产地国家：美国 处 方 药：是 所属类别：600毫克/6毫升(100毫克/毫升)/瓶 包装规格：600毫克/6毫升(100毫克/毫升)/瓶 计价单位：瓶 生产厂家中文参考译名：Elusys Therapeutics，Inc 生产厂家英文名：Elusys Therapeutics，Inc 原产地英文商品名：Anthim 600mg/6mL(100mg/mL)vial 原产地英文药品名：obiltoxaximab 中文参考商品译名：Anthim注射液 600毫克/6毫升(100毫克/毫升)/瓶 中文参考药品译名：obiltoxaximab

简介

近日，FDA批准了一款新的吸入性炭疽治疗药物Anthim(obiltoxaximab)，这是一种单克隆抗体，旨在中和炭疽杆菌(anthrax)产生的毒素。Anthim由Elusys Therapeutics公司开发，通过FDA的动物法则(Animal Rule)获批用于吸入性炭疽的治疗及预防性治疗。 批准日期：2016年3月18日;公司：Elusys Therapeutics，Inc. 最初美国批准：2016年 警告 过敏症和过敏反应请参阅完整的黑框警告的完整处方信息。超敏反应，包括过敏性反应，已ANTHIM输注期间报告。NTHIM应监控设置由经过培训的人员进行管理，并配备管理过敏反应。立即停止输液ANTHIM和适当的治疗，如果过敏或发生过敏反应。 作用机理：Obiltoxaximab是结合炭疽杆菌的PA的单克隆抗体[见微生物学]。 适应症和用法：ANTHIM®是针对炭疽杆菌的保护性抗原的单克隆抗体。它在成人和儿童患者治疗吸入性炭疽的表示，由于炭疽杆菌与适当的抗菌药物的组合，并为吸入性炭疽预防时替代疗法不具备或不恰当。 使用限制 ANTHIM应该只用于预防时，其为预防吸入性炭疽的胜过过敏和过敏性反应的风险益处。 ANTHIM的有效性，在吸入性炭疽的动物模型的疗效研究完全基于。 目前还没有ANTHIM的儿科人群的安全性或药代动力学(PK)的研究。在儿科患者给药是使用群体PK方法的。 ANTHIM没有直接的抗菌活性。 ANTHIM应与适当的抗菌药物组合使用。 ANTHIM预计不会穿过血 - 脑屏障，并且不预防或治疗脑膜炎。 用法用量 前用药与苯海拉明。 推荐ANTHIM的用量： 成年患者：16毫克/公斤。 儿童患者： ➢大于40公斤：16毫克/公斤 ➢大于15公斤至40公斤：24毫克/千克 ➢小于或等于15千克32毫克/千克 稀释注射在0.9%氯化钠注射液，USP，作为静脉(IV)输注用1小时30分钟施用之前。在具备管理一个过敏反应监控设置管理ANTHIM。请参阅完整的处方信息对ANTHIM注射制剂，稀释和行政指令。 剂型和规格 注射：600毫克/6毫升在单剂量小瓶(100毫克/毫升)溶液中。 禁忌症 无 警告和注意事项：超敏反应，包括过敏性反应(黑框警告) 不良反应：在健康成年受试者(≥1.5%)，最常见的不良反应为头痛，皮肤瘙痒，上呼吸道，咳嗽，血管穿刺部位挫伤，注射部位肿胀，鼻塞，输液部位疼痛，荨麻疹和疼痛下肢感染。 特殊人群中使用 儿童用药：目前还没有ANTHIM的儿科人群的安全还是PK的研究。 包装规格/储存与处理 ANTHEM注射液是一种无菌，无防腐剂，清晰乳白色，无色至淡黄色至淡可能含有含有600毫克/6毫升单剂量小瓶一些半透明到白色蛋白质颗粒呈棕黄色溶液(100毫克/毫升)和可用以下封装配置： 纸箱：包含一(1)ANTHIM600毫克/6毫升(NDC69604-204-02)的单剂量小瓶。 在冰箱中保存在2℃到原包装箱8°C(36°F至46°F)，以避光。不冻结。不要摇晃。

英文版说明书

INDICATIONS AND USAGE AND IMPORTANT SAFETY INFORMATION INDICATIONS AND USAGE ANTHIM® (obiltoxaximab) is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs. ANTHIM is indicated for prophylaxis of inhalational anthrax due to B. anthracis when alternative therapies are not available or are not appropriate. LIMITATIONS OF USE •ANTHIM should only be used for prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of serious hypersensitivity reactions and anaphylaxis. •The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax. It is not ethical or feasible to conduct controlled clinical trials with intentional exposure of humans to anthrax. •Safety and PK of ANTHIM have been studied in adult healthy volunteers. There have been no studies of safety or PK of ANTHIM in the pediatric population. A population PK approach was used to derive intravenous infusion dosing regimens that are predicted to provide pediatric patients with exposure comparable to the observed exposure in adults. •ANTHIM binds to the protective antigen (PA) component of B. anthracis toxin; it does not have direct antibacterial activity. ANTHIM is not expected to cross the blood-brain barrier and does not prevent or treat meningitis. ANTHIM should be used in combination with appropriate antibacterial drugs. IMPORTANT SAFETY INFORMATION WARNING: HYPERSENSITIVITY and ANAPHYLAXIS Hypersensitivity and anaphylaxis have been reported during the intravenous infusion of ANTHIM. Due to the risk of hypersensitivity and anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Monitor individuals who receive ANTHIM closely for signs and symptoms of hypersensitivity reactions throughout the infusion and for a period of time after administration. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs. WARNINGS AND PRECAUTIONS Hypersensitivity reactions were the most common adverse reactions in the safety trials of ANTHIM, occurring in 34/320 healthy subjects (10.6%). Three (0.9%) cases of anaphylaxis occurred during or immediately after the infusion. In clinical trials, manifestations of anaphylaxis were rash/urticaria, cough, dyspnea, cyanosis, postural dizziness and chest discomfort. ANTHIM infusion was discontinued in 8 (2.5%) subjects due to hypersensitivity or anaphylaxis. The adverse reactions reported in these 8 subjects included urticaria, rash, cough, pruritus, dizziness, throat irritation, dysphonia, dyspnea and chest discomfort. The remaining subjects with hypersensitivity had predominantly skin-related symptoms such as pruritus and rash, and 6 subjects reported cough. Premedication with diphenhydramine is recommended prior to administration of ANTHIM. Diphenhydramine premedication does not prevent anaphylaxis, and may mask or delay onset of symptoms of hypersensitivity. ADVERSE REACTIONS The safety of ANTHIM has been studied only in healthy volunteers. It has not been studied in patients with inhalational anthrax. The most frequently reported adverse reactions (occurred in >1.5% of healthy subjects) were headache, pruritus, infections of the upper respiratory tract, cough, vessel puncture site bruise, infusion site swelling, urticaria, nasal congestion, infusion site pain, and pain in extremity. USE IN SPECIFIC POPULATIONS Pregnancy No adequate and well-controlled studies in pregnant women were conducted. Because animal reproduction studies are not always predictive of human response, ANTHIM should be used during pregnancy only if clearly needed. Pediatric Use There have been no studies of the safety or PK of ANTHIM in the pediatric population.