英文药名：BRIVIACT(brivaracetam filmcoated tablets) 中文药名：布瓦西坦薄膜片 生产厂家：UCB制药 药品介绍 近日，欧盟正式批准Briviact（Brivaracetam，布瓦西坦）作为辅助药物用于伴或不伴继发全身性发作的成人和16岁及以上青少年癫痫患者的部分性发作的治疗新选择。 BRIVIACT®(布瓦西坦 brivaracetam)片，为口服使用 初次批准：2016 作用机制 不知道BRIVIACT发挥其抗惊厥活性的精准机制。布瓦西坦显示一个高度和选择性亲和力对在脑中突触小泡蛋白2A(SV2A)，这可能有助于抗惊厥作用。 适应证和用途 BRIVIACT是适用为作为辅助治疗在16岁和以上有癫痫患者部分发作性癫痫的治疗。 剂量和给药方法 ⑴ 推荐起始剂量是50mg每天2次。根据个体患者耐受性和治疗反应，剂量可能被向下调整至25mg每天2次(50mg每天)或至100mg每天2次(200mg每天)。 ⑵ 当口服给药是短暂不可行可能使用BRIVIACT注射液。 ⑶ 肝受损：对肝受损的所有期，推荐起始剂量是25mg每天2次；最大剂量是75 mg每天2次。 剂型和规格 ⑴片：10mg，25mg，50mg，75mg，和100mg ⑵ 口服溶液：10mg/mL ⑶ 注射液：50mg/5mL单剂量小瓶 禁忌证 对布瓦西坦或在BRIVIACT中无活性成分的任何超敏性。 警告和注意事项 ⑴  自杀行为和意念：对患者监视自杀行为和意念。 ⑴ 神经学不良反应：对睡意和疲乏监视，和忠告患者不要驾驶或操作机械直至他们对BRIVIACT已得到充分经验。 ⑵ 精神学不良反应：行为反应包括精神症状，易怒，抑郁，攻击性行为，和焦虑；对患者监视症状。 ⑶ 超敏性：支气管痉挛和血管水肿：告知患者寻求立即医学护理。如发生超敏性终止和不要再开始BRIVIACT。 ⑷ 抗癫痫药撤药：BRIVIACT应被逐步地撤去。 不良反应 最常见不良反应(对BRIVIACT至少5%和至少比安慰剂更频2%)是睡意/镇静，眩晕，疲乏，和恶心/呕吐。 药物相互作用 ⑴ 利福平[Rifampin]：因为减低的BRIVIACT浓度，建议同时用利福平患者中增加BRIVIACT 剂量。 ⑵ 卡马西平[Carbamazepine]：因为对卡马西平代谢物增加的暴露，如出现耐受性问题，同时用BRIVIACT患者中考虑减低卡马西平剂量。 ⑶ 苯妥英[Phenytoin]：因为苯妥英浓度可能增加，同时用BRIVIACT患者中应监视苯妥英水平。 ⑷ 左乙拉西坦[Levetiracetam]：当与左乙拉西坦共同给药BRIVIACT不增加治疗获益。 在特殊人群中使用 妊娠：根据动物数据，可能致胎儿危害。 包装规格（注：以下产品德国上市包装，不同规格和不同价格，购买以咨询为准） 薄膜衣片： 10毫克： 14片、56片 25毫克： 14片、56片、168片 50毫克： 14片、56片、168片 75毫克： 14片、56片、168片 100毫克：14片、56片、168片 生产厂家：UCB制药S.A. 完整使用资料附件：http://www.medicines.org.uk/emc/medicine/31452 Briviact film-coated tablets(brivaracetam) - BRIVIACT® (brivaracetam), a new molecular entity, is indicated as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy - The approximately 30% of people with epilepsy whose seizures remain uncontrolled on currently available therapies can experience devastating physical and emotional consequences as a result - Phase 3 data showed BRIVIACT® significantly reduced the frequency of partial-onset seizures over placebo IMPORTANT SAFETY INFORMATION Warnings and Precautions •Suicidal Behavior and Ideation: 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. •Neurological Adverse Reactions: BRIVIACT causes somnolence, fatigue, dizziness, and disturbance in coordination. Somnolence and fatigue-related adverse reactions were reported in 25% of patients taking at least 50 mg per day of BRIVIACT compared to 14% of patients taking placebo. Dizziness and disturbance in gait and coordination were reported in 16% of patients taking at least 50 mg per day of BRIVIACT compared to 10% of patients taking placebo. The risk is greatest early in treatment but can occur at any time. Monitor patients for these signs and symptoms and advise them not to drive or operate machinery until they have gained sufficient experience on BRIVIACT. •Psychiatric Adverse Reactions: BRIVIACT causes psychiatric adverse reactions, including non-psychotic and psychotic symptoms. These events were reported in approximately 13% of patients taking at least 50 mg per day of BRIVIACT compared to 8% of patients taking placebo. A total of 1.7% of adult patients taking BRIVIACT discontinued treatment due to psychiatric reactions compared to 1.3% of patients taking placebo. Advise patients to report these symptoms immediately to a healthcare provider. •Hypersensitivity: 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. •Withdrawal of Antiepileptic Drugs: As with all antiepileptic drugs, BRIVIACT should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. Adverse Reactions The most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) are somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms. http://www.kxxv.com/story/31265654/us-fda-approves-ucbs-new-epilepsy-treatment-briviact-for-patients-with-partial-onset-seizures