FDA已批准Gammagard liquid10%[免疫球蛋白注射液（人用）]通过皮下途径给药。之前Gammagard liquid已获准通过静脉途径给药。Gammagard liquid皮下用药途径通过审批将允许患者每周在家自行用药。Gammagard liquid适合作为成人和年龄32岁儿童原发性体液免疫缺陷患者的替代治疗。Gammagard liquid有5种剂量规格，不添加糖、钠盐和防腐剂。 GAMMAGARD LIQUID（免疫球蛋白输液（人）10％[Immune Globulin Infusion (Human)]） 最初美国批准：2005 百特医疗用品公司 适应症 GAMMAGARD液是静脉注射免疫球蛋白（人类），10％的液体治疗原发性免疫缺陷（PI）的表示。 剂量和用法 仅静脉使用 初始剂量输注率增加滴注速度 300至600毫克/千克 每3至4周0.5毫升/公斤/小时 （0.8毫克/公斤/分钟） 每隔30分钟（如果容忍）到5.0毫升/公斤/小时（8毫克/公斤/分钟）的最高税率 根据临床反应调整剂量。 为每一个病人的个性化率。 建议患者治疗开始GAMMAGARD液体或从另一个IGIV产品切换在低利率开始，然后推进到最大速率 确保与预先存在肾功能不全的病人是没有体积亏损;停止GAMMAGARD液体，如果肾功能恶化。 对于患者的肾功能不全或血栓事件的风险，管理GAMMAGARD液体，在切实可行的最低输液速度。 剂型和优势 GAMMAGARD液体是一种溶液，含有IgG的10％（100毫克/毫升）。 禁忌 过敏史或严重的全身性反应，免疫球蛋白（人类）。 免疫球蛋白A缺乏对IgA的抗体和过敏史的患者。 注意事项： IgA抗体的免疫球蛋白A缺乏患者发展严重过敏和过敏性反应的风险更大。 监测肾功能，包括尿素氮，血肌酐，尿量发展急性肾功能衰竭的风险患者。 在接受GAMMAGARD液体疗法的患者可能发生hyperproteinemia，增加的血清viscosityosmolarity和低钠血症。 可能发生血栓事件。监测患者血栓事件的已知的危险因素;考虑基线血液粘度在为高粘风险的评估。 无菌性脑膜炎综合征（AMS），已在接受GAMMAGARD液体疗法的患者。 溶血性贫血，可以发展后续到GAMMAGARD液体疗法。监测患者的临床症状和溶血和溶血性贫血症状。 监测患者肺部不良反应（输血相关的急性肺损伤，急性肺损伤）。 GAMMAGARD液体是从人血浆中可能含有传染性病原体，如病毒，并从理论上说，克雅氏病（CJD）。 不良反应 ≥5％的受试者在临床试验中观察到的最常见的不良反应是头痛，发烧，疲劳，寒战，恶心，寒战，头晕，呕吐，偏头痛，下肢，荨麻疹和咳嗽疼痛。 在临床试验中发生严重不良反应，无菌性脑膜炎的发作，在一个单一的病人。 药物相互作用 被动转移抗体可能瞬时干扰的免疫反应活病毒疫苗，如麻疹，腮腺炎和风疹。 在特殊人群中使用 怀孕：没有人或动物的数据。如果明确表示只使用。 老年人：在65岁以上的患者或在任何病人在发展中国家肾功能不全的风险，不超过推荐剂量，并注入GAMMAGARD液体在最低输液速度切实可行。 日期：12/2010 GAMMAGARD LIQUID - human immunoglobulin g injection, solution  Baxter Healthcare Corporation GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] 10% GAMMAGARD LIQUID is indicated as a maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN). Detailed Important Risk Information for Healthcare Professionals WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE •Thrombosis may occur with immune globulin products, including GAMMAGARD LIQUID. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. •Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients with immune globulin intravenous (IGIV) products including GAMMAGARD LIQUID. Renal dysfunction and acute failure occur more commonly with IGIV products containing sucrose. GAMMAGARD LIQUID does not contain sucrose. •For patients at risk of thrombosis, administer GAMMAGARD LIQUID at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity. CONTRAINDICATIONS •GAMMAGARD LIQUID is contraindicated in patients who have a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of human immune globulin. GAMMAGARD LIQUID is contraindicated in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity. WARNINGS and PRECAUTIONS •HYPERSENSITIVITY: IgA deficient patients with antibodies to IgA are at greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. In case of hypersensitivity, discontinue GAMMAGARD LIQUID infusion immediately and institute appropriate treatment. •RENAL DYSFUNCTION/FAILURE: Monitor renal function, including blood urea nitrogen, serum creatinine, and urine output in patients at risk of acute renal failure. Ensure that patients with pre-existing renal insufficiency are not volume depleted. For patients at risk for renal dysfunction or thrombotic events, administer GAMMAGARD LIQUID at the minimum infusion rate practicable. •Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving GAMMAGARD LIQUID. •THROMBOSIS: Thrombosis may occur following treatment with immune globulin products, including GAMMAGARD LIQUID. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. •Aseptic Meningitis Syndrome (AMS) may occur with IGIV treatment, and has been reported with intravenous (IV) use of GAMMAGARD LIQUID. AMS may occur more frequently with high dose (2 g/kg) IGIV treatment and/or rapid infusion of IGIV. •Hemolytic anemia can develop subsequent to GAMMAGARD LIQUID treatment due to enhanced RBC sequestration. Risk factors may include: high doses (e.g., ≥2 g/kg cumulative dose), non-O blood group, and underlying inflammation. Monitor patients for clinical signs and symptoms of hemolysis and delayed hemolytic anemia. •Transfusion-Related Acute Lung Injury (TRALI): Non-cardiogenic pulmonary edema has been reported in patients following treatment with IGIV products, including GAMMAGARD LIQUID. Monitor patients for pulmonary adverse reactions. •GAMMAGARD LIQUID is made from human blood. It may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease agent. No confirmed cases of viral transmission or vCJD have been associated with GAMMAGARD LIQUID. •Passive transfer of antibodies may transiently impair the immune responses to live attenuated virus vaccines such as mumps, rubella, varicella, and measles. This passive transfer may also yield false positive serological testing results, with the potential for misleading interpretation. ADVERSE REACTIONS The serious adverse reactions in the MMN (IV administration) clinical trial were pulmonary embolism and blurred vision. The most common adverse reactions observed in ≥ 5% of patients in the clinical trials were: MMN (IV administration): Headache, chest discomfort, muscle spasms, muscular weakness, nausea, oropharyngeal pain, and pain in extremity. Please see the accompanying full Prescribing Information, including Boxed Warning. To report suspected adverse reactions, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=26352 FDA批准免疫球蛋白Gammagard liquid经皮下给药 2011年7月25日宣布，美国食品药品管理局(FDA)已批准Gammagard liquid 10%[免疫球蛋白注射液(人用)]通过皮下途径给药。之前Gammagard liquid已获准通过静脉途径给药。Gammagard liquid皮下用药途径通过审批将允许患者每周在家自行用药。 Gammagard liquid适合作为成人和年龄³2岁儿童原发性体液免疫缺陷患者的替代治疗，包括常见的免疫缺陷疾病、X连锁无丙种球蛋白血症、先天性无丙种球蛋白血症、Wiskott-Aldrich综合征和严重的联合免疫缺陷疾病，但不仅限于上述疾病。 Gammagard liquid有5种剂量规格，不添加糖、钠盐和防腐剂。该产品是利用人血浆制成的，应用过程中有携带感染性致病原的可能[例如病毒、克雅氏病(vCJD)病原体，理论上也可传播典型克雅二氏症病原体]，另外也有携带未知或新发现病毒及其他病原体的风险。尚无与Gammagard liquid使用相关的病毒性疾病或vCJD传播的病例报告。该产品是使用一项专门的3步病毒灭活/清除加工工艺生产的。 Gammagard liquid含有具有溶血素作用的血型抗体，可在体内诱发免疫球蛋白包裹红细胞(RBC)现象。已有急性血管内溶血的病例报告，由于对RBC的隔离作用增强，也可能发生迟发性溶血性贫血。 在有发病倾向患者中应用免疫球蛋白静脉用产品可能发生肾功能障碍、急性肾衰竭、渗透性肾病和死亡。有发生肾功能障碍倾向的患者包括已有任何程度肾功能不全、糖尿病、年龄超过65岁、体液容量减少、脓毒血症、副蛋白血症或接受已知有肾毒性药物治疗的患者。 已有与静脉内应用Gammagard liquid相关的血栓性事件报告，包括心肌梗死、脑血管意外、深静脉血栓形成和肺栓塞，也有与皮下应用免疫球蛋白相关的血栓性事件报告。有血栓性事件发病风险的患者包括有动脉粥样硬化病史、多种心血管危险因素、高龄、心输出量减少、凝血功能异常、长期制动、肥胖、糖尿病、获得性或遗传性血栓倾向、血管疾病病史或既往有血栓形成或血栓栓塞性事件病史的患者。 在临床试验中未见使用Gammagard liquid皮下治疗出现严重的不良反应。皮下治疗期间最常见的不良反应(发生率>5%)为注射部位局部反应。最常见的全身反应为头痛、发热、疲倦、心率加快、收缩压增高和上腹部疼痛。