英文药名：CRESEMBA capsule injection(isavuconazonium) 中文药名：艾沙康唑注射液，艾沙康唑胶囊 生产厂家：安斯泰（Astellas） 药品简介 CRESEMBA(ISAVUCONAZONIUM SULFATE)POWDER IV(INFUSION)/CAPSULE ORAL 近日，美国FDA批准Cresemba(Isavuconazonium sulfate)胶囊和注射剂上市的新型抗菌药物产品，用于治疗侵袭性曲霉菌病及侵袭性毛霉菌病成人患者，这些是罕见但严重的感染疾病。 CRESEMBA(艾沙康唑硫酸酯[isavuconazonium sulfate])胶囊为口服给药 CRESEMBA(艾沙康唑硫酸酯[isavuconazonium sulfate])注射用为静脉给药 美国首次批准：2015年 作用机制 艾沙康唑硫酸酯是艾沙康唑，一种唑类抗真菌药的前药[见临床药理学] 适应症和用法 CRESEMBA是一种唑类抗真菌剂，用于治疗： •侵袭性曲菌病。 •侵袭性毛霉菌病。 剂量和给药 •注射用CRESEMBA必须通过在线过滤器进行至少1小时。 •负荷剂量：每8小时经口服（2粒）或静脉内给药（1个重构的小瓶），每隔6个剂量（48小时）给予372mg硫酸异恶唑硫酮（相当于200mg的伊沙康唑）。 •维持剂量：在最后一次负荷剂量后12至24小时开始，通过口服（2粒）或静脉内给予（1个重建的小瓶）每日一次，给予372mg硫酸异叶叉硫铵（相当于200mg的伊沙康唑）。 •胶囊可以带或不带食物。 剂量形式和强度 •CRESEMBA胶囊含有186mg硫酸伊伐单抗（相当于100mg的伊伐康唑）。 •用于注射的CRESEMBA作为含有372mg硫酸伊伐单抗（相当于200mg的伊沙康唑）的无菌冻干粉末在单剂量小瓶中提供。 禁忌症 •对CRESEMBA的超敏反应。 •与强CYP3A4抑制剂（如酮康唑或高剂量利托那韦）联合给药。 •与强CYP3A4诱导剂，如利福平，卡马西平，圣约翰草或长效巴比妥类药物的联合给药。 •用于家族性短QT综合征患者。 警告和注意事项 •肝脏不良反应：已报道严重的肝脏反应。在CRESEMBA治疗开始和过程中评估肝脏相关实验室检查。 •在静脉内施用CRESEMBA期间报道了输液相关反应。如果发生这些反应，则停止输注。 •超敏反应：在用其它唑类抗真菌剂治疗期间，已经报道了严重的超敏反应和严重的皮肤反应，例如过敏反应或史蒂文斯约翰逊综合征。停止CRESEMBA用于剥脱性皮肤反应。 •胚胎-胎儿毒性：不要对孕妇使用，除非对母亲的好处超过胎儿的风险。告知孕妇的危险。 •药物相互作用：审查患者的伴随药物。几种药物可以显着改变伊沙康唑浓度。伊沙康唑可以改变几种药物的浓度。 •药物颗粒：静脉制剂可能在重建后形成不溶性颗粒。通过在线过滤器管理CRESEMBA。 不良反应 最常见的不良反应：恶心，呕吐，腹泻，头痛，肝化学试验升高，低钾血，便秘，呼吸困难，咳嗽，外周水肿和背痛。 药物相互作用 •CYP3A4抑制剂或诱导剂可能改变伊伐单唑的血浆浓度。 •当与CRESEMBA共同给药时，免疫抑制剂（即他克莫司，西罗莫司和环孢霉素）的适当的治疗药物监测和剂量调整可能是必要的 •具有狭窄的治疗窗口的药物是P-gp底物，例如地高辛，当与CRESEMBA同时施用时可能需要剂量调整。 在特定人群中使用 •怀孕：CRESEMBA只应用于对母亲的益处超过胎儿的风险。通知孕妇有风险。 •母亲在服用CRESEMBA时不应母乳喂养儿童。 •只有当获益超过风险时，才可用于重度肝损伤患者;建议对CRESEMBA相关不良反应进行临床监测。 包装规格 口服胶囊 CRESEMBA BP CAP 186MG 14  ISAVUCONAZONIUM SULFATE   00469-0320-14 CRESEMBA CAP 186MG BP 14  ISAVUCONAZONIUM SULFATE   00469-0520-14 注射（无菌冻干粉） CRESEMBA 372MG LYO PWD SDV PF 1/EA  ISAVUCONAZONIUM SULFATE     00469-0420-99 CRESEMBA SUV 372MG 1  ISAVUCONAZONIUM SULFATE    00469-0420-99  贮存和处置 CRESEMBA胶囊防潮保护贮存在原始包装在20°C至25°C(68°F至77°F)。外出允许从15°C至30°C(59°F至86°F)[见USP控制室温]。 完整资料附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f7f73b8-586a-4df0-935f-fecd4696c16c A new drug, recently approved by the U.S. Food and Drug Administration may be a literal lifesaver for people living with HIV who are fighting invasive (and too often fatal) fungal infections. The FDA has approved Astellas’ new drug Cresemba, an isavuconazonium sulfate medication that treats two life-threatening fungal infections that predominantly attack immunocompromised patients, including those with HIV. Cresemba has been approved to treat both invasive aspergillosis and invasive mucormycosis (also known as zygomycosis), two invasive fungal infections (IFIs) associated with high morbidity and mortality rates. IFIs are debilitating and life-threatening infections that attack organs and other internal tissues and can spread rapidly through the bloodstream. Fungi commonly involved in IFIs include yeasts such as Candida and the molds mentioned above (Aspergillus and Mucorales). The approval of Cresemba marks the unveiling of an important new treatment for patients with these fungal infections that too frequently turn deadly. Health experts say it is a significant addition to the relatively slim treatment options currently available. “We’re pleased with the FDA’s approval of Cresemba for use in treating patients with these life-threatening infections,” said Dr. Bernie Zeiher, the executive vice president of Astella’s global development who also heads their infectious disease department. “We are proud to be able to offer a new treatment for patients in an area for which there is a significant unmet medical need.” Thomas F. Patterson, the division of infectious diseases chief at The University of Texas Health Science Center at San Antonio, said, “Cresemba is an important new therapy for physicians treating patients with invasive aspergillosis and invasive mucormycosis fungal infections. Patterson, who has been involved in the clinical trials since they began, added that it was “extremely gratifying” to give doctors and patients new treatment options in their fight against these potentially deadly infections. The safety and efficacy of Cresemba has been demonstrated in two Phase 3 clinical trials in adult patients with invasive fungal infections. The first (Secure) study was a randomized, double-blind, active-control study of 516 adult patients with invasive aspergillosis; the second (Vital) study an open-label non-comparative study of Cresemba in adult patients with invasive aspergillosis and renal impairment or in patients with invasive fungal disease caused by other rare fungi. The Secure study examined the mortality (due from all causes) of patients during 42-days of treatment and found that patients on Cresemba had nearly 2 percent greater chance of survival than those being treated with voriconazole (a triazole antifungal medication previously approved to treat serious, invasive fungal infections). The vital study, focused on a subpopulation of 37 patients with invasive mucormycosis treated with Cresemba. While 38 percent of the patients on Cresemba passed away, there was a 62 percent survival rate. Unfortunately, this is what passes for good news in a field when some studies show typical mortality rates frequently climb as high as 61 percent. As for side effects, Cresemba demonstrated “similar rates” of non-fatal adverse events as those associated with voriconazole. The most frequent side effects were: nausea (26 percent), vomiting (25 percent), diarrhea (22 percent), headache (17 percent), elevated liver chemistry tests (17 percent), hypokalemia (14 percent), constipation (13 percent), dyspnea (12 percent), cough (12 percent), peripheral edema (11 percent), and back pain (10 percent). Cresemba will be available in capsule form and intravenous injections. HIV positive patients should be aware that coadministration of Cresemba and high-dose ritonavir (400 mg every 12 hours) is not recommended. This means those taking the protease inhibitor, Norvir (aka ritonavir, generally prescribed at 600 mg twice daily to prevent the replication of HIV), should not take Cresemba. Likewise, those taking the the anti-seizure medicine carbamazepine, the the tuberculosis drug rifampin, or other strong CYP3A4 inducers like St. John’s Wort, or long acting barbiturates, should avoid Cresemba. Cases of severe hepatic adverse drug reactions including hepatitis, cholestasis, or hepatic failure including death have been reported in patients with serious underlying medical conditions (like HIV) during treatment with azole antifungal agents, including Cresemba. Liver function should be evaluated by a physician before and during Cresemba treatment. It should not be used during pregnancy or by those who experience severe skin reactions and it is also contraindicated in persons with known hypersensitivity to isavuconazole. For those HIV patients who are also facing debilitating and even fatal cases of fungal infections, Cresemba may literally be a lifesaver. 新型抗菌药物Cresemba(Isavuconazonium sulfate)是第6款的合格抗感染产品获得美国FDA批准 美国FDA于3月6日批准Cresemba(Isavuconazonium sulfate)，这是一款新型抗菌药物产品，用于治疗侵袭性曲霉菌病及侵袭性毛霉菌病成人患者，这些是罕见但严重的感染疾病。曲霉菌病是一种由曲霉属真菌引起的一种真菌感染，毛霉菌病由毛霉菌属真菌引起。这些感染通常发生在免疫系统虚弱的患者身上。 Cresemba属于唑类抗真菌药物，这类药物以真菌细胞壁为靶点。这款药物以口服及注射剂供人们使用。“今天的批准为严重真菌感染患者提供了一种新的治疗选择，凸出了拥有可供使用的安全及有效抗真菌药物的重要性，”FDA药物评价与研究中心抗菌产品办公室主任、医学博士、公共卫生学硕士Cox称。 Cresemba是第6款以合格感染疾病产品(QIDP)资格获得批准的抗菌或抗真菌药物产品。根据FDA安全及创新法案的抗生素激励计划(GAIN)，这一资格授予治疗严重或危及生命感染的抗菌药或抗真菌药。 作为QIDP资格的一部分，Cresemba被授予优先审评，优先审评可以为药物的申请提供一个加快的审评。QIDP资格还使Cresemba有资格获得额外5年的市场专营权，可以添加到食品、药品及化妆品法案已经批准的某些专营权期限中。由于这些类型的真菌感染是罕见的，所以FDA还授予Cresemba治疗侵袭性曲霉菌病及侵袭性毛霉菌病孤儿药资格。 Cresemba获批治疗侵袭性曲霉菌病基于一项由516名受试者参与的临床试验，试验中受试者被随机配给Cresemba或伏立康唑，后者是另一款获批治疗侵袭性曲霉菌病的药物。Cresemba获批治疗侵袭性毛霉菌病基于一项单组临床试验，该试验将37名以Cresemba治疗的受试者与不经治疗毛霉菌病相关自然疾病级数进行了对比。两项研究显示，Cresemba在治疗这些严重真菌感染时安全、有效。 与Cresemba相关的最常见副作用有恶心、呕吐、腹泻、头痛、异常肝脏血液检测、血钾含量降低 (低血钾)、便秘、呼吸急促（呼吸困难）、咳嗽和组织肿胀 (外围水肿)。Cresemba还可能引起严重的副作用，包括肝脏问题、输注反应与严重过敏及皮肤反应。 Cresemba 由位于伊利诺斯州诺斯布鲁克的Astellas制药美国公司上市销售。