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Vyndaqel 20mg capsules(tafamidis meglumine 氯苯唑酸葡甲胺胶囊)
药店国别  
产地国家 美国 
处 方 药: 是 
所属类别 20毫克/粒 120粒/盒 
包装规格 20毫克/粒 120粒/盒 
计价单位: 盒 
生产厂家中文参考译名:
辉瑞公司
生产厂家英文名:
Pfizer
该药品相关信息网址1:
https://www.vyndaqel.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:
Vyndaqel 20mg/capsules 120capsules/box
原产地英文药品名:
tafamidis meglumine
中文参考商品译名:
Vyndaqel胶囊 20毫克/粒 120粒/盒
中文参考药品译名:
氯苯唑酸葡甲胺
曾用名:
简介:

 

近日,美国食品药品监督管理局(FDA)已批准VYNDAQEL(tafamidis meglumine)和VYNDAMAX(tafamidis)用于治疗成年人野生型或遗传型转甲状腺素蛋白淀粉样变心肌病(ATTR-CM),以降低心血管相关死亡率和住院率。
VYNDAQEL和VYNDAMAX是首个转甲状腺素蛋白稳定剂氯苯唑酸的两种口服制剂,也是第一个且目前唯一获得FDA批准治疗ATTR-CM的药物。
转甲状腺素蛋白淀粉样变心肌病是一种罕见的致死性疾病,其特点是错误折叠的蛋白质形成异常物质(淀粉样物质)沉积于心脏,表现为限制性心肌病和进行性心力衰竭。既往并没有获批治疗ATTR-CM的药物;可用的治疗方案仅仅包括对症治疗,在个别情况下进行心脏(或心脏与肝脏)移植。目前在美国大约有10万ATTR-CM患者,其中确诊的患者仅占1-2%。
批准日期:2019年5月6日  公司:辉瑞
YNDAQEL(tafamidis meglumine)胶囊,用于口服
初始美国批准:2019年
VYNDAMAX TM(tafamidis)胶囊,用于口服给药
初始美国批准:2019年
作机制
Tafamidis是TTR的选择性稳定剂。Tafamidis在甲状腺素结合位点与TTR结合,稳定化合物并减缓解离成单体,这是淀粉样蛋白形成过程中的限速步骤。
适应症和用法
VYNDAQEL和VYNDAMAX是转甲状腺素蛋白稳定剂,用于治疗野生型或遗传性心肌病
转甲状腺素介导的成人淀粉样变性,可降低心血管死亡率和心血管相关住院率。
剂量和用量
推荐剂量为:
VYNDAQEL每天口服80毫克,或
VYNDAMAX每天口服61毫克
VYNDAMAX和VYNDAQEL不能以每mg为基础进行替代。
剂量形式和强度
胶囊:Tafamidis葡甲胺20mg和tafamidis 61mg。
禁忌症
无。
要报告疑似不良反应,请致电1-800-438-1985联系辉瑞公司或1-800-FDA-1088或www.fda.gov/medwatch联系FDA。
用于特定人群
怀孕:根据动物研究,可能会导致胎儿伤害。
哺乳期:建议不要母乳喂养。
包装提供/存储和处理
VYNDAQEL 20mg(tafamidis葡甲胺)软明胶胶囊是黄色,不透明,椭圆形,并用“VYN 20”印刷。
VYNDAQEL胶囊
规格
20毫克   NDC:6609-1975-40
包配置
纸箱的4个中间纸箱。每个中间纸箱包含3个吸塑卡。每个泡罩卡包含10个胶囊。(总共120个胶囊)
VYNDAMAX 61毫克(tafamidis)软明胶胶囊为红棕色,不透明,长圆形,并印有
VYNDAMAX胶囊
规格
61毫克   NDC:6609-8730-30
包配置
纸箱的3个吸塑卡。每个吸塑卡含有10粒胶囊。(总共30粒)
将VYNDAQEL和VYNDAMAX储存在20°C至25°C(68°F至77°F)的受控室温下;允许温度为15°C至30°C(59°F至86°F)[参见USP受控室]。温度
完整说明书资料附件:http://labeling.pfizer.com/ShowLabeling.aspx?id=11685
U.S. FDA Approves VYNDAQEL and VYNDAMAX for Use in Patients with Transthyretin Amyloid Cardiomyopathy, a Rare and Fatal Disease
U.S. Food and Drug Administration (FDA) has approved both VYNDAQEL® (tafamidis meglumine) and VYNDAMAX™ (tafamidis) for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. VYNDAQEL and VYNDAMAX are two oral formulations of the first-in-class transthyretin stabilizer tafamidis, and the first and only medicines approved by the FDA to treat ATTR-CM.
Transthyretin amyloid cardiomyopathy is a rare, life-threatening disease characterized by the buildup of abnormal deposits of misfolded protein called amyloid in the heart and is defined by restrictive cardiomyopathy and progressive heart failure. Previously, there were no medicines approved to treat ATTR-CM; the only available options included symptom management, and, in rare cases, heart (or heart and liver) transplant. It is estimated that the preva lence of ATTR-CM is approximately 100,000 people in the U.S. and only one to two percent of those patients are diagnosed today.
“The approvals of VYNDAQEL and VYNDAMAX are a testament to the significant research and development investment in our innovative cardiovascular outcomes trial, ATTR-ACT. We are proud to bring these medicines to ATTR-CM patients who are in dire need of treatment,” said Brenda Cooperstone, MD, Senior Vice President and Chief Development Officer, Rare Disease, Pfizer Global Product Development. “VYNDAQEL and VYNDAMAX reduce cardiovascular mortality and the frequency of cardiovascular-related hospital stays in patients with wild-type or hereditary forms of this rare disease, giving them a chance for more time with their loved ones.”
“Pfizer's purpose is to deliver breakthrough medicines that change patients' lives. The approvals of VYNDAQEL and VYNDAMAX deliver on this promise for patients with ATTR-CM,” said Paul Levesque, Global President, Rare Disease. “This milestone is a gamechanger for patients, who until today had no approved medicines for this rare, debilitating and fatal disease. We will continue to focus efforts on working with the physician community to increase awareness and ultimately detection and diagnosis of this disease.”
The recommended dosage is either VYNDAQEL 80 mg orally once-daily, taken as four 20 mg capsules, or VYNDAMAX 61 mg orally once-daily, taken as a single capsule. VYNDAMAX was developed for patient convenience; VYNDAQEL and VYNDAMAX are not substitutable on a per milligram basis.
“ATTR-CM is not only fatal, but also significantly underdiagnosed, with some patients cycling through multiple doctors and a myriad of tests over a period of years while the disease progresses,” said Isabelle Lousada, Founder and CEO, Amyloidosis Research Consortium. “ATTR-CM is a rare disease for which more education and awareness is needed.
The approval of these medicines represents an important advance for patients; however, it is equally important that we work as a community to recognize the critical importance of early diagnosis.”
The FDA approval was based on data from the pivotal Phase 3 Transthyretin Amyloidosis Cardiomyopathy Clinical Trial (ATTR-ACT), the first global, double-blind, randomized, placebo-controlled clinical study to investigate a pharmacological therapy for the treatment of this disease.
In ATTR-ACT, VYNDAQEL significantly reduced the hierarchical combination of all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo over a 30-month period (p=0.0006). Additionally, individual components of the primary analysis demonstrated a relative reduction in the risk of all-cause mortality and frequency of cardiovascular-related hospitalization of 30% (p=0.026) and 32% (p<0.0001), respectively, with VYNDAQEL versus placebo. Approximately 80% of total deaths were cardiovascular-related in both treatment groups. VYNDAQEL also had significant and consistent treatment effects compared to placebo on functional capacity and health status first observed at six months and continuing through 30 months. Specifically, VYNDAQEL reduced the decline in performance on the six-minute walk test (p<0.0001) and reduced the decline in health status as measured by the Kansas City Cardiomyopathy Questionnaire – Overall Summary score (p<0.0001). VYNDAQEL was well tolerated in this study, with an observed safety profile comparable to placebo.
The frequency of adverse events in patients treated with VYNDAQEL was similar to placebo, and similar proportions of VYNDAQEL-treated patients and placebo-treated patients discontinued the study drug because of an adverse event. 

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