ADVATE抗血友病因子[重组]是一种全长重组FVIII产品，未添加任何血液添加剂，适用于A型血友病患者出血的治疗和预防，不适用于血管性血友病（vWD）的治疗 批准日期：2003年    公司：百特医疗公司 ADVATE（抗血友病因子[重组]  ANTIHEMOPHILIC FACTOR VIII(RECOMBINANT),PLASMA/ALBUMIN-FREE METHO）冻干粉 为重建静脉注射 最初美国批准：2003 作用机理 ADVATE暂时替代，需要进行有效止血缺少凝血因子VIII。 适应症和用法 ADVATE是在儿童和成人血友病A的使用说明重组抗血友病因子： •控制和预防出血发作。 •围手术期处理。 •常规预防，防止或减少出血事件的频率。 ADVATE没有为血管性血友病的治疗表示。 用法用量 仅适用于重建后静脉注射。 ADVATE的每管含有重组因子的标示量。 第八，在国际单位（IU）。 控制和预防出血事件及围手术期管理。 •剂量（IU）=体重（公斤）×所需的因子VIII上升（IU / dl或正常％）×0.5（IU /公斤IU /分升）。 •基于类型的出血事件的决定治疗次数。 常规预防 •每千克20至40IU隔日（3至4次每周）。 •此外，使用有针对性的维护FVIII谷底水平≥1％，每三天给药方案。 剂型和规格 ADVATE可作为在含有标称250,500，1000，1500，2000，3000或4000 IU单次使用的小瓶冻干粉末。 禁忌症 别在谁具有威胁生命的过敏性反应，包括过敏反应的患者不能使用，鼠标或仓鼠蛋​​白质或产物的其它组分（甘露糖醇，海藻糖，氯化钠，组氨酸，三，氯化钙，聚山梨醇酯80，和/或谷胱甘肽）。 警告和注意事项 •过敏反应包括过敏性休克发生。患者可发展过敏小鼠或仓鼠的蛋白质，这是存在于产物痕量。如果出现症状，中止与ADVATE治疗和管理适当的治疗。 •可能发生的活动中和抗体的开发。如果预期血浆因子VIII活性水平没有达到，或者如果出血不与适当的剂量控制，执行该测量的因子VIII的抑制剂浓度的测定。 不良反应 报道•严重药物不良反应和过敏因子VIII抑制剂。 •的患者大于5％所观察到的最常见的不良反应是发热，头痛，咳嗽，和鼻咽炎，关节痛，呕吐，上呼吸道感染，下肢损伤，鼻塞和腹泻。 特殊人群中使用 •怀孕：没有人或动物的数据。只有在确实需要时使用。 •儿童用药：间隙（基于每kg体重）是在儿科人群。可能需要调整剂量 包装规格/储存与处理 附送 ADVATE在BAXJECT III系统打包在2毫升或5无菌水毫升注射，一是泰尔茂微孔输液器（仅2毫升），一个完整的处方医师插入，1例插入。 ADVATE是在包含下列标称产品优势单剂量小瓶可用（包括2毫升SWFI稀释剂） （包括5毫升SWFI稀释） 250IU   200-400IU每瓶          0944-3051-02 500IU   401-800IU每瓶          0944-3052-02 1000IU  每瓶801-1200IU       0944-3053-02 1500IU  1201年至1800年IU每瓶 0944-3054-02 2000IU  2401至00年IU每瓶     0944-3045-10 3000IU  2401-3600IU每瓶      0944-3046-10 4000IU  3601-4800IU每瓶      0944-3047-10 在国际单位实际因子VIII活动的每个ADVATE住房或纸箱的标签上说明。 不与天然橡胶胶乳制成。 储存和处理 •粉末状冷藏ADVATE在2° - 8°C（36° - 46°F）。 •商店在室温至30℃（86°F），为期6个月不超过有效期限。 •在纸箱上的日期ADVATE从制冷删除记录。 •该产品不能恢复到冷藏温度。 •不要超出打印的标签ADVATE或纸箱上的失效日期使用。 •不要冻结。 ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin] Baxter Announces FDA Approval of ADVATE (Antihemophilic Factor [Recombinant]) with BAXJECT III Reconstitution System U.S. Food and Drug Administration (FDA) has approved a new reconstitution system for ADVATE (Antihemophilic Factor [Recombinant]). ADVATE and the diluent come pre-packaged in the new BAXJECT III reconstitution system. ADVATE has the widest range of dosage formulations, allowing for more precise customized dosing, and with the ADVATE with BAXJECT III reconstitution system, patients can prepare their treatment with fewer steps, said Ludwig Hantson, Ph.D., president of Baxter BioScience. This latest approval reflects Baxter’s ongoing leadership in investing and bringing new and innovative therapies to the market that meet the evolving needs of the hemophilia community. The new reconstitution system was developed to reduce the number of steps in the reconstitution process for hemophilia A patients and caregivers, compared to the previous process with the BAXJECT II needle-less transfer device. The new system will be commercially available with ADVATE in the coming months. Baxter has also filed for approval of ADVATE with BAXJECT III system in Europe and expects to launch in 2015. A human factors study was performed with 44 participants, including patients, caregivers and healthcare providers, to evaluate the usability of ADVATE with BAXJECT III reconstitution system. The BAXJECT III reconstitution system successfully met its performance goals in the study, as it was considered adequately safe and effective for its intended use. About ADVATE ADVATE (Antihemophilic Factor [Recombinant]) is indicated for the control and prevention of bleeding episodes in adults and children (0-16 years) with hemophilia A. ADVATE is also indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children (0-16 years) with hemophilia A. The product is not indicated for the treatment of von Willebrand disease. ADVATE has a demonstrated efficacy and safety profile. ADVATE is a full-length (derived from the complete FVIII gene) recombinant FVIII product that is processed without any blood-based additives. Because no blood-derived components are added at any stage of the manufacturing process, the potential risk of transmitting pathogens that may be carried in blood-based additives is eliminated. There have been no confirmed reports of transmission of HIV, HBV or HCV with rFVIII treatments. ADVATE is approved in 61 countries worldwide including the United States, Canada, 27 countries in the European Union, Argentina, Australia, Brazil, Chile, China, Colombia, Croatia, Ecuador, Hong Kong, Iceland, Iraq, Israel, Japan, Kuwait, Macau, Malaysia, Mexico, New Zealand, Norway, Panama, Puerto Rico, Serbia, Singapore, South Korea, Suriname, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, Uruguay and Venezuela. Detailed Important Risk Information for ADVATE ADVATE is contraindicated in patients with known anaphylaxis to mouse or hamster protein or other constituents of the product. Allergic-type hypersensitivity reactions, including anaphylaxis, are possible and have been reported with ADVATE. Symptoms have manifested as dizziness, paresthesias, rash, flushing, face swelling, urticaria, dyspnea, and pruritus. Discontinue use if hypersensitivity symptoms occur and administer appropriate emergency treatment. Carefully monitor patients treated with AHF products for the development of FVIII inhibitors by appropriate clinical observations and laboratory tests. Inhibitors have been reported following administration of ADVATE predominantly in previously untreated patients (PUPs) and previously minimally treated patients (MTPs). If expected plasma FVIII levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures FVIII inhibitor concentration. The serious adverse reactions seen with ADVATE are hypersensitivity reactions and the development of high-titer inhibitors necessitating alternative treatments to FVIII. The most common adverse reactions observed in clinical trials (frequency greater than or equal to 10 percent of subjects) were pyrexia, headache, cough, nasopharyngitis, vomiting, arthralgia, and limb injury. https://www.advate.com/dosing/making-advate.html https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=80fa03d2-cd4c-4155-9b57-1396c4fa42da