{"id":8910,"date":"2026-11-05T15:48:02","date_gmt":"2026-11-05T12:48:02","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=8910"},"modified":"2026-11-05T16:24:26","modified_gmt":"2026-11-05T13:24:26","slug":"duvyzat-givinostat-safety-alert","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/tr\/duvyzat-givinostat-safety-alert\/","title":{"rendered":"Duvyzat (Givinostat) G\u00fcvenlik Uyar\u0131s\u0131: MHRA, Hasta \u00d6l\u00fcm\u00fc Bildirimlerinin Ard\u0131ndan Daha Kapsaml\u0131 Kardiyak \u0130zleme \u00c7a\u011fr\u0131s\u0131nda Bulundu"},"content":{"rendered":"<p class=\"wp-block-paragraph\"><strong>Birle\u015fik Krall\u0131k \u0130la\u00e7 ve Sa\u011fl\u0131k \u00dcr\u00fcnleri D\u00fczenleme Kurumu (MHRA), Duchenne kas distrofisi (DMD) tedavisinde kullan\u0131lan Duvyzat (givinostat) ilac\u0131yla ilgili olarak, ilac\u0131 kullanan hastalar aras\u0131nda uluslararas\u0131 alanda birka\u00e7 \u00f6l\u00fcm vakas\u0131n\u0131n bildirilmesinin ard\u0131ndan \u00f6nemli bir ila\u00e7 g\u00fcvenli\u011fi g\u00fcncellemesi yay\u0131nlad\u0131.<\/strong> Yap\u0131lan a\u00e7\u0131klamada, tedaviyle ili\u015fkili potansiyel olarak ciddi riskleri azaltmak i\u00e7in kalp izlemesinin iyile\u015ftirilmesi ve daha s\u0131k kan testlerinin yap\u0131lmas\u0131 ihtiyac\u0131n\u0131n alt\u0131n\u0131 \u00e7izildi.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u00d6nemli olan, bildirilen \u00f6l\u00fcmlerin tek ba\u015f\u0131na givinostat\u0131n bu \u00f6l\u00fcmlere neden oldu\u011funu kan\u0131tlamamas\u0131d\u0131r. MHRA mevcut vakalar\u0131 incelemi\u015f ve ilac\u0131n izleme gerekliliklerinde \u00f6nerilen de\u011fi\u015fiklikler konusunda bir karar alm\u0131\u015ft\u0131r. Bununla birlikte, uygulama ba\u011f\u0131ms\u0131z bir incelemeye tabidir ve mevcut \u00f6neriler ge\u00e7ici \u00f6nlemlerdir.<\/p>\n\n\n\n<div class=\"wp-block-rank-math-toc-block\" id=\"rank-math-toc\"><h2>\u0130\u00e7indekiler<\/h2><nav><ul><li><a href=\"#key-safety-concern-q-tc-prolongation-and-cardiac-arrhythmias\">Ba\u015fl\u0131ca G\u00fcvenlik Endi\u015fesi: QTc Uzamas\u0131 ve Kalp Aritmileri<\/a><\/li><li><a href=\"#essential-risk-mitigation-and-monitoring-recommendations\">Temel Risk Azaltma ve \u0130zleme \u00d6nerileri<\/a><\/li><li><a href=\"#what-should-patients-and-families-do\">Hastalar ve Aileleri Ne Yapmal\u0131?<\/a><\/li><\/ul><\/nav><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Ba\u015fl\u0131ca G\u00fcvenlik Endi\u015fesi: QTc Uzamas\u0131 ve Kalp Aritmileri<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">En \u00f6nemli endi\u015felerden biri, givinostat\u0131n kalbin aktivitesinin elektriksel bir \u00f6l\u00e7\u00fcm\u00fc olan QTc aral\u0131\u011f\u0131n\u0131 uzatabilmesidir. \u00d6nemli QTc uzamas\u0131, tehlikeli ventrik\u00fcler aritmiler riskini art\u0131rabilir ve potansiyel olarak ya\u015fam\u0131 tehdit eden komplikasyonlara yol a\u00e7abilir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">MHRA, \u00f6zellikle a\u015fa\u011f\u0131daki durumlarda ventrik\u00fcler aritmi riski y\u00fcksek olan hastalarda Duvyzat kullan\u0131m\u0131n\u0131 \u00f6nermemektedir:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Do\u011fu\u015ftan uzun QT sendromu.<\/li>\n\n\n\n<li>Koroner arter hastal\u0131\u011f\u0131.<\/li>\n\n\n\n<li>Elektrolit dengesizlikleri, \u00f6zellikle potasyum, magnezyum veya kalsiyum ile ilgili olanlar.<\/li>\n\n\n\n<li>QT aral\u0131\u011f\u0131n\u0131 uzatt\u0131\u011f\u0131 bilinen ila\u00e7lar\u0131n e\u015f zamanl\u0131 kullan\u0131m\u0131.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Bu risk fakt\u00f6rleri, tedaviye ba\u015flamadan \u00f6nce ve tedavi s\u00fcresince dikkatli bir \u015fekilde de\u011ferlendirilmelidir.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Temel Risk Azaltma ve \u0130zleme \u00d6nerileri<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">MHRA, sa\u011fl\u0131k \u00e7al\u0131\u015fanlar\u0131n\u0131n hasta g\u00fcvenli\u011fini art\u0131rmak i\u00e7in uygulamas\u0131 gereken \u00e7e\u015fitli \u00f6nlemleri vurgulamaktad\u0131r.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">1. D\u00fczenli EKG Takibi<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Elektrokardiogram (EKG) \u00e7ekimi yap\u0131lmal\u0131d\u0131r:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Givinostat tedavisine ba\u015flamadan \u00f6nce.<\/li>\n\n\n\n<li>Tedaviye ba\u015fland\u0131ktan sonraki 2-4 hafta i\u00e7inde.<\/li>\n\n\n\n<li>Bundan sonra her 6 ayda bir.<\/li>\n\n\n\n<li>Klinik olarak gerekli g\u00f6r\u00fcld\u00fc\u011f\u00fc her durumda, doz de\u011fi\u015fikliklerinden sonra da dahil olmak \u00fczere.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Ayr\u0131ca, MHRA, tedavi \u00f6ncesinde 24 saatlik ambulatuvar EKG (Holter) takibi yap\u0131lmas\u0131n\u0131 ve hastan\u0131n stabil bir ila\u00e7 dozuna ula\u015fmas\u0131n\u0131n ard\u0131ndan bunun tekrarlanmas\u0131n\u0131 \u00f6nermektedir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2. Daha S\u0131k Elektrolit Testi<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Potasyum, magnezyum ve kalsiyum d\u00fczeylerini \u00f6l\u00e7en kan testleri a\u015fa\u011f\u0131daki programa g\u00f6re yap\u0131lmal\u0131d\u0131r:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u0130lk 2 ay boyunca her 2 haftada bir.<\/li>\n\n\n\n<li>3. ayda.<\/li>\n\n\n\n<li>Bundan sonra her 3 ayda bir.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Bu testler \u00e7ok \u00f6nemlidir \u00e7\u00fcnk\u00fc elektrolit dengesizlikleri kalp ritim bozukluklar\u0131na yatk\u0131nl\u0131\u011f\u0131 art\u0131rabilir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3. E\u015f zamanl\u0131 kullan\u0131lan t\u00fcm ila\u00e7lar\u0131 g\u00f6zden ge\u00e7irin.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Sa\u011fl\u0131k uzmanlar\u0131, yeni re\u00e7ete edilen ila\u00e7lar ve mevcut tedavilerdeki de\u011fi\u015fiklikler de dahil olmak \u00fczere, hastalar\u0131n kulland\u0131\u011f\u0131 t\u00fcm ila\u00e7lar\u0131 dikkatlice g\u00f6zden ge\u00e7irmelidir. \u00d6zellikle QT aral\u0131\u011f\u0131n\u0131 uzatabilecek ila\u00e7lara dikkat edilmelidir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">4. Uzman Kardiyak De\u011ferlendirme<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Hastalar uygun kardiyak de\u011ferlendirmeden ge\u00e7irilmelidir; EKG bulgular\u0131 veya klinik durumlar artm\u0131\u015f risk g\u00f6steriyorsa kardiyoloji uzman\u0131 da dahil edilmelidir. Tedaviye ba\u015flama ve devam etme, belirlenmi\u015f QTc g\u00fcvenlik e\u015fiklerine uygun olarak yap\u0131lmal\u0131d\u0131r.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Hastalar ve Aileleri Ne Yapmal\u0131?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">MHRA, hastalar\u0131n Duvyzat'\u0131 kendi ba\u015flar\u0131na b\u0131rakmamalar\u0131n\u0131 tavsiye etmektedir. Hastalar, re\u00e7ete edildi\u011fi \u015fekilde tedaviye devam etmeli, planlanan t\u00fcm kontrol randevular\u0131na kat\u0131lmal\u0131 ve kulland\u0131klar\u0131 her ila\u00e7 hakk\u0131nda Duchenne uzman ekibini bilgilendirmelidir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Aileler ayr\u0131ca, yeni belirtiler veya endi\u015feler ortaya \u00e7\u0131kt\u0131\u011f\u0131nda, bir sonraki planl\u0131 randevuyu beklemek yerine, derhal sa\u011fl\u0131k ekibiyle g\u00f6r\u00fc\u015fmelidir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u015e\u00fcpheli t\u00fcm ila\u00e7 yan etkileri, ilgili ulusal farmakovijilans sistemi arac\u0131l\u0131\u011f\u0131yla bildirilmelidir. Birle\u015fik Krall\u0131k'ta bu, MHRA Sar\u0131 Kart sistemidir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued an important drug safety update concerning Duvyzat (givinostat), a treatment for Duchenne muscular dystrophy (DMD), following reports of several deaths internationally among patients receiving the medication. The announcement highlights the need for enhanced cardiac monitoring and more frequent blood tests to reduce potentially serious [&hellip;]<\/p>\n","protected":false},"author":10,"featured_media":8911,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[282],"tags":[46,47,50],"class_list":["post-8910","post","type-post","status-publish","format-standard","has-post-thumbnail","category-editorials","tag-duvyzat","tag-givinostat","tag-mhra"],"subtitle":"MHRA, \u0130ngiltere d\u0131\u015f\u0131nda tedavi g\u00f6ren hastalarda \u00f6l\u00fcm vakalar\u0131 bildirilmesinin ard\u0131ndan Duvyzat (givinostat) i\u00e7in ge\u00e7ici bir g\u00fcvenlik uyar\u0131s\u0131 yay\u0131nlad\u0131. Yeni \u00f6neriler, Duchenne kas distrofisi (DMD) ile ya\u015fayan ki\u015fileri korumaya yard\u0131mc\u0131 olmak i\u00e7in kardiyak riskleri, EKG ve Holter izlemesini ve d\u00fczenli elektrolit testini vurgulamaktad\u0131r.","_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/8910","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/users\/10"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/comments?post=8910"}],"version-history":[{"count":4,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/8910\/revisions"}],"predecessor-version":[{"id":8917,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/8910\/revisions\/8917"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media\/8911"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media?parent=8910"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/categories?post=8910"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/tags?post=8910"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}