Brussels (Belgium), October 14, 2025 – 07:00 (CET)

布鲁塞尔（比利时），2025年10月14日 – 07:00（欧洲中部时间）

– UCB, a global biopharmaceutical company, today announced that the final analysis of an open-label extension (OLE) study on Fintepla (fenfluramine) in Lennox-Gastaut syndrome (LGS) was published in Epilepsy and Behavior.

优时比（UCB），一家全球生物制药公司，今天宣布在《癫痫与行为》杂志上发表了关于Fintepla（芬氟拉明）用于Lennox-Gastaut综合征（LGS）的开放标签扩展（OLE）研究的最终分析结果。

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Children and adults aged 2-35 years treated with fenfluramine showed a significant sustained reduction in frequency of seizures associated with a fall (drop seizures) from Month 2 of OLE to end of study compared with baseline and an improvement in global functioning reported by caregivers and investigators.

接受芬氟拉明治疗的2至35岁儿童和成人，在开放性扩展试验（OLE）的第2个月至研究结束期间，与基线相比，跌倒相关癫痫发作（失张力癫痫发作）频率显著持续减少，同时照顾者和研究者报告的总体功能有所改善。

No new or unexpected treatment-emergent adverse events (TEAEs) were reported..

未报告新的或意外的治疗中出现的不良事件（TEAEs）。

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Parents/caregivers reported improvements in social interactions and activities, feelings of stigma, general health, quality of life, and their own anxiety.

父母/照料者报告称，社交互动和活动、耻辱感、整体健康状况、生活质量和他们自己的焦虑感均有改善。

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These results follow final analysis of OLE study evaluating safety and effectiveness of fenfluramine in Dravet Syndrome earlier this year, showing sustained reduction in monthly convulsive seizure frequency and long-term tolerability.

这些结果来自于今年早些时候对芬氟拉明在Dravet综合征中的安全性和有效性进行的OLE研究的最终分析，显示每月惊厥发作频率持续减少且长期耐受性良好。

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Kelly G Knupp, Associate Professor of Pediatrics and Neurology at the CU Anschutz School of Medicine, and coauthor of the paper, said

凯利·G·克努普（Kelly G Knupp），科罗拉多大学安舒茨医学院儿科与神经学副教授，也是该论文的合著者，表示：

, “These data reinforce the long-term safety and tolerability of fenfluramine in children and adults living with Lennox-Gastaut syndrome, a condition with a significant unmet medical need. The sustained reduction in seizure frequency, coupled with the meaningful improvements in quality of life for both patients and their families, underscores the importance of addressing not just the clinical but also the emotional and social challenges faced by these families every day.”.

“这些数据进一步证实了芬氟拉明在患有伦诺克斯-加斯特奥综合征的儿童和成人中的长期安全性和耐受性，这是一种存在显著未满足医疗需求的疾病。癫痫发作频率的持续减少，加上患者及其家庭生活质量的显著改善，突显了不仅需要解决临床问题，还需要应对这些家庭每天面临的心理和社会挑战的重要性。”

Highlights from the OLE

OLE亮点

247 patients (mean age 14.3±7.6 years) were enrolled from study sites in North America, Europe, and Australia, with a median fenfluramine exposure of 364 days (range: 19–537) and a mean daily dose of 0.4±0.1 mg/kg/day (n=246). Meaningful improvements were seen across the key study endpoints listed below:.

共纳入247例患者（平均年龄14.3±7.6岁），来自北美、欧洲和澳大利亚的研究中心，使用芬氟拉明的中位暴露时间为364天（范围：19-537天），平均每日剂量为0.4±0.1 mg/kg/天（n=246）。在以下列出的关键研究终点方面，均观察到显著改善：

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Common treatment-emergent adverse events (TEAEs) reported in ≥10% of patients included decreased appetite, fatigue, nasopharyngitis, seizures, and pyrexia, with no cases of valvular heart disease or pulmonary arterial hypertension observed.  Only 5.3% (n=13) of patients discontinued the study due to TEAEs..

常见的治疗中出现的不良事件（TEAEs）在≥10%的患者中报告，包括食欲减退、疲劳、鼻咽炎、癫痫发作和发热，未观察到瓣膜性心脏病或肺动脉高压病例。仅有5.3%（n=13）的患者因TEAEs停止研究。

A significant median percentage change in the frequency of seizures associated with a fall from month 2 to the end of the study (−31.1%, P<0.0001, n=240, mITT population), with reductions of −27.6% in pediatric patients (n=170, P=0.0005) and −40.0% in adults (n=70, P<0.0001).

从第2个月到研究结束，与跌倒相关的癫痫发作频率的中位百分比变化显著（−31.1%，P<0.0001，n=240，mITT人群），其中儿科患者减少−27.6%（n=170，P=0.0005），成人减少−40.0%（n=70，P<0.0001）。

At the last visit, parents/caregivers and investigators reported any improvement in 59.9% (n=142/237) and 57.0% (n=135) of patients, respectively, on the Clinical Global Impression—Improvement (CGI-I) scale.

在最后一次访视时，父母/照料者和研究者分别报告了59.9%（n=142/237）和57.0%（n=135）的患者在临床全局印象改善（CGI-I）量表上有所改善。

The Quality of Life in Childhood Epilepsy Questionnaire (QOLCE) was completed by parents/caregivers at pre-RCT baseline and at Month 12 of the OLE. From baseline through Month 12 of the OLE period, the mean change in the overall QoL score, calculated as the average of 16 subscale scores, was 2.9 points (n=148, P=0.0166), indicating improvement..

儿童癫痫生活质量问卷（QOLCE）由家长/照料者在随机对照试验前的基线和开放标签扩展期的第12个月填写。从基线到开放标签扩展期第12个月，整体生活质量评分的平均变化（计算为16个子量表分数的平均值）为2.9分（n=148，P=0.0166），表明有所改善。

In the European Union (EU), fenfluramine is approved for the 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.

在欧盟 (EU)，芬氟拉明被批准用于治疗与 Dravet 综合征和 Lennox-Gastaut 综合征相关的癫痫发作，作为其他抗癫痫药物的辅助疗法，适用于 2 岁及以上患者。

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In the United States, fenfluramine oral solution is indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients 2 years of age and older.

在美国，芬氟拉明口服溶液适用于治疗 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。

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In Japan, fenfluramine is approved for treating seizures associated with Dravet syndrome and Lennox-Gastaut syndrome (LGS) as an add-on therapy to other anti-epileptic medicines for patients 2 years and older.

在日本，芬氟拉明被批准用于治疗与Dravet综合征和Lennox-Gastaut综合征（LGS）相关的癫痫发作，作为2岁及以上患者其他抗癫痫药物的辅助疗法。

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About Lennox-Gastaut syndrome (LGS)

关于Lennox-Gastaut综合征（LGS）

Lennox-Gastaut Syndrome (LGS) is a rare, severe developmental and epileptic encephalopathy (DEE) characterized by the presence of tonic seizures and at least one additional seizure type and severe developmental delays. It typically starts during childhood and persists into adulthood.

Lennox-Gastaut综合征（LGS）是一种罕见的、严重的发育性和癫痫性脑病（DEE），其特征为强直性发作和至少一种其他类型的癫痫发作以及严重发育迟缓。该病通常在儿童时期开始，并持续到成年。

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Approximately 50% of infants with a severe DEE evolve over time to LGS.

大约50%的严重DEE婴儿随着时间的推移会发展为LGS。

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LGS has far-reaching effects beyond seizures; impairments with developmental delay culminating in cognitive impairment, communication, psychiatric symptoms, sleep, behavioral challenges and mobility are common.

LGS的影响远不止于癫痫发作；常伴有发育迟缓、最终导致认知障碍、沟通困难、精神症状、睡眠问题、行为挑战和行动障碍等。

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Seizures largely remain drug-resistant on currently available medications.

癫痫发作在很大程度上仍然对目前可用的药物具有抗药性。

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Sudden unexpected death in epilepsy (SUDEP) is a major concern for patients and families with LGS.

癫痫猝死（SUDEP）是LGS患者及其家属主要担忧的问题。

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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 07386 686779

电话：+44 07386 686779

Anna.Clark@ucb.com

安娜.克拉克@ucb.com

Corporate Communications

企业传播

Laurent Schots

劳伦特·肖茨

T: +32.2.559.92.64

电话：+32.2.559.92.64

laurent.schots@ucb.com

laurent.schots@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

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，并在2024年实现了61.5亿欧元的收入。

UCB is listed on Euronext Brussels (symbol: UCB)..

UCB在布鲁塞尔泛欧交易所上市（股票代码：UCB）。

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，包括但不限于包含“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、预期的法律、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.

由于此类前瞻性陈述的性质，其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，这些因素可能导致UCB的实际结果、财务状况、业绩或成就，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、宏观经济、商业和竞争状况的变化、无法获得必要的监管批准或在可接受的条款内或预期时间内获得这些批准、与研发相关的成本、UCB在研产品或开发中的产品的前景变化、未来司法裁决或政府调查的影响、安全、质量、数据完整性或制造问题；潜在或实际的数据安全和隐私泄露，或我们的信息技术系统中断、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批准产品将在任何市场提交或批准销售，或用于任何额外适应症或标签，或在任何特定时间提交或批准，也无法保证此类产品在未来将会或将继续取得商业成功。

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，除非适用的法律法规要求，否则不承担更新本新闻稿中包含的任何信息的责任，无论这些信息是为了确认实际结果，还是为了报告或反映与其前瞻性声明相关的任何变化，或反映任何基于该声明的事件、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征求购买任何证券的要约，也不得在任何此类要约、征求或销售属于违法的司法管辖区进行证券的要约、征求或销售，除非已根据该司法管辖区的证券法进行注册或取得资格。

Important Safety Information about FINTEPLA▼ (fenfluramine) in the EU

关于芬氟拉明（FINTEPLA▼）在欧盟的重要安全信息

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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治疗，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

用法与用量

: 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

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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stiripentol：起始剂量为每天两次0.1 mg/kg（每天0.2 mg/kg）。7天后，如果耐受良好，可将剂量增加至每天两次0.2 mg/kg（每天0.4 mg/kg）。再过7天后，如果耐受良好且需要进一步减少癫痫发作，可将剂量增加至最大剂量，即每天两次0.35 mg/kg（每天0.7 mg/kg），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（每日两次，每次13毫克）。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.

需要更快滴定的患者可以每4天增加一次剂量。总剂量不应超过17毫克（每日两次8.6毫克）。Lennox-Gastaut综合征：起始剂量为每日两次0.1毫克/千克（每日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（每日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，如有可能，避免突然停药，以尽量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次治疗后3-6个月进行最终的超声心动图检查。肾功能损害：一般而言，对于轻度至重度肾功能损害患者，无需调整剂量，但可考虑较慢的滴定速度。如果出现不良反应。

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病和肺动脉高压患者禁用。在使用单胺氧化酶抑制剂的14天内，由于血清素综合征的风险增加，禁止使用。

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.

主动脉或二尖瓣心脏病和肺动脉高压：在开始治疗前，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。在治疗的前2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改变，应考虑提前随访，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个月内进行最终的超声心动图检查。如果超声心动图结果显示可能存在肺动脉高压，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间概率增加，处方医生、护理人员和心脏病专家应进行芬地普拉继续使用的风险效益评估。如果超声心动图提示高概率，建议停止芬氟拉明治疗。

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）联用时可能会产生叠加效应。监测患者的体重。若患者有神经性厌食症或神经性贪食症病史，在开始治疗前应进行风险收益评估。

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

Fintepla管控访问计划：已创建一个管控访问计划，以1) 防止标签外使用。

efficacy may be reduced. Glaucoma: Fenfluramine can cause mydriasis and can precipitate angle closure glaucoma. Discontinue therapy in patients with acute decreases in visual acuity. Consider discontinuation if ocular pain of unknown origin. Effect of CYP1A2 or CYP2B6 inducers: Co-administration with strong CYP1A2 inducers or CYP2B6 inducers will decrease fenfluramine plasma concentrations, which may lower the efficacy of fenfluramine.

疗效可能会降低。青光眼：芬氟拉明可引起瞳孔散大，并可能诱发闭角型青光眼。如果患者出现急性视力下降，应停止治疗。若出现不明原因的眼痛，应考虑停药。CYP1A2或CYP2B6诱导剂的影响：与强效CYP1A2诱导剂或CYP2B6诱导剂联合使用会降低芬氟拉明的血浆浓度，这可能会降低芬氟拉明的疗效。

If co-administration is considered necessary, the patient should be monitored for reduced efficacy and a dose increase of fenfluramine could be considered provided that it does not exceed twice the.

如果认为共同使用是必要的，应监测患者是否出现药效降低，并且在不超过两倍的情况下，可以考虑增加芬氟拉明的剂量。

maximum daily dose (52 mg/day). If a strong CYP1A2 or CYP2B6 inducer is discontinued during maintenance treatment with fenfluramine, consider gradual reduction of the fenfluramine dosage to the dose administered prior to initiating the inducer. Effect of CYP1A2 or CYP2D6 inhibitors: Initiation of concomitant treatment with a strong CYP1A2 or CYP2D6 inhibitor may result in higher exposure and, therefore, adverse events should be monitored, and a dose reduction may be needed in some patients.

最大日剂量（52毫克/天）。如果在使用芬氟拉明维持治疗期间停用强效CYP1A2或CYP2B6诱导剂，应考虑逐步减少芬氟拉明的剂量至诱导剂开始前的剂量。CYP1A2或CYP2D6抑制剂的影响：与强效CYP1A2或CYP2D6抑制剂同时开始治疗可能导致更高的暴露量，因此应监测不良事件，并且部分患者可能需要减少剂量。

Excipients: Contains sodium ethyl para-hydroxybenzoate (E 215) and sodium methyl para-hydroxybenzoate (E 219) - may cause allergic reactions.

辅料：含乙基对羟基苯甲酸钠（E 215）和甲基对羟基苯甲酸钠（E 219）- 可能引起过敏反应。

(possibly delayed). It also contains sulfur dioxide (E 220) which may rarely cause severe hypersensitivity reactions and bronchospasm. Patients with rare glucose-galactose malabsorption should not take this medicine. The product contains less than 1 mmol sodium (23 mg) per the maximum daily dose of 12 mL; essentially ‘sodium-free’.

（可能有延迟）。它还含有二氧化硫 (E 220)，这可能会极少数情况下引起严重的过敏反应和支气管痉挛。患有罕见的葡萄糖-半乳糖吸收不良的患者不应服用此药。该产品在每日最大剂量12毫升中含钠少于1毫摩尔（23毫克）；基本上“无钠”。

Contains glucose - may be harmful to teeth. Interactions: Pharmacodynamic interactions with other CNS depressants increase the risk of aggravated central nervous system depression. An.

含有葡萄糖——可能对牙齿有害。相互作用：与其他中枢神经系统抑制剂的药效学相互作用会增加中枢神经系统抑制加重的风险。

increase in dose may be necessary when coadministered with rifampicin or a strong CYP1A2 or CYP2B6 inducer. In in vitro studies coadministration with a strong CYP1A2 or CYP2D6 inhibitor may result in higher exposure (see section 4.4 of the SmPC). Coadministration with CYP2D6 substrates or MATE1 substrates may increase their plasma concentrations.

当与利福平或强效CYP1A2或CYP2B6诱导剂联合使用时，可能需要增加剂量。在体外研究中，与强效CYP1A2或CYP2D6抑制剂联合使用可能导致更高的暴露量（见SmPC第4.4节）。与CYP2D6底物或MATE1底物联合使用可能会增加其血浆浓度。

Co-administration with CYP2B6 or CYP3A4 substrates may decrease their plasma concentrations. Pregnancy and lactation: Limited data in pregnant women. As a precaution, avoid use of Fintepla in pregnancy. It is unknown whether fenfluramine/metabolites are excreted in human milk. Animal.

与CYP2B6或CYP3A4底物共同给药可能会降低其血浆浓度。妊娠与哺乳：孕妇中的数据有限。作为预防措施，避免在妊娠期间使用Fintepla。目前尚不清楚芬氟拉明/代谢物是否会排泄到人乳中。动物研究显示。

data have shown excretion of fenfluramine/metabolites in milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Fintepla taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Drive and use machines: Fintepla has moderate influence on the ability to drive/ use machines as it may cause somnolence and fatigue.

数据显示芬氟拉明/代谢物会排泄到乳汁中。必须权衡母乳喂养对婴儿的益处以及治疗对女性的益处，以决定是否停止哺乳或停止/避免使用Fintepla。驾驶和操作机器：Fintepla对驾驶/操作机器的能力有中度影响，因为它可能引起嗜睡和疲劳。

Advise patients not to drive or operate machinery until they have sufficient experience to gauge whether it adversely.

建议患者在没有足够经验来判断是否会产生不良影响之前，不要驾驶或操作机器。

affects their abilities.

影响他们的能力。

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，这些均被认为是生理性的）。

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、肌张力低下、嗜睡、癫痫发作、癫痫持续状态、震颤、便秘、唾液分泌过多、体重减轻和血泌乳素升高。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.

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。

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/fintepla-epar-product-information_en.pdf

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

.

。

FINTEPLA

FINTEPLA

®

®

is a registered trademark of the U

是美国的注册商标

References

参考文献

Fintepla

芬特普

®

®

EU SmPC. Available at:

欧盟药品特性摘要。可于以下网址获取：

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

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

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最后访问时间：2025年9月。

Knupp K, Scheffer I, Schoonjans A, et al. Final analysis from an open-label extension study of fenfluramine for the treatment of seizures in Lennox-Gastaut syndrome: long-term impact on patients and caregivers. Epilepsy & Behavior. 2025;173:110753.

Knupp K，Scheffer I，Schoonjans A，等。芬氟拉明治疗Lennox-Gastaut综合征癫痫发作的开放标签扩展研究最终分析：对患者和护理人员的长期影响。《癫痫与行为》。2025；173：110753。

Scheffer IE, Nabbout R, Lagae L, et al. Long-term safety and effectiveness of fenfluramine in children and adults with Dravet syndrome. Epilepsia. 2025;66(6):1919-32.

Scheffer IE, Nabbout R, Lagae L, 等。芬氟拉明在Dravet综合征儿童和成人中的长期安全性和有效性。《癫痫》。2025;66(6):1919-32。

Fintepla® US PI. Available at:

Fintepla® 美国处方信息。可于：

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

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

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最后访问时间：2025年9月。

Fintepla Japan PI. Available at:

Fintepla日本处方信息。可于以下网址获取：

フィンテプラ内用液2.2mg/mL (pmda.go.jp)

芬特普拉内服液2.2mg/mL (pmda.go.jp)

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最后访问时间：2025年9月。

NORD. LGS. Available at:

北欧。LGS。可用地址：

https://rarediseases.org/rare-diseases/lennox-gastaut-syndrome

https://rarediseases.org/rare-diseases/lennox-gastaut-syndrome

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Specchio N, Wirrell EC, Scheffer IE, et al. International League Against Epilepsy classification and definition of epilepsy syndromes with onset in childhood: Position paper by the ILAE Task Force on Nosology and Definitions. Epilepsia. 2022;63(6):1398-442.

斯佩基奥 N，维尔雷尔 EC，舍费尔 IE，等。国际抗癫痫联盟儿童期发病的癫痫综合征分类与定义：ILAE术语和定义工作组立场文件。《癫痫》杂志，2022年；63卷（6期）：1398-442页。

LGS Foundation. Sudden Unexpected Death in Epilepsy (SUDEP). Available at:

LGS基金会。癫痫猝死（SUDEP）。可用链接：

https://www.lgsfoundation.org/sudep/

https://www.lgsfoundation.org/sudep/

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