英文药名：KENGREAL(cangrelor for injection, for intravenous) 中文药名：坎格雷洛冻干粉注射剂 生产厂家：CHIESI USA INC 药品介绍 美国FDA批准新抗血小板药在心脏操作期间使用。 FDA的药品评价和研究中心心血管和肾脏药部主任Norman Stockbridge，M.D.，Ph.D.说：“对进行经皮冠状动脉介入治疗患者，凝血可致严重问题，”，“Kengreal的批准为患者提供另外治疗选择。” 批准日期：2015年6月22日；公司：CHIESI USA INC KENGREAL™注射用(坎格雷洛[cangrelor])，为静脉使用说明 美国初次批准：2015 作用机制 坎格雷洛是一种直接P2Y12血小板受体抑制剂阻断ADP-诱发的血小板激活和集聚。坎格雷洛与P2Y12受体选择性地和可逆地结合阻止进一步信号和血小板激活。  适应症和用途 KENGREAL是一种P2Y12血小板抑制剂在未曾用过P2Y12血小板抑制剂和没有正在给予一种糖蛋白IIb/IIIa抑制剂患者中适用为一种辅助经皮冠状动脉介入治疗(PCI)为减低围手术期心肌梗死(MI)，重复冠状动脉血运重建，和支架血栓形成(ST)的风险。 剂量和给药方法 ⑴KENGREAL是意向为通过一条专用IV线，只在重建和稀释后给药。 ⑵PCI前给予30g/kg静脉(IV)推注接着立刻通过4μg/kg/min IV输注至少2小时或手术操作前，以较长者为准。 ⑶ 维持血小板抑制KENGREAL输注的终止后，应继续给予P2Y12血小板抑制剂。 剂型和规格 单次使用10mL小瓶含为重建冰冻干燥粉50mg KENGREAL。 禁忌证 ⑴显著活动性出血。 ⑵对KENGREAL或产品任何组分超敏性。 警告和注意事项 出血：像抑制血小板P2Y12功能其他药物，KENGREAL可增加出血的风险。 不良反应 最常见不良反应是出血。 药物相互作用 氯吡格雷：KENGREAL输注期间不要给予。 普拉格雷[Prasugrel]： KENGREAL输注期间不要给予。 包装供应/贮存和处置 KENGREAL 50MG VL 10X10ML CANGRELOR TETRASODIUM  NDC：10122062010 KENGREAL小瓶应被贮存在美国药典USP控制室温，[20°C至25°C(68°F至77°F)与外出允许在15°C和30°C(59°F和86°F)间]。 完整资料附件：https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204958lbl.pdf KENGREAL(cangrelor) for Injection General Information Kengreal (cangrelor) is a direct P2Y12 platelet receptor inhibitor that blocks ADP-induced platelet activation and aggregation. Cangrelor binds selectively and reversibly to the P2Y12 receptor to prevent further signaling and platelet activation. Kengreal is specifically indicated as an adjunct to percutaneous coronary intervention for reducing the risk of periprocedural myocardial infarction, repeat coronary revascularization, and stent thrombosis in patients in who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor. Kengreal is supplied as asterile white to off-white lyophilized powder for reconstitution into an IV infusion. The recommended dosage is a 30 mcg/kg IV bolus followed immediately by a 4 mcg/kg/min IV infusion. Initiate the bolus infusion prior to PCI. The maintenance infusion should ordinarily be continued for at least 2 hours or for the duration of PCI, whichever is longer. IMPORTANT SAFETY INFORMATION KENGREAL® (cangrelor) for Injection is contraindicated in patients with significant active bleeding. KENGREAL® is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to cangrelor or any component of the product. Drugs that inhibit platelet P2Y12 function, including KENGREAL®, increase the risk of bleeding. In CHAMPION PHOENIX, bleeding events of all severities were more common with KENGREAL® than with clopidogrel. Bleeding complications with KENGREAL® were consistent across a variety of clinically important subgroups. Once KENGREAL® is discontinued, there is no antiplatelet effect after an hour. The most common adverse reaction is bleeding. INDICATION KENGREAL® (cangrelor) for Injection is a P2Y12 platelet inhibitor indicated as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor. https://kengreal.com/dosing-and-administration/