich_text" style="" data-hs-cos-general-type="widget" data-hs-cos-type="rich_text"><div class="strip-component bg-tertiary py-0"> 1154<div class="grid-component container"> 1155<div class="row"> 1156<div class="col-md-12 py-0"> 1157<div class="panel-group FAQaccordion limitations-accordion" id="accordion-limitations"> 1158<div class="panel panel-default question"> 1159<div class="panel-heading h5 text-primary pt-0"> 1160<div class="panel-title question-title"><a class="question-link collapsed" data-bs-toggle="collapse" data-bs-target="#collapse-limitations" aria-expanded="false" aria-controls="collapse-limitations" tabindex="0" role="button"> <span class="IBMPlexSans-Bold" style="font-size: 16px;">Limitations of Use</span> </a></div> 1161</div> 1162<div class="panel-collapse collapse" id="collapse-limitations"> 1163<div class="panel-body-mask"> 1164<div class="panel-body question-body pb-1">Following treatment with LYFGENIA, patients with α-thalassemia trait (-α3.7/-α3.7) may experience anemia with erythroid dysplasia that may require chronic red blood cell transfusions. LYFGENIA has not been studied in patients with more than two α-globin gene deletions.<sup>2</sup></div> 1165</div> 1166</div> 1167</div> 1168</div> 1169</div> 1170</div> 1171</div> 1172</div></span></div> 1173 1174</div><!--end widget-span --> 1175</div><!--end row--> 1176</div><!--end row-wrapper --> 1177 1178</div><!--end widget-span --> 1179</div><!--end row--> 1180</div><!--end row-wrapper --> 1181 1182<div class="row-fluid-wrapper row-depth-1 row-number-7 dnd-section main_content-row-3-max-width-section-centering"> 1183<div class="row-fluid "> 1184<div class="span12 widget-span widget-type-cell cell_1781779099680-padding dnd-column" style="" data-widget-type="cell" data-x="0" data-w="12"> 1185 1186<div class="row-fluid-wrapper row-depth-1 row-number-8 dnd-row"> 1187<div class="row-fluid "> 1188<div class="span12 widget-span widget-type-custom_widget dnd-module" style="" data-widget-type="custom_widget" data-x="0" data-w="12"> 1189<div id="hs_cos_wrapper_widget_1781779179924" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"> 1190 1191 1192 1193 1194 1195 1196 1197 1198 1199 1200 1201 1202 1203 1204 1205 1206 1207 1208 1209 1210 1211 1212 1213 1214 1215 1216<div id="widget_1781779179924" class="cards"> 1217 1218 1219 1220 1221 1222 1223 <div class="cards__card card-1"> 1224 1225 1226 1227 1228 1229 <div class="cards__content"> 1230 1231 1232 1233 1234 <div class="cards__copy"><div class="py-0 py-md-3 mb-5 mb-md-0"> 1235<div class="content-tile no-icon content-tile-blue-bg"><img alt="" class="content-tile-img" src="https://www.lyfgeniahcp.com/hubfs/lyfgeniahcp/images/lyf_hcp_icon_DNA.svg"> 1236<div class="content-tile-content"> 1237<p class="IBMPlexSans-Bold text-septenary" style="font-size: 16px;">HOW IT WORKS</p> 1238<h1 class="h1 content-tile-title IBMPlexSerif-Medium text-black">LYFGENIA is a single dose autologous gene addition therapy<sup>2</sup></h1> 1239<div class="content-tile-text pb-1 pb-md-4">Designed to produce anti-sickling adult hemoglobin (HbA<sup>T87Q</sup>) to potentially decrease or stop vaso-occlusive events (VOEs).<sup>2â â¡Â§</sup></div> 1240<div class="d-flex justify-content-start"><a class="btn btn-primary medium" href="/mechanism-of-action?hsLang=en">Learn how LYFGENIA works</a></div> 1241</div> 1242</div> 1243</div></div> 1244 1245 1246 1247 </div> 1248 1249 1250 1251 1252 1253 </div> 1254 1255 1256 1257 1258 1259 1260 1261 <div class="cards__card card-2"> 1262 1263 1264 1265 1266 1267 <div class="cards__content"> 1268 1269 1270 1271 1272 <div class="cards__copy"><div class="py-0 py-md-3"> 1273<div class="content-tile no-icon content-tile-blue-bg"><img alt="" class="content-tile-img" src="https://www.lyfgeniahcp.com/hubfs/lyfgeniahcp/images/lyf_hcp_icon_Cell-Red.svg"> 1274<div class="content-tile-content"><i class="content-tile-icon"></i> 1275<p class="IBMPlexSans-Bold text-septenary" style="font-size: 16px;">CLINICAL EFFECTIVENESS</p> 1276<h1 class="h1 content-tile-title IBMPlexSerif-Medium text-black">A one-time transformational sickle cell disease (SCD) gene therapy with the potential to decrease or stop VOEs<sup>2</sup></h1> 1277<div class="content-tile-text pb-1 mb-5">88% (n=28/32, CI: 71, 97) of evaluable patients in Study 1-C achieved complete resolution of VOEs (VOE-CR) between 6 and 18 months after infusion of LYFGENIA.<sup>2â â¡Â§</sup></div> 1278<div class="d-flex justify-content-start"><a class="btn btn-primary medium" href="/clinical-trials?hsLang=en">See the efficacy data</a></div> 1279</div> 1280</div> 1281</div></div> 1282 1283 1284 1285 </div> 1286 1287 1288 1289 1290 1291 </div> 1292 1293 1294</div> 1295</div> 1296 1297</div><!--end widget-span --> 1298</div><!--end row--> 1299</div><!--end row-wrapper --> 1300 1301<div class="row-fluid-wrapper row-depth-1 row-number-9 dnd-row"> 1302<div class="row-fluid "> 1303<div class="span12 widget-span widget-type-custom_widget dnd-module" style="" data-widget-type="custom_widget" data-x="0" data-w="12"> 1304<div id="hs_cos_wrapper_widget_1782413235774" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"> 1305 1306 1307 1308 1309 1310 1311 1312 1313 1314 1315 1316 1317 1318 1319 1320 1321 1322 1323 1324 1325 1326 1327 1328 1329 1330 1331<div id="widget_1782413235774" class="cards"> 1332 1333
1334 1335 1336 1337 1338 <div class="cards__card card-1 container-narrow"> 1339 1340 1341 1342 1343 1344 <div class="cards__content"> 1345 1346 1347 1348 1349 <div class="cards__copy"><div style="font-family; lato-regular; font-size: 10px; line-height: 12px;"> 1350<p class="mb-2">VOE-CR = elimination of VOEs between 6 and 18 months post infusion.<sup>2</sup></p> 1351<p class="mb-2"><span class="sup-text"><sup style="top: 3px;">â </sup>VOEs were defined as any of the following events requiring evaluation at a medical facility: an episode of acute pain with no medically determined cause other than vaso-occlusion, lasting more than 2 hours, acute chest syndrome, acute hepatic sequestration, or acute splenic sequestration.</span><sup>2</sup></p> 1352<p class="mb-2"><span class="sup-text"><sup style="top: 3px;">â¡</sup>After the primary evaluation period to last follow-up, 4 of 28 patients who achieved VOE-CR experienced VOEs.</span><sup>2</sup></p> 1353<p><span class="sup-text"><sup style="top: 3px;">§</sup>The efficacy of LYFGENIA was studied in a single-arm, 24-month, open-label, multicenter Phase 1/2 study (Study 1-C) and a long-term follow-up study. In Study 1-C, 32 patients with a history of at least 4 VOEs in the 24 months prior to informed consent were evaluated for VOEs.</span><sup>2</sup></p> 1354</div></div> 1355 1356 1357 1358 </div> 1359 1360 1361 1362 1363 1364 </div> 1365 1366 1367</div> 1368</div> 1369 1370</div><!--end widget-span --> 1371</div><!--end row--> 1372</div><!--end row-wrapper --> 1373 1374</div><!--end widget-span --> 1375</div><!--end row--> 1376</div><!--end row-wrapper --> 1377 1378<div class="row-fluid-wrapper row-depth-1 row-number-10 main_content-row-4-padding dnd-section main_content-row-4-max-width-section-centering"> 1379<div class="row-fluid "> 1380<div class="span12 widget-span widget-type-cell cell_17824135797223-padding dnd-column" style="" data-widget-type="cell" data-x="0" data-w="12"> 1381 1382<div class="row-fluid-wrapper row-depth-1 row-number-11 dnd-row"> 1383<div class="row-fluid "> 1384<div class="span12 widget-span widget-type-custom_widget dnd-module" style="" data-widget-type="custom_widget" data-x="0" data-w="12"> 1385<div id="hs_cos_wrapper_module_17824135797225" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"> 1386 1387 1388 1389 1390 1391 1392 1393 1394 1395<div class="strip-component more-topics-container pt-5 more-topics-container-home pb-5 pb-md-9"> 1396 <div class="grid-component container more-topics more-topics-home"> 1397 <div class="row"> 1398 <div class="col-md-6 more-topics-heading"> 1399 <div class="more-topics-heading-text"> 1400 1401 <p class="IBMPlexSans-SemiBold text-white" style="color: #ffffff; line-height: 22px; background-color: #00278f;">Genetix CARES</p> 1402<h1 style="line-height: 40px; color: #ffffff; background-color: #00278f;">Support that never stops</h1> 1403<p> </p> 1404<p style="line-height: 22px; color: #ffffff; background-color: #00278f;">Even before LYFGENIA is prescribed, your patients can enroll in and receive access to<span> </span><a href="https://www.genetixcares.com/?hsLang=en">Genetix CARES</a>âa program that provides a range of support from helping to identify Qualified Treatment Center options for consultation to understanding insurance benefits and the process for prior authorization.</p> 1405<p style="line-height: 22px; color: #ffffff; background-color: #00278f;">Patient Navigators are here to help with education, access, and logistics throughout the decision process and beyond.</p> 1406<p><img src="https://www.lyfgeniahcp.com/hubfs/raw_assets/public/themes/lyfgeniahcp-theme/images/lyf_hcp_icon_mail-white.svg" style="vertical-align: middle; height: auto; 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1524 1525 1526 <div id="hs_cos_wrapper_isi" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"> 1527 1528 1529 1530 1531 1532<div class="important-information-banner"> 1533 1534 1535 <div class="full-content container"> 1536 1537 <div class="row"> 1538 <div class="col-lg-7 col-md-7 col-sm-12 pb-0 pb-lg-3 pt-3"> 1539 <h2 class="IBMPlexSans-Bold mb-2 d-none d-md-block" style="color:#218282; font-size:20px;">Important Safety Information</h2> 1540 <h2 class="IBMPlexSans-Bold mb-2 d-block d-md-none expanded-hide" style="color:#218282; font-size:20px; padding-top:5px; margin-top:-15px; line-height: 1.2;">Important Safety<br> Information</h2> 1541 <h2 class="IBMPlexSans-Bold mb-2 d-block d-md-none expanded-show" style="color:#218282; font-size:20px; padding-top:5px; margin-top:-15px; line-height: 1.2;">Important Safety<br>Information and Indication</h2> 1542 1543 <p class="IBMPlexSans-Bold mb-0 text-primary">Boxed WARNING: HEMATOLOGIC MALIGNANCY</p><p class="IBMPlexSans-Bold mb-2 text-black" style="line-height:22px;">Hematologic malignancy has occurred in patients treated with LYFGENIA. Monitor patients closely for evidence of malignancy through complete blood counts at least every 6 months and through integration site analysis at Months 6, 12, and as warranted.</p><p class="IBMPlexSans-Bold mb-2 text-primary">Hematologic Malignancy</p><p class="mb-2" style="line-height:22px;">Hematologic malignancy has occurred in patients treated with LYFGENIA (Study 1, Group A). At the time of initial product approval, two patients treated with an earlier version of LYFGENIA using a different manufacturing process and transplant procedure (Study 1, Group A) developed acute myeloid leukemia (AML). One patient with <span class="text-nowrap">α-thalassemia</span> trait (Study 1, Group C) has been diagnosed with myelodysplastic syndrome (MDS).</p><p class="mb-2" style="line-height:22px;">The additional hematopoietic stress associated with mobilization, conditioning, and infusion of LYFGENIA, including the need to regenerate the hematopoietic system, may increase the risk of a hematologic malignancy. Patients with sickle cell disease have an increased risk of hematologic malignancy as compared to the general population.</p><p class="mb-2" style="line-height:22px;">Patients treated with LYFGENIA may develop hematologic malignancies and should have lifelong monitoring. Monitor for hematologic malignancies with a complete blood count (with differential) at least every 6 months for at least 15 years after treatment with LYFGENIA, and integration site analysis at Months 6, 12, and as warranted.</p><p class="mb-2" style="line-height:22px;">In the event that a malignancy occurs, contact Genetix Biotherapeutics at 1-833-999-6378 for reporting and to obtain instructions on collection of samples for testing.</p><p class="mb-2" style="line-height:22px;"><span style="text-decoration: underline;">Post-Marketing Long Term Follow-Up Study:</span> Patients who intend to receive treatment with LYFGENIA are encouraged to enroll in the study, as available, to assess the long-term safety of LYFGENIA and the risk of malignancies occurring after treatment with LYFGENIA by calling Genetix Biotherapeutics at 1-833-999-6378. The study includes monitoring (at pre-specified intervals) for clonal expansion.</p><p class="IBMPlexSans-Bold mb-2 text-primary">Delayed Platelet Engraftment</p><p class="mb-2" style="line-height:22px;">Delayed platelet engraftment has been observed with LYFGENIA. Bleeding risk is increased prior to platelet engraftment and may continue after engraftment in patients with prolonged thrombocytopenia. Two patients (4%) required more than 100 days post treatment with LYFGENIA to achieve platelet engraftment.</p><p class="mb-2" style="line-height:22px;">Patients should be made aware of the risk of bleeding until platelet recovery has been achieved. Monitor patients for thrombocytopenia and bleeding according to standard guidelines. Conduct frequent platelet counts until platelet engraftment and platelet recovery are achieved. Perform blood cell count determination and other appropriate testing whenever clinical symptoms suggestive of bleeding arise.</p>
1543<p class="IBMPlexSans-Bold mb-2 text-primary">Neutrophil Engraftment Failure</p><p class="mb-2" style="line-height:22px;">There is a potential risk of neutrophil engraftment failure after treatment with LYFGENIA. Neutrophil engraftment failure is defined as failure to achieve three consecutive absolute neutrophil counts (ANC) ⥠0.5 à 10<sup>9</sup> cells/L obtained on different days by Day 43 after infusion of LYFGENIA. Monitor neutrophil counts until engraftment has been achieved. If neutrophil engraftment failure occurs in a patient treated with LYFGENIA, provide rescue treatment with the back-up collection of CD34+ cells.</p><p class="IBMPlexSans-Bold mb-2 text-primary">Insertional Oncogenesis</p><p class="mb-2" style="line-height:22px;">There is a potential risk of lentiviral vector-mediated insertional oncogenesis after treatment with LYFGENIA.</p><p class="IBMPlexSans-Bold mb-2 text-primary">Hypersensitivity Reactions</p><p class="mb-2" style="line-height:22px;">Allergic reactions may occur with the infusion of LYFGENIA. The dimethyl sulfoxide (DMSO) or dextran 40 in LYFGENIA may cause hypersensitivity reactions, including anaphylaxis.</p><p class="IBMPlexSans-Bold mb-2 text-primary">Anti-retroviral Use</p><p class="mb-2" style="line-height:22px;">Patients should not take prophylactic HIV anti-retroviral medications for at least one month prior to mobilization and until all cycles of apheresis are completed. There are some long-acting anti-retroviral medications that may require a longer duration of discontinuation for elimination of the medication. If a patient is taking anti-retrovirals for HIV prophylaxis, confirm a negative test for HIV before beginning mobilization and apheresis of CD34+ cells.</p><p class="IBMPlexSans-Bold mb-2 text-primary">Hydroxyurea Use</p><p class="mb-2" style="line-height:22px;">Patients should not take hydroxyurea for at least 2 months prior to mobilization and until all cycles of apheresis are completed. If hydroxyurea is administered between mobilization and conditioning, discontinue 2 days prior to initiation of conditioning.</p><p class="IBMPlexSans-Bold mb-2 text-primary">Iron Chelation</p><p class="mb-2" style="line-height:22px;">Drug-drug interactions between iron chelators and the mobilization process and myeloablative conditioning agent must be considered. Iron chelators should be discontinued at least 7 days prior to initiation of mobilization or conditioning. Do not administer myelosuppressive iron chelators (e.g., deferiprone) for 6 months post-treatment with LYFGENIA. Non-myelosuppressive iron chelation should be restarted no sooner than 3 months after LYFGENIA infusion. Phlebotomy can be used in lieu of iron chelation, when appropriate.</p><p class="IBMPlexSans-Bold mb-2 text-primary">Interference with PCR-based Testing</p><p class="mb-2" style="line-height:22px;">Patients who have received LYFGENIA are likely to test positive by polymerase chain reaction (PCR) assays for HIV due to integrated BB305 LVV proviral DNA, resulting in a possible false-positive PCR assay test result for HIV. Therefore, patients who have received LYFGENIA should not be screened for HIV infection using a PCR-based assay.</p><p class="IBMPlexSans-Bold mb-2 text-primary">Adverse Reactions</p><p class="mb-2" style="line-height:22px;">The most common adverse reactions ⥠Grade 3 (incidence ⥠20%) were stomatitis, thrombocytopenia, neutropenia, febrile neutropenia, anemia, and leukopenia.</p><p class="mb-2" style="line-height:22px;">Three patients died during LYFGENIA clinical trials; one from sudden cardiac death due to underlying disease and two from acute myeloid leukemia who were treated with an earlier version of LYFGENIA using a different manufacturing process and transplant procedure (Study 1, Group A).</p><p class="IBMPlexSans-Bold mb-2 text-primary">Pregnancy/Lactation</p><p class="mb-2" style="line-height:22px;">Advise patients of the risks associated with myeloablative conditioning agents, including on pregnancy and fertility.</p><p class="mb-2" style="line-height:22px;">LYFGENIA should not be administered to women who are pregnant, and pregnancy after LYFGENIA infusion should be discussed with the treating physician.</p><p class="mb-2" style="line-height:22px;">LYFGENIA is not recommended for women who are breastfeeding, and breastfeeding after LYFGENIA infusion should be discussed with the treating physician.</p>
1543<p class="IBMPlexSans-Bold mb-2 text-primary">Females and Males of Reproductive Potential</p><p class="mb-2" style="line-height:22px;">A negative serum pregnancy test must be confirmed prior to the start of mobilization and re-confirmed prior to conditioning procedures and before LYFGENIA administration.</p><p class="mb-2" style="line-height:22px;">Women of childbearing potential and men capable of fathering a child should use an effective method of contraception (intra-uterine device or combination of hormonal and barrier contraception) from start of mobilization through at least 6 months after administration of LYFGENIA.</p><p class="mb-2" style="line-height:22px;">Advise patients of the options for fertility preservation.</p><p class="IBMPlexSans-Bold text-black">Please see full <a class="text-link text-primary Lato-Bold" href="https://www.bluebirdbio.com/-/media/bluebirdbio/Corporate%20COM/Files/Lyfgenia/LYFGENIA_Prescribing_Information.pdf?v=20260608123731" rel="noopener noreferrer" style="font-family:IBMPlexSans-Bold; color:#00278F !important;" target="_blank">Prescribing Information</a>, including <span class="IBMPlexSans-Bold">Boxed WARNING</span> for LYFGENIA.</p> 1544 </div> 1545 <div class="col-lg-5 col-md-5 col-sm-12 pt-0 pt-md-3"> 1546 <h2 class="mb-2 IBMPlexSans-Bold pt-0 pt-md-3" style="color:#218282; font-size:20px;">Indication</h2> 1547 1548 <p>LYFGENIA is indicated for the treatment of patients 12 years of age or older with sickle cell disease and a history of vaso-occlusive events.</p><p class="mb-0"><span style="text-decoration: underline;">Limitations of Use</span></p><p>Following treatment with LYFGENIA, patients with <span class="text-nowrap">α-thalassemia</span> trait (-α3.7/-α3.7) may experience anemia with erythroid dysplasia that may require chronic red blood cell transfusions. LYFGENIA has not been studied in patients with more than two α-globin gene deletions.</p> 1549 </div> 1550 </div> 1551 1552 </div> 1553 1554 1555 <div class="banner-content"> 1556 <div class="container"> 1557 1558 <div class="banner-toolbar"> 1559 <i class="banner-icon fas fa-2x fa-angle-down clickable"></i> 1560 <span class="banner-icon-collapse" style="display:none;"><i class="fas fa-2x fa-angle-down"></i></span> 1561 <span class="banner-icon-expand" style="display:none;"><i class="fas fa-2x fa-angle-up"></i></span> 1562 </div> 1563 1564 <div class="row"> 1565 <div class="col-lg-7 col-md-7 col-sm-12 pb-0 pb-lg-3 pt-3"> 1566 <h2 class="IBMPlexSans-Bold mb-2 d-none d-md-block" style="color:#218282; font-size:20px;">Important Safety Information</h2> 1567 <h2 class="IBMPlexSans-Bold mb-2 d-block d-md-none expanded-hide" style="color:#218282; font-size:20px; padding-top:5px; margin-top:-15px; line-height: 1.2;">Important Safety<br> Information</h2> 1568 <h2 class="IBMPlexSans-Bold mb-2 d-block d-md-none expanded-show" style="color:#218282; font-size:20px; padding-top:5px; margin-top:-15px; line-height: 1.2;">Important Safety<br>Information and Indication</h2> 1569 1570 <p class="IBMPlexSans-Bold mb-0 text-primary">Boxed WARNING: HEMATOLOGIC MALIGNANCY</p><p class="IBMPlexSans-Bold mb-2 text-black" style="line-height:22px;">Hematologic malignancy has occurred in patients treated with LYFGENIA. Monitor patients closely for evidence of malignancy through complete blood counts at least every 6 months and through integration site analysis at Months 6, 12, and as warranted.</p><p class="IBMPlexSans-Bold mb-2 text-primary">Hematologic Malignancy</p><p class="mb-2" style="line-height:22px;">Hematologic malignancy has occurred in patients treated with LYFGENIA (Study 1, Group A). At the time of initial product approval, two patients treated with an earlier version of LYFGENIA using a different manufacturing process and transplant procedure (Study 1, Group A) developed acute myeloid leukemia (AML). One patient with <span class="text-nowrap">α-thalassemia</span> trait (Study 1, Group C) has been diagnosed with myelodysplastic syndrome (MDS).</p><p class="mb-2" style="line-height:22px;">The additional hematopoietic stress associated with mobilization, conditioning, and infusion of LYFGENIA, including the need to regenerate the hematopoietic system, may increase the risk of a hematologic malignancy. Patients with sickle cell disease have an increased risk of hematologic malignancy as compared to the general population.</p><p class="mb-2" style="line-height:22px;">Patients treated with LYFGENIA may develop hematologic malignancies and should have lifelong monitoring. Monitor for hematologic malignancies with a complete blood count (with differential) at least every 6 months for at least 15 years after treatment with LYFGENIA, and integration site analysis at Months 6, 12, and as warranted.</p><p class="mb-2" style="line-height:22px;">In the event that a malignancy occurs, contact Genetix Biotherapeutics at 1-833-999-6378 for reporting and to obtain instructions on collection of samples for testing.</p><p class="mb-2" style="line-height:22px;"><span style="text-decoration: underline;">Post-Marketing Long Term Follow-Up Study:</span> Patients who intend to receive treatment with LYFGENIA are encouraged to enroll in the study, as available, to assess the long-term safety of LYFGENIA and the risk of malignancies occurring after treatment with LYFGENIA by calling Genetix Biotherapeutics at 1-833-999-6378. The study includes monitoring (at pre-specified intervals) for clonal expansion.</p>
1570<p class="IBMPlexSans-Bold mb-2 text-primary">Delayed Platelet Engraftment</p><p class="mb-2" style="line-height:22px;">Delayed platelet engraftment has been observed with LYFGENIA. Bleeding risk is increased prior to platelet engraftment and may continue after engraftment in patients with prolonged thrombocytopenia. Two patients (4%) required more than 100 days post treatment with LYFGENIA to achieve platelet engraftment.</p><p class="mb-2" style="line-height:22px;">Patients should be made aware of the risk of bleeding until platelet recovery has been achieved. Monitor patients for thrombocytopenia and bleeding according to standard guidelines. Conduct frequent platelet counts until platelet engraftment and platelet recovery are achieved. Perform blood cell count determination and other appropriate testing whenever clinical symptoms suggestive of bleeding arise.</p><p class="IBMPlexSans-Bold mb-2 text-primary">Neutrophil Engraftment Failure</p><p class="mb-2" style="line-height:22px;">There is a potential risk of neutrophil engraftment failure after treatment with LYFGENIA. Neutrophil engraftment failure is defined as failure to achieve three consecutive absolute neutrophil counts (ANC) ⥠0.5 à 10<sup>9</sup> cells/L obtained on different days by Day 43 after infusion of LYFGENIA. Monitor neutrophil counts until engraftment has been achieved. If neutrophil engraftment failure occurs in a patient treated with LYFGENIA, provide rescue treatment with the back-up collection of CD34+ cells.</p><p class="IBMPlexSans-Bold mb-2 text-primary">Insertional Oncogenesis</p><p class="mb-2" style="line-height:22px;">There is a potential risk of lentiviral vector-mediated insertional oncogenesis after treatment with LYFGENIA.</p><p class="IBMPlexSans-Bold mb-2 text-primary">Hypersensitivity Reactions</p><p class="mb-2" style="line-height:22px;">Allergic reactions may occur with the infusion of LYFGENIA. The dimethyl sulfoxide (DMSO) or dextran 40 in LYFGENIA may cause hypersensitivity reactions, including anaphylaxis.</p><p class="IBMPlexSans-Bold mb-2 text-primary">Anti-retroviral Use</p><p class="mb-2" style="line-height:22px;">Patients should not take prophylactic HIV anti-retroviral medications for at least one month prior to mobilization and until all cycles of apheresis are completed. There are some long-acting anti-retroviral medications that may require a longer duration of discontinuation for elimination of the medication. If a patient is taking anti-retrovirals for HIV prophylaxis, confirm a negative test for HIV before beginning mobilization and apheresis of CD34+ cells.</p><p class="IBMPlexSans-Bold mb-2 text-primary">Hydroxyurea Use</p><p class="mb-2" style="line-height:22px;">Patients should not take hydroxyurea for at least 2 months prior to mobilization and until all cycles of apheresis are completed. If hydroxyurea is administered between mobilization and conditioning, discontinue 2 days prior to initiation of conditioning.</p><p class="IBMPlexSans-Bold mb-2 text-primary">Iron Chelation</p><p class="mb-2" style="line-height:22px;">Drug-drug interactions between iron chelators and the mobilization process and myeloablative conditioning agent must be considered. Iron chelators should be discontinued at least 7 days prior to initiation of mobilization or conditioning. Do not administer myelosuppressive iron chelators (e.g., deferiprone) for 6 months post-treatment with LYFGENIA. Non-myelosuppressive iron chelation should be restarted no sooner than 3 months after LYFGENIA infusion. Phlebotomy can be used in lieu of iron chelation, when appropriate.</p><p class="IBMPlexSans-Bold mb-2 text-primary">Interference with PCR-based Testing</p><p class="mb-2" style="line-height:22px;">Patients who have received LYFGENIA are likely to test positive by polymerase chain reaction (PCR) assays for HIV due to integrated BB305 LVV proviral DNA, resulting in a possible false-positive PCR assay test result for HIV. Therefore, patients who have received LYFGENIA should not be screened for HIV infection using a PCR-based assay.</p>
1570<p class="IBMPlexSans-Bold mb-2 text-primary">Adverse Reactions</p><p class="mb-2" style="line-height:22px;">The most common adverse reactions ⥠Grade 3 (incidence ⥠20%) were stomatitis, thrombocytopenia, neutropenia, febrile neutropenia, anemia, and leukopenia.</p><p class="mb-2" style="line-height:22px;">Three patients died during LYFGENIA clinical trials; one from sudden cardiac death due to underlying disease and two from acute myeloid leukemia who were treated with an earlier version of LYFGENIA using a different manufacturing process and transplant procedure (Study 1, Group A).</p><p class="IBMPlexSans-Bold mb-2 text-primary">Pregnancy/Lactation</p><p class="mb-2" style="line-height:22px;">Advise patients of the risks associated with myeloablative conditioning agents, including on pregnancy and fertility.</p><p class="mb-2" style="line-height:22px;">LYFGENIA should not be administered to women who are pregnant, and pregnancy after LYFGENIA infusion should be discussed with the treating physician.</p><p class="mb-2" style="line-height:22px;">LYFGENIA is not recommended for women who are breastfeeding, and breastfeeding after LYFGENIA infusion should be discussed with the treating physician.</p><p class="IBMPlexSans-Bold mb-2 text-primary">Females and Males of Reproductive Potential</p><p class="mb-2" style="line-height:22px;">A negative serum pregnancy test must be confirmed prior to the start of mobilization and re-confirmed prior to conditioning procedures and before LYFGENIA administration.</p><p class="mb-2" style="line-height:22px;">Women of childbearing potential and men capable of fathering a child should use an effective method of contraception (intra-uterine device or combination of hormonal and barrier contraception) from start of mobilization through at least 6 months after administration of LYFGENIA.</p><p class="mb-2" style="line-height:22px;">Advise patients of the options for fertility preservation.</p><p class="IBMPlexSans-Bold text-black">Please see full <a class="text-link text-primary Lato-Bold" href="https://www.bluebirdbio.com/-/media/bluebirdbio/Corporate%20COM/Files/Lyfgenia/LYFGENIA_Prescribing_Information.pdf?v=20260608123731" rel="noopener noreferrer" style="font-family:IBMPlexSans-Bold; color:#00278F !important;" target="_blank">Prescribing Information</a>, including <span class="IBMPlexSans-Bold">Boxed WARNING</span> for LYFGENIA.</p> 1571 </div> 1572 <div class="col-lg-5 col-md-5 col-sm-12 pt-0 pt-md-3"> 1573 <h2 class="mb-2 IBMPlexSans-Bold pt-0 pt-md-3" style="color:#218282; font-size:20px;">Indication</h2> 1574 1575 <p>LYFGENIA is indicated for the treatment of patients 12 years of age or older with sickle cell disease and a history of vaso-occlusive events.</p><p class="mb-0"><span style="text-decoration: underline;">Limitations of Use</span></p><p>Following treatment with LYFGENIA, patients with <span class="text-nowrap">α-thalassemia</span> trait (-α3.7/-α3.7) may experience anemia with erythroid dysplasia that may require chronic red blood cell transfusions. LYFGENIA has not been studied in patients with more than two α-globin gene deletions.</p> 1576 </div> 1577 </div> 1578 1579 </div> 1580 </div> 1581 1582 <div class="banner-content-overlay"></div> 1583</div></div> 1584 1585 1586 <div class="container-fluid"> 1587<div class="row-fluid-wrapper"> 1588<div class="row-fluid"> 1589<div class="span12 widget-span widget-type-cell " style="" data-widget-type="cell" data-x="0" data-w="12"> 1590 1591<div class="row-fluid-wrapper row-depth-1 row-number-1 dnd-section references-row-0-max-width-section-centering"> 1592<div class="row-fluid "> 1593<div class="span12 widget-span widget-type-cell cell_17817626007183-padding dnd-column" style="" data-widget-type="cell" data-x="0" data-w="12"> 1594 1595<div class="row-fluid-wrapper row-depth-1 row-number-2 dnd-row"> 1596<div class="row-fluid "> 1597<div class="span12 widget-span widget-type-custom_widget dnd-module" style="" data-widget-type="custom_widget" data-x="0" data-w="12"> 1598<div id="hs_cos_wrapper_widget_1781762256264" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"> 1599 1600 1601 1602 1603 1604 1605 1606 1607 1608 1609 1610 1611 1612 1613 1614 1615 1616 1617 1618 1619 1620 1621 1622 1623 1624 1625<div id="widget_1781762256264" class="cards"> 1626 1627
1628 1629 1630 1631 1632 <div class="cards__card card-1"> 1633 1634 1635 1636 1637 1638 <div class="cards__content"> 1639 1640 1641 1642 1643 <div class="cards__copy"><div class="strip-component bg-white"> 1644<div class="row"> 1645<div class="col-md-12 pt-0"> 1646<div class="text-black"> 1647<p class="small IBMPlexSans-Bold mb-1">References</p> 1648<p class="small mb-2" style="position: relative; padding-left: 14px;"><span class="IBMPlexSans-Bold" style="position: absolute; left: -1px;">1.</span> Data on File, DOF-US-00061, Genetix Biotherapeutics Inc.; 2023.</p> 1649<p class="small mb-2" style="position: relative; padding-left: 14px;"><span class="IBMPlexSans-Bold" style="position: absolute; left: -1px;">2.</span> LYFGENIA [prescribing information], Somerville, MA; Genetix Biotherapeutics Inc.</p> 1650</div> 1651</div> 1652</div> 1653</div></div> 1654 1655 1656 1657 </div> 1658 1659 1660 1661 1662 1663 </div> 1664 1665 1666</div> 1667</div> 1668 1669</div><!--end widget-span --> 1670</div><!--end row--> 1671</div><!--end row-wrapper --> 1672 1673</div><!--end widget-span --> 1674</div><!--end row--> 1675</div><!--end row-wrapper --> 1676 1677</div><!--end widget-span --> 1678</div> 1679</div> 1680</div> 1681 1682 <div id="hs_cos_wrapper_footer" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"> 1683 1684 1685 1686 1687<div class="strip-component bg-primary common-footer py-4"> 1688 <div class="grid-component container"> 1689 <div class="row footer-primary-links pt-0 pb-1"> 1690 <div class="col-md-12 pb-0 pt-2"> 1691 <ul class="content-list"> 1692 <li><a class="text-link" href="/faqs?hsLang=en">FAQs</a></li> 1693 <li><a class="text-link" href="/sitemap?hsLang=en">Site Map</a></li> 1694 <li><a class="text-link" href="https://www.genetixbiotx.com/privacy-policy?hsLang=en" rel="noopener noreferrer" target="_blank">Privacy Policy</a></li> 1695 <li><a class="text-link" href="https://www.genetixbiotx.com/terms-of-service?hsLang=en" rel="noopener noreferrer" target="_blank">Terms of Service</a></li> 1696 <li><a class="text-link" href="/cookie-notice/?hsLang=en" rel="noopener noreferrer" target="_self">Cookie Notice</a></li> 1697 <li><a class="text-link" href="/unsubscribe?hsLang=en">Unsubscribe</a></li> 1698 </ul> 1699 </div> 1700 </div> 1701 </div> 1702 <div class="grid-component container"> 1703 <div class="row footer-text"> 1704 <div class="col-md-10 col-12 pb-1 pt-1"> 1705 1706 1707 <p>The information on this website is not intended to make a diagnosis or treatment recommendation or provide medical advice.</p> 1708<p>Genetix Biotherapeutics, the Genetix Biotherapeutics logo, LYFGENIA, and the LYFGENIA logo are trademarks of Genetix Biotherapeutics Inc.</p> 1709<p>© 2026 Genetix Biotherapeutics Inc. All rights reserved. LYF-US-00009-v4 08/26</p> 1710 1711 </div> 1712 <div class="col-md-2 col-12 px-0 pb-0"> 1713 <a href="https://www.bluebirdbio.com/" target="_blank"> 1714 <img alt="Genetix Biotherapeutics logo" src="https://www.lyfgeniahcp.com/hubfs/raw_assets/public/themes/lyfgeniahcp-theme/images/logos/genetix-logo-white.svg" style="width: auto;"> 1715 </a> 1716 </div> 1717 </div> 1718 </div> 1719</div></div> 1720 1721 <div id="hs_cos_wrapper_leaving_site_modal" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"> 1722 1723 1724 1725 1726 1727 1728 <div class="modal modal-leaving-site fade" id="leaving-site" data-keyboard="true" role="dialog" tabindex="-1" aria-labelledby="leaving-site-title" aria-hidden="true" style="display: none;"> 1729 <div class="modal-dialog modal-dialog-centered" role="document"> 1730 <div class="modal-content"> 1731 1732 1733 <div class="modal-header"> 1734 <h5 class="modal-title" id="leaving-site-title"> 1735 1736 </h5> 1737 1738 </div> 1739 1740 1741 <div class="modal-body"> 1742 <div> 1743 <div class="col-sm-12"> 1744 1745 1746 1747 1748 <h3 style="font-size: 26px;">You are about to leave LYFGENIAHCP.com.</h3> 1749 <p class="mb-3">This link will take you to a website that is outside the control of Genetix Biotherapeutics Inc. Links are provided for informational purposes only. We do not make or imply any endorsement of external websites.</p> 1750 1751 1752 1753 1754 <div class="row"> 1755 1756 <div class="col-sm-12 pb-0 text-center"> 1757 <a class="ext-link-out btn btn-senary text-center px-3" style="border: 1px solid var(--color-primary);" href="#" rel="noopener noreferrer" target="_blank">Continue</a> 1758 </div> 1759 1760 1761 <div class="col-sm-12 pb-0 text-center"> 1762 <button type="button" class="btn btn-tertiary text-center py-3 px-2" data-dismiss="modal" data-bs-dismiss="modal" aria-label="Cancel">Cancel</button> 1763 </div> 1764 1765 </div> 1766 1767 1768 </div> 1769 </div> 1770 </div> 1771 1772 </div> 1773 </div> 1774 </div> 1775 1776 1777
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