{"id":2358,"date":"2025-04-24T11:24:06","date_gmt":"2025-04-24T11:24:06","guid":{"rendered":"https:\/\/www.merckconnect.com\/prevymis\/?page_id=2358"},"modified":"2026-03-30T09:24:29","modified_gmt":"2026-03-30T09:24:29","slug":"hsct-pediatric","status":"publish","type":"page","link":"https:\/\/www.merckconnect.com\/prevymis\/hsct-pediatric\/","title":{"rendered":"Pediatric information for HSCT"},"content":{"rendered":"<link rel='stylesheet' id='vivid360-heading-css-css' href='https:\/\/www.merckconnect.com\/prevymis\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/heading\/css\/style.min.css?ver=1765535927' media='all' \/>\n\n<div class=\"vivid360-heading default-hcp-fontsize default-hcp-tablet-fontsize default-hcp-mobile-fontsize\" id=\"ae876afe6-e2bb-4ad7-9012-46ea02e22721\"><h1 class=\"content-width fontWeightRegular\" style=\"--desktopFontSize:var(--h1FontSizeDesktop);--tabletFontSize:var(--h1FontSizeDesktop);--mobileFontSize:var(--h1FontSizeMobile);--desktopLineHeightSize:var(--h1LineHeightDesktop);--tabletLineHeightSize:var(--h1LineHeightDesktop);--mobileLineHeightSize:\" id=\"top\"><strong>PREVYMIS\u00ae (letermovir): pediatric information for hematopoietic stem cell transplantation (HSCT)<\/strong><\/h1><\/div>\n\n\n<link rel='stylesheet' id='vivid360-spacer-css-css' href='https:\/\/www.merckconnect.com\/prevymis\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/spacer\/css\/style.min.css?ver=1765535928' media='all' \/>\n\n<div style=\"background-color:transparent;--desktop-spacer:2px;--mobile-spacer:16px;--tablet-spacer:2px\" class=\"wp-block-vivid360-spacer vivid360-spacer-desktop vivid360-spacer-mobile vivid360-spacer-tablet\"><\/div>\n\n\n\n<div class=\"vivid360-heading default-hcp-fontsize default-hcp-tablet-fontsize default-hcp-mobile-fontsize\" id=\"a2bc90fe0-292c-4886-88a9-712aa1978dc1\"><h2 class=\"has-primary-color content-width fontWeightRegular\" style=\"--desktopFontSize:var(--h2FontSizeDesktop);--tabletFontSize:var(--h2FontSizeDesktop);--mobileFontSize:var(--h2FontSizeMobile);--desktopLineHeightSize:var(--h2LineHeightDesktop);--tabletLineHeightSize:var(--h2LineHeightDesktop);--mobileLineHeightSize:\" id=\"\"><strong>Pediatric recipients of an allogeneic HSCT (Trial P030)&nbsp;<\/strong><\/h2><\/div>\n\n\n\n<div style=\"background-color:transparent;--desktop-spacer:2px;--mobile-spacer:16px;--tablet-spacer:2px\" class=\"wp-block-vivid360-spacer vivid360-spacer-desktop vivid360-spacer-mobile vivid360-spacer-tablet\"><\/div>\n\n\n\n<p>Sixty-three children 2 months to less than 18 years of age who had an allogeneic HSCT were enrolled in a  Phase 2b multicenter, open-label, single-arm pharmacokinetic, safety and effectiveness study of PREVYMIS (P030, NCT03940586). Subjects received PREVYMIS daily either orally or intravenously for CMV prophylaxis within 28 days post-HSCT through Week 14 post-HSCT. The intravenous formulation was used for up to four weeks in subjects who were unable to take oral therapy. The daily doses of PREVYMIS were based on body weight. Among the 63 treated subjects, 8 were 2 months to less than 2 years of age, 27 were 2 to less than 12 years of age and 28 were 12 to less than 18 years of age. The median age was 11 years; 70% were male; 70% were White; 14% were Asian; 5% were Black; and 22% were Hispanic or Latino.&nbsp;<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>Among 56 subjects who received at least one dose of study drug and had no detectable CMV DNA at baseline. The proportion of subjects who failed CMV prophylaxis through Week 24 post-HSCT was 25% (14 of the 56 subjects). Six subjects had initiation of pre-emptive therapy based on CMV viremia and 8 subjects discontinued from the study before Week 24. None of the subjects had CMV end-organ disease.&nbsp;<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>PREVYMIS is indicated for pediatric recipients of an allogeneic HSCT aged 6 months and older and weighing at least <span class=\"no-wrap-text\">6 kg<\/span>.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:16px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-16\"><\/div>\n\n\n\n<div class=\"vivid360-heading default-hcp-fontsize default-hcp-tablet-fontsize default-hcp-mobile-fontsize\" id=\"a70643626-cbe5-4fac-9d7f-50197e79442c\"><h2 class=\"has-primary-color content-width fontWeightRegular\" style=\"--desktopFontSize:var(--h2FontSizeDesktop);--tabletFontSize:var(--h2FontSizeDesktop);--mobileFontSize:var(--h2FontSizeMobile);--desktopLineHeightSize:var(--h2LineHeightDesktop);--tabletLineHeightSize:var(--h2LineHeightDesktop);--mobileLineHeightSize:\" id=\"\"><strong>PREVYMIS\u00ae (letermovir) in pediatric patients<\/strong><\/h2><\/div>\n\n\n\n<div style=\"background-color:transparent;--desktop-spacer:2px;--mobile-spacer:16px;--tablet-spacer:2px\" class=\"wp-block-vivid360-spacer vivid360-spacer-desktop vivid360-spacer-mobile vivid360-spacer-tablet\"><\/div>\n\n\n\n<p><strong>PREVYMIS\u00ae (letermovir) was evaluated in an open-label, single-arm pharmacokinetic, safety,&nbsp;and effectiveness study&nbsp;<\/strong><\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>The use of PREVYMIS for prophylaxis of CMV infection and disease in pediatric recipients of an allogeneic HSCT is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data from pediatric patients in Trial P030 (Pediatric Recipients of an Allogeneic HSCT).&nbsp;<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>The safety and pharmacokinetic results were similar to those in adults.&nbsp;<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>The safety and effectiveness of PREVYMIS have not been established for HSCT recipients less than 6 months of age or weighing less than <span class=\"no-wrap-text\">6 kg<\/span>.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>PREVYMIS is indicated for prophylaxis of CMV infection and disease in pediatric CMV-seropositive recipients [R+] of an allogeneic HSCT 6 months of age and older and weighing at least <span class=\"no-wrap-text\">6 kg<\/span>.<\/p>\n\n\n\n<div class=\"wp-block-vivid360-button-parent btn-block-container content-width button-justify-left\"><link rel='stylesheet' id='vivid360-button-block-css-css' href='https:\/\/www.merckconnect.com\/prevymis\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/button\/css\/style.min.css?ver=1765535927' media='all' \/>\n<link rel='stylesheet' id='vivid360-button-parent-block-css-css' href='https:\/\/www.merckconnect.com\/prevymis\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/button-parent\/css\/style.min.css?ver=6.8.5' media='all' \/>\n\n<div class=\"vivid360-button-block fullWidth-mobile\"><a class=\"btn primary primary-regular\" role=\"button\" style=\"font-size:14px;letter-spacing:0.86px;border-radius:10px;border-style:solid;justify-content:center;text-align:center;width:100%\" href=\"\/prevymis\/adverse-reactions\/#pediatric\" title=\"Safety profile in pediatric patients \" target=\"_self\" rel=\"noopener\" data-design-category=\"button\" data-design-label=\"Safety profile in pediatric patients \" data-design-module=\"element\" data-event-name=\"element_click\">Safety profile in pediatric patients <\/a><\/div>\n<\/div>\n\n\n\n<div style=\"background-color:transparent;height:16px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-16\"><\/div>\n\n\n\n<p><a href=\"#top\" aria-label=\"#\">Back to top<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Sixty-three children 2 months to less than 18 years of age who had an allogeneic HSCT were enrolled in a Phase 2b&#8230;<\/p>\n","protected":false},"author":561,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_trash_the_other_posts":false,"editor_notices":[],"footnotes":""},"ga4_page_audience":[],"ga4_page_birn_id":[],"ga4_page_branding":[],"ga4_page_businessunit":[],"ga4_page_campaign":[],"ga4_page_content_purpose":[],"ga4_page_customer_journey_stage":[],"ga4_page_customer_specialty":[],"ga4_page_experience":[],"ga4_page_indication":[],"ga4_page_material_intent":[],"ga4_page_product":[],"ga4_page_region":[],"ga4_page_therapeuticarea":[],"user_role":[],"mhh-area-of-interest":[],"access":[],"user_status":[],"class_list":["post-2358","page","type-page","status-publish"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Information About PREVYMIS\u00ae (letermovir) for Pediatric HSCT Patients<\/title>\n<meta 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