UCB在2025年美国神经病学学会（AAN）会议上展示了其领先的神经学研究组合的最新研究成果-动脉网

UCB presents latest research across leading neurology portfolio at American Academy of Neurology (AAN) meeting 2025

优时比等信源发布 2025-04-03 13:02



可切换为仅中文







Brussels (Belgium) 3 April 2025 – 07:00 AM (CET)

布鲁塞尔（比利时）2025年4月3日 – 早上7:00（欧洲中部时间）

– UCB, a global biopharmaceutical company, today announced it will present 24 abstracts from its expansive neurology portfolio, including rare epilepsies Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS), generalized myasthenia gravis (gMG) and Thymidine Kinase 2 deficiency (TK2d), at this year’s American Academy of Neurology (AAN) meeting, San Diego California, April 5- 9, 2025..

优时比（UCB），一家全球生物制药公司，今日宣布将在今年的美国神经病学学会（AAN）会议上展示来自其广泛神经学产品组合的24篇摘要。这些摘要涵盖了罕见癫痫，包括Dravet综合征（DS）和Lennox-Gastaut综合征（LGS）、全身性重症肌无力（gMG）以及胸苷激酶2缺乏症（TK2d）。会议将于2025年4月5日至9日在加利福尼亚州圣地亚哥举行。

'We at UCB are deeply committed to driving innovation to improve the treatment and care of people living with severe neurological and neuromuscular conditions such as epilepsy, gMG, and TK2d. The data presented at AAN is a testament to our dedication to exploring new frontiers of science and improving care in areas of high unmet need.

“我们UCB深切致力于推动创新，以改善患有严重神经和神经肌肉疾病（如癫痫、gMG和TK2d）患者的治疗和护理。在AAN上展示的数据证明了我们对探索科学新领域和改善高度未满足需求领域的医疗护理的承诺。

It is our mission to address critical gaps in care, bring meaningful solutions that make real improvements in the lives of the people we serve, now and into the future,' said Donatello Crocetta, Chief Medical Officer at UCB..

“我们的使命是解决护理中的关键差距，提供有意义的解决方案，为我们服务的人们的生活带来真正的改善，现在和未来都是如此，”优时比首席医疗官唐纳泰罗·克罗切塔表示。

Highlights of data to be presented at AAN include:

将在AAN上展示的数据亮点包括：

Epilepsy

癫痫

DS and LGS

DS 和 LGS

: the final long-term safety and effectiveness data from a fenfluramine (FFA) open-label extension (OLE) study of 247 participants with Lennox-Gastaut syndrome,

：来自一项针对247名Lennox-Gastaut综合征患者的芬氟拉明（FFA）开放标签扩展（OLE）研究的最终长期安全性和有效性数据，

data from an observational analysis assessing sleep apnea association with increased mortality in patients 1-17 years old with severe epilepsy

评估睡眠呼吸暂停与1-17岁重度癫痫患者死亡率增加相关性的观察性分析数据

and data from a phase 1 study to assess the safety, tolerability, pharmacokinetics, and efficacy of fenfluramine when combined with cannabidiol in a small cohort of patients with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS).

以及来自一项一期研究的数据，该研究评估了芬氟拉明与大麻二酚联合使用时，在一小群Dravet综合征（DS）或Lennox-Gastaut综合征（LGS）患者中的安全性、耐受性、药代动力学和疗效。

Focal onset seizures

局灶性发作癫痫

: data include brivaracetam long-term clinical outcomes in pediatric patients with primary generalized seizures* from an open-label phase 3 follow up study,

：数据包括布瓦西坦在原发性全面性癫痫发作的儿科患者中的长期临床结果*，来自一项开放标签的3期随访研究，

healthcare resource utilization of brivaracetam monotherapy† from a claims analysis.

从索赔分析中得到的布立西坦单药治疗的医疗资源利用情况。

Women of childbearing age

育龄妇女

: data include results of a social media listening analysis on the experiences and challenges of women living with epilepsy during their motherhood journey.

数据包括对患有癫痫的女性在母亲旅程中的经历和挑战进行的社交媒体倾听分析结果。

Quality of life

生活质量

: including data from a survey evaluating the disruptive impact of developmental and epileptic encephalopathies on patients’ and families’ quality of life,

：包括一项评估发育性和癫痫性脑病对患者及其家庭生活质量的破坏性影响的调查数据，

and data from a study exploring the impact of prolonged seizures on patients’ and caregivers’ quality of life.

以及一项研究的数据，该研究探讨了长时间癫痫发作对患者和护理者生活质量的影响。

UCB pipeline

UCB管道

: data include investigational therapy Staccato® alprazolam‡, being studied in management of stereotypical prolonged seizures.

：数据包括正在研究用于控制刻板性长时间发作的试验性治疗药物Staccato® alprazolam‡。

9,18

9，18

gMG

Rozanolixizumab self-administration study

罗扎诺利珠单抗自我给药研究

: phase 3, open-label, randomized study which observed the safety and efficacy of manual push (MP) and syringe driver (SD) self-administration of rozanolixizumab was consistent with known profile.

：第三阶段、开放标签、随机研究，观察到手动推注（MP）和注射器驱动（SD）自我给药rozanolixizumab的安全性和有效性与已知特性一致。

This data informed EU and Japan approval of self-administration.

该数据为欧盟和日本批准自我给药提供了依据。

Ocular symptoms study in gMG

gMG的眼部症状研究

: results from post hoc analyses from the randomized, placebo-controlled, Phase 3 MycarinG study investigating the effect of rozanolixizumab on ocular symptoms in patients with gMG.

：来自随机、安慰剂对照的3期MycarinG研究的事后分析结果，该研究调查了rozanolixizumab对gMG患者眼部症状的影响。

Study investigating switching to zilucoplan

研究转换为使用zilucoplan的情况

: phase 3b study on safety, efficacy, and patient preference and satisfaction for subcutaneous zilucoplan in myasthenia gravis after switching from intravenous complement component 5 inhibitors.

：在从静脉注射补体成分5抑制剂转换后，进行皮下注射zilucoplan治疗重症肌无力的3b期安全性、有效性以及患者偏好和满意度研究。

MG-specific subdomain scores

MG特定子域分数

: results from analysis from the randomized, placebo-controlled, Phase 3 RAISE study investigating the effect of zilucoplan on MG-ADL and QMG subdomain scores.

：来自随机、安慰剂对照的 3 期 RAISE 研究的分析结果，该研究调查了 zilucoplan 对 MG-ADL 和 QMG 子域评分的影响。

Quality of life with gMG

gMG的生活质量

: a new international patient registry in gMG linking clinical and patient-reported outcomes data aims to improve understanding of the symptoms and quality of life to optimize future disease management.

：一个新的国际患者登记册在gMG中将临床和患者报告的结果数据联系起来，旨在提高对症状和生活质量的理解，以优化未来的疾病管理。

TK2d

Disease course

病程

: findings from the largest international TK2d dataset evaluating the disease course of people living with TK2d who were ≤12 years at TK2d symptom onset

：来自最大的国际TK2d数据集的研究结果，评估了在TK2d症状发作时年龄≤12岁的TK2d患者的病程

and over 12 at TK2d symptom onset and not on treatment.

并且在TK2d症状发作时超过12岁且未接受治疗。

* Brivaracetam is not approved for use in primary generalized seizures by any Regulatory Authority.

* 任何监管机构均未批准布瓦西坦用于原发性全面性癫痫发作。

† BRIVIACT® is not licensed for use in monotherapy in Europe.

† BRIVIACT® 在欧洲未获准用于单一疗法。

‡ STACCATO® alprazolam is an investigational treatment, and its safety and efficacy has not been established.

‡ STACCATO® 阿普唑仑是一种研究性治疗药物，其安全性和有效性尚未确定。

It is not currently approved for use by any regulatory authority worldwide.

目前，全球任何监管机构均未批准其使用。

Rare Disease Connect in Neurology (RDCN)

神经病学中的罕见疾病连接 (RDCN)

UCB is proud to host its inaugural US Rare Disease Connect in Neurology (RDCN) Annual Summit at AAN, to provide a forum for needs-driven medical education for the generalized myasthenia gravis community. This event is being held exclusively for healthcare providers who are involved in patient care. .

UCB很荣幸在AAN举办其首届美国神经病学罕见疾病连接（RDCN）年度峰会，为广义重症肌无力社区提供需求驱动的医学教育论坛。此次活动专为参与患者护理的医疗保健提供者举办。

Symposia

研讨会

AAN 2025 will feature two UCB-supported symposia:

AAN 2025 将推出两场由UCB支持的研讨会：

Earlier identification and treatment of patients with a developmental and epileptic encephalopathy: taking a close look at Lennox-Gastaut syndrome - Saturday 5th April 11:45 am – 12:45 pm.

更早识别和治疗发育性和癫痫性脑病患者：仔细观察Lennox-Gastaut综合征 - 星期六4月5日上午11点45分至下午12点45分。

Rethinking seizure emergencies: expert perspectives on a new paradigm – Monday 7th April 6 pm.

重新思考癫痫急症：专家对新范式的看法 —— 4月7日星期一晚6点。

For further information, contact UCB:

如需更多信息，请联系UCB：

Global Communications

全球通讯

Anna Clark

安娜·克拉克

T: +44.73.8.668.67.79

电话：+44.73.8.668.67.79

Anna.clark@ucb.com

安娜.克拉克@ucb.com

Corporate Communications, Media Relations

企业传播、媒体关系

Laurent Schots

劳伦特·肖茨

T +32.2.559.92.64

电话：+32.2.559.92.64

Laurent.schots@ucb.com

Rare Disease Communications

罕见病交流

Daphne Teo

张黛芬

T +1 (770) 880-7655

电话：+1 (770) 880-7655

email daphne.teo@ucb.com

电子邮件 daphne.teo@ucb.com

Epilepsy and Rare Syndromes Communications

癫痫和罕见综合征通讯

Becky Malone

贝琪·马龙

T +1 (919) 605-9600

电话：+1 (919) 605-9600

email becky.malone@ucb.com

电子邮件：becky.malone@ucb.com

Investor Relations

投资者关系

Antje Witte

安特耶·维特

T +32.2.559.94.14

电话：+32.2.559.94.14

antje.witte@ucb.com

About UCB

关于UCB

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9 000 people in approximately 40 countries, the company generated revenue of € 6.15 billion in 2024.

优时比公司（UCB），位于比利时布鲁塞尔（www.ucb.com），是一家全球生物制药公司，专注于发现和开发创新药物与解决方案，以改变免疫系统或中枢神经系统严重疾病患者的生活。该公司在约40个国家拥有约9,000名员工，并于2024年创造了61.5亿欧元的收入。

UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news. .

优时比在布鲁塞尔泛欧交易所上市（股票代码：UCB）。请在Twitter上关注我们：@UCB_news。

Forward-looking statements

前瞻性声明

This press release may contain forward-looking statements including, without limitation, statements containing the words “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “continue” and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management.

本新闻稿可能包含前瞻性陈述，包括但不限于含有“相信”、“预期”、“预计”、“打算”、“计划”、“寻求”、“估计”、“可能”、“将”、“继续”等词语及类似表达的陈述。这些前瞻性陈述基于管理层当前的计划、估计和信念。

All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results.

所有声明，除历史事实声明外，均可能被视为前瞻性声明，包括收入、营业利润率、资本支出、现金、其他财务信息、预期法律、仲裁、政治、监管或临床结果或实践以及其他此类估计和结果。

By their nature, such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to differ materially from those that may be expressed or implied by such forward-looking statements contained in this press release.

此类前瞻性陈述因其性质并非未来业绩的保证，并且受到已知和未知风险、不确定性及假设的影响，这可能导致实际结果、财务状况、业绩或UCB的成就，或行业结果，与本新闻稿中包含的此类前瞻性陈述所表达或暗示的结果存在重大差异。

Important factors that could result in such differences include: the global spread and impact of COVID-19, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability .

可能导致此类差异的重要因素包括：新冠疫情的全球传播和影响、总体经济、商业和竞争环境的变化、无法获得必要的监管批准或以可接受的条件或在预期时间内获得这些批准、与研发相关的成本、UCB在研产品或开发中产品的前景变化、未来司法裁决或政府调查的影响、安全性、质量、数据完整性或生产问题；潜在或实际的数据安全和隐私泄露，或我们信息技术系统的中断、产品责任。

Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future..

鉴于这些不确定性，您不应过分依赖任何此类前瞻性声明。无法保证本新闻稿中描述的在研或已获批产品将会在任何市场提交或获批销售，或获得任何额外适应症或标签，或在任何特定时间获批，也无法保证此类产品将来会取得商业成功或继续取得商业成功。

UCB is providing this information, including forward-looking statements, only as of the date of this press release and it does not reflect any potential impact from the evolving COVID-19 pandemic, unless indicated otherwise. UCB is following the worldwide developments diligently to assess the financial significance of this pandemic to UCB.

UCB仅在本新闻稿发布之日提供此信息，包括前瞻性声明，并且除非另有说明，否则该信息并未反映不断演变的COVID-19大流行可能带来的影响。UCB正在密切关注全球发展，以评估这场大流行对UCB的财务重要性。

UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations..

UCB明确表示，不对本新闻稿中包含的任何信息承担更新义务，除非根据适用的法律法规要求，无论是为了确认实际结果，还是为了报告或反映与其前瞻性陈述相关的任何变化，或基于该等陈述的任何事件、条件或情况的变化。

Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. .

此外，本文件中包含的信息不构成出售或招揽购买任何证券的要约，也不得在任何管辖区域内进行证券的要约、招揽或销售，若在该管辖区域内，此类要约、招揽或销售在根据其证券法进行注册或资格认定之前是非法的。

Important Safety Information about RYSTIGGO

关于RYSTIGGO的重要安全信息

▼ (rozanolixizumab) in the EU*

▼ （rozanolixizumab）在欧盟*

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

▼该药品受到额外监控。这将有助于快速识别新的安全信息。医疗专业人员被要求报告任何可疑的不良反应。

The most commonly reported adverse reactions were headache (48.4%), diarrhoea (25.0%) and pyrexia (12.5%). The adverse reactions from clinical studies in gMG are as follows: Very common (≥1/10) headache, diarrhoea, and pyrexia; Common (≥1/100 to <1/10) upper respiratory tract infections, including cases of nasopharyngitis, rash, angioedema, arthralgia, and injection site reactions; Not known, aseptic meningitis (from spontaneous post-marketing reporting).

最常见的不良反应为头痛（48.4%）、腹泻（25.0%）和发热（12.5%）。gMG临床研究中的不良反应如下：非常常见（≥1/10）头痛、腹泻和发热；常见（≥1/100 至 <1/10）上呼吸道感染，包括鼻咽炎病例、皮疹、血管性水肿、关节痛和注射部位反应；未知，无菌性脑膜炎（来自上市后自发报告）。

In MG0003, headache was the most common reaction reported in 31 (48.4%) and 13 (19.4%) of the patients treated with rozanolixizumab and placebo, respectively. All headaches, except 1 (1.6%) severe headache, were either mild (28.1% [n=18]) or moderate (18.8% [n=12]) and there was no increase in incidences of headache with repeated cyclic treatment..

在MG0003中，头痛是最常见的反应，分别有31例（48.4%）和13例（19.4%）的患者在使用罗扎诺利珠单抗和安慰剂治疗时报告。所有头痛中，除1例（1.6%）严重头痛外，均为轻度（28.1% [n=18]）或中度（18.8% [n=12]），并且随着重复周期性治疗，头痛的发生率并未增加。

Rozanolixizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.

罗扎诺利珠单抗禁用于对活性成分或任何辅料过敏的患者。

Treatment with rozanolixizumab in patients with impending or manifest myasthenic crisis has not been studied. Aseptic meningitis (drug induced aseptic meningitis) has been reported following rozanolixizumab treatment. If symptoms consistent with aseptic meningitis (headache, pyrexia, neck stiffness, nausea, vomiting) occur, diagnostic workup and treatment should be initiated as per standard of care. .

在即将发生或已显现的重症肌无力危象患者中，尚未研究使用罗扎诺利珠单抗治疗的情况。已有报告称，在使用罗扎诺利珠单抗治疗后出现无菌性脑膜炎（药物引起的无菌性脑膜炎）。如果出现与无菌性脑膜炎相符的症状（头痛、发热、颈部僵硬、恶心、呕吐），应按照护理标准进行诊断和治疗。

As rozanolixizumab causes transient reduction in IgG levels the risk of infections may increase. Treatment with rozanolixizumab should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. During treatment with rozanolixizumab, clinical signs and symptoms of infections should be monitored.

由于罗扎诺利珠单抗会引起IgG水平的短暂下降，感染风险可能会增加。在患有临床重要的活动性感染的患者中，不应开始使用罗扎诺利珠单抗治疗，直至感染痊愈或得到适当治疗。在使用罗扎诺利珠单抗治疗期间，应监测感染的临床体征和症状。

If a clinically important active infection occurs, withholding rozanolixizumab until the infection has resolved should be considered. .

如果发生临床重要的活动性感染，应考虑暂停使用罗扎诺利珠单抗，直到感染得到解决。

Infusion reactions such as rash or angioedema may occur. In the clinical trial, these were mild to moderate. Patients should be monitored during treatment with rozanolixizumab and for 15 minutes after the administration is complete for clinical signs and symptoms of hypersensitivity reactions. If a hypersensitivity reaction occurs during administration, rozanolixizumab infusion should be discontinued and appropriate measures should be initiated if needed.

输注反应如皮疹或血管性水肿可能发生。在临床试验中，这些反应为轻度至中度。患者在使用罗扎诺利珠单抗治疗期间及给药完成后15分钟内应被监测是否出现超敏反应的临床体征和症状。如果在给药过程中发生超敏反应，应停止罗扎诺利珠单抗输注，并在必要时采取适当的措施。

Once resolved, administration may be resumed. .

一旦解决，可以恢复管理。

Immunisation with vaccines during rozanolixizumab therapy has not been studied. The safety of immunisation with live or live-attenuated vaccines and the response to immunisation with vaccines are unknown. All vaccines should be administered according to immunisation guidelines and at least 4 weeks before initiation of treatment.

在罗扎诺利珠单抗治疗期间接种疫苗的免疫效果尚未得到研究。接种活疫苗或减毒活疫苗的安全性以及对接种疫苗的免疫反应尚不清楚。所有疫苗应根据免疫指南进行接种，并且至少在治疗开始前4周接种。

For patients that are on treatment, vaccination with live or live-attenuated vaccines is not recommended. For all other vaccines, they should take place at least 2 weeks after the last infusion of a treatment cycle and 4 weeks before initiating the next cycle. .

对于正在接受治疗的患者，不建议接种活疫苗或减毒活疫苗。对于所有其他疫苗，应在治疗周期最后一次输注后至少 2 周进行接种，并在下一周期开始前 4 周完成。

This medicinal product contains 29 mg of proline in each ml. The use in patients suffering from hyperprolinaemia should be restricted to cases where no alternative treatment is available. This medicinal product contains 0.3 mg of polysorbate 80 in each ml. Polysorbates may cause allergic reactions. .

该药物每毫升含29毫克脯氨酸。对于患有高脯氨酸血症的患者，仅在没有替代治疗方案时才可使用。该药物每毫升含0.3毫克聚山梨醇酯80。聚山梨醇酯可能引起过敏反应。

Please consult the full prescribing information in relation to other side effects, full safety and prescribing information.

请查阅完整的处方信息以了解其他副作用、完整安全和处方信息。

https://www.ema.europa.eu/

*EU is an abbreviation for the European Union. EEA is an abbreviation for the European Economic Area.

*EU 是欧洲联盟的缩写。EEA 是欧洲经济区的缩写。

Important Safety Information about ZILBRYSQ

关于ZILBRYSQ的重要安全信息

(zilucoplan) in the EU

（zilucoplan）在欧盟

▼该药品受到额外的监控。这将有助于快速识别新的安全信息。医疗专业人员被要求报告任何可疑的不良反应。有关如何报告不良反应，请参见第4.8节。

The most frequently reported adverse reactions were injection site reactions (injection site bruising (13.9%) and injection site pain (7.0%)) and upper respiratory tract infections (nasopharyngitis (5.2%), upper respiratory tract infection (3.5%) and sinusitis (3.5%)).

最常见的不良反应是注射部位反应（注射部位瘀斑 (13.9%) 和注射部位疼痛 (7.0%)）以及上呼吸道感染（鼻咽炎 (5.2%)、上呼吸道感染 (3.5%) 和鼻窦炎 (3.5%)）。

Zilucoplan is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.

齐卢科普兰禁用于对活性物质或任何辅料过敏的患者。

The most common reactions were injection site bruising, pain, nodule, pruritus and haematoma. All cases were mild or moderate in severity, and less than 3% of reactions led to treatment

最常见的反应是注射部位瘀伤、疼痛、结节、瘙痒和血肿。所有病例的严重程度均为轻度或中度，不到3%的反应需要治疗。

discontinuation.

终止。

The most common infections were nasopharyngitis, upper respiratory tract infection and sinusitis.

最常见的感染是鼻咽炎、上呼吸道感染和鼻窦炎。

More than 95% of the cases were mild or moderate in severity and did not lead to treatment

超过95%的病例为轻度或中度严重程度，并未导致治疗。

discontinuation. In pooled placebo-controlled studies, upper respiratory tract infections were reported

停止。在汇总的安慰剂对照研究中，报告了上呼吸道感染

in 13.0% of patients treated with zilucoplan and in 7.8% of patients treated with placebo.

在13.0%的接受zilucoplan治疗的患者和7.8%的接受安慰剂治疗的患者中。

Cases of lipase increase (5.2%) and/or amylase increase (6.1%) were observed. These elevations were transient and rarely led to treatment discontinuation. The majority occurred within 2 months of starting zilucoplan and normalized within 2 months.

观察到脂肪酶升高（5.2%）和/或淀粉酶升高（6.1%）的病例。这些升高是暂时的，很少导致治疗中断。大多数发生在开始使用zilucoplan后的2个月内，并在2个月内恢复正常。

Elevations of blood eosinophils were observed. These were transient and not leading to treatment discontinuation. The majority occurred within 2 months of starting zilucoplan and normalized within 1 month.

观察到嗜酸性粒细胞升高。这些升高是暂时的，并未导致治疗中断。大多数情况发生在开始使用zilucoplan后的2个月内，并在1个月内恢复正常。

Cases of morphoea were observed after long-term treatment during the open-label extension study. The majority of the cases had a time to onset longer than one year after start of treatment, were mild or moderate in severity and did not lead to treatment discontinuation.

在开放标签延长期研究中观察到长期治疗后出现硬斑病病例。大多数病例的发病时间在治疗开始一年以上，严重程度为轻度或中度，并未导致治疗中断。

Due to its mechanism of action, the use of zilucoplan may increase the patient’s susceptibility to infections with Neisseria meningitidis. As a precautionary measure, all patients must be vaccinated against meningococcal infections, at least 2 weeks prior to the start of treatment. If treatment needs to start less than 2 weeks after vaccination against meningococcal infections, the patient must receive appropriate prophylactic antibiotic treatment until 2 weeks after the first vaccination dose.

由于其作用机制，使用zilucoplan可能会增加患者感染脑膜炎奈瑟菌的易感性。作为预防措施，所有患者必须在治疗开始前至少2周接种脑膜炎球菌疫苗。如果治疗需要在接种脑膜炎球菌疫苗后不到2周内开始，患者必须接受适当的预防性抗生素治疗，直到第一次疫苗接种后2周。

Meningococcal vaccines reduce but do not completely eliminate the risk of meningococcal infections. .

脑膜炎球菌疫苗可以降低但不能完全消除脑膜炎球菌感染的风险。

There are no data from the use of zilucoplan in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Treatment of pregnant women with Zilbrysq should only be considered if the clinical benefit outweighs the risks.

目前尚无在孕妇中使用zilucoplan的数据。动物研究未显示在生殖毒性方面存在直接或间接的有害影响。仅当临床获益大于风险时，才应考虑对孕妇使用Zilbrysq。

Important Safety Information about FINTEPLA

关于FINTEPLA的重要安全信息

▼ (fenfluramine) in the EU

▼ （芬氟拉明）在欧盟

Indications

适应症

: Treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.

：作为其他抗癫痫药物的辅助疗法，用于治疗2岁及以上患者的Dravet综合征和Lennox-Gastaut综合征相关的癫痫发作。

Dosage and Administration

剂量与用法

: Please refer to SmPC for full information. Should be initiated and supervised by physicians with experience in the treatment of epilepsy. Fintepla is prescribed and dispensed according to the Fintepla controlled access programme. Dravet syndrome: Patients who are

：有关完整信息，请参阅SmPC。应由有癫痫治疗经验的医生启动和监督。Fintepla根据Fintepla受控获取计划进行处方和分发。Dravet综合征：患者

not

不是

taking stiripentol: Starting dose is 0.1 mg/kg twice daily (0.2 mg/kg/day). After 7 days, if tolerated, can increase dose to 0.2 mg/kg twice daily (0.4 mg/kg/day). After an additional 7 days, if tolerated and further seizure reduction required, can increase dose to a maximum of 0.35 mg/kg twice daily (0.7 mg/kg/day), which is the recommended maintenance dose.

服用斯特里潘托尔：起始剂量为每日两次0.1毫克/千克（每日0.2毫克/千克）。7天后，如果耐受良好，可将剂量增加至每日两次0.2毫克/千克（每日0.4毫克/千克）。再过7天后，如果耐受良好且需要进一步减少癫痫发作，可将剂量增加至每日两次0.35毫克/千克（每日0.7毫克/千克），这是推荐的维持剂量。

Patients requiring more rapid titration may increase the dose every 4 days. Do not exceed maximum daily dose of 26 mg (13 mg twice daily). Patients who are taking stiripentol: Starting dose is 0.1 mg/kg twice daily (0.2 mg/kg/day). After 7 days, if tolerated, can increase dose to 0.2 mg/kg twice daily (0.4 mg/kg/day), which is the recommended maintenance dose.

需要更快速滴定的患者可以每4天增加一次剂量。每日最大剂量不得超过26毫克（13毫克，每日两次）。正在服用stiripentol的患者：起始剂量为每日两次0.1毫克/千克（每日0.2毫克/千克）。7天后，如果耐受良好，可将剂量增加至每日两次0.2毫克/千克（每日0.4毫克/千克），这是推荐的维持剂量。

Patients requiring more rapid titration may increase the dose every 4 days. Do not exceed a total dose of 17 mg (8.6 mg twice daily). Lennox-Gastaut syndrome: Starting dose is 0.1 mg/kg twice daily (0.2 mg/kg/day). After 7 days, the dose should be increased to 0.2 mg/kg twice daily (0.4 mg/kg/day), if tolerated.

需要更快速滴定的患者可每4天增加一次剂量。总剂量不应超过17毫克（8.6毫克，每日两次）。Lennox-Gastaut综合征：起始剂量为每日两次0.1毫克/千克（每天0.2毫克/千克）。如果耐受良好，7天后剂量应增加至每日两次0.2毫克/千克（每天0.4毫克/千克）。

After an additional 7 days, if tolerated, dose should be increased to 0.35 mg/kg twice daily (0.7 mg/kg/day), which is the recommended maintenance dose. Do not exceed maximum daily dose of 26 mg (13 mg twice daily). Discontinuation: When discontinuing treatment, decrease the dose gradually. As with all anti-epileptic medicines, avoid abrupt discontinuation when possible to minimize the risk of increased seizure frequency and status epilepticus.

在额外7天后，如果耐受良好，剂量应增加至每日两次0.35 mg/kg（每日总量0.7 mg/kg），这是推荐的维持剂量。每日最大剂量不应超过26 mg（每次13 mg，每日两次）。停药：停药时应逐渐减少剂量。与所有抗癫痫药物一样，尽可能避免突然停药，以减少癫痫发作频率增加和癫痫持续状态的风险。

A final echocardiogram should be conducted 3-6 months after the last dose of treatment with fenfluramine. Renal impairment: Generally, no dose adjustment is recommended when administered to patients with mild to severe renal impairment, however, a slower titration may be considered. If adverse reactions are rep.

应在芬氟拉明最后一剂治疗后3-6个月进行最终的超声心动图检查。肾功能损害：一般来说，对于轻度至重度肾功能受损的患者，无需调整剂量，但可以考虑较慢的滴定速度。如果出现不良反应，请报告。

Contraindications

禁忌症

: Hypersensitivity to active substance or any excipients. Aortic or mitral valvular heart disease and pulmonary arterial hypertension. Within 14 days of the administration of monoamine oxidase inhibitors due to an increased risk of serotonin syndrome.

对活性物质或任何辅料过敏者禁用。主动脉或二尖瓣心脏疾病及肺动脉高压患者禁用。在使用单胺氧化酶抑制剂后14天内因增加血清素综合症的风险而禁用。

Warnings and Precautions

警告和注意事项

: Aortic or mitral valvular heart disease and pulmonary arterial hypertension: Prior to starting treatment, patients must undergo an echocardiogram to establish a baseline and exclude any pre-existing valvular heart disease or pulmonary hypertension. Conduct echocardiogram monitoring every 6 months for the first 2 years and annually thereafter.

主动脉或二尖瓣瓣膜性心脏病和肺动脉高压：在开始治疗之前，患者必须接受超声心动图检查，以建立基线并排除任何先前存在的瓣膜性心脏病或肺动脉高压。在前两年每6个月进行一次超声心动图监测，此后每年一次。

If an echocardiogram indicates pathological valvular changes, consider follow-up earlier to evaluate whether the abnormality is persistent. If pathological abnormalities seen on echocardiogram, evaluate the benefit versus risk of continuing fenfluramine treatment with the prescriber, caregiver and cardiologist.

如果超声心动图显示病理性瓣膜变化，应考虑提前进行随访，以评估异常是否持续存在。如果超声心动图显示病理性异常，应与处方医生、护理人员和心脏病专家评估继续使用芬氟拉明治疗的益处与风险。

Once treatment is discontinued for any reasons, a final echocardiogram should be conducted 3-6 months after the last dose of treatment with fenfluramine. If echocardiogram findings suggestive of pulmonary arterial hypertension, perform a repeat echocardiogram as soon as possible and within 3 months to confirm these findings.

一旦因任何原因停止治疗，应在最后一次服用芬氟拉明后3-6个月进行最终的超声心动图检查。如果超声心动图结果显示有肺动脉高压的迹象，应尽快并在3个月内重复进行超声心动图以确认这些结果。

If echocardiogram finding is confirmed suggestive of an increased probability of pulmonary arterial hypertension defined as intermediate probability, conduct a benefit-risk evaluation of continuation of Fintepla by the prescriber, carer and cardiologist. If echocardiogram suggests a high probability, it is recommended fenfluramine treatment should be stopped.

如果超声心动图检查结果确认提示肺动脉高压的中等概率，处方医生、护理人员和心脏病专家应进行芬特拉（Fintepla）继续治疗的获益-风险评估。如果超声心动图提示高概率，建议停止芬氟拉明（fenfluramine）治疗。

Decreased appetite and weight loss: Fenfluramine can cause decreased appetite and weight loss - an additive effect can occur in combination with other anti-epileptic medicines such as stiripentol. Monitor the patient’s weight. Undertake risk-benefit evaluation before starting treatment if history of anorexia nervosa or bulimia nervosa.

食欲减退和体重减轻：芬氟拉明可导致食欲减退和体重减轻——与其它抗癫痫药物（如司替戊醇）合用时可能会产生叠加效应。监测患者的体重。如果患者有神经性厌食症或神经性贪食症病史，在开始治疗前进行风险效益评估。

Fintepla controlled access programme: A controlled access programme has been created to 1) prevent off-label use .

Fintepla管控访问计划：已创建管控访问计划以1）防止标签外使用。

Adverse effects

不良反应

: Dravet syndrome: Very common (≥1/10): Upper respiratory tract infection, decreased appetite, somnolence, diarrhoea, pyrexia, fatigue, blood glucose decreased, echocardiogram abnormal (Consisted of trace and mild mitral regurgitation, and trace aortic regurgitation, which are considered physiologic).

Dravet综合征：很常见（≥1/10）：上呼吸道感染、食欲减退、嗜睡、腹泻、发热、疲劳、血糖降低、超声心动图异常（包括微量和轻度二尖瓣反流以及微量主动脉反流，这些均被视为生理现象）。

Common (≥1/100 to <1/10): Bronchitis, abnormal behaviour, aggression, agitation, insomnia, mood swings, ataxia, hypotonia, lethargy, seizure, status epilepticus, tremor, constipation, salivary hypersecretion, weight decreased and blood prolactin increased. Lennox-Gastaut syndrome: Very common (≥1/10): Upper respiratory tract infection, decreased appetite, somnolence, diarrhoea, vomiting, fatigue.

常见（≥1/100 至 <1/10）：支气管炎、异常行为、攻击性、躁动、失眠、情绪波动、共济失调、肌张力减退、嗜睡、癫痫发作、癫痫持续状态、震颤、便秘、唾液分泌过多、体重减轻和催乳素升高。Lennox-Gastaut 综合征：很常见（≥1/10）：上呼吸道感染、食欲下降、嗜睡、腹泻、呕吐、疲劳。

Common (≥1/100 to <1/10): Bronchitis, influenza, pneumonia, seizure, status epilepticus, lethargy, tremor, constipation, salivary hypersecretion, blood prolactin increased, weight decreased, fall. Refer to SmPC for other adverse reactions. .

常见（≥1/100 至 <1/10）：支气管炎、流感、肺炎、癫痫发作、癫痫持续状态、嗜睡、震颤、便秘、唾液分泌过多、血泌乳素升高、体重减轻、跌倒。其他不良反应请参阅 SmPC。

▼

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

本药品受到额外的监控。这将有助于快速识别新的安全信息。医疗专业人员被要求报告任何可疑的不良反应。

Refer to the European Summary of Product Characteristics for other adverse reactions and full Prescribing Information.

请参阅欧洲产品特性总结以获取其他不良反应和完整的处方信息。

https://www.ema.europa.eu/en/documents/product-information/fintepla-epar-product-information_en.pdf

(accessed October 2024)

（访问于2024年10月）

Important Safety Information about BRIVIACT

关于BRIVIACT的重要安全信息

(brivaracetam) in the EU

（布立西坦）在欧盟

Therapeutic indications

治疗指示

: BRIVIACT is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy.

BRIVIACT 作为辅助治疗，用于治疗 2 岁及以上患有癫痫的成人、青少年和儿童的部分性发作（伴或不伴继发性全身性发作）。

Posology and method of administration

用法和用量

: The physician should prescribe the most appropriate formulation and strength according to weight and dose. It is recommended to parent and care giver to administer BRIVIACT oral solution with the measuring device (10 ml or 5 ml oral dosing syringe) provided in the carton box. BRIVIACT solution for injection/infusion is an alternative route of administration for patients when oral administration is temporarily not feasible.

医生应根据体重和剂量开具最合适的剂型和强度。建议父母和护理人员使用盒装内提供的测量装置（10毫升或5毫升口服注射器）给予BRIVIACT口服溶液。当暂时无法口服时，BRIVIACT注射/输注溶液是患者的另一种给药途径。

There is no experience with twice daily intravenous administration of.

没有每日两次静脉注射的经验。

brivaracetam for a period longer than 4 days. Adults: The recommended starting dose is 50 or 100 mg/day based on physician’s assessment of required for seizure reduction versus potential side effects. Brivaracetam can be taken with or without food. Based on individual patient response and tolerability, the dose may be adjusted in the effective dose range of 50 mg/day to 200 mg/day.

服用布瓦西坦超过4天。成人：根据医生对减少癫痫发作的需求与潜在副作用的评估，推荐起始剂量为每天50或100毫克。布瓦西坦可以随餐或空腹服用。基于个体患者的反应和耐受性，剂量可以在有效剂量范围每天50毫克至200毫克之间进行调整。

Children and adolescents weighing 50 kg or more: The recommended starting dose is 50 mg/day. Brivaracetam may also be initiated at 100 mg/day based on physician’s assessment of need for seizure control. The recommended maintenance dose is 100 mg/day. Based on individual patient response, the dose may be adjusted in the effective dose range of 50 mg/day to 200 mg/day.

体重在50公斤或以上的儿童和青少年：推荐的起始剂量为每天50毫克。根据医生对癫痫控制需求的评估，布立西坦也可以从每天100毫克开始使用。推荐的维持剂量为每天100毫克。根据个别患者的反应，剂量可以在每天50毫克至200毫克的有效剂量范围内进行调整。

Children and adolescents weighing from 20 kg to less than 50 kg: The recommended starting dose is 1 mg/kg/day. Brivaracetam may also be initiated at doses up to 2 mg/kg/day based on physician’s assessment of need for seizure control. The recommended maintenance dose is 2 mg/kg/day. Based on individual patient response, the dose may be adjusted in the effective dose range of 1 mg/kg/day to 4 mg/kg/day.

体重在20公斤至不足50公斤的儿童和青少年：推荐的起始剂量为每天1毫克/公斤。根据医生对癫痫控制需求的评估，布立西坦也可从高达每天2毫克/公斤的剂量开始使用。推荐的维持剂量为每天2毫克/公斤。根据个别患者的反应，剂量可在每天1毫克/公斤至4毫克/公斤的有效剂量范围内进行调整。

Children weighing from 10 kg to less than 20 kg: The recommended starting dose is 1 mg/kg/day. Brivaracetam may also be initiated at doses up to 2.5 mg/kg/day based on physician’s assessment of need for seizure control. The recommended maintenance dose is 2.5 mg/kg/day. Based on individual patient response, the dose may be adjusted in the effective dose range of 1 mg/kg/day to 5 mg/kg/day.

体重在10公斤至20公斤以下的儿童：推荐的起始剂量为每天1毫克/公斤。根据医生对癫痫控制需求的评估，布立西坦也可以从高达每天2.5毫克/公斤的剂量开始使用。推荐的维持剂量为每天2.5毫克/公斤。根据个别患者的反应，剂量可以在每天1毫克/公斤到5毫克/公斤的有效剂量范围内进行调整。

For adults, adolescents and children from 2 years of age, the dose should be administered in two equally divided doses,.

对于2岁及以上的成人、青少年和儿童，剂量应分为两等份给予。

approximately 12 hours apart.

大约相隔12小时。

If patients miss one dose or more, it is recommended that they take a single dose as soon as they remember and take the following dose at the usual morning or evening time. Brivaracetam oral solution can be diluted in water or juice shortly before swallowing; a nasogastric tube or a gastrostomy tube may also be used.

如果患者漏服一次或多次剂量，建议他们一旦想起就立即服用单次剂量，并在通常的早晨或晚上时间服用下一剂。布立西坦口服液可以在吞咽前短时间用水或果汁稀释；也可以使用鼻胃管或胃造口管。

Brivaracetam may be initiated with either intravenous or oral administration. When converting from oral to intravenous administration or vice versa, the total daily dose and frequency of administration should be maintained. Brivaracetam may be administered as an intravenous bolus without dilution or diluted in a compatible diluent and administered as a 15-minute intravenous infusion.

布瓦西坦可通过静脉或口服给药启动。当从口服转换为静脉给药或反之亦然时，应维持每日总剂量和给药频率。布瓦西坦可以不经稀释直接作为静脉推注给药，或稀释于相容的稀释剂中，并作为15分钟的静脉输注给药。

This medicinal product must not be mixed with other medicinal products. Brivaracetam bolus injection or intravenous infusion has not been studied in acute conditions, e.g. status epilepticus, and is therefore not recommended for such conditions. For patients from 16 years of age, if brivaracetam has to be discontinued, it is recommended that the dose is reduced gradually by 50 mg/day on a weekly basis.

本药品不得与其他药品混合使用。布立西坦推注注射或静脉输注尚未在急性情况下（例如癫痫持续状态）进行研究，因此不建议用于此类情况。对于16岁及以上的患者，如果必须停用布立西坦，建议每周将剂量逐步减少50毫克/天。

For patients below the age of 16 years, if brivaracetam has to be discontinued, it is recommended that the dose is reduced by a maximum of half the dose every week until a dose of 1 mg/kg/day (for patients with a body weight less than 50 kg) or 50 mg/day (for patients with body weight of 50 kg or more) is reached.

对于16岁以下的患者，如果必须停用布立西坦，建议每周剂量最多减少一半，直到达到每日每公斤体重1毫克（适用于体重小于50公斤的患者）或每日50毫克（适用于体重50公斤或以上的患者）。

After 1 week of treatment at 50 mg/day, a final week of treatment at 20 mg/day is recommended. No dose adjustment is needed for elderly patients (≥65 years of age) or for those with renal impairment. Based on data in adults, no dose adjustment is necessary in paediatric patients with impaired renal function.

在以每日50毫克的剂量治疗1周后，建议再以每日20毫克的剂量进行最后一周的治疗。老年患者（≥65岁）或肾功能受损者无需调整剂量。根据成人数据，肾功能受损的儿科患者也无需调整剂量。

No clinical data are available on paediatric patients with ren.

没有关于肾病儿童患者的临床数据可用。

Contraindications

禁忌症

: Hypersensitivity to the active substance, other pyrrolidone derivatives or any of the excipients.

对活性物质、其他吡咯烷酮衍生物或任何辅料过敏。

Special warnings and precautions for use

使用时的特别警告和注意事项

: Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic drugs (AEDs) in several indications, including brivaracetam. Patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers) should be advised to seek medical advice should any signs of suicidal ideation or behaviour emerge.

在接受包括布立西坦在内的抗癫痫药物（AEDs）治疗的患者中，已报告出现自杀意念和行为的情况。应监测患者是否出现自杀意念和行为的迹象，并考虑适当的治疗措施。应告知患者（及护理人员），若出现任何自杀意念或行为的迹象，需寻求医疗建议。

Clinical data on the use of brivaracetam in patients with pre-existing hepatic impairment are limited. Dose adjustments are recommended for patients with hepatic impairment. Brivaracetam film-coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take brivaracetam..

在已有肝功能损害患者中使用布立西坦的临床数据有限。建议对肝功能损害患者进行剂量调整。布立西坦薄膜衣片含有乳糖。患有罕见的半乳糖不耐受、完全性乳糖酶缺乏或葡萄糖-半乳糖吸收不良的患者不应服用布立西坦。

Brivaracetam film-coated tablets, solution for injection/infusion and oral solution contain less than 1 mmol sodium (23mg) per tablet/vial/ml respectively, that is to say essentially ‘sodium free’. Brivaracetam oral solution contains 168 mg sorbitol (E420) in each ml. Patients with hereditary fructose intolerance (HFI) should not take this medicinal product.

布立西坦薄膜衣片、注射/输注用溶液和口服溶液每片/瓶/毫升分别含有少于1毫摩尔钠（23毫克），即基本上“无钠”。布立西坦口服溶液每毫升含168毫克山梨醇（E420）。患有遗传性果糖不耐症（HFI）的患者不应服用此药物。

The oral solution contains methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed). Brivaracetam oral solution contains propylene glycol (E1520). .

口服溶液含有对羟基苯甲酸甲酯 (E218)，可能会引起过敏反应（可能延迟）。布立西坦口服溶液含有丙二醇 (E1520)。

Interaction with other medicinal products and other forms of interaction

与其他药物的相互作用及其他形式的相互作用

: In clinical studies, although patient numbers were limited, brivaracetam had no observed benefit over placebo among patients taking concomitant levetiracetam. No additional safety or tolerability concern was observed. In an interaction study between brivaracetam 200 mg single dose and ethanol 0.6 g/L continuous infusion in healthy volunteers, there was no pharmacokinetic interaction, but the effect of alcohol on psychomotor function, attention and memory was approximately doubled with the intake of brivaracetam.

在临床研究中，虽然患者数量有限，但在同时服用左乙拉西坦的患者中，布里伐西坦与安慰剂相比未观察到益处。未发现额外的安全性或耐受性问题。在一项健康志愿者中进行的200毫克单剂量布里伐西坦与持续输注0.6克/升乙醇的相互作用研究中，未发现药代动力学相互作用，但酒精对精神运动功能、注意力和记忆的影响在服用布里伐西坦后大约增加了一倍。

Intake of brivaracetam with alcohol is not recommended. In vitro data suggest that brivaracetam has a low interaction potential. The main disposition pathway of brivaracetam® is by CYP-independent hydrolysis; a second pathway involves hydroxylation mediated by CYP2C19. Brivaracetam plasma concentrations may increase when co-administered with CYP2C19 strong inhibitors (e.g.

不建议将布立西坦与酒精一起服用。体外数据显示布立西坦的相互作用潜力较低。布立西坦的主要代谢途径是通过非CYP依赖性的水解；另一条途径涉及由CYP2C19介导的羟基化。当与CYP2C19强抑制剂（例如

fluconazole, fluvoxamine), but the risk of a clinically relevant CYP2C19 mediated interaction is considered to be low. Limited clinical data are available implying that coadministration of cannabidiol may increase the plasma exposure of brivaracetam, possibly through CYP2C19 inhibition, but the clinical relevance is uncertain.

氟康唑、氟伏沙明），但临床上相关CYP2C19介导的相互作用风险被认为较低。有限的临床数据表明，合用大麻二酚可能会增加布瓦西坦的血浆暴露量，可能通过CYP2C19抑制作用，但临床相关性尚不确定。

In healthy subjects, co-administration with the strong enzyme inducer rifampicin (600 mg/day for 5 days), decreased brivaracetam area under the plasma concentration curve (AUC) by 45%. Prescribers should consider adjusting the dose of brivaracetam in patients starting or ending treatment with rifampicin.

在健康受试者中，与强效酶诱导剂利福平（每天600毫克，持续5天）共同给药时，布立西坦的血浆浓度曲线下面积（AUC）降低了45%。开处方者应考虑调整正在开始或结束利福平治疗的患者的布立西坦剂量。

Brivaracetam plasma concentrations are decreased when co-administered with strong enzyme-inducing AEDs (carbamazepine, phenobarbital, phenytoin) but no dose adjustment is required. Other strong enzyme inducers such as St John’s wort (Hypericum perforatum) may decrease .

与强酶诱导抗癫痫药物（卡马西平、苯巴比妥、苯妥英）联合使用时，布立西坦的血浆浓度会降低，但无需调整剂量。其他强酶诱导剂如贯叶连翘（Hypericum perforatum）也可能降低其浓度。

clinically relevant CYP3A4 interactions is considered low. In vitro studies have shown that brivaracetam exhibits little or no inhibition of CYP450 isoforms except for CYP2C19 and may therefore increase plasma concentrations of medicinal products metabolised by CYP2C19 (e.g. lansoprazole, omeprazole, diazepam).

临床上相关的CYP3A4相互作用被认为较低。体外研究表明，布立西坦对CYP450亚型几乎没有或只有很少的抑制作用，但CYP2C19除外，因此可能会增加由CYP2C19代谢的药物（如兰索拉唑、奥美拉唑、地西泮）的血浆浓度。

Brivaracetam did not induce CYP1A1/2 but induced CYP3A4 and CYP2B6 in vitro. No CYP3A4 induction was found in vivo. CYP2B6 induction has not been investigated in vivo and brivaracetam may decrease plasma concentrations of medicinal products metabolised by CYP2B6 (e.g. efavirenz). In vitro interaction studies to determine the potential inhibitory effects on transporters concluded that there were no clinically relevant effects, except for OAT3.

布立西坦未诱导CYP1A1/2，但在体外诱导了CYP3A4和CYP2B6。在体内未发现CYP3A4的诱导作用。CYP2B6的诱导作用尚未在体内进行研究，布立西坦可能会降低经CYP2B6代谢的药物（如依法韦仑）的血浆浓度。用于确定对转运蛋白潜在抑制作用的体外相互作用研究表明，除了OAT3之外，没有临床上显著的影响。

In vitro, brivaracetam inhibits OAT3 with a half maximal inhibitory concentration 42-fold higher than the Cmax at the highest clinical dose. Brivaracetam 200 mg/day may increase plasma concentrations of medicinal products transported by OAT3. Brivaracetam is a moderate reversible inhibitor of epoxide hydrolase, resulting in an increased concentration of carbamazepine epoxide, an active metabolite of carbamazepine.

在体外，布立西坦抑制OAT3的半数最大抑制浓度比最高临床剂量下的Cmax高42倍。布立西坦200毫克/天可能会增加由OAT3转运的药物的血浆浓度。布立西坦是环氧化物水解酶的中度可逆抑制剂，导致卡马西平环氧化物（卡马西平的活性代谢物）浓度升高。

In controlled clinical studies, carbamazepine epoxide plasma concentration increased by a mean of 37%, 62% and 98% with little variability at Brivaracetam doses of 50 mg/day, 100 mg/day and 200 mg/day, respectively. No safety risks were observed. There was no additive effect of brivaracetam and valproate on the AUC of carbamazepine epoxide.

在对照临床研究中，卡马西平环氧物的血浆浓度在每天50毫克、100毫克和200毫克的布立西坦剂量下分别平均增加了37%、62%和98%，且变异较小。未观察到安全性风险。布立西坦和丙戊酸对卡马西平环氧物的AUC没有显示出叠加效应。

No dose adjustment is needed when brivaracetam is co-administered with carbamazepine, phenobarbital or phenytoin. Brivaracetam had no clinically relevant effect on the plasma concentrations of clobazam, clonazepam, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, phenobarb.

当布立西坦与卡马西平、苯巴比妥或苯妥英联合使用时，无需调整剂量。布立西坦对氯巴占、氯硝西泮、拉科酰胺、拉莫三嗪、左乙拉西坦、奥卡西平、苯巴比妥的血浆浓度没有临床相关影响。

plasma concentrations. Co-administration of brivaracetam (100 mg/day) with an oral contraceptive containing ethinylestradiol (0.03 mg) and levonorgestrel (0.15 mg) did not influence the pharmacokinetics of either substance. However, when brivaracetam was coadministered at a dose of 400 mg/day (twice the recommended maximum daily dose), a reduction in estrogen and progestin AUCs of 27% and 23%, respectively, was observed without impact on suppression of ovulation.

血浆浓度。布立西坦（100 毫克/天）与含炔雌醇（0.03 毫克）和左炔诺孕酮（0.15 毫克）的口服避孕药联合使用时，不影响任何一种物质的药代动力学。然而，当布立西坦以 400 毫克/天（推荐最大日剂量的两倍）联合给药时，观察到雌激素和孕激素的 AUC 分别减少了 27% 和 23%，但对排卵抑制无影响。

Pregnancy: Data on the use of brivaracetam in pregnant women are limited. There are no data on placental transfer in humans, but brivaracetam was shown to readily cross the placenta in rats. The potential risk for humans is unknown. Animal studies did not detect any teratogenic potential of brivaracetam.

妊娠：关于布立西坦在孕妇中使用的数据有限。尚无关于其在人体中胎盘转移的数据，但已显示布立西坦在大鼠中易于通过胎盘。其对人类的潜在风险未知。动物研究未发现布立西坦有任何致畸潜力。

In clinical studies, adjunctive brivaracetam used concomitantly with carbamazepine induced a dose-related increase in the concentration of.

在临床研究中，作为辅助治疗的布立西坦与卡马西平同时使用时，会引发剂量相关的浓度升高。

the active metabolite, carbamazepine-epoxide. There are insufficient data to determine the clinical significance of this effect in pregnancy. Brivaracetam should not be used during pregnancy unless clinically necessary.

活性代谢物卡马西平环氧物。尚无足够的数据来确定这种影响在妊娠期的临床意义。除非临床上必要，否则不应在妊娠期使用布瓦西坦。

Breast-feeding

母乳喂养

: Brivaracetam is excreted in human breast milk. The decision to discontinue either breastfeeding or brivaracetam should be made based on the benefit of the medicinal product to the mother. In case of co-administration of brivaracetam and carbamazepine, the amount of carbamazepine-epoxide excreted in breast milk could increase.

布立西坦会排泄到人乳中。是否停止哺乳或停止使用布立西坦应根据该药物对母亲的益处来决定。如果同时使用布立西坦和卡马西平，可能会增加卡马西平-环氧化物在乳汁中的排泄量。

The clinical significance remains unknown. .

临床意义尚不清楚。

Fertility

生育能力

: No human data on the effect of brivaracetam on fertility are available. There was no effect on fertility in rats.

：关于布立西坦对生育能力影响的人体数据尚无。在大鼠中未发现对生育能力的影响。

Effects on ability to drive and use machines

对驾驶和使用机器能力的影响

: Brivaracetam has minor or moderate influence on the ability to drive and use machines. Patients should be advised not to drive a car or to operate other potentially hazardous machines until they are familiar with the effects of brivaracetam on their ability to perform such activities.

布立西坦对驾驶和使用机器的能力有轻微或中度的影响。应告知患者，在熟悉布立西坦对其从事此类活动能力的影响之前，不要驾驶汽车或操作其他潜在危险的机器。

Undesirable effects

不良反应

: The most frequently reported adverse reactions with brivaracetam were somnolence (14.3%) and dizziness (11.0%); they were usually mild-to-moderate in intensity. Somnolence and fatigue were reported at a higher incidence with increasing dose. Very common adverse reactions (≥1%-<10%) were influenza, decreased appetite, depression, anxiety, insomnia, irritability, convulsion, vertigo, upper respiratory tract infections, cough, nausea, vomiting, constipation and fatigue.

最常见的不良反应为嗜睡（14.3%）和头晕（11.0%），通常强度为轻至中度。随着剂量增加，嗜睡和疲劳的报告频率更高。非常常见的不良反应（≥1%-<10%）包括流感、食欲下降、抑郁、焦虑、失眠、易怒、癫痫发作、眩晕、上呼吸道感染、咳嗽、恶心、呕吐、便秘和疲劳。

Neutropenia was reported in 6/1099 (0.5%) of brivaracetam and none (0/459) of the placebo-treated patients. Four of these subjects had decreased neutrophil counts at baseline. None of the neutropenia cases were severe, required any specific treatment or led to discontinuation of brivaracetam and none had associated infections.

在1099名服用布立西坦的患者中有6名（0.5%）报告了中性粒细胞减少，而在459名服用安慰剂的患者中则没有（0/459）。其中四名患者在基线时中性粒细胞计数已减少。所有中性粒细胞减少的病例均不严重，无需特殊治疗，也未导致布立西坦停药，并且没有任何相关感染。

Suicidal ideation was reported in 0.3% (3/1099) of brivaracetam and 0.7% (3/459) of placebo-treated patients. In short-term clinical studies of brivaracetam in patients with epilepsy, there were no cases of completed suicide and suicide.

在接受布立西坦治疗的患者中，有0.3%（3/1099）报告了自杀意念，而接受安慰剂治疗的患者中有0.7%（3/459）。在布立西坦针对癫痫患者的短期临床研究中，没有发生完成自杀或自杀的案例。

attempt; however, both were reported in open-label extension studies. The safety profile of brivaracetam observed in children from 1 month of age was consistent with the safety profile observed in adults. In the open label, uncontrolled, long-term studies suicidal ideation was reported in 4.7 % of paediatric patients (assessed from 6 years onwards, more common in adolescents) compared with 2.4 % of adults and behavioural disorders were reported in 24.8 % of paediatric patients compared with 15.1 % of adults.

尝试；然而，这两项研究都在开放标签扩展研究中被报道。布立西坦在从1个月大的儿童中的安全性与在成人中观察到的安全性一致。在开放标签、非对照的长期研究中，6岁及以上儿童患者中有4.7％报告了自杀意念（在青少年中更为常见），而成人中这一比例为2.4％；24.8％的儿童患者报告了行为障碍，而成人中这一比例为15.1％。

The majority of events were mild or moderate in intensity, were non-serious, and did not lead to discontinuation of study drug. An additional adverse reaction reported in children was psychomotor hyperactivity (4.7 %). No specific pattern of adverse event (AE) was identified in children from 1 month to < 4 years of age when compared to older paediatric age groups.

大多数事件的强度为轻度或中度，不严重，且未导致研究药物的停用。儿童中报告的另一不良反应为精神运动过度活跃（4.7%）。在对比年长儿科年龄组时，未发现1个月至不到4岁的儿童中有特定的不良事件（AE）模式。

No significant safety information was identified indicating the.

未发现表明该问题的重要安全信息。

increasing incidence of a particular AE in this age group. As data available in children younger than 2 years of age are limited, brivaracetam is not indicated in this age range. Limited clinical data are available in neonates. Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of brivaracetam patients (9/3022) during clinical development.

在这一年龄段，某种特定不良事件（AE）的发生率正在增加。由于2岁以下儿童的数据有限，不建议在此年龄段使用布立西坦。新生儿中的临床数据也很有限。在临床开发期间，有少数布立西坦患者（9/3022）报告了提示即时（I型）超敏反应的症状。

Overdose: There is limited clinical experience with brivaracetam overdose in humans. Somnolence and dizziness have been reported in a healthy.

过量服用：关于人类过量服用布立西坦的临床经验有限。有报道称健康人出现嗜睡和头晕。

subject taking a single dose of 1,400 mg of brivaracetam. The following adverse reactions were reported with brivaracetam overdose: nausea, vertigo, balance disorder, anxiety, fatigue, irritability, aggression, insomnia, depression, and suicidal ideation in the postmarketing experience. In general, the adverse reactions associated with brivaracetam overdose were consistent with the known adverse reactions.

受试者单次服用1400毫克布立西坦。在过量服用布立西坦的情况下，报告了以下不良反应：恶心、眩晕、平衡障碍、焦虑、疲劳、易怒、攻击性、失眠、抑郁以及在上市后经验中出现的自杀意念。总体而言，与布立西坦过量相关的不良反应与其已知的不良反应一致。

There is no specific antidote for overdose with brivaracetam. Treatment of an overdose should include general supportive measures. Since <10% of brivaracetam is excreted in urine, haemodialysis is not expected to significantly enhance brivaracetam clearance..

对于布立西坦过量服用，没有特定的解毒剂。过量治疗应包括一般的支持性措施。由于布立西坦在尿液中的排泄量不到10%，因此血液透析预计不会显著提高布立西坦的清除率。

Refer to the European Summary of Product Characteristics for other adverse reactions and full Prescribing Information.

请参阅欧洲产品特性总结中的其他不良反应和完整处方信息。

https://www.ema.europa.eu/en/documents/product-information/briviact-epar-product-information_en.pdf

(Accessed October 2024)

（访问于2024年10月）

BRIVIACT

布里瓦克特

and FINTEPLA

和 FINTEPLA

are registered trademarks of the UCB Group of Companies. Staccato

是UCB集团公司注册商标。Staccato

is a registered trademark of Alexza Pharmaceuticals, Inc., and is used by UCB Pharma under license.

是Alexza Pharmaceuticals, Inc.的注册商标，UCB Pharma在授权下使用。

Important Safety Information about RYSTIGGO® (rozanolixizumab-noli) in the US

美国关于RYSTIGGO®（rozanolixizumab-noli）的重要安全信息

RYSTIGGO (rozanolixizumab-noli) is a neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

RYSTIGGO（罗扎诺利珠单抗）是一种新生儿Fc受体阻滞剂，适用于治疗抗乙酰胆碱受体（AChR）或抗肌肉特异性酪氨酸激酶（MuSK）抗体阳性的成人全身性重症肌无力（gMG）患者。

IMPORTANT SAFETY INFORMATION

重要安全信息

WARNINGS AND PRECAUTIONS

警告和注意事项

Infections: RYSTIGGO may increase the risk of infection. Delay RYSTIGGO administration in patients with an active infection until the infection is resolved. During treatment with RYSTIGGO, monitor for clinical signs and symptoms of infection. If serious infection occurs, administer appropriate treatment and consider withholding RYSTIGGO until the infection has resolved..

感染：RYSTIGGO可能增加感染风险。对于有活动性感染的患者，应延迟使用RYSTIGGO，直至感染得到解决。在RYSTIGGO治疗期间，需监测感染的临床症状和体征。如果发生严重感染，应给予适当的治疗，并考虑暂停使用RYSTIGGO，直至感染消除。

Immunization

免疫接种

Immunization with vaccines during RYSTIGGO treatment has not been studied. The safety of immunization with live or live-attenuated vaccines and the response to immunization with any vaccine are unknown. Because RYSTIGGO causes a reduction in IgG levels, vaccination with live-attenuated or live vaccines is not recommended during treatment with RYSTIGGO.

在RYSTIGGO治疗期间接种疫苗的免疫效果尚未得到研究。接种活疫苗或减毒活疫苗的安全性以及对任何疫苗接种的反应尚不清楚。由于RYSTIGGO会导致IgG水平降低，因此在RYSTIGGO治疗期间不建议接种减毒活疫苗或活疫苗。

Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with RYSTIGGO..

根据免疫指南，在开始使用RYSTIGGO进行新的治疗周期之前，评估接种适龄疫苗的必要性。

Aseptic Meningitis

无菌性脑膜炎

: Serious adverse reactions of aseptic meningitis (also called drug-induced aseptic meningitis) have been reported in patients treated with RYSTIGGO. If symptoms consistent with aseptic meningitis develop, diagnostic workup and treatment should be initiated according to the standard of care.

：在接受RYSTIGGO治疗的患者中，已报告严重不良反应无菌性脑膜炎（也称为药物诱发的无菌性脑膜炎）。如果出现与无菌性脑膜炎一致的症状，应根据医疗标准进行诊断和治疗。

Hypersensitivity Reactions

超敏反应

: Hypersensitivity reactions, including angioedema and rash, were observed in patients treated with RYSTIGGO. Management of hypersensitivity reactions depends on the type and severity of the reaction. Monitor patients during treatment with RYSTIGGO and for 15 minutes after for clinical signs and symptoms of hypersensitivity reactions.

在使用RYSTIGGO治疗的患者中观察到包括血管性水肿和皮疹在内的超敏反应。对超敏反应的管理取决于反应的类型和严重程度。在RYSTIGGO治疗期间及之后15分钟内，应监测患者的超敏反应的临床体征和症状。

If a reaction occurs, institute appropriate measures if needed..

如果发生反应，必要时采取适当的措施。

ADVERSE REACTIONS

不良反应

In a placebo-controlled study, the most common adverse reactions (reported in at least 10% of RYSTIGGO-treated patients) were headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea. Serious infections were reported in 4% of patients treated with RYSTIGGO. Three fatal cases of pneumonia were identified, caused by COVID-19 infection in two patients and an unknown pathogen in one patient.

在一项安慰剂对照研究中，最常见的不良反应（在至少10%的使用RYSTIGGO治疗的患者中报告）为头痛、感染、腹泻、发热、超敏反应和恶心。在使用RYSTIGGO治疗的患者中，有4%报告了严重感染。发现三例致命的肺炎病例，其中两例由COVID-19感染引起，另一例由未知病原体引起。

Six cases of infections led to discontinuation of RYSTIGGO..

六例感染导致停止使用RYSTIGGO。

The full Prescribing Information is available at

完整的处方信息可在

https://www.ucb-usa.com/RYSTIGGO-prescribing-information.pdf

Important Safety Information about ZILBRYSQ® (zilucoplan) in the US

美国关于ZILBRYSQ®（zilucoplan）的重要安全信息

ZILBRYSQ is a complement inhibitor indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

ZILBRYSQ 是一种补体抑制剂，用于治疗抗乙酰胆碱受体 (AChR) 抗体阳性的成人全身性重症肌无力 (gMG) 患者。

IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING

重要的安全信息，包括方框警告

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

警告：严重的脑膜炎球菌感染

Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early. ZILBRYSQ, a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis..

接受补体抑制剂治疗的患者发生了危及生命和致命的脑膜炎球菌感染。这些感染如果不能早期识别和治疗，可能会迅速危及生命或致命。ZILBRYSQ 作为一种补体抑制剂，会增加由脑膜炎奈瑟菌引起的严重感染风险。

Complete or update meningococcal vaccination (for serogroups A, C, W, and Y, and B) at least 2 weeks prior to the first dose of ZILBRYSQ, unless the risk of delaying therapy outweigh the risks of developing a meningococcal infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccination against meningococcal bacteria in patients receiving a complement inhibitor..

在接种ZILBRYSQ的第一剂至少两周前，完成或更新脑膜炎球菌疫苗接种（针对血清群A、C、W、Y和B），除非延迟治疗的风险超过发生脑膜炎球菌感染的风险。遵循免疫实践咨询委员会（ACIP）关于接受补体抑制剂治疗患者预防脑膜炎球菌感染的最新建议。

Persons receiving ZILBRYSQ are at increased risk for invasive disease caused by Neisseria meningitidis, even if they develop antibodies following vaccination. Monitor patients for signs of serious meningococcal infections and evaluate immediately if infection is suspected.

接受ZILBRYSQ治疗的人员即使在接种疫苗后产生抗体，仍然面临由脑膜炎奈瑟菌引起的侵袭性疾病的风险增加。监测患者是否有严重脑膜炎球菌感染的迹象，并在怀疑感染时立即进行评估。

Because of the risk of serious meningococcal infections, ZILBRYSQ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ZILBRYSQ REMS.

由于存在严重的脑膜炎球菌感染风险，ZILBRYSQ 只能通过一项称为 ZILBRYSQ REMS 的风险评估与缓解策略 (REMS) 限制性计划获取。

CONTRAINDICATIONS

禁忌症

ZILBRYSQ is contraindicated for initiation in patients with unresolved

ZILBRYSQ 禁用于未解决的患者启动治疗。

Neisseria meningitidis

脑膜炎奈瑟菌

infection.

感染。

WARNINGS AND PRECAUTIONS

警告与预防措施

Serious Meningococcal Infections

严重的脑膜炎球菌感染

ZILBRYSQ, a complement inhibitor, increases a patient’s susceptibility to serious, life-threatening, or fatal infections caused by meningococcal bacteria (septicemia and/or meningitis) in any serogroup, including non-groupable strains. Life-threatening and fatal meningococcal infections have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors; ZILBRYSQ is a complement inhibitor.

ZILBRYSQ 是一种补体抑制剂，会增加患者感染由脑膜炎奈瑟菌（包括任何血清组，甚至不可分组的菌株）引起的严重、危及生命或致命感染（败血症和/或脑膜炎）的易感性。在接受补体抑制剂治疗的已接种和未接种疫苗的患者中，均已发生危及生命和致命的脑膜炎球菌感染；ZILBRYSQ 即为一种补体抑制剂。

The use of ZILBRYSQ increases a patient’s susceptibility to serious and life-threatening meningococcal infections (septicemia and/or meningitis) caused by any serogroup, including non-groupable strains..

使用ZILBRYSQ会增加患者对由任何血清组（包括不可分组菌株）引起的严重和危及生命的脑膜炎球菌感染（败血症和/或脑膜炎）的易感性。

Complete or update meningococcal vaccination (for both serogroups A, C, W, and B [MenACWY] and serogroup B [MenB]) at least 2 weeks prior to administering the first dose of ZILBRYSQ, according to current ACIP recommendations for patients receiving a complement inhibitor.

根据当前 ACIP 对接受补体抑制剂的患者的建议，在给予 ZILBRYSQ 的第一剂至少 2 周前完成或更新脑膜炎球菌疫苗接种（包括血清群 A、C、W 和 B [MenACWY] 以及血清群 B [MenB]）。

If urgent ZILBRYSQ therapy is indicated in a patient who is not up to date with meningococcal vaccines according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer meningococcal vaccines as soon as possible.

如果根据ACIP建议，对未及时接种脑膜炎球菌疫苗的患者指示进行紧急ZILBRYSQ治疗，则应为患者提供抗菌药物预防，并尽快接种脑膜炎球菌疫苗。

Closely monitor patients for early signs and symptoms of meningococcal infection and evaluate patients immediately if infection is suspected. Consider interruption of ZILBRYSQ in patients who are undergoing treatment for serious meningococcal infection, depending on the risks of interrupting treatment in the disease being treated..

密切监测患者是否有脑膜炎球菌感染的早期体征和症状，并在怀疑感染时立即评估患者。对于正在接受严重脑膜炎球菌感染治疗的患者，根据中断治疗对所治疗疾病的风险，考虑暂停使用ZILBRYSQ。

ZILBRYSQ REMS

齐尔布里斯克雷姆斯

Due to the risk of meningococcal infections, ZILBRYSQ is available only through a restricted program under a REMS called ZILBRYSQ REMS.

由于存在脑膜炎球菌感染的风险，ZILBRYSQ 只能通过一个名为 ZILBRYSQ REMS 的风险评估和缓解策略（REMS）限制性计划获得。

Under the ZILBRYSQ REMS, prescribers must enroll in the program. Prescribers must counsel patients about the risk of meningococcal infection, provide the patients with the REMS educational materials, and ensure patients are vaccinated with meningococcal vaccines. Additional information on the REMS requirements is available at .

根据ZILBRYSQ REMS规定，处方医生必须注册加入该计划。医生需向患者说明脑膜炎球菌感染的风险，提供REMS教育资料，并确保患者接种脑膜炎球菌疫苗。有关REMS要求的更多信息，请访问。

www.ZILBRYSQREMS.com

or 1-877-414-8353.

或 1-877-414-8353。

Other Infections

其他感染

ZILBRYSQ blocks terminal complement activation; therefore, patients may have increased susceptibility to infections, especially with encapsulated bacteria, such as infections caused by Neisseria meningitidis but also

ZILBRYSQ 阻断末端补体激活；因此，患者可能对感染的易感性增加，尤其是由封装细菌引起的感染，例如脑膜炎奈瑟菌引起的感染，但也包括其他。

Streptococcus pneumoniae, Haemophilus influenzae

肺炎链球菌，流感嗜血杆菌

, and to a lesser extent,

，并在较小程度上，

Neisseria gonorrhoeae

淋病奈瑟菌

. Administer vaccinations for the prevention of

. 进行疫苗接种以预防

Streptococcus pneumoniae

肺炎链球菌

according to ACIP recommendations. Patients receiving ZILBRYSQ are at increased risk for infections due to these organisms, even if they develop antibodies following vaccination.

根据ACIP建议，即使接种疫苗后产生抗体，接受ZILBRYSQ治疗的患者因这些微生物导致感染的风险仍然增加。

Pancreatitis And Other Pancreatic Conditions

胰腺炎和其他胰腺疾病

Pancreatitis and pancreatic cysts have been reported in patients treated with ZILBRYSQ. Patients should be informed of this risk before starting ZILBRYSQ. Obtain lipase and amylase levels at baseline before starting treatment with ZILBRYSQ. Discontinue ZILBRYSQ in patients with suspected pancreatitis and initiate appropriate management until pancreatitis is ruled out or has resolved..

接受ZILBRYSQ治疗的患者中有报告胰腺炎和胰腺囊肿的病例。在开始使用ZILBRYSQ之前，应告知患者这一风险。在开始ZILBRYSQ治疗前，获取患者的脂肪酶和淀粉酶基线水平。对于疑似胰腺炎的患者，应停用ZILBRYSQ，并进行适当的管理，直到排除或解决胰腺炎问题。

ADVERSE REACTIONS

不良反应

In a placebo-controlled study, the most common adverse reactions (reported in at least 10% of gMG patients treated with ZILBRYSQ) were injection site reactions, upper respiratory tract infections, and diarrhea.

在一项安慰剂对照研究中，最常见（报告于至少10%接受ZILBRYSQ治疗的gMG患者中）的不良反应为注射部位反应、上呼吸道感染和腹泻。

Please see the full

请参阅完整内容

Prescribing Information

处方信息

for additional Important Safety Information.

有关其他重要的安全信息。

Important Safety Information about FINTEPLA

关于FINTEPLA的重要安全信息

(fenfluramine) in the US

（芬氟拉明）在美国

INDICATIONS AND USAGE

适应症和用法

FINTEPLA is indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients 2 years of age and older.

FINTEPLA 适用于治疗 2 岁及以上患者的 Dravet 综合征和 Lennox-Gastaut 综合征相关的癫痫发作。

IMPORTANT SAFETY INFORMATION

重要安全信息

BOXED WARNING: VALVULAR HEART DISEASE and PULMONARY ARTERIAL HYPERTENSION

黑框警告：心脏瓣膜病和肺动脉高压

There is an association between serotonergic drugs with 5-HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease and pulmonary arterial hypertension.

5-HT2B受体激动剂活性的血清素能药物，包括芬氟拉明（FINTEPLA中的活性成分），与瓣膜性心脏病和肺动脉高压之间存在关联。

Echocardiogram assessments are required before, during, and after treatment with FINTEPLA.

在使用FINTEPLA治疗前、治疗期间和治疗后，都需要进行超声心动图评估。

FINTEPLA is available only through a restricted program called the FINTEPLA REMS.

FINTEPLA 只能通过名为 FINTEPLA REMS 的限制性计划获取。

CONTRAINDICATIONS

禁忌症

FINTEPLA is contraindicated in patients with hypersensitivity to fenfluramine or any of the excipients in FINTEPLA and with concomitant use, or within 14 days of the administration, of monoamine oxidase inhibitors because of an increased risk of serotonin syndrome.

FINTEPLA禁用于对芬氟拉明或FINTEPLA中任何辅料过敏的患者，也禁用于与单胺氧化酶抑制剂同时使用或在单胺氧化酶抑制剂给药后14天内使用，因为这会增加血清素综合征的风险。

WARNINGS AND PRECAUTIONS

警告和注意事项

Valvular Heart Disease and Pulmonary Arterial Hypertension (see Boxed Warning)

瓣膜性心脏病和肺动脉高压（见方框警告）

: Because of the association between serotonergic drugs with 5 HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease (VHD) and pulmonary arterial hypertension (PAH), cardiac monitoring via echocardiogram is required prior to starting treatment, during treatment, and after treatment with FINTEPLA concludes.

由于5-HT2B受体激动剂活性的血清素能药物（包括芬氟拉明（FINTEPLA的活性成分））与瓣膜性心脏病（VHD）和肺动脉高压（PAH）之间的关联，在开始使用FINTEPLA治疗之前、治疗期间以及治疗结束后，需要通过超声心动图进行心脏监测。

Cardiac monitoring via echocardiogram can aid in early detection of these conditions. In clinical trials for DS and LGS of up to 3 years in duration, no patient receiving FINTEPLA developed VHD or PAH..

通过超声心动图进行心脏监测有助于这些疾病的早期检测。在长达3年的DS和LGS临床试验中，没有接受FINTEPLA治疗的患者出现VHD或PAH。

Monitoring

监控

: Prior to starting treatment, patients must undergo an echocardiogram to evaluate for VHD and PAH. Echocardiograms should be repeated every 6 months, and once at 3-6 months post treatment with FINTEPLA.

在开始治疗前，患者必须接受超声心动图检查，以评估 VHD 和 PAH。超声心动图应每 6 个月重复一次，并在使用 FINTEPLA 治疗后 3-6 个月时再进行一次。

The prescriber must consider the benefits versus the risks of initiating or continuing treatment with FINTEPLA if any of the following signs are observed via echocardiogram: valvular abnormality or new abnormality; VHD indicated by mild or greater aortic regurgitation or moderate or greater mitral regurgitation, with additional characteristics of VHD (eg, valve thickening or restrictive valve motion); PAH indicated by elevated right heart/pulmonary artery pressure (PASP >35 mmHg)..

如果通过超声心动图观察到以下任何迹象，处方医生必须权衡开始或继续使用FINTEPLA治疗的利弊：瓣膜异常或新的异常；由轻度或更严重的主动脉反流或中度或更严重的二尖瓣反流所提示的瓣膜性心脏病（VHD），并伴有VHD的其他特征（如瓣膜增厚或限制性瓣膜运动）；由右心/肺动脉压力升高（PASP >35 mmHg）所提示的肺动脉高压（PAH）。

FINTEPLA REMS Program (see Boxed Warning):

FINTEPLA REMS计划（见方框警告）：

FINTEPLA is available only through a restricted distribution program called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program. Prescribers must be certified by enrolling in the FINTEPLA REMS. Prescribers must counsel patients receiving FINTEPLA about the risk of VHD and PAH, how to recognize signs and symptoms of VHD and PAH, the need for baseline (pretreatment) and periodic cardiac monitoring via echocardiogram during FINTEPLA treatment, and cardiac monitoring after FINTEPLA treatment.

FINTEPLA 只能通过名为 FINTEPLA 风险评估与缓解策略 (REMS) 计划的受限分销计划获取。处方医生必须通过注册 FINTEPLA REMS 计划获得认证。处方医生必须向接受 FINTEPLA 治疗的患者提供关于 VHD 和 PAH 风险的咨询，告知如何识别 VHD 和 PAH 的体征和症状，在 FINTEPLA 治疗期间通过超声心动图进行基线（治疗前）和定期心脏监测的必要性，以及在 FINTEPLA 治疗后进行心脏监测。

Patients must enroll in the FINTEPLA REMS and comply with ongoing monitoring requirements. The pharmacy must be certified by enrolling in the FINTEPLA REMS and must only dispense to patients who are authorized to receive FINTEPLA. Wholesalers and distributors must only distribute to certified pharmacies.

患者必须注册参加 FINTEPLA REMS 并遵守持续的监测要求。药房必须通过注册参与 FINTEPLA REMS 认证，并且只能向获授权接受 FINTEPLA 的患者配药。批发商和分销商只能向认证药房分销。

Further information is available at www.FinteplaREMS.com or by telephone at 1-877-964-3649..

更多信息可访问 www.FinteplaREMS.com 或拨打 1-877-964-3649 获取。

Decreased Appetite and Decreased Weight

食欲减退和体重减轻

: FINTEPLA can cause decreases in appetite and weight. Decreases in weight appear to be dose related. Approximately half of the patients with LGS and most patients with DS resumed the expected measured increases in weight during the open-label extension studies. Weight should be monitored regularly during treatment with FINTEPLA, and dose modifications should be considered if a decrease in weight is observed. .

FINTEPLA可能导致食欲下降和体重减轻。体重减轻似乎与剂量相关。在开放标签扩展研究中，大约一半的LGS患者和大多数DS患者的体重恢复到了预期的增长水平。在使用FINTEPLA治疗期间应定期监测体重，如果发现体重下降，应考虑调整剂量。

Somnolence, Sedation, and Lethargy

嗜睡、镇静和昏睡

: FINTEPLA can cause somnolence, sedation, and lethargy. Other central nervous system (CNS) depressants, including alcohol, could potentiate these effects of FINTEPLA. Prescribers should monitor patients for somnolence and sedation and should advise patients not to drive or operate machinery until they have gained sufficient experience on FINTEPLA to gauge whether it adversely affects their ability to drive or operate machinery..

FINTEPLA可能导致嗜睡、镇静和昏睡。其他中枢神经系统（CNS）抑制剂，包括酒精，可能会增强FINTEPLA的这些效果。处方医生应监测患者的嗜睡和镇静情况，并应建议患者在对FINTEPLA有足够的使用经验以判断其是否会影响驾驶或操作机械的能力之前，不要驾驶或操作机械。

Suicidal Behavior and Ideation

自杀行为与意念

: Antiepileptic drugs (AEDs), including FINTEPLA, increase the risk of suicidal thoughts or behaviors in patients taking these drugs for any indication. Patients treated with an AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behaviors, or any unusual changes in mood or behavior..

抗癫痫药物（AEDs），包括FINTEPLA，会增加任何适应症患者产生自杀念头或行为的风险。任何适应症接受AED治疗的患者都应监测是否出现或加重抑郁、自杀念头或行为，以及情绪或行为上的任何异常变化。

Anyone considering prescribing FINTEPLA or any other AED must balance the risk of suicidal thoughts or behaviors with the risks of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behaviors.

任何考虑开具FINTEPLA或其他抗癫痫药物（AED）处方的人，都必须在自杀念头或行为的风险与未治疗疾病的风险之间进行权衡。癫痫和许多其他需要开具抗癫痫药物的疾病本身便与发病率、死亡率以及自杀念头和行为风险增加相关。

Should suicidal thoughts and behaviors emerge during treatment, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated..

如果在治疗期间出现自杀念头和行为，应考虑这些症状在任何特定患者中的出现是否与正在治疗的疾病有关。

Withdrawal of Antiepileptic Drugs

撤回抗癫痫药物

: As with most AEDs, FINTEPLA should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. If withdrawal is needed because of a serious adverse reaction, rapid discontinuation can be considered.

与大多数抗癫痫药物（AED）一样，由于增加癫痫发作频率和癫痫持续状态的风险，FINTEPLA通常应逐渐停药。如果因严重不良反应需要停药，可以考虑快速停药。

Serotonin Syndrome

血清素综合征

: Serotonin syndrome, a potentially life-threatening condition, may occur with FINTEPLA, particularly during concomitant administration of FINTEPLA with other serotonergic drugs, including, but not limited to, selective serotonin-norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), bupropion, triptans, dietary supplements (eg, St.

：芬特普拉（FINTEPLA）可能引发血清素综合征，这是一种可能危及生命的状况，尤其在同时使用其他具有血清素作用的药物时，包括但不限于选择性5-羟色胺和去甲肾上腺素再摄取抑制剂（SNRIs）、选择性5-羟色胺再摄取抑制剂（SSRIs）、三环类抗抑郁药（TCAs）、安非他酮、曲坦类药物、膳食补充剂（如圣约翰草）。

John’s Wort, tryptophan), drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors [MAOIs], which are contraindicated with FINTEPLA), dextromethorphan, lithium, tramadol, and antipsychotics with serotonergic agonist activity. Patients should be monitored for the emergence of signs and symptoms of serotonin syndrome, which include mental status changes (eg, agitation, hallucinations, coma), autonomic instability (eg, tachycardia, labile blood pressure, hyperthermia), neuromuscular signs (eg, hyperreflexia, incoordination), and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea).

约翰草、色氨酸）、影响血清素代谢的药物（包括单胺氧化酶抑制剂 [MAOIs]，与FINTEPLA合用为禁忌）、右美沙芬、锂、曲马多以及具有5-羟色胺激动剂活性的抗精神病药物。应监测患者是否出现血清素综合症的体征和症状，包括精神状态改变（如激越、幻觉、昏迷）、自主神经不稳定性（如心动过速、血压波动、高热）、神经肌肉症状（如反射亢进、共济失调）和/或胃肠道症状（如恶心、呕吐、腹泻）。

If serotonin syndrome is suspected, treatment with FINTEPLA should be stopped immediately and symptomatic treatment should be started. .

如果怀疑出现血清素综合征，应立即停止使用FINTEPLA并开始对症治疗。

Increase in Blood Pressure

血压升高

: FINTEPLA can cause an increase in blood pressure. Rare cases of significant elevation in blood pressure, including hypertensive crisis, has been reported in adult patients treated with fenfluramine, including patients without a history of hypertension. In clinical trials for DS and LGS of up to 3 years in duration, no pediatric or adult patient receiving FINTEPLA developed hypertensive crisis.

FINTEPLA可能导致血压升高。在使用芬氟拉明治疗的成年患者中，包括无高血压病史的患者，有少数出现显著血压升高的病例报告，包括高血压危象。在长达3年的DS和LGS临床试验中，没有接受FINTEPLA治疗的儿童或成人患者发生高血压危象。

Monitor blood pressure in patients treated with FINTEPLA..

监测使用FINTEPLA治疗的患者的血压。

Glaucoma

青光眼

: Fenfluramine can cause mydriasis and can precipitate angle closure glaucoma. Consider discontinuing treatment with FINTEPLA in patients with acute decreases in visual acuity or ocular pain.

：芬氟拉明可导致瞳孔扩大，并可能引发闭角型青光眼。对于视力急性下降或眼部疼痛的患者，考虑停止使用FINTEPLA治疗。

ADVERSE REACTIONS

不良反应

The most common adverse reactions observed in DS studies (incidence at least 10% and greater than placebo) were decreased appetite; somnolence, sedation, lethargy; diarrhea; constipation; abnormal echocardiogram; fatigue, malaise, asthenia; ataxia, balance disorder, gait disturbance; blood pressure increased; drooling, salivary hypersecretion; pyrexia; upper respiratory tract infection; vomiting; decreased weight; fall; status epilepticus..

在DS研究中观察到的最常见的不良反应（发生率至少为10%且高于安慰剂）包括食欲下降；嗜睡、镇静、乏力；腹泻；便秘；心电图异常；疲劳、不适、虚弱；共济失调、平衡障碍、步态异常；血压升高；流涎、唾液分泌过多；发热；上呼吸道感染；呕吐；体重减轻；跌倒；癫痫持续状态。

The most common adverse reactions observed in the LGS study (incidence at least 10% and greater than placebo) were diarrhea; decreased appetite; fatigue; somnolence; vomiting.

在LGS研究中观察到的最常见的不良反应（发生率至少为10％且高于安慰剂）是腹泻；食欲下降；疲劳；嗜睡；呕吐。

DRUG INTERACTIONS

药物相互作用

Strong CYP1A2, CYP2B6, or CYP3A Inducers: Coadministration with strong CYP1A2, CYP2B6, or CYP3A inducers will decrease fenfluramine plasma concentrations. If coadministration of a strong CYP1A2, CYP2B6, or CYP3A inducer with FINTEPLA is necessary, monitor the patient for reduced efficacy and consider increasing the dosage of FINTEPLA as needed.

强效CYP1A2、CYP2B6或CYP3A诱导剂：与强效CYP1A2、CYP2B6或CYP3A诱导剂联合使用会降低芬氟拉明的血浆浓度。如果必须将强效CYP1A2、CYP2B6或CYP3A诱导剂与FINTEPLA联合使用，应监测患者的疗效是否降低，并根据需要考虑增加FINTEPLA的剂量。

If a strong CYP1A2, CYP2B6, or CYP3A inducer is discontinued during maintenance treatment with FINTEPLA, consider gradual reduction in the FINTEPLA dosage to the dose administered prior to initiating the inducer..

如果在使用FINTEPLA维持治疗期间停用强效CYP1A2、CYP2B6或CYP3A诱导剂，应考虑逐步减少FINTEPLA的剂量至开始使用诱导剂前的剂量。

Strong CYP1A2 or CYP2D6 Inhibitors: Coadministration with strong CYP1A2 or CYP2D6 inhibitors will increase fenfluramine plasma concentrations. If FINTEPLA is coadministered with strong CYP1A2 or CYP2D6 inhibitors, the maximum daily dosage of FINTEPLA is 20 mg. If a strong CYP1A2 or CYP2D6 inhibitor is discontinued during maintenance treatment with FINTEPLA, consider gradual increase in the FINTEPLA dosage to the dose recommended without CYP1A2 or CYP2D6 inhibitors.

强效CYP1A2或CYP2D6抑制剂：与强效CYP1A2或CYP2D6抑制剂联合使用会增加芬氟拉明的血浆浓度。如果FINTEPLA与强效CYP1A2或CYP2D6抑制剂联合使用，FINTEPLA的最大日剂量为20毫克。如果在使用FINTEPLA维持治疗期间停用强效CYP1A2或CYP2D6抑制剂，考虑逐步增加FINTEPLA的剂量至未使用CYP1A2或CYP2D6抑制剂时推荐的剂量。

If FINTEPLA is coadministered with stiripentol and a strong CYP1A2 or CYP2D6 inhibitor, the maximum daily dosage of FINTEPLA is 17 mg..

如果FINTEPLA与stiripentol和强效CYP1A2或CYP2D6抑制剂联合使用，FINTEPLA的每日最大剂量为17毫克。

USE IN SPECIFIC POPULATIONS

特定人群中的使用

In patients with severe impairment of kidney function (estimated glomerular filtration rate [eGFR]) 15 to 29 mL/min/1.73m2, dosage adjustments are recommended. FINTEPLA has not been studied in patients with kidney failure (eGFR <15 mL/min/1.73m2).

在肾功能严重受损（估算肾小球滤过率 [eGFR] 为 15 至 29 mL/min/1.73m2）的患者中，建议调整剂量。FINTEPLA 尚未在肾衰竭（eGFR <15 mL/min/1.73m2）患者中进行研究。

Combined molar exposures of fenfluramine and norfenfluramine were increased in subjects with various degrees of hepatic impairment (Child-Pugh Class A, B, and C), necessitating a dosage adjustment in these patients.

肝功能损害（Child-Pugh A级、B级和C级）不同程度的受试者中，芬氟拉明和去甲芬氟拉明的合并摩尔暴露量增加，因此这些患者需要调整剂量。

To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 1 844-599-2273 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

要报告可疑的不良反应，请联系UCB公司，电话1-844-599-2273，或FDA，电话1-800-FDA-1088，或访问www.fda.gov/medwatch。

Please see [

请参见 [

directional

方向性的

] full Prescribing Information, including Boxed Warning, for additional Important Safety Information.

] 完整的处方信息，包括加框警告，以获取更多重要的安全信息。

Important Safety Information about BRIVIACT

关于BRIVIACT的重要安全信息

(brivaracetam) in the US

美国的布立西坦（brivaracetam）

Indication

指示

BRIVIACT

布立伐特

(brivaracetam) CV is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.

（布立西坦）CV 适用于治疗1个月及以上年龄患者的局灶性癫痫发作。

IMPORTANT SAFETY INFORMATION

重要安全信息

WARNINGS AND PRECAUTIONS

警告和注意事项

Suicidal Behavior and Ideation

自杀行为和意念

: Antiepileptic drugs, including BRIVIACT, increase the risk of suicidal behavior and ideation. Monitor patients taking BRIVIACT for the emergence or worsening of depression; unusual changes in mood or behavior; or suicidal thoughts, behavior, or self-harm. Advise patients, their caregivers, and/or families to be alert for these behavioral changes and report them immediately to a healthcare provider..

：包括BRIVIACT在内的抗癫痫药物会增加自杀行为和意念的风险。对服用BRIVIACT的患者进行监测，观察是否出现抑郁症状的产生或恶化；情绪或行为的异常变化；或者自杀念头、行为或自残。建议患者、他们的看护者和/或家属警惕这些行为变化，并立即向医疗保健提供者报告。

Neurological Adverse Reactions

神经系统不良反应

: BRIVIACT causes somnolence, fatigue, dizziness, and disturbance in coordination. Monitor patients for these signs and symptoms and advise them not to drive or operate machinery until they have gained sufficient experience on BRIVIACT.

BRIVIACT会引起嗜睡、疲劳、头晕和协调障碍。监测患者这些症状，并建议他们在对BRIVIACT有足够的使用经验之前不要驾驶或操作机械。

Psychiatric Adverse Reactions

精神科不良反应

: BRIVIACT causes psychiatric adverse reactions, including non-psychotic and psychotic symptoms in adult and pediatric patients. Advise patients to report these symptoms immediately to a healthcare provider.

BRIVIACT会引起精神方面的不良反应，包括成人和儿童患者的非精神病性和精神病性症状。建议患者立即向医疗保健提供者报告这些症状。

Hypersensitivity

超敏反应

: BRIVIACT can cause hypersensitivity reactions. Bronchospasm and angioedema have been reported. Discontinue BRIVIACT if a patient develops a hypersensitivity reaction after treatment. BRIVIACT is contraindicated in patients with a prior hypersensitivity reaction to brivaracetam or any of the inactive ingredients..

BRIVIACT可能引起过敏反应。已报告有支气管痉挛和血管性水肿。如果患者在治疗后出现过敏反应，请停止使用BRIVIACT。对布立西坦或任何非活性成分有过敏反应史的患者禁用BRIVIACT。

Withdrawal of Antiepileptic Drugs

撤回抗癫痫药物

: As with all antiepileptic drugs, BRIVIACT should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus.

：与所有抗癫痫药物一样，由于癫痫发作频率增加和癫痫持续状态的风险，BRIVIACT通常应逐渐停药。

DOSING CONSIDERATIONS

剂量考虑

Dose adjustments are recommended for patients with all stages of hepatic impairment.

建议对所有阶段的肝功能损害患者进行剂量调整。

When BRIVIACT is co-administered with rifampin, an increase in the BRIVIACT dose is recommended.

当BRIVIACT与利福平联合使用时，建议增加BRIVIACT的剂量。

ADVERSE REACTIONS

不良反应

In adult adjunctive therapy placebo-controlled clinical trials, the most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) were somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms. Adverse reactions reported in clinical studies of pediatric patients were generally similar to those in adult patients.

在成人辅助治疗的安慰剂对照临床试验中，最常见的不良反应（BRIVIACT至少5%，且发生率比安慰剂高至少2%）为嗜睡和镇静、头晕、疲劳以及恶心和呕吐症状。儿科患者的临床研究中报告的不良反应与成人患者总体相似。

Adverse reactions with BRIVIACT injection in adult and pediatric patients were generally similar to those observed with BRIVIACT tablets. Other adverse events that occurred in adult patients who received BRIVIACT injection included dysgeusia, euphoric mood, feeling drunk, and infusion site pain..

成人和儿科患者使用BRIVIACT注射剂的不良反应通常与使用BRIVIACT片剂观察到的相似。接受BRIVIACT注射剂的成年患者中出现的其他不良事件包括味觉异常、情绪高涨、醉酒感和注射部位疼痛。

BRIVIACT is a Schedule V controlled substance.

BRIVIACT 是第五类管制物质。

Please refer to the full

请参阅完整内容

Prescribing Information

处方信息

。

Important Safety Information about VIMPAT

关于VIMPAT的重要安全信息

(lacosamide) CV in the US

（拉科酰胺）CV在美国

INDICATION

适应症

VIMPAT

维派特

is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. VIMPAT is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.

用于治疗1个月及以上患者的局灶性癫痫发作。VIMPAT作为辅助疗法，用于治疗4岁及以上患者的原发性全面性强直-阵挛性癫痫发作。

VIMPAT IMPORTANT SAFETY INFORMATION

VIMPAT重要安全信息

VIMPAT is associated with important warnings and precautions including suicidal behavior and ideation, dizziness and ataxia, cardiac rhythm and conduction abnormalities, syncope, and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi-organ hypersensitivity.

VIMPAT伴有重要的警告和注意事项，包括自杀行为和意念、头晕和共济失调、心脏节律和传导异常、晕厥，以及嗜酸性粒细胞增多和全身症状的药物反应（DRESS），也称为多器官超敏反应。

Partial-Onset Seizures

部分性发作癫痫

In the adult adjunctive placebo-controlled trials for partial-onset seizures, the most common adverse reactions (≥10% and greater than placebo) were dizziness, headache, nausea, and diplopia. In the adult monotherapy clinical trial, adverse reactions were generally similar to those observed and attributed to drug in adjunctive placebo-controlled trials, with the exception of insomnia (observed at a higher rate of ≥2%).

在针对部分性发作癫痫的成人辅助性安慰剂对照试验中，最常见的不良反应（≥10%且高于安慰剂组）为头晕、头痛、恶心和复视。在成人单药治疗临床试验中，不良反应总体上与辅助性安慰剂对照试验中观察到并归因于药物的反应相似，但失眠除外（发生率较高，≥2%）。

Pediatric adverse reactions were similar to those seen in adult patients..

儿科不良反应与成年患者相似。

Primary Generalized Tonic-Clonic Seizures

全面性强直-阵挛发作

In the adjunctive therapy placebo-controlled trial for primary generalized tonic-clonic seizures, the adverse reactions were generally similar to those that occurred in the partial-onset seizures trials. The adverse reactions most commonly reported were dizziness, somnolence, headache, and nausea.

在原发性全面性强直-阵挛性发作的辅助治疗安慰剂对照试验中，不良反应总体上与部分性发作试验中出现的不良反应相似。最常报告的不良反应是头晕、嗜睡、头痛和恶心。

The adverse reactions associated with VIMPAT injection in adult patients with primary generalized tonic-clonic seizures are expected to be similar to those seen in adults with partial-onset seizures. The adverse reactions associated with VIMPAT injection in pediatric patients are expected to be similar to those noted in adults.

预计VIMPAT注射液在原发性全面性强直-阵挛发作的成年患者中引发的不良反应与部分性发作的成年患者中观察到的相似。VIMPAT注射液在儿科患者中的不良反应预计与成人中观察到的相似。

Infusion times less than 30 minutes were not adequately studied in pediatric patients..

输注时间少于30分钟在儿科患者中未得到充分研究。

VIMPAT contains lacosamide, a Schedule V controlled substance.

VIMPAT含有拉科酰胺，这是一种第五类管制物质。

Please refer to the full

请参阅完整内容

Prescribing Information

处方信息

。

BRIVIACT

博里瓦クト

, FINTEPLA

，FINTEPLA

, RYSTIGGO

，RYSTIGGO

, and ZILBRYSQ

，以及ZILBRYSQ

are registered trademarks of the UCB Group of Companies. VIMPAT® is a registered trademark used under license from Harris FRC Corporation. Staccato

是UCB集团公司注册商标。VIMPAT® 是根据Harris FRC公司的许可使用的注册商标。Staccato

is a registered trademark of Alexza Pharmaceuticals, Inc.,

是Alexza Pharmaceuticals, Inc.的注册商标，

and is used by UCB Pharma under license.

并由UCB Pharma根据许可使用。

References:

参考文献：

Rystiggo

里斯蒂戈

EU SmPC. https://www.ema.europa.eu/en/documents/product-information/rystiggo-epar-product-information_en.pdf. Accessed February 2025.

欧盟药品特性摘要（SmPC）。https://www.ema.europa.eu/en/documents/product-information/rystiggo-epar-product-information_en.pdf。访问时间：2025年2月。

Rystiggo

里希戈

US PI. https://www.ucb-usa.com/RYSTIGGO-prescribing-information.pdf. Accessed February 2025.

美国处方信息。https://www.ucb-usa.com/RYSTIGGO-prescribing-information.pdf。引用日期：2025年2月。

Zilbrysq

齐尔布里什

EU SmPC. https://www.ema.europa.eu/en/documents/product-information/zilbrysq-epar-product-information_en.pdf. Accessed February 2025.

欧盟药品特性摘要（SmPC）。https://www.ema.europa.eu/en/documents/product-information/zilbrysq-epar-product-information_en.pdf。访问时间：2025年2月。

Zilbrysq

齐尔布里什

US PI. https://www.ucb-usa.com/zilbrysq-prescribing-information.pdf Accessed February 2025.

美国处方信息。https://www.ucb-usa.com/zilbrysq-prescribing-information.pdf 访问时间：2025年2月。

Fintepla

芬特拉

EU SmPC. https://www.ema.europa.eu/en/documents/product-information/fintepla-epar-product-information_en.pdf. Accessed February 2025.

欧盟药品特性摘要（SmPC）。https://www.ema.europa.eu/en/documents/product-information/fintepla-epar-product-information_en.pdf。访问时间：2025年2月。

Fintepla

芬特普拉

US PI. https://www.ucb-usa.com/fintepla-prescribing-information.pdf. Accessed February 2025.

美国处方信息。https://www.ucb-usa.com/fintepla-prescribing-information.pdf。访问时间：2025年2月。

Briviact

布里瓦克特

EU SmPC. https://www.ema.europa.eu/en/documents/product-information/briviact-epar-product-information_en.pdf. Accessed February 2025.

欧盟药品特性摘要（SmPC）。https://www.ema.europa.eu/en/documents/product-information/briviact-epar-product-information_en.pdf。访问时间：2025年2月。

Briviact

布里瓦克特

US PI https://ucb-usa.com/sites/default/files/2022-08/Briv%20prescribing%202022.pdf?_gl=1*1a42elk*_ga*NjA2OTM3NDAwLjE2ODI1ODQwNzc.*_ga_TXC8S80N6W*MTY5OTAyNTU2NS4yNy4xLjE2OTkwMjU1NzYuNDkuMC4w Accessed February 2025.

美国处方信息 https://ucb-usa.com/sites/default/files/2022-08/Briv%20prescribing%202022.pdf?_gl=1*1a42elk*_ga*NjA2OTM3NDAwLjE2ODI1ODQwNzc.*_ga_TXC8S80N6W*MTY5OTAyNTU2NS4yNy4xLjE2OTkwMjU1NzYuNDkuMC4w 访问时间：2025年2月。

UCB acquires Engage Therapeutics: Staccato[®] Alprazolam - A potential solution for acute on-demand seizure management for people living with epilepsy. https://www.ucb.com/stories-media/Press-Releases/article/UCB-acquires-Engage-Therapeutics-Staccato-Alprazolam-A-potential-solution-for-acute-on-demand-seizure-management-for-people-living-with-epilepsy.

UCB收购Engage Therapeutics：Staccato[®] 阿普唑仑 - 一种潜在的针对癫痫患者急性按需发作管理的解决方案。https://www.ucb.com/stories-media/Press-Releases/article/UCB-acquires-Engage-Therapeutics-Staccato-Alprazolam-A-potential-solution-for-acute-on-demand-seizure-management-for-people-living-with-epilepsy.

Accessed February 2025..

访问于2025年2月。

Knupp, et al. Safety and Effectiveness of Fenfluramine for the Treatment of Seizures in Lennox-Gastaut Syndrome: Results From the Final Analysis of an Open-Label Extension Study.

Knupp 等。芬氟拉明治疗 Lennox-Gastaut 综合征癫痫发作的安全性和有效性：来自开放标签扩展研究的最终分析结果。

Dedeurwaerdere, et al. Sleep Apnea is Associated with High Mortality Risk in Children with Severe Epilepsies: Observational Analysis from Large Scale US Claims Data.

Dedeurwaerdere等人。睡眠呼吸暂停与严重癫痫儿童的高死亡风险相关：来自美国大规模索赔数据的观察性分析。

Zhang Roper, et al. Safety, Tolerability, Pharmacokinetics, and Efficacy of Fenfluramine in Combination With Cannabidiol: Results From a Phase 1 Study.

张·罗珀等。芬氟拉明与大麻二酚联合使用的安全性、耐受性、药代动力学和疗效：一项1期研究的结果。

Lagae, et al. Long-term Tolerability and Efficacy of Adjunctive Brivaracetam in Pediatric Patients With Primary Generalized Seizures: Subgroup Analysis of an Open-label, Follow-up Trial.

拉加埃等。布里瓦拉塞坦辅助治疗原发性全面性癫痫儿童患者的长期耐受性与疗效：一项开放标签随访试验的亚组分析。

Bessons, et al. Brivaracetam Monotherapy Patient Characteristics, Treatment Patterns, and Healthcare Resource Utilization Among Patients With Epilepsy: A Cohort Study Using US Claims Data.

贝松等。布瓦拉西坦单药治疗癫痫患者的特点、治疗模式及医疗资源利用：一项使用美国索赔数据的队列研究。

Baker, et al. Experiences of Women of Childbearing Age with Epilepsy Throughout their Motherhood Journey: Results From a Social Media Listening Study.

贝克等。育龄癫痫女性在整个母亲旅程中的体验：来自社交媒体倾听研究的结果。

Bailey, et al. Disruptive Impacts of Developmental and Epileptic Encephalopathies on Patient and Family Life: a Quality-of-Life Survey.

贝利等。发育性和癫痫性脑病对患者及其家庭生活的破坏性影响：一项生活质量调查。

Kaye, et al. Impact of Prolonged Seizures on Patients’ and Caregivers’ Quality of Life.

凯伊等。长期癫痫发作对患者及其照顾者生活质量的影响。

Daniels, et al. Inhalation as an Efficient Delivery Route of Alprazolam for the Treatment of Acute Seizures: Randomized Study of Staccato

丹尼尔斯等。吸入作为阿普唑仑治疗急性癫痫发作的有效递送途径：Staccato 的随机研究

Alprazolam Compared to Oral Alprazolam.

阿普唑仑与口服阿普唑仑的比较。

Bril, et al. Self-Administration of Rozanolixizumab in Patients With Generalized Myasthenia Gravis: The MG0020 Study

Bril 等。 Rozanolixizumab 在全身性重症肌无力患者中的自我管理：MG0020 研究

CHMP opinion on Rozanolixizumab EU SmPC. 16 January 2025. https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-meeting-27-30-january-2025_en.pdf. Accessed January 2025.

CHMP 对 Rozanolixizumab 欧盟产品特性摘要（SmPC）的意见。2025年1月16日。https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-meeting-27-30-january-2025_en.pdf。访问于2025年1月。

Mahuwala, et al. Effect of Rozanolixizumab on Ocular Symptoms in Patients With Generalized Myasthenia Gravis: A Post Hoc Item-Level Analysis of Myasthenia Gravis-Specific Outcomes in MycarinG .

马胡瓦拉等。罗扎诺利珠单抗对全身性重症肌无力患者眼部症状的影响：MycarinG中重症肌无力特定结果的事后项目水平分析。

Freimer, et al. Switching to Subcutaneous Zilucoplan From Intravenous Complement Component 5 Inhibitors in Myasthenia Gravis: Patient Preference and Satisfaction From a Phase 3b Study.

Freimer 等。从静脉注射补体成分5抑制剂转换为皮下注射Zilucoplan治疗重症肌无力：来自一项3b期研究的患者偏好与满意度。

Weiss, et al. Effect of Zilucoplan on Myasthenia Gravis–Specific Outcome Subdomain Scores in RAISE: A Phase 3 Study.

Weiss 等。Zilucoplan 对 RAISE 中重症肌无力特定结局子域评分的影响：一项 3 期研究。

Amini, et al. A Novel International Patient Registry in Myasthenia Gravis Linking Clinical and Patient-Reported Outcomes Data: The Vitaccess Real MG (VRMG) Registry.

阿米尼等人。重症肌无力中连接临床和患者报告结果数据的新型国际患者登记：Vitaccess Real MG（VRMG）登记。

Hirano, et al. The Disease Course of Untreated Patients with Thymidine Kinase 2 Deficiency (TK2d) Aged ≤12 Years at TK2d Symptom Onset: Findings from the Largest International TK2d Dataset.

平野等人。未治疗的胸苷激酶2缺乏症（TK2d）患者在12岁及以下出现TK2d症状的病程：来自最大国际TK2d数据集的发现。

Cristina Dominguez Gonzalez, et al. The Disease Course of Untreated Patients with Thymidine Kinase 2 Deficiency (TK2d) Aged >12 Years at TK2d Symptom Onset: Findings from the Largest International TK2d Dataset.

克里斯蒂娜·多明格斯·冈萨雷斯等人。未经治疗的胸苷激酶2缺乏症（TK2d）患者在12岁以上出现TK2d症状时的病程：来自最大国际TK2d数据集的发现。

Nabbout, et al. Impact of Fenfluramine on Convulsive Seizure Frequency in Dose-Capped Patients With Dravet Syndrome.

纳布图等。芬氟拉明对Dravet综合征剂量封顶患者的惊厥发作频率的影响。

Ameen, et al. Understanding the Incidence, Prevalence, Characteristics, and Healthcare Resource Utilization for Patients With Dravet and Lennox-Gastaut Syndromes.

阿米恩等人。了解Dravet综合征和Lennox-Gastaut综合征患者的发病率、患病率、特征及医疗资源利用情况。

Lhatoo, et al. Real-world Use of Fenfluramine for Dravet Syndrome: a Retrospective Cohort Study Using a National Pharmacy Database.

Lhatoo等。芬氟拉明治疗Dravet综合征的真实世界应用：使用国家药房数据库的回顾性队列研究。

Bass, et al. Interim Results of the US Fenfluramine Oral Solution Cardiovascular Safety Registry Study.

巴塞尔等人。美国芬氟拉明口服溶液心血管安全注册研究的中期结果。

Nabbout, et al. A Stratified Analysis of Efficacy and Safety of Fenfluramine in Patients With Dravet Syndrome.

纳布图等。芬氟拉明在Dravet综合征患者中的疗效与安全性分层分析。

Ameen, et al. A Retrospective Claims Study Evaluating Mortality in Patients with Lennox-Gastaut Syndrome or Dravet Syndrome in the United States.

阿米恩等。一项回顾性索赔研究，评估美国Lennox-Gastaut综合征或Dravet综合征患者的死亡率。

Pascuzzi, et al. Correlation Between MG Symptoms PRO and Existing MG-Specific Outcome Scores in the Phase 3 MycarinG Study: Post Hoc Analysis.

Pascuzzi 等。在 3 期 MycarinG 研究中 MG 症状患者报告结果 (PRO) 与现有 MG 特异性结局评分之间的相关性：事后分析。

Thompson, et al. Solutions to Address the Unmet Needs of the gMG Patient Journey in the US: A Multistakeholder Delphi Consensus Study (RWE0970).

汤普森等。解决美国gMG患者旅程中未满足需求的方案：一项多利益相关者德尔菲共识研究（RWE0970）。

VIMPAT

维派特

US PI. https://www.ucb-usa.com/vimpat-prescribing-information.pdf. (Accessed: April 2024).

美国处方信息。https://www.ucb-usa.com/vimpat-prescribing-information.pdf。（访问时间：2024年4月）。

全球产业链接平台

重庆市渝北区金星科技大厦A区5楼512室

联系电话：023-67139735（重庆）

关于我们

产品服务

商务合作

动脉网APP