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Zulresso injection 100mg/20mL(brexanolone)
药店国别  
产地国家 美国 
处 方 药: 是 
所属类别 100毫克/20毫升(5毫克/毫升)/瓶 
包装规格 100毫克/20毫升(5毫克/毫升)/瓶 
计价单位: 瓶 
生产厂家中文参考译名:
Sage Therapeutics,Inc
生产厂家英文名:
Sage Therapeutics,Inc
该药品相关信息网址1:
https://www.sagerx.com/
该药品相关信息网址2:
该药品相关信息网址3:
原产地英文商品名:
Zulresso injection 100mg/20mL(5mg/mL)/Vial
原产地英文药品名:
brexanolone
中文参考商品译名:
Zulresso注射溶液 100毫克/20毫升(5毫克/毫升)/瓶
中文参考药品译名:
brexanolone
曾用名:
简介:

 

ZULRESSO(brexanolone)注射溶液,获FDA批准为首次和唯一一种特别适用于产后抑郁症的治疗方法.
近日,美国食品和药物管理局(FDA)已批准Zulresso(brexanolone)注射液,用于治疗产后抑郁症(PPD),这是一种最常见的分娩并发症。此次批准,使Zulresso成为全球首个也是唯一一个专门被批准治疗PDD的药物,将改变PPD的临床治疗模式。
批准日期:2019年3月20日 公司:Sage Therapeutics,Inc
ZULRESSOTM(brexanolone)注射液,用于静脉注射[受控物质待定]
美国最初批准:[待定受控物质调度]
警告:过度的日常生活和突然的损失意识.查看完整的盒装警告的完整处方信息。
•患者在服用ZULRESSO期间有过度镇静或突然丧失意识的风险。
•由于存在严重伤害的风险,必须监测患者的过度镇静和突然意识丧失,并进行连续脉搏血氧饱和度监测。患者必须在与孩子互动时陪伴。
•ZULRESSO仅通过名为ZULRESSO REMS的受限程序提供。
作用机制
苯来松酮在成人PPD治疗中的作用机制尚不完全清楚,但被认为与其对GABAA受体的正向变构调节有关。
适应症和用法
ZULRESSO是一种神经活性类固醇γ-氨基丁酸(GABA)受体阳性调节剂,适用于治疗成人产后抑郁症(PPD)。
剂量和给药
•必须在现场提供医疗服务提供者,以便持续监控患者,并在输液期间根据需要进行干预。
•在60小时(2.5天)内连续静脉输注如下:
o 0至4小时:以30 mcg/kg/小时的剂量开始
o 4至24小时:增加剂量至60 mcg/kg/小时
o 24至52小时:将剂量增加至90 mcg/kg/小时(或者对于那些不能耐受90mcg/kg /小时的人,考虑60mcg/kg/小时的剂量)
o 52至56小时:减少剂量至60 mcg/kg/小时
o 56至60小时:减少剂量至30 mcg/kg/小时
•给药前需要稀释。
剂量形式和强度
注射:100mg/20mL(5mg/mL)单剂量小瓶。
禁忌症
没有。
警告和注意事项
自杀的想法和行为:考虑改变治疗方案,包括停止ZULRESSO,在PPD变得更糟或经历新出现的自杀念头和行为的患者中。
不良反应
最常见的不良反应(发生率≥5%,至少是安慰剂的两倍)是镇静/嗜睡,口干,意识丧失和冲洗/热潮红。
要报告疑似不良反应,请联系Sage Therapeutics,Inc。电话1-844-4-SAGERX(1-844-472-4379),或联系FDA,电话1-800-FDA-1088或www.fda.gov/medwatch
用于特定人群
•怀孕:可能导致胎儿伤害。
•避免用于终末期肾病(ESRD)患者。
包装提供/存储和处理
提供
ZULRESSO注射剂以20毫克(5毫克/毫升)单剂量小瓶中的100毫克brexanolone提供,该小瓶含有无菌,无防腐剂,透明,无色的溶液。NDC 72152-547-20
存储和处理
将未稀释的ZULRESSO产品储存在2°C至8°C(36°F至46°F)的温度下。不要冻结。避光存储保护。
输液袋中的稀释产品可在室温下使用长达12小时。如果稀释后不立即使用稀释产品,则在冷藏条件下储存长达96小时[见剂量和用法]。
完整说明书资料附件:https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211371lbl.pdf
Sage Therapeutics Announces FDA Approval of ZULRESSO (brexanolone) Injection, the First and Only Treatment Specifically Indicated for Postpartum Depression
The U.S. Food and Drug Administration today approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA specifically for PPD.
"Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond. This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option," said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA’s Center for Drug eva luation and Research. "Because of concerns about serious risks, including excessive sedation or sudden loss of consciousness during administration, Zulresso has been approved with a Risk eva luation and Mitigation Strategy (REMS) and is only available to patients through a restricted distribution program at certified health care facilities where the health care provider can carefully monitor the patient."
PPD is a major depressive episode that occurs following childbirth, although symptoms can start during pregnancy. As with other forms of depression, it is characterized by sadness and/or loss of interest in activities that one used to enjoy and a decreased ability to feel pleasure (anhedonia) and may present with symptoms such as cognitive impairment, feelings of worthlessness or guilt, or suicidal ideation.
Zulresso will be available only through a restricted program called the Zulresso REMS Program that requires the drug be administered by a health care provider in a certified health care facility. The REMS requires that patients be enrolled in the program prior to administration of the drug. Zulresso is administered as a continuous IV infusion over a total of 60 hours (2.5 days). Because of the risk of serious harm due to the sudden loss of consciousness, patients must be monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring (monitors oxygen levels in the blood). While receiving the infusion, patients must be accompanied during interactions with their child(ren). The need for these steps is addressed in a Boxed Warning in the drug’s prescribing information. Patients will be counseled on the risks of Zulresso treatment and instructed that they must be monitored for these effects at a health care facility for the entire 60 hours of infusion. Patients should not drive, operate machinery, or do other dangerous activities until feelings of sleepiness from the treatment have completely gone away.
The efficacy of Zulresso was shown in two clinical studies in participants who received a 60-hour continuous intravenous infusion of Zulresso or placebo and were then followed for four weeks. One study included patients with severe PPD and the other included patients with moderate PPD. The primary measure in the study was the mean change from baseline in depressive symptoms as measured by a depression rating scale. In both placebo controlled studies, Zulresso demonstrated superiority to placebo in improvement of depressive symptoms at the end of the first infusion. The improvement in depression was also observed at the end of the 30-day follow-up period.
The most common adverse reactions reported by patients treated with Zulresso in clinical trials include sleepiness, dry mouth, loss of consciousness and flushing. Health care providers should consider changing the therapeutic regimen, including discontinuing Zulresso in patients whose PPD becomes worse or who experience emergent suicidal thoughts and behaviors. 

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