产地国家：美国 处 方 药：是 所属类别：60毫克/片 60片/瓶 包装规格：60毫克/片 60片/瓶 计价单位：瓶 生产厂家中文参考译名：阿斯利康 生产厂家英文名：AstraZeneca 原产地英文商品名：Brilinta 60mg/tablet 60tablets/bottle 原产地英文药品名：ticagrelor 中文参考商品译名：Brilinta片 60毫克/片 60片/瓶 中文参考药品译名：替卡格雷

简介：

替卡格雷(Brilinta/ticagrelor)冠心病新药薄膜片获美国FDA批准，降低高危患者首次心脏病发作/中风风险。 近日，美国食品和药物管理局(FDA)已批准抗凝血剂Brilinta(ticagrelor 中文译名：替卡格雷)薄膜片，用于高危冠状动脉疾病(CAD)患者，降低首次心脏病发作或中风的风险。CAD是最常见的心脏病类型。 批准日期：2020年06月02日 公司：阿斯利康 Brilinta(替卡格雷[ticagrelor])片剂，供口服使用 美国初次批准：2011年 警告：(A)出血风险，以及(B)阿司匹林剂量和布林替尼有效 有关完整的盒装警告，请参阅完整的处方信息。 流血风险： •BRILINTA与其他抗血小板药一样，可能导致严重的出血，甚至致命的出血。 •对于活动性病理性出血或有颅内出血史的患者，请勿使用BRILINTA。 •请勿在接受紧急冠状动脉搭桥术(CABG)的患者中开始BRILINTA。 •如果可能，在不中断BRILINTA的情况下处理出血。停止BRILINTA会增加随后发生心血管事件的风险。 阿司匹林剂量和西林达效力 •每天维持100毫克以上阿司匹林的剂量会降低BRILINTA的有效性，应避免使用。 作用机理： 替卡格雷及其主要代谢产物可与血小板P2Y12 ADP受体可逆地相互作用，以防止信号转导和血小板活化。 替卡格雷(Ticagrelor)及其活性代谢物大致相等。 适应症和用途： BRILINTA是一种P2Y12血小板抑制剂 •降低患有急性冠脉综合征(ACS)或有MI史的患者发生心血管(CV)死亡，心肌梗塞(MI)和中风的风险。至少在ACS后的前12个月，它优于氯吡格雷。BRILINTA还可以降低已经接受支架治疗ACS的患者发生支架血栓的风险。 •降低发生此类事件的高风险冠心病(CAD)患者发生首次MI或中风的风险。尽管使用的方法不仅限于此设置，但BRILINTA的功效已在2型糖尿病(T2DM)人群中确立。 剂量和给药： •ACS或MI历史 在ACS的管理中，以180mg口服负荷剂量开始治疗。然后在第一年每天两次服用90毫克。一年后，每天两次服用60毫克。 •患有CAD且无中风或MI的患者 每天两次，每次60mg。 使用BRILINTA，阿司匹林的每日维持剂量为75-100mg。 剂量形式和强度：60mg和90mg片剂。 禁忌症： •颅内出血的历史。 •活动性病理性出血。 •对替卡格雷或产品任何成分过敏。 警告和注意事项： •在临床试验中，与对照药物相比，BRILINTA呼吸困难的发生率更高。BRILINTA的呼吸困难是自限性的。 •严重肝功能不全：可能增加替卡格雷的暴露量。 •实验室检查干扰：已报道肝素诱导的血小板减少症(HIT)的假阴性血小板功能检查结果。预计BRILINTA不会影响HIT的PF4抗体测试。 不良反应：最常见的不良反应(>5%)是出血和呼吸困难。 药物相互作用： •避免与强CYP3A抑制剂或CYP3A诱导剂一起使用；阿片类药物：减少替卡格雷的暴露；考虑使用肠胃外抗血小板药。 •每天接受超过40毫克辛伐他汀或洛伐他汀治疗的患者可能增加他汀类药物相关不良反应的风险。 •监测BRIGINTA开始或任何变化时的地高辛水平。 在特定人口中使用 •哺乳期：不建议母乳喂养。 包装供应/存储和处理方式：BRILINTA(替卡格雷)90 mg呈圆形，双凸，黄色，薄膜衣片，一侧的“ T”上方为“ 90”： 每瓶60–NDC 0186-0777-60 100计数医院单位剂量– NDC 0186-0777-39 BRILINTA(替卡格雷)60 mg呈圆形，双凸，粉红色，薄膜衣片，一侧的“ T”上方带有“ 60”： 每瓶60–NDC 0186-0776-60 储存：储存在25°C(77°F); 允许在15°至30°C(59°至86°F)的范围内进行偏移[请参阅USP控制的室温]。

英文说明书

US FDA APPROVES EXPANDED INDICATION FOR BRILINTA TO INCLUDE LONG-TERM USE IN PATIENTS WITH A HISTORY OF HEART ATTACK US Food and Drug Administration(FDA)has approved BRILINTA®(ticagrelor)tablets at a new 60mg dose to be used in patients with a history of heart attack beyond the first year. With this expanded indication, BRILINTA is now approved to reduce the rate of cardiovascular death, myocardial infarction(MI also known as heart attack)and stroke in patients with acute coronary syndrome (ACS)or a history of MI. BRILINTA is an oral antiplatelet treatment that works by inhibiting platelet activation and was first approved by the FDA in July 2011 on the basis of data from the PLATO study. For at least the first 12 months following ACS, it is superior to clopidogrel and is the first and only FDA approved oral antiplatelet to demonstrate superior reductions in CV death vs clopidogrel. BRILINTA also reduces the rate of stent thrombosis in patients who have been stented for the treatment of ACS.In the management of ACS, the recommended maintenance dose of BRILINTA is 90mg twice daily during the first year after an ACS event. After one year, patients with a history of heart attack can now be treated with 60mg twice daily. BRILINTA should be used with a daily maintenance dose of aspirin of 75-100mg. INDICATIONS BRILINTA is indicated to reduce the rate of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction.For at least the first 12months following ACS, it is superior to clopidogrel. BRILINTA also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS. DOSING In the management of ACS, initiate BRILINTA treatment with a 180-mg loading dose. Administer 90 mg twice daily during the first year after an ACS event. After one year administer 60 mg twice daily. Use BRILINTA with a daily maintenance dose of aspirin of 75-100 mg. IMPORTANT SAFETY INFORMATION FOR BRILINTA (ticagrelor) 60-MG AND 90-MG TABLETS WARNING:(A)BLEEDING RISK, (B) ASPIRIN DOSE AND BRILINTA EFFECTIVENESS A. BLEEDING RISK BRILINTA, like other antiplatelet agents, can cause significant, sometimes fatal bleeding Do not use BRILINTA in patients with active pathological bleeding or a history of intracranial hemorrhage Do not start BRILINTA in patients undergoing urgent coronary artery bypass graft surgery If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events B. ASPIRIN DOSE AND BRILINTA EFFECTIVENESS Maintenance doses of aspirin above 100 mg reduce the effectiveness of BRILINTA and should be avoided CONTRAINDICATIONS BRILINTA is contraindicated in patients with a history of intracranial hemorrhage or active pathological bleeding such as peptic ulcer or intracranial hemorrhage. BRILINTA is also contraindicated in patients with hypersensitivity(eg, angioedema)to ticagrelor or any component of the product WARNINGS AND PRECAUTIONS Dyspnea was reported in about 14% of patients treated with BRILINTA, more frequently than in patients treated with control agents. Dyspnea resulting from BRILINTA is often self-limiting Discontinuation of BRILINTA will increase the risk of MI, stroke, and death. When possible, interrupt therapy with BRILINTA for 5 days prior to surgery that has a major risk of bleeding. If BRILINTA must be temporarily discontinued, restart as soon as possible Avoid use of BRILINTA in patients with severe hepatic impairment. Severe hepatic impairment is likely to increase serum concentration of ticagrelor and there are no studies of BRILINTA in these patients ADVERSE REACTIONS The most common adverse reactions associated with the use of BRILINTA included bleeding and dyspnea: In PLATO, for BRILINTA vs clopidogrel, non-CABG PLATO-defined major bleeding (3.9% vs 3.3%) and dyspnea(14% vs 8%); in PEGASUS, BRILINTA vs aspirin alone, TIMI Total Major bleeding (1.7% vs 0.8%)and dyspnea (14% vs 6%) DRUG INTERACTIONS Avoid use with strong CYP3A inhibitors and strong CYP3A inducers. BRILINTA is metabolized by CYP3A4/5. Strong inhibitors substantially increase ticagrelor exposure and so increase the risk of adverse events. Strong inducers substantially reduce ticagrelor exposure and so decrease the efficacy of ticagrelor Patients receiving more than 40 mg per day of simvastatin or lovastatin may be at increased risk of statin-related adverse events Monitor digoxin levels with initiation of, or change in, BRILINTA therapy