HIZENTRA
Manufacturer:
CSL Behring, LLC
Pharmacological Class:
Immune globulin subcutaneous (human) (IGSC)
Active Ingredient(s):
Immune serum globulin (human) 0.2g/mL (20%); liq for slow SC infusion; contains L-proline, polysorbate-80; preservative-free.
Indication(s):
Primary immunodeficiency, as replacement therapy.
Pharmacology:
Hizentra is an immune globulin (IgG) that is given by subcutaneous (SC) infusion only. It is prepared from pooled human plasma using a process that retains the Fc and Fab functions of the IgG molecule, and it undergoes screening, testing, and manufacturing steps to reduce the risk of viral transmission.
Hizentra provides opsonizing and neutralizing IgG antibodies against a wide variety of bacterial and viral agents. It is indicated as replacement therapy for primary humoral immunodeficiency, including congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
Compared to gamma globulin that is administered by IV infusion (IVIG), this product, given as weekly SC infusions, results in relatively stable (lower peak and higher trough) steady-state serum IgG levels.
Clinical Trials:
A prospective, open-label, multicenter, single-arm clinical study was conducted to assess the efficacy, tolerability, and safety of this product in both adult and pediatric patients with primary humoral immunodeficiency. Subjects who had previously received monthly treatment with IVIG were switched to weekly subcutaneous infusions with Hizentra for 15 months (a 12-month efficacy period after a 3-month wash-in/out period). The annual rate of serious bacterial infections (bacterial pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, visceral abscess) was evaluated. In the mean intent-to-treat population of 38 subjects, the annual rate of serious bacterial infections was 0, and the annual rate of any infection was 2.76 infections/subject year. Twenty-seven subjects (71.1%) used prophylactic antibiotics, with an annual rate of 48.5 days/subject year. Also, the use of antibiotics and the days out of work/school, and hospitalizations due to infections were examined. Of 12,605 subject days, 71 days were missed from school or work, with an annual rate of 2.06 days/subject year. The number of days of hospitalization for infections was 7, with an annual rate of 0.2 days/subject year.
Legal Classification:
Rx
Contraindication(s):
IgA-deficiency with IgA antibodies and history of hypersensitivity. Hyperprolinemia. Previous severe reaction to human immune globulin.
Adults & Children:
See literature. Give once weekly by slow (over approx. 1 hour) subcutaneous infusion using infusion pump into abdomen, thigh, upper arm, or lateral hip areas; may use up to 4 sites simultaneously. Start treatment 1 week after last IgG (IGIV) infusion. Obtain serum IgG trough level. Initial dose: (1.53 x previous IVIG dose [in grams])/number of weeks between IGIV doses; max volume of 15mL/site for first dose; may increase to 20–25mL/site for subsequent infusions; max flow rate of 15mL/hour per site for first dose; may increase to 25mL/hour per site for subsequent infusions; max 50mL/hour for all sites combined; reduce infusion rate in renal dysfunction or thrombosis risk. Adjust subsequent doses based on serum IgG trough levels after 2–3 months (see dosing chart in literature) and clinical response. Ensure adequate dose (≥200mg/kg) if exposed to measles.
Warnings/Precautions:
Correct volume depletion, check renal function before and during therapy; discontinue if renal function deteriorates. Diabetes mellitus, overweight, hypovolemia: increased risk of renal dysfunction. Hypertriglyceridemia, advanced age, impaired cardiac output, hypercoagulation, prolonged immobilization, hyperviscosity, monoclonal gammopathies: increased risk of thrombotic events. Monitor for aseptic meningitis, hemolysis, delayed hemolytic anemia, transfusion-related acute lung injury (eg, pulmonary edema, dyspnea, hypoxemia). Antibody formation. Risk of transmission of blood-borne diseases. Elderly. Pregnancy (Cat.C). Nursing mothers.
Interaction(s):
Concomitant nephrotoxic drugs: increased risk of renal toxicity. May affect response to live virus vaccinations. May interfere with serological test interpretation.
Adverse Reaction(s):
Local reactions (eg, swelling, redness, heat, pain, itching), headache, vomiting, pain, fatigue, cough, nausea, rash.
How Supplied:
Single-use vial (5mL, 10mL, 20mL)—1
注射用免疫球蛋白（Hizentra）
制造商：
杰特贝林有限责任公司
药理分类：
皮下免疫球蛋白（人类）（IGSC）
活性成分（补）：
血清免疫球蛋白（人类）0.2g/mL（20％），缓慢注入Liq的资深大律师;包含L -脯氨酸，聚山梨酯- 80;不含防腐剂。
指示（补）：
原发性免疫缺陷，作为替代疗法。
药理作用：
Hizentra是一种免疫球蛋白（IgG抗体），由皮下（SC）的只给输液。它准备从人血浆汇集，保留使用过程中的抗体分子的Fc和Fab功能，它经历了筛选，测试，生产步骤，以减少病毒传播的危险。
Hizentra提供opsonizing和中针对细菌和病毒制剂品种繁多IgG抗体。它表示为替代治疗原发性体液免疫缺陷，包括先天性agammaglobulinemia，共同变量免疫缺陷，X -连锁agammaglobulinemia，Wiskott - Aldrich综合征，重症联合免疫缺陷和。
相较于丙种球蛋白，是由静脉注射（免疫球蛋白），此产品为每周注射资深大律师，在相对稳定的（较低的峰值和高槽）稳态血清IgG水平的结果给出了管理。
临床试验：
一项前瞻性，开放标签，多中心，单臂临床研究进行评估的疗效，耐受性，而本在成人和小儿原发性免疫缺陷患者的体液产品的安全性。谁曾收到每月的治疗与免疫球蛋白受试者被切换到与15个月Hizentra（后3个月wash-in/out期12个月的有效期），每周皮下输注。严重（细菌性肺炎，菌血症/败血症，骨髓炎/化脓性关节炎，细菌性脑膜炎，内脏脓肿）细菌感染年率进行了评价。在平均意向性治疗共38人，人口，严重细菌感染的年增长率为0，而任何感染年利率为2.76感染/主题年。二十七个科目（71.1％）使用预防性抗生素，具有48.5天/主题年的年增长率。此外，抗生素的使用和失去工作/上学，因为感染住院的日子进行了审查。主题的12605天，71天是错过了上学或上班，与2.06天/主题年的年增长率。对住院天数为7的感染，为0.2天/主题年的年增长率。
法律分类：
接收
禁忌（补）：
免疫球蛋白A缺乏症的免疫球蛋白A抗体和过敏史。 Hyperprolinemia。上一个严重的反应，人体免疫球蛋白。
成人和儿童：
见文献。每周一次给缓慢（超过约1小时。）注射到皮下输液用腹部，大腿，上臂，臀部或横向领域泵;最多可以使用4个位点同时进行。开始治疗后1周的最后抗体（IGIV）输液。获取血清IgG水平槽。初始剂量：（1.53 x以前球蛋白[克]剂量）/周数在IGIV剂量，最大剂量为第一15mL/site货量可能会增加到20-25mL/site其后注射，最大流量的15毫升/每首剂站点小时;可能会增加到每个站点25mL/hour随后注入，最大50mL/hour不论部位，减少血栓形成，肾功能不全或风险输注速率。调整对血清免疫球蛋白水平为基础槽后2-3个月以后的剂量（见文献计量表）和临床反应。确保有足够的剂量（≥200mg/kg）如果暴露于麻疹。
警告/注意事项：
正确的容量减少，并在治疗前检查肾功能，肾功能恶化，如果停止。糖尿病，肥胖，低血容量：肾功能不全的风险增加。高甘油三酯血症，高龄，受损的心输出量，高凝，长期固定化，高粘血症，单克隆gammopathies：血栓事件的风险增加。监控无菌性脑膜炎，溶血，延迟溶血性贫血，输血相关急性肺损伤（例如，肺水肿，呼吸困难，低氧血症）。抗体的形成。风险血源性疾病的传播。老人。妊娠（Cat.C）。哺乳的母亲。
互动（补）：
伴随肾毒性药物：肾毒性的风险增加。可能会影响到活病毒疫苗的反应。可能会干扰血清学检测的解释。
不良反应（补）：
局部反应（如肿胀，发红，热，痛，痒），头痛，呕吐，疼痛，乏力，咳嗽，恶心，皮疹。
如何提供：
单用小瓶（5毫升，10毫升，加入20mL）-1
最后更新：
2010年4月22日