新类重组FVIII药物OBIZUR（Antihemophilic Factor[Recombinant], Porcine Sequence）于2015年10月23日获美国FDA批准用于获得性A型血友病（获得性因子VIII [FVIII]缺乏）成人患者出血发作治疗。 obizur（抗血友病因子[重组]，猪序列）冻干粉为溶液   供静脉注射 批准日期:2014年10月24日；公司:BaxterInternationalInc. 美国初次批准：2014 作用机制 OBIZUR暂时取代对有获得性血友病A患者有效止血所需被抑制的内源性因子VIII。 适应证和用途 obizur，抗血友病因子(重组)，猪序列，是一种抗血友病因子适用在为有获得性血友病A成年中出血发作的治疗。 使用限制： ⑴尚未确定有基线抗-猪因子VIII抑制剂滴度大于20BU患者中obizur的安全性和疗效。 ⑵obizur不适用为先天性血友病A或血管性血友病[vonWillebranddisease]的治疗。 剂量和给药方法 只为重建后静脉使用。 ⑴obizur的初始剂量为200单位每3kg。 ⑵根据因子VIII回收水平和个体临床反应滴定调整剂量和给药频数。 剂型和规格 可以得到obizur为冻干粉为溶液在一次用小瓶含名义上500单位每小瓶。 禁忌证 在有对obizur或其组分，包括仓鼠蛋白危及生命超敏性反应患者不要使用。 警告和注意事项 ⑴可能发生超敏性反应，包括过敏反应。症状发生时终止obizur和给予适当治疗。 ⑵曾发生抑制性抗体发展。如未达到期望血浆因子VIII活性水平，或如用适当剂量出血不能控制，进行分析测量猪因子VIII抑制剂浓度。 不良反应 在临床试验中大于5%受试者观察到常见不良反应是发生对猪因子VIII抑制剂。 Obizur目前暂未在中国上市，国内客户若想购买此药可以联系美国连锁药房Haoeyou Pharmacy[好医友美国药房]寻求帮助。 如何供应/贮存和处置 供应 OBIZUR以白色冻干粉在一次用小瓶内以下列包装大小供应： 每个包装含一个包装插件和适当下面列出与小瓶包装大小相关的组分各自数量： ● 一次用小瓶OBIZUR [NDC 0944-5011-01] ●预装注射器与1mL无菌注射用水[NDC 0944-0011-01] ●小瓶适配器与滤器 在每个小瓶标签上说明真实的OBIZUR单位量。 OBIZUR [Antihemophilic Factor (Recombinant), Porcine Sequence] Lyophilized Powder for Solution for Intravenous Injection OBIZUR [Antihemophilic Factor (Recombinant), Porcine Sequence] Important Information Indication OBIZUR, Antihemophilic Factor (Recombinant), Porcine Sequence, is a recombinant DNA derived, antihemophilic factor indicated for the treatment of bleeding episodes in adults with acquired hemophilia A. Limitations of Use: •Safety and efficacy of OBIZUR has not been established in patients with baseline anti-porcine factor VIII inhibitor titer greater than 20 BU •OBIZUR is not indicated for the treatment of congenital hemophilia A or von Willebrand disease Detailed Important Risk Information CONTRAINDICATIONS OBIZUR is contraindicated in patients who have had life-threatening hypersensitivity reactions to OBIZUR or its components (including traces of hamster proteins). WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Hypersensitivity reactions can occur with OBIZUR. OBIZUR contains trace amounts of hamster proteins. Early signs of allergic reactions, which can progress to anaphylaxis, include angioedema, chest-tightness, dyspnea, hypotension, wheezing, urticaria, and pruritus. Immediately discontinue administration and initiate appropriate treatment if allergic or anaphylactic-type reactions occur. Inhibitory Antibodies Inhibitory antibodies to OBIZUR have occurred. Monitor patients for the development of antibodies to OBIZUR by appropriate assays. If the plasma factor VIII level fails to increase as expected, or if bleeding is not controlled after OBIZUR administration, suspect the presence of an anti-porcine factor VIII antibody. If such inhibitory antibodies to anti-porcine factor VIII are suspected and there is a lack of clinical response, consider other therapeutic options. Monitoring Laboratory Tests •Perform one-stage clotting assay to confirm that adequate factor VIII levels have been achieved and maintained -Monitor factor VIII activity 30 minutes and 3 hours after initial dose -Monitor factor VIII activity 30 minutes after subsequent doses •Monitor the development of inhibitory antibodies to OBIZUR. Perform a Nijmegen Bethesda inhibitor assay if expected plasma factor VIII activity levels are not attained or if bleeding is not controlled with the expected dose of OBIZUR. Use Bethesda Units (BU) to report inhibitor levels ADVERSE REACTIONS Common adverse reactions observed in greater than 5% of subjects in the clinical trial were development of inhibitors to porcine factor VIII. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a69ccbb3-7648-4978-8c6d-7ca6b95a9b01