2013年4月29日美国食品和药品监管局(FDA)批准Kcentra(人凝血酶原复合浓缩物Prothrombin Complex Concentrate，Human)在有急性重大出血成年中为紧迫逆转维生素K拮抗剂(VKA)的抗凝作用。在美国血浆是唯一被批准使用的其他产品。
在有些条件下，例如房颤或存在一个人工心脏瓣膜，为了预防血液凝固用华法林[warfarin]和其他VKA抗凝剂治疗，患者接受慢性抗凝作用治疗有时发生急性出血。像血浆一样，Kcentra是与维生素K联合使用，逆转抗凝作用效应和停止出血。与血浆不一样，Kcentra不需要血型或解冻，所以可能比冰冻血浆更迅速给予。
生物制品评价和研究中心主任Karen Midthun，M.D说：“FDA这个新产品的批准给予医生当决定如何治疗紧迫逆转VKA抗凝作用患者时一个选择”。“Kcentra在给予推荐剂量给药时以比血浆显著较低体积，为不能耐受逆转VKA抗凝作用需要血浆体积的患者提供另一种选择”。
Kcentra对适应证使用时伴有发生血凝块，而带有关血凝块风险的黑框警告。警告还解释应监视接受Kcentra患者血栓栓塞事件的体征和症状，因为临床试验和上市后监察都曾报道致命性和非致命性动脉和静脉血栓栓塞并发症。
Kcentra 是从健康供体合并血浆制造。制造过程是以缩小传播病毒和其他疾病风险方式制造。FDA 批准Kcentra 是根据一项216例曾接受 VKA抗凝作用和有急性重大出血随着凝血试验 值指示抗凝剂使用患者的研究。证实Kcentra 阻止急性重大出血方面的能力与血浆相似。
药物由总部在德国墨墨尔本的CSL Behring制造。
批准日期：4月29，2013；公司：CSL Behring.
KCENTRA(人凝血酶原浓缩物[ Prothrombin Complex Concentrate (Human)])
为静脉使用，为配制冻干粉
适应证和用途
Kcentra，凝血酶原复合浓缩物(人)，适用为由维生素K拮抗剂(VKA，如，华法林)治疗诱发有急性重大出血在成年患者紧迫逆转获得性凝血因子缺乏症。
在为紧迫逆转VKA抗凝作用无急性重大出血患者中不适用Kcentra。
剂量和给药方法
只为静脉使用。
（1）应根据患者的基线国际标准化比值(INR)值，和体重个体化给药。
（2）对接受 Kcentra患者一旦Kcentra影响已消失同时地给予维生素K以维持因子水平。
（3）临床数据不支持重复给予和不推荐。
（4）以0.12 mL/kg/min速率(~3 units/kg/min)直至最大速率8.4 mL/min(~210 units/min.)给予配置好的Kcentra。

剂型和规格
(1)可得到的Kcentra为含凝血因子II，VII，IX和X，和抗血栓蛋白C和S为冻干浓缩物。
禁忌证
以下患者禁忌使用Kcentra：
（1）已知对Kcentra或Kcentra中任何组分包括肝素，因子II，VII，IX，X，蛋白C和S，抗凝血酶 III和人白蛋白过敏或严重全身反应。
（2）弥散性血管内凝血。
（3）已知肝素-诱发血小板减少。Kcentra含肝素。
警告和注意事项
（1）可能发生超敏性反应。如有必要，终止给药和实行适当治疗。
（2）接受Kcentra患者中曾报道动脉和静脉血栓栓塞并发症。接受Kcentra患者监视栓栓塞事件体征和症状。尚未在3个月以前内有血栓形成或血栓栓塞 (TE)事件受试者中研究Kcentra。在个月以前中有血栓栓塞事件患者可能不宜使用Kcentra。
（3）Kcentra是从人血制造和可能携带传播传染性病原体风险，如，病毒，Creutzfeldt-Jakob病(vCJD)病原体变种，和理论上，Creutzfeldt-Jakob病(CJD)病原体。
不良反应
（1）接受Kcentra受试者中观察到最常见不良反应(ARs)(频数 ≥2.8%)是头痛，恶心/呕吐，关节痛，和低血压。
（2）最严重ARs是血栓栓塞事件包括卒中，肺栓塞，和深部静脉血栓形成。
特殊人群中使用-
妊娠：无人或动物资料。只有明确需求才使用。

Important Safety Information
Kcentra™, Prothrombin Complex Concentrate (Human) is indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA—eg, warfarin) therapy in adult patients with acute major bleeding. Kcentra is not indicated for urgent reversal of VKA anticoagulation in patients without acute major bleeding. Kcentra is for intravenous use only.
Warning: Patients being treated with Vitamin K antagonist therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the risk of thromboembolic events, especially in patients with history of such events. Resumption of anticoagulation therapy should be carefully considered once the risk of thromboembolic events outweighs the risk of acute bleeding. Both fatal and nonfatal arterial and venous thromboembolic complications have been reported in clinical trials and postmarketing surveillance. Monitor patients receiving Kcentra, and inform them of signs and symptoms of thromboembolic events. Kcentra was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation (DIC), cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months. Kcentra might not be suitable for patients with thromboembolic events in the prior 3 months.
Kcentra is contraindicated in patients with known anaphylactic or severe systemic reactions to Kcentra or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). Kcentra is also contraindicated in patients with DIC. Because Kcentra contains heparin, it is contraindicated in patients with heparin-induced thrombocytopenia (HIT).
Hypersensitivity reactions to Kcentra may occur. If patient experiences severe allergic or anaphylactic type reactions, discontinue administration and institute appropriate treatment.
In clinical trials, the most frequent (≥2.8%) adverse reactions observed in subjects receiving Kcentra were headache, nausea/vomiting, arthralgia, and hypotension. The most serious adverse reactions were thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.
Kcentra is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
The safety and efficacy of Kcentra in pediatric use have not been studied, and Kcentra should be used in women who are pregnant or nursing only if clearly needed.
Please see full prescribing information for Kcentra.