Duvyzat®▼（givinostat）：在收到患者服用 givinostat 期间死亡报告后关于风险缓解措施的临时建议
正文 · 中文译文
Duvyzat®▼（givinostat）：在收到患者服用givinostat期间死亡报告后关于风险缓解措施的临时建议 国际上已有数例关于杜氏肌营养不良（DMD）患者在接受Duvyzat®（givinostat）治疗期间死亡的报告。在对这些病例及相关证据进行审查后，MHRA提出了对产品信息的更新建议。 发布机构： 英国药品和健康产品管理局（MHRA） 发布日期： 2026年11月5日 治疗领域： 心血管疾病与脂质学、神经病学、儿科学与新生儿学及药学 发布日期： 2026年11月5日 目录 摘要 致医疗专业人员的建议 致医疗专业人员向患者提供的建议 背景 报告建议 下载文件 补充信息 利益相关方参与 摘要 国际上已有数例关于杜氏肌营养不良（DMD）患者在接受Duvyzat®（givinostat）治疗期间死亡的报告。在对这些病例及相关证据进行审查后，MHRA提出了对产品信息的更新建议。在MHRA立场接受独立审查并最终确定之前，MHRA基于上述建议提供临时监测建议。 致医疗专业人员的建议： 继续避免在室性心律失常风险增加的患者中使用Duvyzat®，例如患有先天性长QT综合征、冠状动脉疾病、电解质紊乱的患者，或正在服用其他已知可引起QT延长的药物的患者 继续遵循杜氏肌营养不良英国护理（北极星）临床指南，该指南提供了关于心脏监测和临床监测的信息 在开始治疗前、开始使用givinostat后2-4周内获取心电图，此后每6个月进行一次，以符合杜氏肌营养不良英国护理（北极星）临床指南。该指南还提供了关于心脏病学介入阈值的建议。此外，MHRA建议在基线时也应进行24小时动态心电图监测，并在患者处于稳定药物剂量时重复进行 MHRA还建议，血清电解质（包括钾、镁和钙）应与血液学检查相同频率监测，即治疗前2个月每2周一次，第3个月一次，此后每3个月一次 Duvyzat®▼（givinostat）是一种黑三角药物，需接受额外监测。请通过黄卡报告所有与Duvyzat®相关的可疑药物不良反应 提供给患者的医疗保健专业人员建议： 在英国以外，已有少量杜氏肌营养不良患者在服用Duvyzat®（givinostat）期间死亡的报告。英国尚未报告死亡病例。MHRA已审查现有信息，并在独立审查最终完成之前，提供关于监测频率（如心电图或血液检查）的临时建议 拟议的监测变更旨在确保Duvyzat®对所有杜氏肌营养不良患者尽可能安全 请按处方继续服用Duvyzat®并参加所有预约就诊。请告知医生您正在服用的任何其他药物，或如果这些药物发生变化。 如果您对治疗有任何疑虑，请与您的杜氏肌营养不良专科团队沟通。 Duvyzat®▼（givinostat）是一种黑三角药物，须接受额外监测。请通过黄卡报告所有与Duvyzat®相关的可疑药物不良反应。 背景 2025年11月，Duvyzat®（givinostat）的上市许可持有人发布了一份致医疗保健专业人员的直接医疗通讯（DHPC），告知医疗保健专业人员，国际上已报告多例正在接受Duvyzat治疗的杜氏肌营养不良（DMD）患者死亡。英国未报告死亡病例。 MHRA已审查这些病例，并据此，许可管理机构已就其对Duvyzat®（givinostat）的审查作出决定。这包括更新产品信息中所含的监测要求，包括更频繁的心电图和电解质测量。该决定的实施须待一项正在进行的独立审查。在产品信息作出任何修订之前，MHRA将考虑独立审查报告。将发布进一步的DSU以通报任何最终确定的产品信息变更。 同时，提醒医疗专业人员遵循产品信息中当前的监测要求和警告。Duvyzat®可导致QTc延长，因此对于室性心律失常风险增加的患者，例如患有先天性长QT综合征、冠状动脉疾病、电解质紊乱的患者，或正在服用其他已知可导致QT延长的药物的患者，应避免使用该药。 此外，提醒医疗专业人员应继续遵循杜氏肌营养不良英国护理（北极星）关于心脏和临床监测的临床指南。该指南建议，所有患者应在开始治疗前、开始使用Duvyzat®后2-4周内进行心电图检查，之后每6个月进行一次。也可根据临床指征和剂量调整时要求进行心电图检查。该指南还提供了关于不启动Duvyzat®的QTc阈值、心脏病学评估意见和停止治疗的建议。除现有临床指南外，MHRA建议还应在基线时进行24小时动态心电图监测，并在患者处于稳定药物剂量时重复进行。 MHRA还建议，在开始使用Duvyzat®时和治疗期间，血清电解质（包括钾、镁和钙）应与血液学检查以相同频率进行监测，即治疗前2个月每2周一次，第3个月一次，此后每3个月一次。 报告建议 Duvyzat®▼（givinostat）需接受额外监测。请医疗专业人员、患者和照护者通过以下方式使用黄卡计划（Yellow Card scheme）以电子方式提交报告： 黄卡网站 黄卡应用程序；可从 Apple App Store 或 Google Play Store 下载 部分面向医疗专业人员的临床IT系统（EMIS、SystmOne、Vision、MiDatabank 和 Ulysses） 报告疑似药物不良反应时，请尽可能提供详细信息，包括病史、任何合并用药、发生时间及治疗日期。 下载文件 Duvyzat®▼（givinostat）：关于患者服用 givinostat 期间出现死亡报告后风险缓解措施的临时建议 附加信息 您可以注册接收药物安全性更新（Drug Safety Updates）的电子邮件通知。 您可以注册接收我们每月汇总的安全性通讯。 如有任何查询，请联系 info@mhra.gov.uk 利益相关方参与 NHS England 国家患者安全团队 权力下放行政机构 文章引用：MHRA Drug Safety Update 第20卷，第4期：2026年11月：1 目录 探索该主题 警报与召回
正文 · 英文原文
Duvyzat®▼ (givinostat): interim advice on risk mitigation measures following reports of deaths in patients while taking givinostat There have been several reports internationally of deaths in patients with Duchenne muscular dystrophy (DMD) while being treated with Duvyzat® (givinostat). Following a review of these cases and associated evidence, the MHRA has proposed updates to the product information. From: Medicines and Healthcare products Regulatory Agency Published: 5 November 2026 Therapeutic area: Cardiovascular disease and lipidology, Neurology, Paediatrics and neonatology and Pharmacy Published: 5 November 2026 Contents Summary Advice for Healthcare Professionals Advice for Healthcare Professionals to Provide to Patients Background Reporting advice Download document Additional information Stakeholder engagement Summary There have been several reports internationally of deaths in patients with Duchenne muscular dystrophy (DMD) while being treated with Duvyzat® (givinostat). Following a review of these cases and associated evidence, the MHRA has proposed updates to the product information. Interim monitoring advice is being provided by the MHRA based on these proposals, pending independent review and finalisation of the MHRA’s position. Advice for Healthcare Professionals: continue to refrain from using Duvyzat® in patients at increased risk for ventricular arrhythmias, such as those with congenital long QT syndrome, coronary artery disease, electrolyte disturbances, or those taking other medicines known to cause QT prolongation continue to follow the Duchenne Care UK (North Star) clinical guidance, which provides information on cardiac monitoring and clinical monitoring obtain ECGs before initiating treatment, within 2-4 weeks after starting givinostat, and then every 6 months thereafter, in line with Duchenne Care UK (North Star) clinical guidance. The guidance also provides advice on thresholds for cardiology input. Additionally, the MHRA advises that 24-hour ambulatory ECG monitoring should also be undertaken at baseline, and repeated when the patient is on a stable dose of medication the MHRA also advises that serum electrolytes (including potassium, magnesium and calcium) should be monitored at the same frequency as haematological bloods every 2 weeks for the first 2 months of treatment, at month 3, and then every 3 months thereafter Duvyzat®▼ (givinostat) is a black triangle medicine and is subject to additional monitoring. Report ALL suspected adverse drug reactions associated with Duvyzat® on a Yellow Card Advice for Healthcare Professionals to Provide to Patients: a small number of deaths have been reported outside the UK in people with Duchenne muscular dystrophy while taking Duvyzat® (givinostat). No deaths have been reported in the UK. The MHRA has reviewed the available information and is providing interim advice on the frequency of monitoring (such as ECGs or blood tests), pending finalisation of an independent review the proposed changes to monitoring aim to ensure that Duvyzat® remains as safe as possible for all Duchenne muscular dystrophy patients continue taking Duvyzat® as prescribed and attend all appointments. Tell your doctor about any additional medications you are taking or if they change speak to your specialist Duchenne’s team if you have any concerns about your treatment Duvyzat®▼ (givinostat) is a black triangle medicine and is subject to additional monitoring. Report ALL suspected adverse drug reactions associated with Duvyzat® on a Yellow Card Background In November 2025, the Marketing Authorisation holder of Duvyzat® (givinostat) issued a Direct Healthcare Professional Communication (DHPC) informing healthcare professionals that a number of deaths have been reported internationally in patients with Duchenne muscular dystrophy (DMD) who were being treated with Duvyzat. No deaths have been reported in the UK. The MHRA has reviewed these cases and based on this, the licensing authority has reached a decision on its review of Duvyzat® (givinostat). This includes updates to the monitoring requirements contained within the product information, including more frequent ECG and electrolyte measurements. Implementation of this decision is subject to an ongoing independent review. The MHRA will consider the independent review report before any amendments to the product information are made. A further DSU will be issued to communicate any finalised product information changes. In the meantime, healthcare professionals are reminded to follow the current monitoring requirements and warnings in the product information. Duvyzat® can cause prolongation of QTc, so its use should be avoided in patients at increased risk for ventricular arrhythmias, such as those with congenital long QT syndrome, coronary artery disease, electrolyte disturbances, or those taking other medicines known to cause QT prolongation. In addition, healthcare professionals are reminded that they should continue to follow the Duchenne Care UK (North Star) clinical guidance on cardiac and clinical monitoring. The guidance advises that in all patients, ECGs should be obtained prior to initiating treatment, within 2-4 weeks after starting Duvyzat®, and then every 6 months. ECGs can also be requested as clinically indicated and at dose changes. The guidance also provides advice for QTc thresholds for not initiating Duvyzat®, cardiology input and treatment cessation. In addition to the existing clinical guidance, the MHRA advises that 24-hour ambulatory ECG monitoring should also be undertaken at baseline, and repeated when the patient is on a stable dose of medication. The MHRA also advises that serum electrolytes (including potassium, magnesium and calcium) should be monitored at the same frequency as haematological bloods, when initiating and during treatment with Duvyzat®, every 2 weeks for the first 2 months of treatment, at month 3, and then every 3 months thereafter. Reporting advice Duvyzat®▼ (givinostat) is subject to additional monitoring. Healthcare professionals, patients, and caregivers are asked to submit reports using the Yellow Card scheme electronically using: the Yellow Card website the Yellow Card app; download from the Apple App Store or Google Play Store some clinical IT systems for healthcare professionals (EMIS, SystmOne, Vision, MiDatabank, and Ulysses) When reporting suspected adverse drug reactions, please provide as much information as possible, including information about medical history, any concomitant medication, onset timing, and treatment dates. Download document Duvyzat®▼ (givinostat): interim advice on risk mitigation measures following reports of deaths in patients while taking givinostat Additional information You can sign up to receive email notifications for Drug Safety Updates. You can sign up to receive our monthly roundup of safety communications. For any enquiries, please contact info@mhra.gov.uk Stakeholder engagement NHS England National Patient Safety Team Devolved Administrations Article citation: MHRA Drug Safety Update volume 20, issue 4: November 2026: 1 Contents Explore the topic Alerts and recalls