近日，新型抗癫痫药物Briviact（Brivaracetam，布瓦西坦）已被美国食品药品管理局（FDA）批准用于治疗16岁及以上癫痫患者的局部性癫痫发作。
FDA药品评价和研究中心中神经学产品部主任Billy Dunn，M.D.说：“患者对可得到的各种癫痫发作药物可能有不同反应，” “随Briviact的批准，我感到高兴患者对癫痫有新治疗选择。”
批准日期：2016年2月19日；公司：UCB, Inc
BRIVIACT®(布瓦西坦 brivaracetam)片，为口服使用
BRIVIACT®(布瓦西坦 brivaracetam)口服溶液
BRIVIACT®(布瓦西坦 brivaracetam)注射液，为静脉使用
美国初次批准：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：10 mg/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。
报告怀疑不良反应，联系UCB，Inc.电话1-844-599-2273或FDA电话1-800-FDA-1088或www.fda.gov/medwatch。
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。
供应/贮存和处置[注：以下产品不同规格和不同价格，采购以咨询为准]
供应
BRIVIACT片
● 10mg是白色至淡白色，圆，膜包衣，和一侧凹陷有"u10"。它们被供应如下:
60片瓶 NDC 50474-370-66
● 25mg是灰色，椭圆，膜包衣，和一侧凹陷有"u25"。它们被供应如下：
60片瓶 NDC 50474-470-66
100片单元剂量纸盒 NDC 50474-470-09
● 50mg是黄色，椭圆，膜包衣，和一侧凹陷有"u50"。它们被供应如下：
60片瓶 NDC 50474-570-66
100片单元剂量纸盒 NDC 50474-570-09
● 75mg是紫色，椭圆，膜包衣，和一侧凹陷有“u75”，它们被供应如下：
60片瓶 NDC 50474-670-66
● 100 mg是绿灰色，椭圆，膜包衣，和一侧凹陷有“u100”。它们被供应如下：
60片瓶 NDC 50474-770-66
100片单元剂量纸盒 NDC 50474-770-09
BRIVIACT口服溶液
● 10mg/mL是一个略微粘稠，透明，无色至淡黄色，覆盆子味的液体。在棕色玻璃瓶内供应:
300 mL瓶 NDC 50474-870-15
BRIVIACT注射液
● 50mg/5 mL是一个透明，无色，无菌溶液在无色单剂量玻璃小瓶内供应。
10小瓶纸盒 NDC 50474-970-75
16.2 贮存和处置
贮存在25°C(77°F)；外出允许15°C至30°C(59°F至86°F)间。见USP控制室温。
不要冻结BRIVIACT注射液或口服溶液。
遗弃首次打开瓶保留5个月后的任何未使用BRIVIACT口服溶液。
BRIVIACT注射液小瓶是仅为单剂量使用[见剂量和给药方法]。
INDICATION
BRIVIACT® (brivaracetam) is indicated as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy.
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.