{"id":98045,"date":"2025-04-07T20:32:56","date_gmt":"2025-04-07T20:32:56","guid":{"rendered":"https:\/\/www.mymsd.ch\/it\/?post_type=product&#038;p=98045"},"modified":"2025-12-12T12:25:52","modified_gmt":"2025-12-12T12:25:52","slug":"tollerabilita","status":"publish","type":"product","link":"https:\/\/www.mymsd.ch\/it\/products\/welireg\/ls004\/tollerabilita\/","title":{"rendered":"Tollerabilit\u00e0"},"content":{"rendered":"\n<h2 class=\"wp-block-heading has-border-color has-has-red-border-color-border-color has-text-color has-link-color wp-elements-04d3ead6a0837b6d375efa0cded75053  mhh-mcn-v1-heading mhh-mcn-v1-heading--582a6298d878aee6baff7d8d92b9b4a8\" style=\"color:#123a8a\">Effetti indesiderati correlati al trattamento con WELIREG\u00ae in \u2265 10% dei\/delle pazienti nello studio LITESPARK-004<sup>1<\/sup><\/h2>\n\n\n\n<h3 class=\"wp-block-heading has-border-color has-has-red-border-color-border-color  mhh-mcn-v1-heading mhh-mcn-v1-heading--286a2b62fc5e18d064a1794ce6bbb682\">Analisi di follow-up a 49.9 mesi (intervallo: 48.2\u201358.1 mesi)<sup>1<\/sup><\/h3>\n\n\n<figure class=\"mhh-mcn-v1-image mhh-mcn-v1-image--29d54f88fc7fe4b77c88bb4435871547\">\n                    <img loading=\"lazy\" decoding=\"async\"\n        class=\"mhh-mcn-image mhh-mcn-image--full wp-image-102112\"\n        src=\"https:\/\/www.mymsd.ch\/it\/wp-content\/uploads\/sites\/47\/2025\/04\/I-WELIREG-LS004-Treatement-Related-AEs.jpg?quality=80&#038;lossy=1\"\n        width=\"1800\"\n        height=\"1152\"\n                alt=\"Analisi di follow-up a 49.9 mesi (intervallo: 48.2\u201358.1 mesi) - table\"\n            \/>\n            <\/figure>\n\n\n\n<p class=\"has-gray-700-color has-text-color has-link-color has-border-color has-has-red-border-color-border-color has-black-color has-object-object-font-size   mhh-mcn-v1-paragraph mhh-mcn-v1-paragraph--70cfaa346eda90b7a5b44ce599a3da6b wp-block-paragraph\"><em><mark class=\"has-inline-color has-black-color\">Adattato da Srinivasan R., et al., AACR 2024.<sup>1<\/sup><br>a. Altri EI di grado 3 in 1 paziente ciascuno sono stati: vesciche, ipossia e infezione del tratto urinario.<br>Non si sono verificati effetti indesiderati di grado 4 o 5.<sup>1<\/sup><br>Tempo mediano di follow-up dalla prima dose fino alla data di cut-off dei dati (3 aprile 2023): 49.9 mesi (intervallo: 48.2\u201358.1).<\/mark><\/em><\/p>\n\n\n\n<div style=\"height:80px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"mhh-mcn-columns mhh-mcn-columns--vertical-alignment-center mhh-mcn-v1-columns--35095cf8042dd71f2cd1e2639f8a13f1 mhh-mcn-v1-columns mhh-mcn-columns--gutter-m\">\n    <div class=\"mhh-mcn-columns-inner\">\n        \n<div class=\"mhh-mcn-v1-column mhh-mcn-v1-column--9d868bac18358936d21b523ac257cec5 mhh-mcn-column mhh-mcn-column--12 mhh-mcn-column--m-3 mhh-mcn-column--l-3\">\n    <\/div>\n\n\n<div class=\"mhh-mcn-v1-column mhh-mcn-v1-column--09a7d9038cc1b6be2f768a9e5d26121e mhh-mcn-column mhh-mcn-column--12 mhh-mcn-column--m-6 mhh-mcn-column--l-6\">\n    \n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\" \/>\n\n<\/div>\n\n\n<div class=\"mhh-mcn-v1-column mhh-mcn-v1-column--9d868bac18358936d21b523ac257cec5 mhh-mcn-column mhh-mcn-column--12 mhh-mcn-column--m-3 mhh-mcn-column--l-3\">\n    <\/div>\n\n    <\/div>\n\n    <\/div>\n\n\n\n<div style=\"height:80px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"mhh-mcn-v1-accordion mhh-mcn-v1-accordion--538baefa8d2076e3494f20c0f1c25af9 mhh-mcn-v1-accordion--multiple\" data-configuration=\"{&quot;variation&quot;:&quot;multiple&quot;,&quot;speed&quot;:0,&quot;hasFirstItemExpanded&quot;:false}\"    dir=\"ltr\"    lang=\"en-US\">\n    \n\n<section\n    id=\"accordion-6af95f0e58d27\"\n    class=\"mhh-mcn-v1-accordion-molecule mhh-mcn-v1-accordion-molecule--e263af81103ec054fb46bc9890e9d5c8 mhh-mcn-v1-accordion-molecule--closed\"\n            >\n    <h4\n        id=\"accordion-6af95f0e58d27-header\"\n        class=\"mhh-mcn-v1-accordion-molecule-header\"\n    >\n        <button\n            class=\"mhh-mcn-v1-accordion-molecule-header__heading\"\n            aria-expanded=\"false\"\n            aria-controls=\"accordion-6af95f0e58d27-content\"\n        >\n                        <span class=\"mhh-mcn-v1-accordion-molecule-header__title\">\n                Effetti indesiderati pi\u00f9 frequenti sotto WELIREG\u00ae <sup>2<\/sup> (aggiornato a maggio 2024)            <\/span>\n            <span class=\"mhh-mcn-v1-accordion-molecule-header__icon-dropdown\" aria-hidden=\"true\">\n                \n<svg width=\"1em\" height=\"1em\" class=\"mh-icon mh-icon--kind-generic mh-icon--name-dropdown-arrow mh-icon--dropdown-arrow\" role=\"img\" aria-hidden=\"true\">\n    \n    \n    <use xlink:href=\"https:\/\/www.mymsd.ch\/it\/wp-content\/themes\/cex-wpvip-mhh-mconnect-theme-new-3.0\/modules\/icons\/resources\/icons\/svg\/generic\/dropdown-arrow.svg#dropdown-arrow\"><\/use>\n<\/svg>\n            <\/span>\n        <\/button>\n    <\/h4>\n    <div\n        id=\"accordion-6af95f0e58d27-content\"\n        class=\"mhh-mcn-v1-accordion-molecule-content\"\n        role=\"region\"\n        aria-labelledby=\"accordion-6af95f0e58d27-header\"\n    >\n        <div class=\"mhh-mcn-v1-accordion-molecule-content__body\">\n            \n<div class=\"mhh-mcn-columns mhh-mcn-v1-columns--50eb4994d6e9f6d24dee58314bfd6510 mhh-mcn-v1-columns mhh-mcn-columns--gutter-m\">\n    <div class=\"mhh-mcn-columns-inner\">\n        \n<div class=\"mhh-mcn-v1-column mhh-mcn-v1-column--bcdc97e041d0479c3641df358f87643b mhh-mcn-column mhh-mcn-column--12 mhh-mcn-column--m-12 mhh-mcn-column--l-12\">\n    \n<div class=\"mhh-mcn-columns mhh-mcn-v1-columns--2055e7ca5dbc597dbf1c17bcc0f5b8be mhh-mcn-v1-columns mhh-mcn-columns--gutter-m\">\n    <div class=\"mhh-mcn-columns-inner\">\n        \n<div class=\"mhh-mcn-v1-column mhh-mcn-v1-column--727bbffb07cb49bf7564a02fcab04280 mhh-mcn-column mhh-mcn-column--12 mhh-mcn-column--m-12 mhh-mcn-column--l-12\">\n    \n<div class=\"mhh-mcn-columns mhh-mcn-columns--vertical-alignment-top mhh-mcn-v1-columns--9414625141c0926b98e300c7eada4790 mhh-mcn-v1-columns mhh-mcn-columns--gutter-m\">\n    <div class=\"mhh-mcn-columns-inner\">\n        \n<div class=\"mhh-mcn-v1-column mhh-mcn-v1-column--d7f96fbf411978d3d4ff9225141e37ca mhh-mcn-column mhh-mcn-column--12 mhh-mcn-column--m-12 mhh-mcn-column--l-12\">\n    \n\n<h2 class=\"wp-block-heading has-border-color has-has-red-border-color-border-color has-text-color  mhh-mcn-v1-heading mhh-mcn-v1-heading--0148fcd26ca8db7642551164721513ac\" style=\"color:#231f20\">Effetti indesiderati pi\u00f9 frequenti sotto WELIREG\u00ae <sup>2<\/sup> (aggiornato a maggio 2024<u>)<\/u><\/h2>\n\n\n\n<div style=\"height:24px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<figure class=\"mhh-mcn-v1-image mhh-mcn-v1-image--ac9623d227e1e7a7b13140688dd5727d\">\n                    <img decoding=\"async\"\n        class=\"mhh-mcn-image mhh-mcn-image--full wp-image-98072\"\n        src=\"https:\/\/www.mymsd.ch\/it\/wp-content\/uploads\/sites\/47\/2024\/04\/Graph-6-IT.png?quality=80&#038;lossy=1\"\n        width=\"1718\"\n        height=\"845\"\n        loading=\"lazy\"        alt=\"Effetti indesiderati pi\u00f9 frequenti sotto WELIREG\u00ae 2 (aggiornato a maggio 2024)\"\n            \/>\n            <\/figure>\n\n\n\n<p class=\"has-gray-700-color has-text-color has-link-color has-border-color has-has-red-border-color-border-color has-object-object-font-size   mhh-mcn-v1-paragraph mhh-mcn-v1-paragraph--f6857a7ade0b696392fca85e2f83118e wp-block-paragraph\"><em><mark class=\"has-inline-color has-black-color\">Adattato dall\u2019informazione professionale di WELIREG\u00ae, aggiornata a maggio 2024.<sup>2<\/sup><\/mark><\/em><\/p>\n\n\n\n<div style=\"height:24px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"has-text-color has-object-object-font-size   mhh-mcn-v1-paragraph mhh-mcn-v1-paragraph--5c3c58f058061fdf9bb20c78ab14a388 wp-block-paragraph\" style=\"color:#231f20\"><strong>La valutazione della sicurezza di WELIREG\u00ae si basa sui dati di sicurezza relativi a 576 pazienti di quattro studi clinici (LS-001, LS-004, LS-005 e LS-013) che includevano pazienti con tumori solidi avanzati, RCC associato a VHL e RCC avanzato.<sup>2<\/sup><\/strong><\/p>\n\n\n\n<div style=\"height:24px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"mhh-mcn-columns mhh-mcn-v1-columns--70d409f15959b390794cb752788c34a5 mhh-mcn-v1-columns mhh-mcn-columns--gutter-m\">\n    <div class=\"mhh-mcn-columns-inner\">\n        \n<div class=\"mhh-mcn-v1-column mhh-mcn-v1-column--e49d014903a64aa272689a8ea5965baf mhh-mcn-column mhh-mcn-column--12 mhh-mcn-column--m-12 mhh-mcn-column--l-12\">\n    \n\n<p class=\"has-white-color has-text-color has-border-color has-has-red-border-color-border-color   mhh-mcn-v1-paragraph mhh-mcn-v1-paragraph--2b882edf34d05ebaba87c6902a732b2e wp-block-paragraph\"><strong>Soltanto il 2.3% dei\/delle pazienti ha sospeso definitivamente WELIREG\u00ae a causa di effetti indesiderati correlati al trattamento.<sup>2<\/sup><\/strong><\/p>\n\n<\/div>\n\n    <\/div>\n\n    <\/div>\n\n\n\n<div style=\"height:24px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"mhh-mcn-columns mhh-mcn-v1-columns--d348535845da6241a9a63afef66edb1c mhh-mcn-v1-columns mhh-mcn-columns--gutter-m\">\n    <div class=\"mhh-mcn-columns-inner\">\n        \n<div class=\"mhh-mcn-v1-column mhh-mcn-v1-column--c57f60c06f374536be431a661d6c5fff mhh-mcn-column mhh-mcn-column--12 mhh-mcn-column--m-6 mhh-mcn-column--l-6\">\n    \n\n<p class=\"has-white-color has-text-color has-border-color has-has-red-border-color-border-color   mhh-mcn-v1-paragraph mhh-mcn-v1-paragraph--fe3b3d52cb999f617c5665e09a64bdba wp-block-paragraph\">La durata mediana dell\u2019esposizione al WELIREG\u00ae \u00e8 stata di 13.5 mesi (intervallo: 0.1-55.4 mesi).<sup>2<\/sup><\/p>\n\n<\/div>\n\n\n<div class=\"mhh-mcn-v1-column mhh-mcn-v1-column--0069087616ed6e22e03190d41d62f862 mhh-mcn-column mhh-mcn-column--12 mhh-mcn-column--m-6 mhh-mcn-column--l-6\">\n    \n\n<p class=\"has-white-color has-text-color has-border-color has-has-red-border-color-border-color   mhh-mcn-v1-paragraph mhh-mcn-v1-paragraph--825da80166fe7f84ded63978252f61e2 wp-block-paragraph\">Nel 12.2% dei\/delle pazienti trattati\/e con WELIREG\u00ae sono comparsi effetti indesiderati seri, tra cui ipossia (7.1%), anemia (4.7%) e dispnea (1.2%).<sup>2<\/sup><\/p>\n\n<\/div>\n\n\n<div class=\"mhh-mcn-v1-column mhh-mcn-v1-column--69b559a6cde36b1db301449469e3e950 mhh-mcn-column mhh-mcn-column--12 mhh-mcn-column--m-6 mhh-mcn-column--l-6\">\n    \n\n<p class=\"has-white-color has-text-color has-border-color has-has-red-border-color-border-color   mhh-mcn-v1-paragraph mhh-mcn-v1-paragraph--dbc14babe6529ce5c412e62a528a60af wp-block-paragraph\">In circa il 17.7% dei pazienti, il trattamento con WELIREG\u00ae \u00e8 stato interrotto a causa di effetti indesiderati. Gli effetti indesiderati pi\u00f9 comuni che hanno portato all\u2019interruzione del trattamento con WELIREG\u00ae sono stati anemia (7.1%), ipossia (5.4%), stanchezza\/spossatezza (2.6%) e nausea (2.4%).<sup>2<\/sup><\/p>\n\n<\/div>\n\n\n<div class=\"mhh-mcn-v1-column mhh-mcn-v1-column--135d85b0c8ed15e1345a6b56861dfaad mhh-mcn-column mhh-mcn-column--12 mhh-mcn-column--m-6 mhh-mcn-column--l-6\">\n    \n\n<p class=\"has-white-color has-text-color has-border-color has-has-red-border-color-border-color   mhh-mcn-v1-paragraph mhh-mcn-v1-paragraph--ffd7b099c46e6101673f2bf85f522d3e wp-block-paragraph\">BIn circa l\u201911.6% dei pazienti, la dose di WELIREG\u00ae \u00e8 stata ridotta a causa di effetti indesiderati. Gli effetti indesiderati pi\u00f9 comuni che hanno portato a una riduzione della dose di WELIREG\u00ae sono stati ipossia (6.3%), anemia (3.8%) e stanchezza\/spossatezza (1.7%).<sup>2<\/sup><\/p>\n\n<\/div>\n\n    <\/div>\n\n    <\/div>\n\n<\/div>\n\n    <\/div>\n\n    <\/div>\n\n<\/div>\n\n    <\/div>\n\n    <\/div>\n\n<\/div>\n\n    <\/div>\n\n    <\/div>\n\n        <\/div>\n    <\/div>\n<\/section>\n\n<\/div>\n\n\n\n<div style=\"height:80px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"mhh-mcn-columns mhh-mcn-columns--vertical-alignment-center mhh-mcn-v1-columns--35095cf8042dd71f2cd1e2639f8a13f1 mhh-mcn-v1-columns mhh-mcn-columns--gutter-m\">\n    <div class=\"mhh-mcn-columns-inner\">\n        \n<div class=\"mhh-mcn-v1-column mhh-mcn-v1-column--9d868bac18358936d21b523ac257cec5 mhh-mcn-column mhh-mcn-column--12 mhh-mcn-column--m-3 mhh-mcn-column--l-3\">\n    <\/div>\n\n\n<div class=\"mhh-mcn-v1-column mhh-mcn-v1-column--09a7d9038cc1b6be2f768a9e5d26121e mhh-mcn-column mhh-mcn-column--12 mhh-mcn-column--m-6 mhh-mcn-column--l-6\">\n    \n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\" \/>\n\n<\/div>\n\n\n<div class=\"mhh-mcn-v1-column mhh-mcn-v1-column--9d868bac18358936d21b523ac257cec5 mhh-mcn-column mhh-mcn-column--12 mhh-mcn-column--m-3 mhh-mcn-column--l-3\">\n    <\/div>\n\n    <\/div>\n\n    <\/div>\n\n\n\n<div style=\"height:80px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-border-color has-has-red-border-color-border-color has-text-color  mhh-mcn-v1-heading mhh-mcn-v1-heading--d0c0c45e6c747f7c77b0e5e9570a7d77\" style=\"color:#123a8a\">Avvertenze e misure precauzionali<sup>2<\/sup><\/h2>\n\n\n<div class=\"mhh-mcn-v1-accordion mhh-mcn-v1-accordion--4653d7d41056a604aadcbf711740aedc mhh-mcn-v1-accordion--multiple\" data-configuration=\"{&quot;variation&quot;:&quot;multiple&quot;,&quot;speed&quot;:0,&quot;hasFirstItemExpanded&quot;:false}\"    dir=\"ltr\"    lang=\"en-US\">\n    \n\n<section\n    id=\"accordion-6af95f0e59fae\"\n    class=\"mhh-mcn-v1-accordion-molecule mhh-mcn-v1-accordion-molecule--632a0ab6ea6b3299d358019c6fb6837c mhh-mcn-v1-accordion-molecule--closed\"\n            >\n    <h4\n        id=\"accordion-6af95f0e59fae-header\"\n        class=\"mhh-mcn-v1-accordion-molecule-header\"\n    >\n        <button\n            class=\"mhh-mcn-v1-accordion-molecule-header__heading\"\n            aria-expanded=\"false\"\n            aria-controls=\"accordion-6af95f0e59fae-content\"\n        >\n                            <span class=\"mhh-mcn-v1-accordion-molecule-header__icon\" aria-hidden=\"true\">\n                    <figure class=\"mhh-mcn-v1-image mhh-mcn-v1-image--1149c6eaa11ae59827eb289e85c22366\">\n                    <img decoding=\"async\"\n        class=\"mhh-mcn-image mhh-mcn-image--thumbnail wp-image-102094\"\n        src=\"https:\/\/www.mymsd.ch\/it\/wp-content\/uploads\/sites\/47\/2025\/04\/Icon_Anemia.png?w=66&#038;h=67&#038;crop=1&#038;quality=80&#038;lossy=1\"\n        width=\"66\"\n        height=\"67\"\n        loading=\"lazy\"        alt=\"\"\n            \/>\n            <\/figure>\n                <\/span>\n                        <span class=\"mhh-mcn-v1-accordion-molecule-header__title\">\n                Anemia            <\/span>\n            <span class=\"mhh-mcn-v1-accordion-molecule-header__icon-dropdown\" aria-hidden=\"true\">\n                \n<svg width=\"1em\" height=\"1em\" class=\"mh-icon mh-icon--kind-generic mh-icon--name-dropdown-arrow mh-icon--dropdown-arrow\" role=\"img\" aria-hidden=\"true\">\n    \n    \n    <use xlink:href=\"https:\/\/www.mymsd.ch\/it\/wp-content\/themes\/cex-wpvip-mhh-mconnect-theme-new-3.0\/modules\/icons\/resources\/icons\/svg\/generic\/dropdown-arrow.svg#dropdown-arrow\"><\/use>\n<\/svg>\n            <\/span>\n        <\/button>\n    <\/h4>\n    <div\n        id=\"accordion-6af95f0e59fae-content\"\n        class=\"mhh-mcn-v1-accordion-molecule-content\"\n        role=\"region\"\n        aria-labelledby=\"accordion-6af95f0e59fae-header\"\n    >\n        <div class=\"mhh-mcn-v1-accordion-molecule-content__body\">\n            \n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<ul class=\"mhh-mcn-v2-clist mhh-mcn-v2-clist--83e8d04b62b779bcb41e7370ea2e3544 mhh-mcn-list mhh-mcn-v2-clist--unordered mhh-mcn-v2-clist--unordered-dot\" dir=\"ltr\" lang=\"en-US\" start=\"1\">\n    \n<li class=\"mhh-mcn-list-item mhh-mcn-v2-list-item\">\n    Nei dati di sicurezza aggregati, l\u2019anemia \u00e8 stata riportata nell\u201984.2% dei pazienti, di cui il 28.8% presentava un\u2019anemia di grado 3-4. Il tempo mediano alla comparsa di eventi di anemia di tutti i gradi di gravit\u00e0 \u00e8 stato di 51.7 giorni (intervallo: da 1 giorno a 27.4 mesi). In 41 pazienti (7.1%) sono comparsi eventi di anemia che hanno portato alla sospensione del trattamento in studio, e in 22 pazienti (3.8%) la dose \u00e8 stata ridotta a causa dell\u2019anemia. In 2 pazienti (0.3%) il trattamento \u00e8 stato interrotto a causa dell\u2019anemia. Secondo il rapporto, 165 pazienti (34%) si erano ripresi dall\u2019anemia e 249 pazienti (51%) non si erano ancora ripresi.    <\/li>\n\n\n<li class=\"mhh-mcn-list-item mhh-mcn-v2-list-item\">\n    Prima dell\u2019inizio e regolarmente durante il trattamento con WELIREG\u00ae, i pazienti devono essere monitorati per rilevare eventuali segni di anemia, con un monitoraggio pi\u00f9 frequente durante i primi 6 mesi di trattamento.    <\/li>\n\n\n<li class=\"mhh-mcn-list-item mhh-mcn-v2-list-item\">\n    Nei pazienti in cui compare un\u2019anemia di grado 3 (Hb &lt;8 g\/dl), WELIREG\u00ae deve essere sospeso e i pazienti devono essere trattati secondo la prassi medica usuale. In caso di anemia ricorrente di grado 3, il trattamento con WELIREG\u00ae deve essere interrotto. Nei pazienti in cui compare un\u2019anemia di grado 4, la dose di WELIREG\u00ae deve essere ridotta o il medicamento deve essere interrotto definitivamente.    <\/li>\n\n\n<li class=\"mhh-mcn-list-item mhh-mcn-v2-list-item\">\n    L\u2019uso di principi attivi stimolanti l\u2019eritropoiesi (ESA) per il trattamento dell\u2019anemia non \u00e8 raccomandato nei pazienti in trattamento con WELIREG\u00ae.    <\/li>\n\n<\/ul>\n\n        <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section\n    id=\"accordion-6af95f0e5a821\"\n    class=\"mhh-mcn-v1-accordion-molecule mhh-mcn-v1-accordion-molecule--a8181aacd6c9a9a5700f46bbe84c7647 mhh-mcn-v1-accordion-molecule--closed\"\n            >\n    <h4\n        id=\"accordion-6af95f0e5a821-header\"\n        class=\"mhh-mcn-v1-accordion-molecule-header\"\n    >\n        <button\n            class=\"mhh-mcn-v1-accordion-molecule-header__heading\"\n            aria-expanded=\"false\"\n            aria-controls=\"accordion-6af95f0e5a821-content\"\n        >\n                            <span class=\"mhh-mcn-v1-accordion-molecule-header__icon\" aria-hidden=\"true\">\n                    <figure class=\"mhh-mcn-v1-image mhh-mcn-v1-image--ffca57c563617c440047e29c2b9714dd\">\n                    <img decoding=\"async\"\n        class=\"mhh-mcn-image mhh-mcn-image--thumbnail wp-image-102098\"\n        src=\"https:\/\/www.mymsd.ch\/it\/wp-content\/uploads\/sites\/47\/2025\/04\/Icon_Hypoxia.png?w=67&#038;h=67&#038;crop=1&#038;quality=80&#038;lossy=1\"\n        width=\"67\"\n        height=\"67\"\n        loading=\"lazy\"        alt=\"\"\n            \/>\n            <\/figure>\n                <\/span>\n                        <span class=\"mhh-mcn-v1-accordion-molecule-header__title\">\n                Ipossia            <\/span>\n            <span class=\"mhh-mcn-v1-accordion-molecule-header__icon-dropdown\" aria-hidden=\"true\">\n                \n<svg width=\"1em\" height=\"1em\" class=\"mh-icon mh-icon--kind-generic mh-icon--name-dropdown-arrow mh-icon--dropdown-arrow\" role=\"img\" aria-hidden=\"true\">\n    \n    \n    <use xlink:href=\"https:\/\/www.mymsd.ch\/it\/wp-content\/themes\/cex-wpvip-mhh-mconnect-theme-new-3.0\/modules\/icons\/resources\/icons\/svg\/generic\/dropdown-arrow.svg#dropdown-arrow\"><\/use>\n<\/svg>\n            <\/span>\n        <\/button>\n    <\/h4>\n    <div\n        id=\"accordion-6af95f0e5a821-content\"\n        class=\"mhh-mcn-v1-accordion-molecule-content\"\n        role=\"region\"\n        aria-labelledby=\"accordion-6af95f0e5a821-header\"\n    >\n        <div class=\"mhh-mcn-v1-accordion-molecule-content__body\">\n            \n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<ul class=\"mhh-mcn-v2-clist mhh-mcn-v2-clist--29711c05dbf6be43f549e222af014881 mhh-mcn-list mhh-mcn-v2-clist--unordered mhh-mcn-v2-clist--unordered-dot\" dir=\"ltr\" lang=\"en-US\" start=\"1\">\n    \n<li class=\"mhh-mcn-list-item mhh-mcn-v2-list-item\">\n    Nei dati di sicurezza aggregati, l\u2019ipossia \u00e8 comparsa in 94 pazienti (16.3%), con ipossia di grado 3-4 in 70 pazienti (12.2%). In 31 pazienti (5.4%) sono comparsi eventi di ipossia che hanno portato alla sospensione del trattamento in studio, in 36 pazienti (6.3%) la dose \u00e8 stata ridotta a causa dell\u2019ipossia e 8 pazienti (1.4%) hanno interrotto il trattamento a causa dell\u2019ipossia.    <\/li>\n\n\n<li class=\"mhh-mcn-list-item mhh-mcn-v2-list-item\">\n    Prima dell\u2019inizio e regolarmente durante il trattamento con WELIREG\u00ae, deve essere monitorata la saturazione dell\u2019ossigeno mediante pulsossimetria, con un monitoraggio pi\u00f9 frequente durante i primi 6 mesi di trattamento. In considerazione del rischio di ipossia, si raccomanda di smettere di fumare.    <\/li>\n\n\n<li class=\"mhh-mcn-list-item mhh-mcn-v2-list-item\">\n    In caso di ipossia di grado 2, si devono prendere in considerazione la somministrazione supplementare di ossigeno e la continuazione o la sospensione del trattamento. Dopo la sospensione, il trattamento con WELIREG\u00ae deve essere ripreso a dose ridotta. Nei pazienti con ipossia di grado 3, WELIREG\u00ae deve essere sospeso, l\u2019ipossia deve essere trattata e deve essere presa in considerazione una riduzione della dose. Se compare di nuovo un\u2019ipossia di grado 3, il trattamento deve essere terminato. In caso di ipossia di grado 4, il trattamento deve essere interrotto definitivamente.    <\/li>\n\n<\/ul>\n\n        <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section\n    id=\"accordion-6af95f0e5affe\"\n    class=\"mhh-mcn-v1-accordion-molecule mhh-mcn-v1-accordion-molecule--ef11b5c65b08f60853e16a8bec059a56 mhh-mcn-v1-accordion-molecule--closed\"\n            >\n    <h4\n        id=\"accordion-6af95f0e5affe-header\"\n        class=\"mhh-mcn-v1-accordion-molecule-header\"\n    >\n        <button\n            class=\"mhh-mcn-v1-accordion-molecule-header__heading\"\n            aria-expanded=\"false\"\n            aria-controls=\"accordion-6af95f0e5affe-content\"\n        >\n                            <span class=\"mhh-mcn-v1-accordion-molecule-header__icon\" aria-hidden=\"true\">\n                    <figure class=\"mhh-mcn-v1-image mhh-mcn-v1-image--b9c57a054a779658026c0f75cf73fd85\">\n                    <img decoding=\"async\"\n        class=\"mhh-mcn-image mhh-mcn-image--thumbnail wp-image-102090\"\n        src=\"https:\/\/www.mymsd.ch\/it\/wp-content\/uploads\/sites\/47\/2025\/04\/Icon_Side-effect.png?w=66&#038;h=67&#038;crop=1&#038;quality=80&#038;lossy=1\"\n        width=\"66\"\n        height=\"67\"\n        loading=\"lazy\"        alt=\"\"\n            \/>\n            <\/figure>\n                <\/span>\n                        <span class=\"mhh-mcn-v1-accordion-molecule-header__title\">\n                Effetti indesiderati            <\/span>\n            <span class=\"mhh-mcn-v1-accordion-molecule-header__icon-dropdown\" aria-hidden=\"true\">\n                \n<svg width=\"1em\" height=\"1em\" class=\"mh-icon mh-icon--kind-generic mh-icon--name-dropdown-arrow mh-icon--dropdown-arrow\" role=\"img\" aria-hidden=\"true\">\n    \n    \n    <use xlink:href=\"https:\/\/www.mymsd.ch\/it\/wp-content\/themes\/cex-wpvip-mhh-mconnect-theme-new-3.0\/modules\/icons\/resources\/icons\/svg\/generic\/dropdown-arrow.svg#dropdown-arrow\"><\/use>\n<\/svg>\n            <\/span>\n        <\/button>\n    <\/h4>\n    <div\n        id=\"accordion-6af95f0e5affe-content\"\n        class=\"mhh-mcn-v1-accordion-molecule-content\"\n        role=\"region\"\n        aria-labelledby=\"accordion-6af95f0e5affe-header\"\n    >\n        <div class=\"mhh-mcn-v1-accordion-molecule-content__body\">\n            \n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<ul class=\"mhh-mcn-v2-clist mhh-mcn-v2-clist--27646ac44c072b015954a393417b3712 mhh-mcn-list mhh-mcn-v2-clist--unordered mhh-mcn-v2-clist--unordered-dot\" dir=\"ltr\" lang=\"en-US\" start=\"1\">\n    \n<li class=\"mhh-mcn-list-item mhh-mcn-v2-list-item\">\n    La valutazione della sicurezza di WELIREG\u00ae si basa sui dati di sicurezza aggregati relativi a 576 pazienti di quattro studi clinici, ossia lo studio 001 (58 pazienti), lo studio 004 (61 pazienti), lo studio 005 (381 pazienti, tra cui pazienti giapponesi) e lo studio 013 (76 pazienti), in cui \u00e8 stata impiegata la dose raccomandata di 120 mg di WELIREG\u00ae una volta al giorno in pazienti con tumori solidi avanzati, RCC associato a VHL e RCC avanzato. La durata mediana dell\u2019esposizione a WELIREG\u00ae \u00e8 stata di 13.5 mesi (intervallo: 0.1-55.4 mesi). Gli effetti indesiderati pi\u00f9 comuni con WELIREG\u00ae sono stati anemia (83.2%), stanchezza\/spossatezza (42.7%), nausea (24.1%), dispnea (21.4%), capogiro (17.9%) e ipossia (16.3%).    <\/li>\n\n\n<li class=\"mhh-mcn-list-item mhh-mcn-v2-list-item\">\n    Gli effetti indesiderati di grado 3 o 4 pi\u00f9 comuni sono stati anemia (28.8%) e ipossia (12.2%). Nel 12.2% dei pazienti trattati con WELIREG\u00ae sono comparsi effetti indesiderati seri, tra cui ipossia (7.1%). anemia (4,7%) e dispnea (1.2%). In circa il 17.7% dei pazienti, il trattamento con WELIREG\u00ae \u00e8 stato interrotto a causa di effetti indesiderati. Gli effetti indesiderati pi\u00f9 comuni che hanno portato all\u2019interruzione del trattamento con WELIREG\u00ae sono stati anemia (7.1%), ipossia (5.4%), stanchezza\/spossatezza (2.6%) e nausea (2.4%). In circa l\u201911.6% dei pazienti, la dose di WELIREG\u00ae \u00e8 stata ridotta a causa di effetti indesiderati. Gli effetti indesiderati pi\u00f9 comuni che hanno portato a una riduzione della dose di WELIREG\u00ae sono stati ipossia (6.3%), anemia (3.8%) e stanchezza\/spossatezza (1.7%). In circa il 2.3% dei pazienti, WELIREG\u00ae \u00e8 stato sospeso a causa di effetti indesiderati. L\u2019effetto indesiderato pi\u00f9 comune che ha portato alla sospensione di WELIREG\u00ae \u00e8 stato l\u2019ipossia (1.4%).    <\/li>\n\n<\/ul>\n\n        <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section\n    id=\"accordion-6af95f0e5b948\"\n    class=\"mhh-mcn-v1-accordion-molecule mhh-mcn-v1-accordion-molecule--9108f391434785763b6ddb220f2bee41 mhh-mcn-v1-accordion-molecule--closed\"\n            >\n    <h4\n        id=\"accordion-6af95f0e5b948-header\"\n        class=\"mhh-mcn-v1-accordion-molecule-header\"\n    >\n        <button\n            class=\"mhh-mcn-v1-accordion-molecule-header__heading\"\n            aria-expanded=\"false\"\n            aria-controls=\"accordion-6af95f0e5b948-content\"\n        >\n                            <span class=\"mhh-mcn-v1-accordion-molecule-header__icon\" aria-hidden=\"true\">\n                    <figure class=\"mhh-mcn-v1-image mhh-mcn-v1-image--47513cb73a6bb4823359f87993e0f8f3\">\n                    <img decoding=\"async\"\n        class=\"mhh-mcn-image mhh-mcn-image--thumbnail wp-image-102095\"\n        src=\"https:\/\/www.mymsd.ch\/it\/wp-content\/uploads\/sites\/47\/2025\/04\/Icon_Drugs-interaction.png?w=66&#038;h=67&#038;crop=1&#038;quality=80&#038;lossy=1\"\n        width=\"66\"\n        height=\"67\"\n        loading=\"lazy\"        alt=\"\"\n            \/>\n            <\/figure>\n                <\/span>\n                        <span class=\"mhh-mcn-v1-accordion-molecule-header__title\">\n                Interazioni farmacologiche            <\/span>\n            <span class=\"mhh-mcn-v1-accordion-molecule-header__icon-dropdown\" aria-hidden=\"true\">\n                \n<svg width=\"1em\" height=\"1em\" class=\"mh-icon mh-icon--kind-generic mh-icon--name-dropdown-arrow mh-icon--dropdown-arrow\" role=\"img\" aria-hidden=\"true\">\n    \n    \n    <use xlink:href=\"https:\/\/www.mymsd.ch\/it\/wp-content\/themes\/cex-wpvip-mhh-mconnect-theme-new-3.0\/modules\/icons\/resources\/icons\/svg\/generic\/dropdown-arrow.svg#dropdown-arrow\"><\/use>\n<\/svg>\n            <\/span>\n        <\/button>\n    <\/h4>\n    <div\n        id=\"accordion-6af95f0e5b948-content\"\n        class=\"mhh-mcn-v1-accordion-molecule-content\"\n        role=\"region\"\n        aria-labelledby=\"accordion-6af95f0e5b948-header\"\n    >\n        <div class=\"mhh-mcn-v1-accordion-molecule-content__body\">\n            \n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<ul class=\"mhh-mcn-v2-clist mhh-mcn-v2-clist--3629bcdfd390d0da3ebadc07bccf4b82 mhh-mcn-list mhh-mcn-v2-clist--unordered mhh-mcn-v2-clist--unordered-dot\" dir=\"ltr\" lang=\"en-US\" start=\"1\">\n    \n<li class=\"mhh-mcn-list-item mhh-mcn-v2-list-item\">\n    In uno studio clinico, la somministrazione ripetuta di WELIREG\u00ae 120 mg una volta al giorno ha determinato una riduzione del 40% dell\u2019AUC del midazolam, un effetto compatibile con un induttore debole del CYP3A4. Sulla base di un modello PBPK, WELIREG\u00ae pu\u00f2 mostrare una moderata induzione del CYP3A4 nei pazienti con una maggiore esposizione plasmatica a WELIREG\u00ae.    <\/li>\n\n\n<li class=\"mhh-mcn-list-item mhh-mcn-v2-list-item\">\n    La somministrazione concomitante di WELIREG\u00ae con substrati del CYP3A4, compresi i contraccettivi ormonali, riduce le concentrazioni dei substrati del CYP3A4, il che pu\u00f2 diminuire l\u2019efficacia di questi substrati.    <\/li>\n\n\n<li class=\"mhh-mcn-list-item mhh-mcn-v2-list-item\">\n    Evitare la somministrazione concomitante di WELIREG\u00ae con substrati sensibili del CYP3A4, per i quali una minima riduzione della concentrazione pu\u00f2 comportare un fallimento terapeutico del substrato. Se la somministrazione concomitante non pu\u00f2 essere evitata, aumentare la dose del substrato sensibile del CYP3A4 secondo la rispettiva informazione professionale.    <\/li>\n\n\n<li class=\"mhh-mcn-list-item mhh-mcn-v2-list-item\">\n    La somministrazione concomitante di WELIREG\u00ae con contraccettivi ormonali pu\u00f2 causare un fallimento della contraccezione o un aumento dei sanguinamenti intermestruali.    <\/li>\n\n\n<li class=\"mhh-mcn-list-item mhh-mcn-v2-list-item\">\n    <strong>Effetto di altri medicamenti su WELIREG\u00ae<\/strong><br>La somministrazione concomitante di WELIREG\u00ae con inibitori di UGT2B17 o di CYP2C19 aumenta l\u2019esposizione plasmatica a WELIREG\u00ae, il che pu\u00f2 aumentare l\u2019incidenza e il grado di gravit\u00e0 degli effetti indesiderati di WELIREG\u00ae. Monitorare l\u2019anemia e l\u2019ipossia e ridurre la dose di WELIREG\u00ae come raccomandato.    <\/li>\n\n<\/ul>\n\n        <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section\n    id=\"accordion-6af95f0e5c21b\"\n    class=\"mhh-mcn-v1-accordion-molecule mhh-mcn-v1-accordion-molecule--2ff0f71486d86a2ec6c705ba8e9427e7 mhh-mcn-v1-accordion-molecule--closed\"\n            >\n    <h4\n        id=\"accordion-6af95f0e5c21b-header\"\n        class=\"mhh-mcn-v1-accordion-molecule-header\"\n    >\n        <button\n            class=\"mhh-mcn-v1-accordion-molecule-header__heading\"\n            aria-expanded=\"false\"\n            aria-controls=\"accordion-6af95f0e5c21b-content\"\n        >\n                            <span class=\"mhh-mcn-v1-accordion-molecule-header__icon\" aria-hidden=\"true\">\n                    <figure class=\"mhh-mcn-v1-image mhh-mcn-v1-image--38b9aa2e5040d244e55931b6248118b6\">\n                    <img decoding=\"async\"\n        class=\"mhh-mcn-image mhh-mcn-image--thumbnail wp-image-102096\"\n        src=\"https:\/\/www.mymsd.ch\/it\/wp-content\/uploads\/sites\/47\/2025\/04\/Icon_Female-and-male.png?w=66&#038;h=67&#038;crop=1&#038;quality=80&#038;lossy=1\"\n        width=\"66\"\n        height=\"67\"\n        loading=\"lazy\"        alt=\"\"\n            \/>\n            <\/figure>\n                <\/span>\n                        <span class=\"mhh-mcn-v1-accordion-molecule-header__title\">\n                Riproduzione            <\/span>\n            <span class=\"mhh-mcn-v1-accordion-molecule-header__icon-dropdown\" aria-hidden=\"true\">\n                \n<svg width=\"1em\" height=\"1em\" class=\"mh-icon mh-icon--kind-generic mh-icon--name-dropdown-arrow mh-icon--dropdown-arrow\" role=\"img\" aria-hidden=\"true\">\n    \n    \n    <use xlink:href=\"https:\/\/www.mymsd.ch\/it\/wp-content\/themes\/cex-wpvip-mhh-mconnect-theme-new-3.0\/modules\/icons\/resources\/icons\/svg\/generic\/dropdown-arrow.svg#dropdown-arrow\"><\/use>\n<\/svg>\n            <\/span>\n        <\/button>\n    <\/h4>\n    <div\n        id=\"accordion-6af95f0e5c21b-content\"\n        class=\"mhh-mcn-v1-accordion-molecule-content\"\n        role=\"region\"\n        aria-labelledby=\"accordion-6af95f0e5c21b-header\"\n    >\n        <div class=\"mhh-mcn-v1-accordion-molecule-content__body\">\n            \n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<ul class=\"mhh-mcn-v2-clist mhh-mcn-v2-clist--99a90cdfd44229ce8b7aedeff6956e70 mhh-mcn-list mhh-mcn-v2-clist--unordered mhh-mcn-v2-clist--unordered-dot\" dir=\"ltr\" lang=\"en-US\" start=\"1\">\n    \n<li class=\"mhh-mcn-list-item mhh-mcn-v2-list-item\">\n    Sulla base dei risultati degli studi sugli animali, WELIREG\u00ae pu\u00f2 compromettere la fertilit\u00e0 nell\u2019uomo e nella donna in et\u00e0 fertile. I\/le pazienti devono essere informati\/e di questo possibile rischio. Non \u00e8 noto se l\u2019effetto sulla fertilit\u00e0 sia reversibile. Se necessario, discutere la pianificazione familiare con i\/le pazienti.    <\/li>\n\n\n<li class=\"mhh-mcn-list-item mhh-mcn-v2-list-item\">\n    <strong>Donne<\/strong><br>Alle donne in et\u00e0 fertile va raccomandato di utilizzare un metodo contraccettivo altamente efficace durante il trattamento con WELIREG\u00ae e per almeno 1 settimana dopo l\u2019ultima dose. L\u2019uso di WELIREG\u00ae pu\u00f2 ridurre l\u2019efficacia dei contraccettivi ormonali. Alle pazienti che utilizzano contraccettivi ormonali deve essere raccomandato di utilizzare un metodo contraccettivo alternativo non ormonale o di chiedere al partner maschile di utilizzare il preservativo durante il trattamento con WELIREG\u00ae.    <\/li>\n\n\n<li class=\"mhh-mcn-list-item mhh-mcn-v2-list-item\">\n    <strong>Uomini<\/strong><br>Ai pazienti di sesso maschile e alle loro partner in et\u00e0 fertile va raccomandato di utilizzare un metodo contraccettivo altamente efficace durante il trattamento del paziente maschile con WELIREG\u00ae e per almeno 1 settimana dopo l\u2019ultima dose. Ai pazienti di sesso maschile con partner in gravidanza va raccomandato di utilizzare un metodo contraccettivo di barriera durante il trattamento con WELIREG\u00ae e per 1 settimana dopo l\u2019ultima dose.    <\/li>\n\n<\/ul>\n\n        <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section\n    id=\"accordion-6af95f0e5c91d\"\n    class=\"mhh-mcn-v1-accordion-molecule mhh-mcn-v1-accordion-molecule--ca755793cc13efabcdbe59591e1ba056 mhh-mcn-v1-accordion-molecule--closed\"\n            >\n    <h4\n        id=\"accordion-6af95f0e5c91d-header\"\n        class=\"mhh-mcn-v1-accordion-molecule-header\"\n    >\n        <button\n            class=\"mhh-mcn-v1-accordion-molecule-header__heading\"\n            aria-expanded=\"false\"\n            aria-controls=\"accordion-6af95f0e5c91d-content\"\n        >\n                            <span class=\"mhh-mcn-v1-accordion-molecule-header__icon\" aria-hidden=\"true\">\n                    <figure class=\"mhh-mcn-v1-image mhh-mcn-v1-image--2794a2c078af3ea415c8a4f227e37a36\">\n                    <img decoding=\"async\"\n        class=\"mhh-mcn-image mhh-mcn-image--thumbnail wp-image-102097\"\n        src=\"https:\/\/www.mymsd.ch\/it\/wp-content\/uploads\/sites\/47\/2025\/04\/Icon_Fetus.png?w=66&#038;h=67&#038;crop=1&#038;quality=80&#038;lossy=1\"\n        width=\"66\"\n        height=\"67\"\n        loading=\"lazy\"        alt=\"\"\n            \/>\n            <\/figure>\n                <\/span>\n                        <span class=\"mhh-mcn-v1-accordion-molecule-header__title\">\n                Gravidanza            <\/span>\n            <span class=\"mhh-mcn-v1-accordion-molecule-header__icon-dropdown\" aria-hidden=\"true\">\n                \n<svg width=\"1em\" height=\"1em\" class=\"mh-icon mh-icon--kind-generic mh-icon--name-dropdown-arrow mh-icon--dropdown-arrow\" role=\"img\" aria-hidden=\"true\">\n    \n    \n    <use xlink:href=\"https:\/\/www.mymsd.ch\/it\/wp-content\/themes\/cex-wpvip-mhh-mconnect-theme-new-3.0\/modules\/icons\/resources\/icons\/svg\/generic\/dropdown-arrow.svg#dropdown-arrow\"><\/use>\n<\/svg>\n            <\/span>\n        <\/button>\n    <\/h4>\n    <div\n        id=\"accordion-6af95f0e5c91d-content\"\n        class=\"mhh-mcn-v1-accordion-molecule-content\"\n        role=\"region\"\n        aria-labelledby=\"accordion-6af95f0e5c91d-header\"\n    >\n        <div class=\"mhh-mcn-v1-accordion-molecule-content__body\">\n            \n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<ul class=\"mhh-mcn-v2-clist mhh-mcn-v2-clist--9179d8dff1f4e757fbdbfbbe5f5b72d9 mhh-mcn-list mhh-mcn-v2-clist--unordered mhh-mcn-v2-clist--unordered-dot\" dir=\"ltr\" lang=\"en-US\" start=\"1\">\n    \n<li class=\"mhh-mcn-list-item mhh-mcn-v2-list-item\">\n    Non sono disponibili dati sull\u2019uso del WELIREG\u00ae in donne in gravidanza. Studi sperimentali sugli animali hanno messo in evidenza una tossicit\u00e0 per la riproduzione. WELIREG\u00ae non deve essere usato durante la gravidanza e in donne in et\u00e0 fertile che non utilizzano contraccettivi.    <\/li>\n\n<\/ul>\n\n        <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section\n    id=\"accordion-6af95f0e5d025\"\n    class=\"mhh-mcn-v1-accordion-molecule mhh-mcn-v1-accordion-molecule--6506ffc79cb08edd81cbc4c5275ed18b mhh-mcn-v1-accordion-molecule--closed\"\n            >\n    <h4\n        id=\"accordion-6af95f0e5d025-header\"\n        class=\"mhh-mcn-v1-accordion-molecule-header\"\n    >\n        <button\n            class=\"mhh-mcn-v1-accordion-molecule-header__heading\"\n            aria-expanded=\"false\"\n            aria-controls=\"accordion-6af95f0e5d025-content\"\n        >\n                            <span class=\"mhh-mcn-v1-accordion-molecule-header__icon\" aria-hidden=\"true\">\n                    <figure class=\"mhh-mcn-v1-image mhh-mcn-v1-image--29f719f5fec5d487bde4280ad3543229\">\n                    <img decoding=\"async\"\n        class=\"mhh-mcn-image mhh-mcn-image--thumbnail wp-image-102099\"\n        src=\"https:\/\/www.mymsd.ch\/it\/wp-content\/uploads\/sites\/47\/2025\/04\/Icon_Lactation.png?w=66&#038;h=67&#038;crop=1&#038;quality=80&#038;lossy=1\"\n        width=\"66\"\n        height=\"67\"\n        loading=\"lazy\"        alt=\"\"\n            \/>\n            <\/figure>\n                <\/span>\n                        <span class=\"mhh-mcn-v1-accordion-molecule-header__title\">\n                Allattamento            <\/span>\n            <span class=\"mhh-mcn-v1-accordion-molecule-header__icon-dropdown\" aria-hidden=\"true\">\n                \n<svg width=\"1em\" height=\"1em\" class=\"mh-icon mh-icon--kind-generic mh-icon--name-dropdown-arrow mh-icon--dropdown-arrow\" role=\"img\" aria-hidden=\"true\">\n    \n    \n    <use xlink:href=\"https:\/\/www.mymsd.ch\/it\/wp-content\/themes\/cex-wpvip-mhh-mconnect-theme-new-3.0\/modules\/icons\/resources\/icons\/svg\/generic\/dropdown-arrow.svg#dropdown-arrow\"><\/use>\n<\/svg>\n            <\/span>\n        <\/button>\n    <\/h4>\n    <div\n        id=\"accordion-6af95f0e5d025-content\"\n        class=\"mhh-mcn-v1-accordion-molecule-content\"\n        role=\"region\"\n        aria-labelledby=\"accordion-6af95f0e5d025-header\"\n    >\n        <div class=\"mhh-mcn-v1-accordion-molecule-content__body\">\n            \n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<ul class=\"mhh-mcn-v2-clist mhh-mcn-v2-clist--99d189fdc0dad3387960eb09d8319e82 mhh-mcn-list mhh-mcn-v2-clist--unordered mhh-mcn-v2-clist--unordered-dot\" dir=\"ltr\" lang=\"en-US\" start=\"1\">\n    \n<li class=\"mhh-mcn-list-item mhh-mcn-v2-list-item\">\n    Non \u00e8 noto se nell\u2019essere umano WELIREG\u00ae o i suoi metaboliti passino nel latte materno. Non si pu\u00f2 escludere un rischio per i neonati\/lattanti. L\u2019allattamento deve essere interrotto durante il trattamento con WELIREG\u00ae e per 1 settimana dopo l\u2019ultima dose.    <\/li>\n\n<\/ul>\n\n        <\/div>\n    <\/div>\n<\/section>\n\n<\/div>\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\" \/>\n\n\n<div class=\"mhh-mcn-v1-links mhh-mcn-v1-links--0056ef7d2a8749bb8c67692000b02ce1\">\n    <a class=\"mhh-mcn-v1-link mhh-mcn-v1-link--c49d89ba3eb935601346a7b71b9707cf\" href=\"mailto:%20dpoc.switzerland@msd.com\" target=\"_self\" aria-label=\"All&#039;occorrenza, \u00e8 possibile richiedere copie delle pubblicazioni degli studi all&#039;indirizzo dpoc.switzerland@msd.com.\">\n                    <span class=\"mhh-mcn-v1-link__label\">All&#8217;occorrenza, \u00e8 possibile richiedere copie delle pubblicazioni degli studi all&#8217;indirizzo dpoc.switzerland@msd.com.<\/span>\n                <\/a><\/div>\n\n\n\n<div style=\"height:32px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"mhh-mcn-columns mhh-mcn-v1-columns--8c1d9b700ea7f256cf86f0dcc7f9948c mhh-mcn-v1-columns mhh-mcn-columns--gutter-m\">\n    <div class=\"mhh-mcn-columns-inner\">\n        \n<div class=\"mhh-mcn-v1-column mhh-mcn-v1-column--5a2de59d439a0ca3cc5352c4ab76225e mhh-mcn-column mhh-mcn-column--12 mhh-mcn-column--m-12 mhh-mcn-column--l-12\">\n    \n\n<h5 class=\"wp-block-heading has-border-color has-has-red-border-color-border-color  mhh-mcn-v1-heading mhh-mcn-v1-heading--97132ee60de38e1f3cda631be1fed8f3\"><em><strong><mark class=\"has-inline-color has-black-color\">Disegno dello studio LITESPARK-004<sup>3<\/sup><\/mark><\/strong><\/em><\/h5>\n\n\n\n<p class=\"has-gray-700-color has-text-color has-object-object-font-size has-border-color has-has-red-border-color-border-color has-black-color   mhh-mcn-v1-paragraph mhh-mcn-v1-paragraph--1354e0406c97e1ab6fa95e482391ecbf wp-block-paragraph\"><em><mark class=\"has-inline-color has-black-color\">Lo studio di fase II in aperto includeva 61 adulti di et\u00e0 pari o superiore a 18 anni a cui era stata diagnosticata una malattia associata a VHL dovuta a una mutazione di VHL nella linea germinale. I\/Le pazienti dovevano avere almeno un carcinoma a cellule renali misurabile che non fosse pi\u00f9 grande di 3 cm e nessuna altra neoplasia associata a VHL che richiedesse un intervento chirurgico immediato. I\/Le pazienti inclusi\/e avevano altri tumori associati a VHL, documentati radiologicamente, come emangioblastomi del sistema nervoso centrale e pNET. Il trattamento \u00e8 stato somministrato per via orale alla dose di 120 mg una volta al giorno (in tre compresse da 40 mg ciascuna). I\/Le pazienti sono stati\/e sottoposti\/e a esame radiologico circa 12 settimane dopo l\u2019inizio del trattamento e successivamente ogni 12 settimane, mentre il trattamento dello studio \u00e8 stato continuato per almeno 3 anni. L\u2019endpoint primario era il tasso di risposta obiettiva al trattamento con belzutifan (risposta completa o risposta parziale), secondo RECIST versione 1.1, nei pazienti con carcinoma a cellule renali associato alla malattia di VHL. Gli endpoint secondari includevano la durata della risposta, il tempo alla risposta e la sopravvivenza libera da progressione e endpoint aggiuntivi per lesioni pancreatiche, emangioblastomi del SNC e pNET, nonch\u00e9 la sicurezza del belzutifan.<sup>3<\/sup><\/mark><\/em><\/p>\n\n<\/div>\n\n    <\/div>\n\n    <\/div>\n\n\n<div class=\"mhh-mcn-columns mhh-mcn-v1-columns--8268005c2e0b401b105e2a4909aa005e mhh-mcn-v1-columns mhh-mcn-columns--gutter-m\">\n    <div class=\"mhh-mcn-columns-inner\">\n        \n<div class=\"mhh-mcn-v1-column mhh-mcn-v1-column--b67eb525bcd888859d36342bb43d3d1f mhh-mcn-column mhh-mcn-column--12 mhh-mcn-column--m-12 mhh-mcn-column--l-12\">\n    \n\n<h5 class=\"wp-block-heading has-border-color has-has-red-border-color-border-color  mhh-mcn-v1-heading mhh-mcn-v1-heading--414023fc8dcfb40c6c995fedc694b7a0\"><em><mark class=\"has-inline-color has-black-color\"><strong>Abbreviazioni<\/strong>:<\/mark><\/em><\/h5>\n\n\n\n<p class=\"has-gray-700-color has-text-color has-object-object-font-size has-border-color has-has-red-border-color-border-color   mhh-mcn-v1-paragraph mhh-mcn-v1-paragraph--60a9689ca33678c014d66aa0b2f21735 wp-block-paragraph\"><em><mark class=\"has-inline-color has-black-color\"><strong>EI<\/strong>: effetto indesiderato; <strong>RCC<\/strong>: carcinoma a cellule renali (renal cell carcinoma); <strong>VHL<\/strong>: Von-Hippel-Lindau.<\/mark><\/em><\/p>\n\n<\/div>\n\n    <\/div>\n\n    <\/div>\n\n\n<div class=\"mhh-mcn-columns mhh-mcn-v1-columns--9b4ac2296f472c5cd59897a84f6a8463 mhh-mcn-v1-columns mhh-mcn-columns--gutter-m\">\n    <div class=\"mhh-mcn-columns-inner\">\n        \n<div class=\"mhh-mcn-v1-column mhh-mcn-v1-column--3fa570093f8b55d87cc62f26ca84de73 mhh-mcn-column mhh-mcn-column--12 mhh-mcn-column--m-12 mhh-mcn-column--l-12\">\n    \n\n<h5 class=\"wp-block-heading has-border-color has-has-red-border-color-border-color  mhh-mcn-v1-heading mhh-mcn-v1-heading--2d13f7e932621573f3c57e11dc20430a\"><em><mark class=\"has-inline-color has-black-color\"><strong>Riferimenti bibliografici:<\/strong> <\/mark><\/em><\/h5>\n\n\n\n<ol class=\"mhh-mcn-v2-clist mhh-mcn-v2-clist--6ab76b336422895d782533285d309e71 mhh-mcn-list mhh-mcn-v2-clist--ordered mhh-mcn-v2-clist--ordered-decimal\" dir=\"ltr\" lang=\"en-US\" start=\"1\">\n    \n<li class=\"mhh-mcn-list-item mhh-mcn-v2-list-item\">\n    <em>Srinivasan R, et al. Belzutifan, a Hypoxia-Inducible Factor-2\u03b1 Inhibitor, for von Hippel-Lindau Disease\u2013Associated Neoplasms: Long-Term Results of the Phase 2 LITESPARK-004 Study. Presented at the American Association for Cancer Research (AACR) Annual Meeting; San Diego, California; April 5 \u2013 10, 2024.<\/em>    <\/li>\n\n\n<li class=\"mhh-mcn-list-item mhh-mcn-v2-list-item\">\n    <em>Informazione professionale di WELIREG\u00ae (belzutifan)<mark class=\"has-inline-color has-gray-700-color\"><mark class=\"has-inline-color has-gray-700-color\">,\u00a0<a href=\"https:\/\/www.swissmedicinfo.ch\/ShowText.aspx?textType=FI&amp;lang=DE&amp;authNr=68531\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">www.swis<\/a><a href=\"https:\/\/www.swissmedicinfo.ch\/ShowText.aspx?textType=FI&amp;lang=IT&amp;authNr=68531\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">smedicinfo.ch<\/a><\/mark><\/mark>, ultima consultazione il 07.03.2025.<\/em>    <\/li>\n\n\n<li class=\"mhh-mcn-list-item mhh-mcn-v2-list-item\">\n    <em>Jonasch E, et al. Belzutifan for Renal Cell Carcinoma in von Hippel-Lindau Disease. N Engl J Med. 2021;385:2036\u2009\u2013\u20092046. DOI: 10.1056\/NEJMoa2103425.<\/em>    <\/li>\n\n<\/ol>\n\n<\/div>\n\n    <\/div>\n\n    <\/div>\n\n\n\n<p class=\"has-object-object-font-size has-border-color has-has-red-border-color-border-color   mhh-mcn-v1-paragraph mhh-mcn-v1-paragraph--e8d31638f2611570b2aebec9dc3721f6 wp-block-paragraph\"><mark class=\"has-inline-color has-black-color\">\u25bc <em>Questo medicamento \u00e8 soggetto a monitoraggio addizionale. Per ulteriori informazioni, vedere l\u2019informazione professionale di WELIREG\u00ae su  <a href=\"https:\/\/www.swissmedicinfo.ch\/ShowText.aspx?textType=FI&amp;lang=IT&amp;authNr=68531\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">www.swissmedicinfo.ch<\/a>.<\/em><br><\/mark><br><em><mark class=\"has-inline-color has-black-color\">Prima della prescrizione, consultare l\u2019informazione professionale completa pubblicata sul sito \u00a0<a href=\"https:\/\/www.swissmedicinfo.ch\/ShowText.aspx?textType=FI&amp;lang=IT&amp;authNr=68531\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">www.swissmedicinfo.ch<\/a>.<\/mark><\/em><\/p>\n\n\n<div class=\"mhh-mcn-v1-links mhh-mcn-v1-links--5682d2c89fb57b0acbf380254c7e3af6\">\n    <a class=\"mhh-mcn-v1-link mhh-mcn-v1-link--7fb85d14f625190951d130864977aaf5 mhh-mcn-v1-link--is-variation mhh-mcn-v1-link--button-custom\" href=\"https:\/\/swissmedicinfo.ch\/showText.aspx?textType=FI&#038;lang=IT&#038;authNr=68531&#038;supportMultipleResults=1\" target=\"_blank\" rel=\"noopener noreferrer\" aria-label=\"Informazione professionale di WELIREG\u00ae\">\n                    <span class=\"mhh-mcn-v1-link__label\">Informazione professionale di WELIREG\u00ae<\/span>\n                <\/a><\/div>\n\n\n<div class=\"mhh-mcn-v1-links mhh-mcn-v1-links--82f4f88e83937229adc69a03cc2590a1\">\n    <a class=\"mhh-mcn-v1-link mhh-mcn-v1-link--8cb60f55b198dba4707914fb5c7f7502 mhh-mcn-v1-link--is-variation mhh-mcn-v1-link--button-custom\" href=\"https:\/\/www.mymsd.ch\/it\/succinctstatement\/welireg\/\" target=\"_blank\" rel=\"noopener noreferrer\" aria-label=\"Informazione professionale breve di WELIREG\u00ae\">\n                    <span class=\"mhh-mcn-v1-link__label\">Informazione professionale breve di WELIREG\u00ae<\/span>\n                <\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Gli effetti indesiderati pi\u00f9 comuni nella terapia con 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